Loading…
Attending this event?
Sunday, June 16
 

9:00am PDT

92F: Toolkit Approach to Best Practices in Root Cause Analysis and CAPA Management Workshop
Component Type: Tutorial
CE: ACPE 7.50 Application UAN: 0286-0000-24-515-L04-P; CME 7.50; RN 7.50

Pre-registration required and is an additional fee.

Already registered? Log in to DIA's My Account/ My Events.

According to the FDA (as well as other regulators), CAPA management and lack of proper investigation of challenges is a top observation among companies in the industry. In this workshop, we will demonstrate by interactive case study sessions how to perform a proper investigation into a robust root cause analysis using industry standard tools, in a toolkit approach. Also, we will explore the challenges of proper CAPA planning and defining appropriate effectiveness checks to ensure these observations do not occur again and how to properly document what was performed. We will use some direct case studies from various FDA 483s to show real-life situations on how to apply our toolkit approach to avoid action by regulators and ensure compliance in your processes and company culture.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals who want a better understanding of how to perform a robust root cause analysis and CAPA plan to shift from a reactive organization to a proactive organization. This workshop is best suited for those in regulated industries in various industry areas such as quality, regulatory, operations/production, laboratories, etc.

Learning Objectives

  • Determine the best approach to train individuals on best industry practices in CAPA management
  • Utilize proven tools, in a toolkit format, to properly investigate observations and formulate robust CAPA plans and Effectiveness Checks to ensure compliance and remediation of observations
  • Analyze case studies for techniques and strategies that will help solidify how to use the different tools and why to use each one



Speakers
avatar for Christy Mazzarisi

Christy Mazzarisi

Quality COE Lead, Network Partners Group, United States
Head of Quality, with a broad background in Pharmaceutical and Laboratory sciences (specializing in business development) with R&D and commercial manufacturing (sterile and non-sterile) experience with over 17 years industry practice. Overall background and specialties include GMP... Read More →
avatar for Danielle Metzger

Danielle Metzger

Consultant, Network Partners Group, United States
Accomplished Quality Professional with a broad background in pharmaceutical life sciences having R&D through commercial experience with 25 years of practice in Quality & Manufacturing, global consulting, and business development. Experienced and well versed in GMP and have working... Read More →
avatar for Renata Skros

Renata Skros

Quality Consultant, Network Partners Group, United States
I have been working in the Pharmaceutical Industry since 2000, with experience ranging in Quality Control Microbiology, Quality Systems, and Regulatory Affairs. I have extensive knowledge of both Commercial (sterile and non-sterile) and Research & Development. I specialize in GLP... Read More →
avatar for Brendan Burns

Brendan Burns

Manager, Document Control & Training, Mersana Therapeutics
Brendan is a Manager, Document Control & Training at Mersana Therapeutics, with over 15 years of biopharma industry experience in development landscapes ranging from preclinical to commercial organizations. Overall background includes roles ranging from manufacturing operator on the... Read More →


Sunday June 16, 2024 9:00am - 5:00pm PDT
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:00am PDT

93F: Leadership Bootcamp
Component Type: Tutorial
CE: ACPE 7.50 Application UAN: 0286-0000-24-516-L04-P; CME 7.50; PDU 7.50 PMI 2166YFM51Z; RN 7.50

Pre-registration required and is an additional fee.

Already registered? Log in to DIA's My Account/ My Events.

Whether you are a manager, a team leader, or simply someone who wants to be more influential in your personal and professional life, this short course will help you develop the skills and knowledge you need to be an effective leader. You will have the opportunity to practice and hone your leadership skills and receive feedback from others. Identify your strengths and weaknesses as a leader and how to leverage them in your everyday life.

This leadership bootcamp will focus on the following key areas and provide hands-on opportunities to apply your leadership skills and practice overcoming common leadership challenges. This workshop will be delivered through a combination of lectures to introduce key concepts and group exercises for role-playing and hands-on practice the key elements of leadership. Participants will have the opportunity to ask questions and learn from an experienced leader, mentor, and coach, and to practice their leadership skills in a safe and supportive environment.

By the end of this bootcamp, participants will have honed their leadership skills and will be able to:
  • Understand the key principles of effective leadership and stakeholder management
  • Build strong team alignment with team members that collaborate well with one another
  • Develop the skills to influence others without requiring formal authority
  • Motivate and inspire others to achieve their goals
  • Communicate clearly and effectively especially when delegating to others
  • Solve problems effectively
  • Manage conflict
  • Practice the art of negotiation
  • Make sound decisions under pressure
  • Lead people through change effectively
  • Adapt their leadership style to the individual situation
  • Be respected as a leader with integrity


Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Who should attend?

Professionals involved in or interested in becoming a more effective leader, regardless of their current position or title.

Learning Objectives

  • Apply the key principles of effective leadership and stakeholder management at all levels in an organization
  • Perform hands-on practice strategies to overcome leadership challenges such as aligning teams on a common vision, dealing with difficult people, prioritizing and managing expectations, developing effective negotiation strategies, making tough decisions, facing change, etc.



  • Speakers
    avatar for Susan Carino

    Susan Carino

    Director, Program Management, Mammoth Biosciences, United States
    Susan Carino is a Director of Program Management with Mammoth Biosciences. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She has led diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →
    avatar for Yoshiko Stowell

    Yoshiko Stowell

    Head of Regulatory Affairs, Neuron23, United States
    Yoshiko Stowell, PhD, PMP is a Head of Regulatory Affairs at Neuron 23. She has over 19 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has experience in all states of development from proof of concepts to global Phase III Clinical... Read More →


    Sunday June 16, 2024 9:00am - 5:00pm PDT
    TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Tutorial |   20: Short Courses, Tutorial

    7:00pm PDT

    DIA Annual Meeting Networking Reception - USS Midway
    Component Type: Social Evt / Reception

    Live the adventure. Honor the legend. Join us in Celebrating DIA’s 60th Anniversary aboard the historical USS Midway — San Diego’s Aircraft Carrier Museum.

    Kick-off DIA 2024 by meeting up with old friends and making new acquaintances as you take in an unparalleled 360-degree view of San Diego’s sparkling skyline and Coronado Bay Bridge.

    The USS Midway - San Diego’s Aircraft Carrier Museum is the longest-serving aircraft carrier in U.S. Navy history and today it is the most visited floating naval ship museum in the world.

    We invite you to join us for what is sure to be a memorable evening where you can inspect the military aircraft on display, take a tour with a docent, or climb onto a flight simulator and feel what it was really like. You can also simply watch the sun go down on Mission Bay while enjoying a beverage (hosted soft drinks, beer, and wine) and a taste of San Diego cuisine from several different food stations.

    Cost is $70

    Pre-registration is required.

    Attendance is limited.

    Add to Cart




    Sunday June 16, 2024 7:00pm - 9:00pm PDT
    USS Midway 910 N Harbor Dr, San Diego, CA 92101
     
    Monday, June 17
     

    7:00am PDT

    Coffee and Light Refreshments
    Component Type: Social Event
    Meet with your colleagues to plan your day and/or discuss what you learned the previous day, all while networking with other attendees.



    Monday June 17, 2024 7:00am - 8:00am PDT
    Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    7:00am PDT

    DIA Annual Meeting Orientation
    Component Type: Session

    First time at the DIA Annual Meeting? We encourage you to attend the Annual Meeting Orientation to learn how to make the most of your time at the meeting and meet fellow first-timers.

    Chair

    Susan Benedetti


    Speakers
    avatar for Susan Benedetti

    Susan Benedetti

    Senior Project Manager, Annual Meeting, DIA, United States


    Monday June 17, 2024 7:00am - 8:00am PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    8:00am PDT

    #100: Opening Plenary and Keynote Address
    Component Type: Forum

    Join our opening plenary session, Innovation: The Possibilities, The Boundaries: Charting New Horizons, led by Tom and Emily Whitehead, who will give the incredible journey of Emily Whitehead, the pioneering pediatric patient who defied the odds and became the first in the world to undergo CAR T-cell therapy. Tom and Emily will share their invaluable insights into the transformative power of CAR-T therapy, offering a unique perspective that promises to captivate and inspire. Dean Kamen will discuss the Future of Regenerative Therapies, How Public-Private Partnerships Can Impact Advancement. Following your keynotes, we will have a panel discussion. Attendees can expect a lively and engaging discussion, with a diverse range of perspectives and insights from panelists who are leaders and at the forefront of our industry; including panelists from the Gates Foundation, regulatory agencies, and the patient perspective.

    Chair

    Marwan Fathallah, MBA, MSc

    Speaker

    Developing Cell Therapies for Cancer Patients
    Carsten Linnermann, PhD

    Keynote Speaker: Insights into the Transformative Power of CAR-T Therapy
    Tom Whitehead

    Keynote Speaker: Insights into the Transformative Power of CAR-T Therapy
    Emily Whitehead

    Keynote Speaker: Future of Regenerative Therapies - How Public-Private Partnerships Can Impact Advancement
    Dean Kamen

    Plenary Panel: Innovation - The Possibilities, the Boundaries - Charting New Horizons
    David Mukanga, PhD, MPH

    Panelist: Innovation
    Dean Kamen

    Panelist: EMA Perspective
    Emer Cooke, MBA, MSc

    Panelist: FDA Perspective
    Peter W. Marks, MD, PhD

    Panelist: Patient Perspective
    Stacy Hurt, MBA, MHA



    Speakers
    avatar for Marwan Fathallah

    Marwan Fathallah

    President & Global Chief Executive, DIA, United States
    Prior to joining DIA in 2023, Fathallah was the Operating Officer and EVP at Ortho Clinical Diagnostics, accountable for Operations, Post Market Product Science and Engineering, Regulatory, Quality, Medical, Clinical, Scientific Affairs, and Process Excellence. Before joining Ortho... Read More →
    avatar for Dean Kamen

    Dean Kamen

    Founder, DEKA Research & Development Corp., United States
    Serial inventor and the founder of the ARMI-Advance Regeneratve Manufacturing Institute
    avatar for Peter Marks

    Peter Marks

    Director, Center for Biologics Evaluation and Research, FDA, United States
    Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
    avatar for Emily Whitehead

    Emily Whitehead

    Co-founder, Emily Whitehead Foundation, United States
    Emily Whitehead was diagnosed with acute lymphoblastic leukemia (ALL) in May 2010 when she was five years old. Typically, children diagnosed with this type of leukemia have an 85% to 90% chance of being cured; however, she relapsed twice. The leukemia became resistant to treatment... Read More →
    avatar for Tom Whitehead

    Tom Whitehead

    Co-founder and President, Emily Whitehead Foundation, United States
    Emily’s parents, Tom and Kari, were not willing to give up. They heard about an experimental treatment, called CAR T-cell therapy, that was available as a Phase I clinical trial at Children’s Hospital of Philadelphia (CHOP). In April 2012, they enrolled Emily in the clinical trial... Read More →
    avatar for Stacy Hurt, MBA, MHA

    Stacy Hurt, MBA, MHA

    Chief Patient Officer, Parexel International, United States
    Stacy Hurt, MHA, MBA is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as... Read More →
    avatar for Emer Cooke

    Emer Cooke

    Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
    Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
    avatar for Carsten Linnermann

    Carsten Linnermann

    Chief Executive Officer, Neogene Therapeutics, AstraZeneca Group, Netherlands
    Co-founder and CEO of Neogene Therapeutics, AstraZeneca Group will speak about his experience in developing cell therapies for cancer patients and the importance of collaboration to transform innovative science into new medicines for patients.


    Monday June 17, 2024 8:00am - 10:00am PDT
    Ballroom San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      00: Plenary, Forum |   09: Regulatory, Forum |   06: TranslationalDelivery Tech-PrecMedicine, Forum

    10:00am PDT

    #SCC: Student Case Competition
    Component Type: Session




    Speakers
    OA

    Olivia Atkins

    MS Biotechnology Student, Georgetown University, United States
    RD

    Rama Doddi

    MS Regulatory Affairs Student, Northeastern University, United States
    VM

    Vandana Mandavilli

    MS Regulatory Affairs Student, Northeastern University, United States
    TS

    Tejendra Sri Ajith Nalluri

    MS Regulatory Affairs Student, Northeastern University, United States
    IN

    Ifeoma Njubigbo

    PharmD Student, University of Illinois Chicago, United States
    KP

    Keerthi Pendri

    MS Regulatory Affairs Student, Northeastern University, United States
    DS

    Deeksha Surisetty

    MS Biotechnology Student, Georgetown University, United States
    BT

    Bintou Timbine

    PharmD Student, University of Illinois Chicago, United States


    Monday June 17, 2024 10:00am - 11:00am PDT
    Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    10:00am PDT

    Coffee Break
    Component Type: Social Event
    Meet with your colleagues to plan your day and/or discuss what you learned the previous day, all while networking with other attendees.



    Monday June 17, 2024 10:00am - 11:00am PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    10:15am PDT

    #101 IT: Taimei Technology Innovation Theater: Next-Gen Trials Platform: AI-Native, Collaboration-First, and Site Network
    Component Type: Session

    AI-Driven Study Building: Experience the revolution in EDC database creation with AI, streamlining study building efficiency. Strategic Orchestration: Explore Trials Brain, a system comprehending project strategies and orchestrating resources for trial management. Collaboration: Explore next-gen trials tech, merging Virtual Site Network (VSN), Remote Monitoring Network (RMN), and Participant Recruitment Network (PRN) for seamless communication, fostering innovation in clinical research.

    Chair

    Taimei Technology, Inc.

    Speaker

    Speaker
    Nate Zhang

    Speaker
    Shou Yuan



    Speakers
    avatar for Nate Zhang

    Nate Zhang

    GM, Taimei Overseas Business Unit, Taimei Technology, United States
    15+ years' experience in enterprise software and healthcare across Asia, North America and Europe Founder of Alibaba Cloud digital health ecosystem and was leading the digital health solutions and Global-ISV solutions of Alibaba Cloud Founder of the Medtronic Digital Health team and... Read More →
    avatar for Shou Yuan

    Shou Yuan

    Directer, Global Solutions, Taimei Technology, United States
    Over 10 years of extensive experience in clinical project and system management Successfully completed 40+ projects in System R&D, DM, and Solution Delivery Specialization in EDC, IWRS, eCOA, CTMS, eTMF, system integration, and migration Proven leadership as a Data Management and... Read More →
    avatar for Shou Yuan

    Shou Yuan

    Product Innovation and Global Operations Representative, Taimei Technology Inc., United States
    Over 10 years of extensive experience in clinical project and system management Successfully completed 40+ projects in System R&D, DM, and Solution Delivery Specialization in EDC, IWRS, eCOA, CTMS, eTMF, system integration, and migration Proven leadership as a Data Management and... Read More →


    Monday June 17, 2024 10:15am - 10:45am PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    10:15am PDT

    #102 IT: Appian Innovation Theater: AI in Life Sciences - Promise or Peril?
    Component Type: Session

    Brace for impact as Evi Cohen and Juan Jiménez of Appian take you on a thrilling journey into the heart of AI-driven automation in life sciences. Will this powerful technology revolutionize the industry or leave us lost in a regulatory maze? Strap in for a thought-provoking exploration of the opportunities, challenges, and everything in between. Don't miss this electrifying discussion on navigating the future of life sciences!

    Chair

    Appian

    Speaker

    Speaker
    Evi Cohen, MBA, MS, MSc

    Speaker
    Juan Jiménez, MBA



    Speakers
    avatar for Appian

    Appian

    United States
    avatar for Evi Cohen

    Evi Cohen

    Industry Leader, Life Sciences, Appian, United States
    Evi is the Life Sciences Industry Leader at Appian. He is an experienced pharmaceutical executive with an extensive background developing global business portfolios with emphasis on new products, technologies, and IP. Previously, as Global Head of Life Sciences at ServiceNow Evi lead... Read More →
    avatar for Juan Jiménez

    Juan Jiménez

    Lead Software Engineer, Product Strategy, Appian, United States
    Juan has been with Appian for four years and currently serves as the Process Automation Technology Lead for Product Strategy. Prior to joining Appian, Juan worked for over 15 years as a consultant and independent contractor, leading customized software development projects for medium... Read More →


    Monday June 17, 2024 10:15am - 10:45am PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    10:15am PDT

    #103 IT: Mendel AI Innovation Theater: RWD 2.0 - Decoding Patient Journeys at Scale through Clinical AI
    Component Type: Session

    Discover how healthcare and life sciences companies are leveraging clinical AI to interpret vast datasets at an unprecedented pace, finding the right trial participants more efficiently than ever. This session will share data demonstrating that industry-specific clinical AI outperforms general domain LLMs and explore the science behind creating true, physician-like intelligence - representing a leap in generative real-world data applications.

    Chair

    Mendel.ai

    Speaker

    Speaker
    Karim Galil, MD



    Speakers
    avatar for Mendel.ai

    Mendel.ai

    United States
    avatar for Karim Galil

    Karim Galil

    CEO and Co-founder, Mendel.ai, United States
    Karim Galil, MD, is co-founder and CEO of Mendel AI. Mendel’s mission is to make medicine objective by enabling the world’s largest index of patient journeys, leveraging AI that understands medicine like a physician. Dr. Galil’s experience as a physician demonstrated that medicine... Read More →


    Monday June 17, 2024 10:15am - 10:45am PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    #104: Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-518-L04-P; CME 1.00; RN 1.00

    Reporting of pre-market and post market safety reports to be submitted in ICH E2B (R3) format to FDA Adverse Event Reporting System (FAERS). The presenters will discuss system readiness, testing approach, challenges, and lesson learned for reporting premarket and post market safety reports, both from FDA’s and industry’s perspective.

    Learning Objectives

    Recognize that FDA will go live with E2B R3 standard early next year and will require reporting of Investigational New Drug (IND) and post market safety reports to be submitted in ICH E2B (R3) format to FAERS via the FDA Gateway or using the Safety Reporting Portal; Describe regional data elements, system readiness, testing approach, challenges and lesson learned that are key for post market, IND and IND-exempt BA/BE safety reporting, both from FDA’s and industry’s perspective.

    Chair

    Suranjan De, MBA, MS

    Speaker

    Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
    Sheila M Estela, BSN, RN

    Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
    Subhan Ahmed Sharief



    Speakers
    avatar for Suranjan De

    Suranjan De

    Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
    Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
    avatar for Sheila M Estela

    Sheila M Estela

    Regional Patient Safety Head US and Canada, Novartis Pharmaceuticals Corporation, United States
    I am a Registered Nurse currently working as the Regional Patient Safety Head for US & Canada at Novartis Pharmaceuticals. In this role, I lead a team of almost 70 dedicated PV professionals in the region. Additionally, I hold the position of US Country Patient Safety Head (CPSH... Read More →
    SA

    Subhan Ahmed Sharief

    Director, ArisGlobal LLC, United States


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    11:00am PDT

    #108: Risk Management in Advanced Device Technology Development
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-522-L04-P; CME 1.00; RN 1.00

    This panel will discuss innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Risk management pertaining to future technologies will be critical as product become more patient centric.

    Learning Objectives

    Analyze latest expectations and challenges utilizing an integrated risk management approach for combination products; Discuss the importance of an integrated risk management approach to increase product understanding earlier within the product development phase.

    Chair

    James Wabby, MHS

    Speaker

    Panelist
    Kimberly Trautman, MS

    Panelist
    Donna Rycroft, BSN

    Panelist
    Olivia Wong, MBA



    Speakers
    avatar for Kimberly Trautman

    Kimberly Trautman

    Managing Director, Trautman International Services, United States
    Experienced Medical Devices, IVD and Combination Product Expert with over 40 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4... Read More →
    avatar for James Wabby

    James Wabby

    Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
    James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
    avatar for Donna Rycroft

    Donna Rycroft

    Director, Study Risk Management, AbbVie, United States
    Strategic Leader in Clinical Development with 11 years expertise in Risk-based Quality Management (RBQM) leading the development, implementation and change management of RBQM models and supporting systems at AbbVie and Allergan. Currently leading a team of Study Risk Leads supporting... Read More →
    avatar for Olivia Wong

    Olivia Wong

    Director, Quality, Combination Products, Gilead, United States
    Olivia Wong is the Director of Quality, Combination Products at Gilead Sciences in Foster City, CA. She has 22 years of industry experience in medical devices and combination products, where she has provided quality engineering expertise throughout the product lifecycle, including... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Forum |   06: TranslationalDelivery Tech-PrecMedicine, Forum

    11:00am PDT

    #106: Machine Learning and Simulations to Facilitate Clinical Trials
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-520-L04-P; CME 1.00; RN 1.00

    The past decade has seen significant strides in machine learning and AI technologies. This session will provide an in depth investigate the various uses of machine learning and AI-based simulations within clinical development, ranging from data analysis, endpoint selection, the potential improvement of decision making within trial teams by clarifying tradeoffs to clinicians and statisticians, and more.

    Learning Objectives

    Describe the potential benefits of simulations in clinical trial protocol development and trial analysis, and the benefits of employing machine learning tools throughout clinical development; Discuss the novel approaches to conducting studies with such tools incorporated and relate to the regulatory guidance for adaptive trial design where relevant.

    Chair

    Raviv Pryluk, PhD

    Speaker

    Doing More with Less: Using ML to Drastically Improve Trial Simulation and Design
    Raviv Pryluk, PhD

    Clinical Trial Simulation: the Antidote to Wishful Thinking
    Sam Miller, MSc

    Digital Twins for Clinical Trials
    Charles Fisher, PhD



    Speakers
    avatar for Raviv Pryluk

    Raviv Pryluk

    CEO & Co-founder, PhaseV, United States
    Raviv is the co-founder & CEO of PhaseV, a technology company that leverages causal-ML and advanced software capabilities to support advanced & innovative clinical trials. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion (Cum Laude) and Ph.D. in computational neuroscience... Read More →
    CF

    Charles Fisher

    Founder and Chief Executive Officer, Unlearn.AI, United States
    SM

    Sam Miller

    Head of Strategic Consulting, Exploristics, United Kingdom
    Sam has over 25 years’ experience as a statistician in the pharmaceutical industry. At Exploristics, he oversees the Statistical Consulting team. With a BA in Mathematics from the University of Cambridge and an MSc in Statistics from University College London, Sam has broad knowledge... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Session

    11:00am PDT

    #107: Cloud-Driven Transformation: Empowering Pharma Industry and Regulators
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-521-L04-P; CME 1.00; RN 1.00

    This forum will identify how cloud-based technologies may be utilized to promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally. Speakers will discuss several regulatory use cases and initiatives that are leveraging these technologies to modernize data exchange and regulatory review.

    Learning Objectives

    Illustrate how cloud-based technologies may promote interactive and collaborative regulatory review (applicant-regulator; inter-regulator) both regionally and internationally discussion of several regulatory and scientific use cases opportunities leveraging cloud-based solutions; Discuss relevant PDUFA VII provisions and FDA’s public-private partnerships and European Medicines Agency initiatives in advancing regulatory science through the application of cloud technology.

    Chair

    Vada A. Perkins, DrSc, MSc

    Speaker

    US FDA/Industry Regulatory Cloud Research Collaboration: Project PRISM (PrecisionFDA Regulatory Information Service Module)
    Vada A. Perkins, DrSc, MSc

    FDA Update
    Ginny Hussong

    FDA Update
    Ron Fitzmartin, PhD, MBA



    Speakers
    avatar for Vada Perkins

    Vada Perkins

    Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
    Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →
    avatar for Ron Fitzmartin

    Ron Fitzmartin

    Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
    Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
    avatar for Virginia Hussong

    Virginia Hussong

    Branch Chief, Data Standards, CBER, FDA, United States
    Ginny serves as Chief of CBER's Data Standards Branch, where she leads a multidisciplinary team that advances standards such as eCTD, CDISC, IDMP, ICSR, SPL and related terminologies. In addition, conducts technical validation of clinical study data, leads related reviewer training... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    11:00am PDT

    #105: The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-519-L04-P; CME 1.00; RN 1.00

    Experts in pediatric rare disease product development, pediatric ethics and patients/advocates discuss designing studies to best benefit the patient, and how patients/caregivers assess risks and benefits in early phase trials.

    Learning Objectives

    Discuss the ethical and scientific considerations for designing studies for rare diseases that impact children, including the level of evidence needed to initiate early phase trials; Discuss how patients and caregivers weigh the risks of early-phase studies against the benefits of a potential treatment for their rare disease, especially when there are limited to no other options.

    Chair

    Donna Snyder, MD

    Speaker

    Ethical Considerations for Including Children in Rare Disease Trials
    Donna Snyder, MD

    Update from ORPURM/DRDMG
    Mehul Desai, MD

    Patient Perspective
    Mark Dant

    Patient Perspective
    Ryan Dant



    Speakers
    avatar for Donna Snyder

    Donna Snyder

    Executive Physician, WCG, United States
    Donna Snyder, MD, MBE is the Executive Physician of WCG where she contributes subject matter expertise and operational guidance across WCG to ensure that research will be conducted to the highest ethical standards. Prior to WCG, Dr. Snyder served as the leader and Senior Pediatric... Read More →
    avatar for Mark Dant

    Mark Dant

    Volunteer Executive Director, The Ryan Foundation, The Ryan Foundation for Rare Disease Research, United States
    Mark is the Founder and Volunteer Executive Director of the Ryan Foundation and is the former Board Chair of the of the EveryLife Foundation for Rare Diseases. Mark and his family founded the Ryan Foundation in 1992 shortly after their only child Ryan was diagnosed with MPS I. Since... Read More →
    avatar for Ryan Dant

    Ryan Dant

    Patient Advocate, The Ryan Foundation for Rare Disease Research, United States
    Ryan Dant is a long-time patient advocate diagnosed at the age of three with Mucopolysaccharidosis type 1 (MPS 1), a rare lysosomal storage disorder. When doctor’s predicted Ryan’s life to be cut short due to the disease, Ryan’s parents, Mark and Jeanne, spearheaded the funding... Read More →
    avatar for Mehul Desai

    Mehul Desai

    Medical Reviewer, ORDPURM/DRDMG, OND, CDER, FDA, United States
    Mehul Desai M.D. is a medical officer in the Division of Rare Diseases and Medical Genetics (DRDMG), Office of New Drugs (OND), Center for Drug Evaluation Research (CDER), with the US Food and Drug Administration (FDA). Dr. Desai has clinical development experience in both the pharmaceutical... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

    11:00am PDT

    #109: GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-523-L04-P; CME 1.00; RN 1.00

    In this session, we will invite speakers from EMA, FDA, and PMDA, and share the latest regulations, perspective to revised ICH guidelines, and challenges to implement the guideline in own region.

    Learning Objectives

    Recognize direction of revising ICH-GCP guideline; Discuss how to utilize it in real inspection.

    Chair

    Junko Sato, PhD

    Speaker

    FDA Update
    Kassa Ayalew, MD, MPH

    EMA Update
    Peter Twomey

    PMDA Update
    Yoshiaki Nodera, MPharm



    Speakers
    avatar for Junko Sato

    Junko Sato

    Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
    avatar for Kassa Ayalew

    Kassa Ayalew

    Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
    Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →
    avatar for Yoshiaki Nodera

    Yoshiaki Nodera

    Principal Inspector, Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Yoshiaki Nodera currently serves as a principal inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA). He joined PMDA in 2008 and had been working as a reviewer of biotechnological/biological products, medical devices... Read More →
    avatar for Peter Twomey

    Peter Twomey

    Head of Inspections, European Medicines Agency, Netherlands
    Peter is the Irish representative at both the GCP and PV EMA co-ordinated inspector working groups, a member of the GCP IWG CMDh working party (which focuses on bioequivalence inspections), and is a member of two expert groups tasked with proposing text for implementing acts of the... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Session

    11:00am PDT

    #110: Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-524-L04-P; CME 1.00; RN 1.00

    In 2017, CDER began modernizing the New Drugs Regulatory Program. This session shares progress updates and offers dialogue to enhance the program's key areas.

    Learning Objectives

    Describe the impetus for modernizing CDER’s Drug Regulatory Program (NDRP); Identify the NDRP strategic objectives and their associated initiatives; Discuss the progress and outcomes of the NDRP workstreams.

    Chair

    Yoni Tyberg, MHA

    Speaker

    Panelist
    Kevin Bugin, PhD, MS, RAC

    Panelist
    Meghana Chalasani, MHA

    Panelist
    Michael Monteleone, MS, RAC

    Panelist
    Andrew Emmett, MPH



    Speakers
    avatar for Kevin Bugin

    Kevin Bugin

    Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
    Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →
    avatar for Meghana Chalasani

    Meghana Chalasani

    Lead, Advisory Committees, Office of New Drugs, CDER, FDA, United States
    Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →
    avatar for Andrew Emmett

    Andrew Emmett

    FDA Liaison | US Regulatory Policy and Global Intelligence, Pfizer Inc, United States
    Andrew Emmett is Pfizer's FDA Liaison and Executive Director for U.S. Regulatory Policy & Global Intelligence. In his role, Andrew develops and advocates for Pfizer policy positions to enhance the regulatory environment for biomedical innovation. He leads key initiatives on real-world... Read More →
    MM

    Michael Monteleone

    Associate Director for Labeling, OND, CDER, FDA, United States
    Mr. Michael Monteleone is currently an Associate Director for Labeling in the Office of New Drugs at CDER, FDA. Michael has also held positions in Regulatory Affairs and Project Management throughout his 15 year tenure at the FDA.
    YT

    Yoni Tyberg

    Associate Director of Special Programs, Office of New Drugs, CDER, FDA, United States
    Yoni Tyberg is the Associate Director of Special Program Staff (SPS) at the Office of New Drugs within CDER. In this role, Yoni supports the strategic planning, project development and execution of the New Drug Regulatory Program Modernization efforts across OND and CDER. He had also... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    11:00am PDT

    #111: China Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-525-L04-P; CME 1.00; RN 1.00

    In this forum, speakers from the National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE) and Center for Food and Drug Inspection (CFDI) will present and discuss the latest information on regulation, drug review and approval, and international collaboration. Attendees will have an opportunity to discuss the issues related to drug regulation with NMPA officials.

    Learning Objectives

    Summarize the latest information on the National Medical Products Administration’s activities in drug regulation and international collaboration; Describe the recent update on the progress in drug review, inspection and approvals in China; Identify challenges in drug regulation in China.

    Chair

    Ling Su, PhD

    Speaker

    Opening Remarks and Introductions
    Lili Cao, MS

    Panelist
    Zhimin Yang, MD

    Panelist
    Jiangyong Yu

    Panelist
    Shun Lu



    Speakers
    avatar for Ling Su

    Ling Su

    Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China
    Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry... Read More →
    avatar for Lili Cao

    Lili Cao

    Deputy Director, China Center for Food and Drug International Exchange, National Medical Products, China
    avatar for Shun Lu

    Shun Lu

    Director, Center for Clinical Medicine of Lung Cancer, Shanghai Chest Hospital,, Shanghai Jiaotong University, China
    Shun Lu, MD, PhD, is a Director of the Oncology Department and Professor at Shanghai Chest Hospital. Dr. Lu serves on the International Affairs Committee of the American Society of Clinical Oncology, and Multidisciplinary Cancer Management Courses Working Group. He is also a member... Read More →
    avatar for Zhimin Yang

    Zhimin Yang

    Deputy Director, Center for Drug Evaluation, National Medical Products Administration (NMPA), China
    Dr. Yang is the head of the Medical Review Department I, Centre for Drug Evaluation (CDE), National Medical Products Administration (NMPA), China. Graduated from Peking University, she first worked as pediatrics physician in PKU People’s Hospital for 8 years, and joined CDE as medical... Read More →
    JY

    Jiangyong Yu

    Director, Department of Drug Registration, National Medical Products Administration (NMPA), China


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    11:00am PDT

    #112: Regulatory Convergence for CMC Requirements: The Challenges and Benefits of a Single Global Dossier
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-526-L04-P; CME 1.00; RN 1.00

    The session will share concrete experiences and expectations for the use of a single global dossier for CMC requirements. The panel will bring perspectives of regulators and industry, connecting the topic to regulatory convergence and reliance.

    Learning Objectives

    Identify the benefits of a single global dossier strategy for regulatory convergence and reliance initiatives in the area of CMC; Describe experiences from multinational companies with the implementation of harmonized dossier content for global submissions; Analyze and discuss the challenges and opportunities perceived by regulators for the use of a single global dossier for CMC requirements.

    Chair

    Ana Padua, MSc, RPh

    Speaker

    ICH M4Q(R2): Opportunity for One Global Dossier
    Lawrence Yu, PhD

    EMA Update
    Evdokia Korakianiti, PhD, MSc

    ANVISA Update
    Nélio Cézar de Aquino, SR, MSc

    Regional Regulatory Hub Strategist Team Lead: Specialty Care Portfolio LatAm
    Agustin Brito Del Pino

    Industry Update
    Susanne Ausborn, PhD



    Speakers
    avatar for Nélio Cézar de Aquino

    Nélio Cézar de Aquino

    General Manager of Medicines, ANVISA, Brazil
    Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →
    avatar for Susanne Ausborn

    Susanne Ausborn

    Global Head International Regulatory Policy, Roche, Switzerland
    Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
    avatar for Evdokia Korakianiti

    Evdokia Korakianiti

    Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
    avatar for Ana Padua

    Ana Padua

    Director EU Global Regulatory and Scientific Policy, EMD Serono, Switzerland
    Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory... Read More →
    AB

    Agustin Brito Del Pino

    Regional Regulatory Hub Team Lead, Pfizer Inc, Uruguay
    avatar for Lawrence Yu

    Lawrence Yu

    Director, Office of New Drug Products, OPQ, CDER, FDA, United States
    Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Session

    11:00am PDT

    #113: Master Protocols: Integrating and Debating Clinical Trial Designs
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-527-L04-P; CME 1.00; RN 1.00

    This workshop is a deep discovery of the potential and impact of master protocol for clinical development programs. These conversations are essential in challenging traditional clinical trials as a path forward for innovation in clinical research.

    Learning Objectives

    Recognize the history and basics of clinical research as it relates to master protocols; Compare and contrast master protocols to traditional (fixed sample size) and adaptive trial designs; Describe important methodological principles of master protocols and simulation-guided design; Discuss key benefits of master protocols for stakeholders of clinical development programs.

    Chair

    Muhammad Ali Hameed, CPA, MBA

    Speaker

    Facilitator
    Jay Park, PhD, MSc

    Facilitator
    J. Kyle Wathen, PhD, MS



    Speakers
    MA

    Muhammad Ali Hameed

    Chief Operating Officer, Population Health Research Institute, Canada
    JP

    Jay Park

    Scientific Lead and Founder, Core Clinical Sciences, Canada
    Jay Park is the Founder and Scientific Lead of Core Clinical Sciences (CCS) with over 10 years of experience in complex innovative trial and quantitative research methods. He is also an Assistant Professor at McMaster University. Jay specializes in innovative trial designs (adaptive... Read More →
    avatar for J. Kyle Wathen

    J. Kyle Wathen

    Vice President, Scientific Strategy and Innovation, Cytel Inc., United States
    Kyle has diverse experience in academia, consulting & industry. He is currently a Director of Model Based Drug Development at Jansen R&D for 9 years. Prior to that, he was at M.D. Anderson Cancer Institute where he had been for +10 years. He has also designed and implemented software... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Workshop

    11:00am PDT

    #114: Breaking Boundaries: Overcoming Policy Crosstalk and Globalization Barriers to Foster Innovation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-528-L04-P; CME 1.00; RN 1.00

    We all want to see innovation in treatments and prevention that meets the many unmet needs of patients globally. And yet, despite this compelling goal, the complexity and uncertainty involved in delivering innovation has baffled policy makers, regulators, healthcare systems and companies at every step of the process. The response has been to establish policies and requirements to “direct” innovation to best effect. The result has been a confused environment where crosstalk of policy measures and requirements collectively and often constrain, rather than enable, innovation.

    In this forum, we are going to aim to take a more holistic framing of the drive for innovation and explore three recent cases where policy crosstalk risks frustrating innovation.

    Learning Objectives

    Explore how various legislative and other policy-related initiatives, including some not directly targeting the industry, are threatening the climate for development of innovative products.

    Chair

    Virginia Acha, PhD, MSc

    Speaker

    Policy Cross-Talk Case Study: Clinical Research
    Karen A Noonan, MA

    Policy Cross-Talk Case Study: Supply Chains and Resilience
    Christopher Colwell, MPA

    Policy Cross-Talk Case Study: Pricing and Access Policies
    Duane Schulthess, MBA



    Speakers
    avatar for Virginia Acha

    Virginia Acha

    AVP, Global Regulatory Policy, Merck & Co, United States
    Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She joined MSD in 2017 to lead regulatory policy efforts ex-US for innovation that leads to better... Read More →
    CC

    Christopher Colwell

    Vice President, International Government and Regulatory Affairs, US Pharmacopeia, United States
    Chris Colwell is Vice President, International Government & Regulatory Affairs at the United States Pharmacopeia (USP). He leads a team that develops USP’s position on public policy and regulatory affairs issues related to its mission to improve global health through public standards.Chris... Read More →
    avatar for Karen Noonan

    Karen Noonan

    Senior Vice President, Global Regulatory Policy, Association of Clinical Research Organizations (ACRO), United States
    Karen joined the Association of Clinical Research Organizations (ACRO) in 2014. Founded in 2002, ACRO represents the world’s leading clinical research and technology organizations. In her role as Senior Vice President of Global Regulatory Policy, she leads ACRO’s global regulatory... Read More →
    avatar for Duane Schulthess

    Duane Schulthess

    Chief Executive Officer, Vital Transformation LLC, United States
    Duane Schulthess is the CEO of Vital Transformation, an economics consultancy in Brussels, Belgium and Washington, DC. He is a member of the U.S. Congressional Health Care Task Force, and the Executive Producer of the Vital Health Podcast, ranked in the top 30 healthcare podcasts... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      12: Value-Access, Forum

    11:00am PDT

    #115: From Intention to Action: Building Diversity, Equity, and Inclusion Initiatives to Create a Culture of Belonging
    Component Type: Session
    Level: Basic

    It is well understood that diversity in the workplace contributes to innovation and improved business outcomes. Interweaving diversity, equity, and Inclusion (DEI) strategies into the work of an organization can improve performance and create thriving workplace cultures. Building such a culture translates into a sense of belonging that inspires employees across the pharmaceutical industry to be more engaged, considering their organization a great place to work and committing to the company mission. While most companies include DEI in their strategic plans, there remains a disconnect between having DEI as a company priority and the actual cultivation of an inclusive workplace. DEI efforts at many companies are limited to only passive learning (e.g., online modules and training) and a shift to a more engaging, fit-for-purpose approach is needed. In this session, we will share case studies of ongoing diversity, equity, and inclusion (DEI) workplace initiatives and we will delve into concrete action plans to translate DEI company priorities.

    Learning Objectives

    Describe existing diversity, equity, and inclusion (DEI) policies within the workplace to identify strengths and gaps; Discuss DEI initiatives that foster a culture of belonging in the workplace.

    Chair

    Ruth Milena Gómez Vargas, MS

    Speaker

    Case Study: Medical Writing Inclusion, Diversity, and Equity Alliance
    Ruth Milena Gómez Vargas, MS

    Case Study
    Xoli Belgrave, MSc

    Case Study
    Carlos Orantes, MBA



    Speakers
    avatar for Xoli Belgrave

    Xoli Belgrave

    Senior Director, Head of Patient Inclusion, Parexel, United Kingdom
    Xoli has been leading Clinical Trial DEI at Parexel since July 2022. As the Head of Patient Diversity, Equity & Inclusion, she helps customers build a DEI strategy and partners with Clinical Development to operationalize. Xoli has 20+ years of global clinical research experience in... Read More →
    avatar for Carlos Orantes

    Carlos Orantes

    Chief Executive Officer, Alcanza Clinical Research, United States
    RG

    Ruth Gómez Vargas

    Senior Medical Writer, Merck & Co., Inc., Colombia
    Ruth Gómez, M.Sc., is a Regulatory Medical Writer at Merck & Co, with 14 years of experience in scientific research. She has had the opportunity to work across various fields, which has given her a profound appreciation for the power of diversity. At Merck & Co, a whole world of... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Session

    11:00am PDT

    #116: Navigating the Trusted, Responsible, and Ethical Horizon of Artificial Intelligence: Uniting Healthcare Perspectives
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-529-L04-P; CME 1.00; RN 1.00

    Artificial Intelligence (AI) is making its presence known in health care, presenting unprecedented opportunities and challenges. It is crucial to devise strategies that ensure its ethical and responsible utilization for the betterment of health care and society. This imperative can only be met by harnessing the collective power of the broad Healthcare ecosystem. Join us for an engaging DIAmond session featuring esteemed panelists from technology companies, pharmaceuticals, patient advocacy groups, and academia/research to delve into how we can leverage the momentum of AI while establishing a foundation of trust. In this session, we will address the following questions: • How is the health care data landscape evolving in conjunction with AI, and what implications does it hold in terms of opportunities and concerns for our stakeholders? • What expectations do stakeholders have of us as leaders in ensuring ethical innovation? • What emerging practices, supported by real examples and lessons learned, are paving the way for the integration of ethical considerations into actionable strategies? • Where should we seek cross-sector partnerships to further propel momentum and establish standards for the ethical and responsible deployment of AI? Let us unite in paving the way towards a future where innovation is fueled by trust, driven by the responsible utilization of our burgeoning capabilities.

    Learning Objectives

    Define responsible innovation and ethical use of artificial intelligence (AI) in health care and life sciences; Explore the intersection of ethical considerations with technological advancements; Examine the role of cross-sector partnerships in driving trusted and responsible AI use.

    Chair

    Martin Hodosi, MSc

    Speaker

    Panelist
    Junaid Bajwa, MD, MBA, MSc, FRCP

    Panelist
    Karla Childers, MS

    Panelist
    Dave deBronkart



    Speakers
    avatar for Martin Hodosi

    Martin Hodosi

    Partner, Healthcare and Life Sciences Practices, Kearney, United Kingdom
    More than a decade of experience in Strategy Consulting across sectors, with 8+ years across value chains in Pharmaceuticals, MedTech and Life Sciences. Focused on helping biopharma Research & Development (R&D) leaders bring superior treatments to patients more quickly by transforming... Read More →
    avatar for Junaid Bajwa

    Junaid Bajwa

    Practicing Physician, UK’s National Health Service; Chief Medical Scientist, Microsoft Research, United Kingdom
    Junaid is the Chief Medical Scientist at Microsoft Research and a practicing physician in the UK’s National Health Service. Junaid has worked across primary care, secondary care, and public health settings in addition to acting as a payer, and policymaker within the UK, where he... Read More →
    avatar for Karla Childers

    Karla Childers

    Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
    Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
    avatar for Dave deBronkart

    Dave deBronkart

    Patient Advocate, E-Patient Dave, LLC, United States
    "e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →


    Monday June 17, 2024 11:00am - 12:00pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      14: DIAmond, Forum

    12:00pm PDT

    #117 CH: Rare Diseases Multistakeholder Collaboration Towards Regulatory Endorsed Innovative Clinical Development Approach
    Component Type: Workshop
    Level: Intermediate

    ERDERA focuses on accelerating rare diseases drug development by combining real-world data processing, Patient Centered Outcome measures integration, a streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.

    Learning Objectives

    Identify innovative methodologies, technologies and tools for innovative therapy development; Prepare a collaboration with an innovative Rare Disease research Ecosystem and recall its funding opportunities.

    Chair

    Solange Corriol-Rohou, DrMed, MD, PhD

    Speaker

    Facilitator
    Alexandre Betourne, PharmD, PhD



    Speakers
    avatar for Alexandre Betourne

    Alexandre Betourne

    Executive Director, Critical Path Institute, United States
    Alexandre Bétourné, PhD, PharmD, is Executive Director for the Rare Disease Cures Accelerator-Data and Analytics Platform initiative. Dr. Bétourné holds both a PhD and a PharmD from the University of Toulouse in France. Before joining C-Path, he worked with a team of senior U.S... Read More →
    avatar for Solange Corriol-Rohou

    Solange Corriol-Rohou

    Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
    Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines... Read More →


    Monday June 17, 2024 12:00pm - 12:30pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:00pm PDT

    Luncheon Service
    Component Type: Social Event




    Monday June 17, 2024 12:00pm - 2:00pm PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:15pm PDT

    #119 IT: RWS Innovation Theater: Accelerate Time-to-Market with Smart, Structured Content, Reuse, and AI
    Component Type: Session

    Accelerate time-to-market is getting more and more important to our customers in pharma and life sciences. With structured content, we see benefits in the areas of efficiency, speed and consistency. During this session, we will share the benefits that our launching customers experience with the Fonto Integrated Authoring Platform. How AI, structured data and smart reuse contribute to time-to-market acceleration and an increase in efficiency, speed and consistency.

    Chair

    RWS

    Speaker

    Speaker
    Jan Benedictus, MS, MSc



    Speakers
    avatar for Jan Benedictus

    Jan Benedictus

    Managing Director, Fonto, RWS, Netherlands
    Jan Benedictus is founder and managing director of Fonto - a user-friendly authoring tool for structured content. Fonto is widely used in content-intense industries such as Publishing, Aviation, Technical Documentation, and increasingly in Pharma and Life Sciences. Jan is actively... Read More →
    avatar for RWS

    RWS

    United States


    Monday June 17, 2024 12:15pm - 12:45pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:15pm PDT

    #120 IT: Datacubed Health Innovation Theater: The Impact of Digital Tools on Pediatric and Elderly Clinical Trials
    Component Type: Session

    This presentation highlights the role of patient engagement technologies in boosting retention in clinical studies, particularly among pediatric and elderly groups. It covers case studies on interactive tools for children that enhance participation and digital platforms for the elderly that address mobility and usability, showing how these technologies improve engagement and retention by meeting patient needs.

    Chair

    Datacubed Health

    Speaker

    Speaker
    Kyle Hogan



    Speakers
    avatar for Datacubed Health

    Datacubed Health

    United States
    avatar for Kyle Hogan

    Kyle Hogan

    President, Datacubed Health, United States
    Kyle has been dedicated to advancing the voice of the patient through the promise of ePRO/eCOA since 2007, in that time helping deliver over 500 successful trials for CROs and Pharmaceutical companies globally. He is a recognized expert for implementing innovative and patient centric... Read More →


    Monday June 17, 2024 12:15pm - 12:45pm PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:15pm PDT

    #121 IT: Castor Innovation Theater: Practical AI - Creating a Future Without Manual Data Re-Entry
    Component Type: Session

    This year, at DIA, Castor will demonstrate their newest human-in-the loop AI capability, Castor CoPilot. This AI assistant reduces the need for manual data (re-)entry and source data verification, cutting down the time spent on manual, repetitive tasks. This session will be interactive, offering attendees a chance to see Castor CoPilot in action through a live demonstration, emphasizing the practical application and efficiency of Castor's AI solutions in streamlining clinical trials.

    Chair

    Castor

    Speaker

    Speaker
    Derk Arts, MD, PhD

    Speaker
    Kristen Harnack



    Speakers
    avatar for Derk Arts

    Derk Arts

    Founder & CEO, Castor, Netherlands
    Dr. Derk Arts, MD, Ph.D., has 20 years of experience in medicine, research, and technology innovation. He founded Castor in 2012, a clinical trial platform focused on patient-centric solutions and data-driven outcomes. Under his leadership, Castor has recently advanced its AI capabilities... Read More →
    avatar for Castor

    Castor

    Netherlands
    avatar for Kristen Harnack

    Kristen Harnack

    Director of Solutions Consulting, Castor, United States
    Kristen Harnack, Director of Solutions Consulting at Castor, is responsible for advising customers on the technical functionality of Castor’s products to provide a seamless and scalable patient experience for clinical trial patients. Prior to Castor, Kristen spent 9 years educating... Read More →


    Monday June 17, 2024 12:15pm - 12:45pm PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:15pm PDT

    #118 RT: Roundtable Discussion: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development
    Component Type: Session

    Join the Bioethics Community for a follow up round table discussion tied to session: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development (Monday, June 17 | 11:00AM - 12:00PM PDT). Space is limited.

    Chair

    Lindsay McNair, MD, MPH, MS


    Speakers
    avatar for Lindsay McNair

    Lindsay McNair

    Principal Consultant, Equipoise Consulting, United States
    Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →


    Monday June 17, 2024 12:15pm - 1:15pm PDT
    Ballroom 20 Lobby San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:15pm PDT

    #POS 1: Professional and Student Poster Session 1
    Component Type: Session

    Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.


    Speakers
    IA

    Ilyoung Ahn

    Scientific Officer, Institute of Food and Drug Safety Evaluation, Korea, Republic of
    SA

    Salman Alharthi

    Head of Formulary Management, Security Forces Hospital, Saudi Arabia
    avatar for Jorge Azar

    Jorge Azar

    Senior Area Regulatory Director for Latin America, AstraZeneca, United States
    Jorge Azar is currently Senior Area Regulatory Director for Latin America with 25 years’ experience on different roles at local, regional and global level in the Regulatory Affairs field, including product strategy, regulatory policy and intelligence. Jorge earned a degree in Pharmacy... Read More →
    avatar for Jan-Georg Bohlken

    Jan-Georg Bohlken

    Student, University of Bremen, Germany
    I studied biology at the University of Göttingen, with a focus on bioinformatics. While working at the Max-Planck Institute for Experimental Medicine, I discovered my interest in statistics. In April of 2024, I finished my Masters in biostatistics. During an industry internship in... Read More →
    avatar for Paul Bolot

    Paul Bolot

    Global Regulatory Strategist, Bayer Consumer Care AG, Switzerland
    Paul Bolot is a PharmD by training, with a Master's degree in International Drug Registration and Development. He worked as a regulatory consultant at PharmaLex for three years. Since 2021, he works at Bayer as Global Regulatory Strategist. His work focuses on Regulatory Science... Read More →
    avatar for Tuiana Brown

    Tuiana Brown

    PharmD Candidate 2025, Chicago State University, United States
    My name is Tuiana Brown, a PharmD Candidate (2025) at Chicago State University College of Pharmacy. During my tenure at Chicago State, I began to appreciate research very much. I completed three years of research with the RISE, CAHMPS, and SRTP programs. I also completed an internship... Read More →
    avatar for James Browning

    James Browning

    Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
    James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 14 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →
    avatar for Xianwen Chen

    Xianwen Chen

    student, University of Macau, Macao
    Chen Xianwen is currently a PhD candidate in the Institute of Chinese Medical Sciences at the University of Macau. Her research interests include drug regulatory science and drug policy. In 2020–2022 she obtained her Master’s degree at University of Macau, then she worked as an... Read More →
    JC

    Joan Cheung

    Senior Consultant, NNIT, United States
    Joan Cheung received her Doctor of Pharmacy degree from St. John's University and has been recognized by her colleagues in developing a labeling solution with a Product Excellence Award in 2022. She leverages her pharmacy background and technical acumen as a Business Analyst and Project... Read More →
    avatar for Constance Chisha

    Constance Chisha

    PhD Student, University of the Witswatersrand, South Africa
    Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
    avatar for Grace Collins

    Grace Collins

    Regulatory Policy Analyst, Friends of Cancer Research, United States
    Grace Collins is a regulatory policy analyst at Friends of Cancer Research where she conducts research to support the organization’s science, policy, and patient advocacy initiatives. In her role, she leads the creation of public data dashboards for assessing trends in oncology... Read More →
    SD

    Sahith Doppalapudi

    Sr.Manager, PV Analytics Center of Excellence, Bristol-Myers Squibb Company, United States
    Sahith Doppalapudi holds a master's degree in Chemical Engineering from Oklahoma State University and has accumulated over 14 years of experience in the pharmaceutical industry. Throughout his career, he has served in different roles including Quality Analyst, Validation Lead, and... Read More →
    avatar for Christopher Doyle

    Christopher Doyle

    Senior Director, IBC Services, WCG, United States
    Chris is Sr. Director of IBC Services at WCG, where he works with clinical trial stakeholders to ensure research involving gene-based medicines is conducted safely and efficiently. Chris received his PhD in Molecular Genetics and Microbiology from Stony Brook University in 2014. Prior... Read More →
    NE

    Nora Emmott

    Senior Policy Analyst, Duke Margolis Institute For Health Policy, United States
    Nora Emmott is the Senior Policy Analyst for the Real-World Evidence Collaborative at Duke-Margolis Center for Health Policy where she works on projects related to patient-generated health data, pharmacogenomics, and precision medicine. She has an MPH with a concentration in Health... Read More →
    JF

    Jeanine Flanigan

    HEOR specialist, Sandoz, United States
    Jeanine Flanigan is a HEOR Specialist at Sandoz. She is a graduate of the University of Pittsburgh School of Pharmacy (PharmD '21 and MS '23) and completed a fellowship with Pitt Pharmacy & Sandoz in pharmacoanalytics and outcomes research.
    avatar for Kayla Garvin

    Kayla Garvin

    Sr Regulatory Health Project Manager, FDA, United States
    I am a Senior Regulatory Health Project Manager with FDA/CDER’s Office of Medical Policy (OMP). I have an MPH from the University of New England and have been with the Agency for 19 years and with OMP for 15 years. I coordinate the workflow for various cross-Agency programs, including... Read More →
    NG

    Neda Gharavi

    Senior Director Medical Writing & Regulatory Affairs, BioPharma Services, Canada
    Dr. Gharavi's career in the pharmaceutical industry has been defined by her unwavering passion for science. With a Pharm D degree and a PhD in Drug Metabolism, she has made significant contributions to pharmaceutical industry. Starting as a Pharmacokinetic Scientist at Apotex, she... Read More →
    TG

    Tapash Ghosh

    TL, FDA, United States
    avatar for Nick Henscheid

    Nick Henscheid

    Senior Scientist, Critical Path Institute, United States
    Nick Henscheid completed his PhD in Applied Mathematics in 2018 with a focus on image science and precision medicine. Since 2021 he has worked for the Critical Path Institute developing advanced quantitative modeling solutions for a variety of needs across the drug development li... Read More →
    avatar for Li Huang

    Li Huang

    Principal Biostatistician, Phastar, United States
    Li Huang is a principal biostatistician in PHASTAR since 2020. She received Doctor of Dental Surgery (DDS) from Hubei Medical University (China), Master of Science in Dentistry from National University of Singapore (NUS), and Master of Science in Applied Statistics from California... Read More →
    avatar for Toshiko Ishibashi

    Toshiko Ishibashi

    Oncology Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., Japan
    Toshiko Ishibashi is an Associate Director of Oncology Medical Science in Medical Affairs at Daiichi Sankyo Co., LTD. since 2020. She served Ono Pharmaceutical Company from 2018 to 2020. She was a Clinical Operations Manager at Abbvie, 2016-2018. She has experience as an assistant... Read More →
    RI

    Rajashekhar Ittedi

    Student, Northeastern University, United States
    I am a motivated and aspiring regulatory affairs professional with a strong pharmacy background and clinical research skills. Currently, I am pursuing my Master's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices at Northeastern University, where I am gaining... Read More →
    avatar for Zarnab Jillani

    Zarnab Jillani

    Medication Error Pharmacovigilance and Risk Management Fellow, FDA, United States
    avatar for James Kim

    James Kim

    Undergraduate Student Researcher, University of Southern California, United States
    James is a rising junior studying Neuroscience at the University of Southern California. He is an undergraduate student researcher in the Regulatory Science Team and is studying the use of patient-reported outcome measures in clinical trials for Parkinson's Disease. At school, James... Read More →
    avatar for Yueh-Wen Lan

    Yueh-Wen Lan

    Senior Project Manager, Center for Drug Evaluation, Taiwan, Taiwan
    Yueh-Wen Lan, a senior project manager in the Division of Regulatory Affairs and Compliance at CDE Taiwan for more than 6 years, has participated in project management for reviewing cases of clinical trials, generic drug registration, and new drug registration. I hold a Master's Degree... Read More →
    avatar for Juan Lara

    Juan Lara

    Senior Research Analyst, Centre For Innovation In Regulatory Science, Mexico
    Juan is a Senior Research Analyst at the Center for Innovation in Regulatory Science. He holds a Bachelor's degree in Pharmaceutical-Biological Chemistry and has diverse experience in quality assurance, production, R&D, and regulatory affairs. Juan supports a wide range of regulatory... Read More →
    avatar for Liyang Lyu

    Liyang Lyu

    Student, University of Macau, Macao
    Liyang Lyu, a PhD candidate at the University of Macau, specializes in pharmaceutical patent research, with a primary focus on cancer immunotherapy. She has authored two articles in Nature Biotechnology, focusing on the advancements in iPSC and CAR-T therapies.
    avatar for Jessica Miller

    Jessica Miller

    1st-Year Fellow, Global Regulatory Affairs CMC, GlaxoSmithKline, United States
    avatar for Namosha Mohite

    Namosha Mohite

    Manager, Global Regulatory Affairs, Bayer, United States
    Namosha Mohite, PharmD, is a Manager in the Global Regulatory Affairs group at Bayer. In her current role, she serves as a US regulatory strategist for a product in late-stage development and also supports related global regulatory activities. Her background in pharmacy and interest... Read More →
    avatar for Nancy Ngum

    Nancy Ngum

    Student, University of Hertfordshire, United Kingdom
    Nancy Yang-Ngum is currently a Doctoral student with the University of Hertfordshire in the United Kingdom. Her research in regulatory science is focused on an assessment of the Regulatory Review Systems in the East Africa Community (EAC) with a view to improving Patients’ Access... Read More →
    BN

    Bridget Nugent

    Science Policy Analyst, FDA, United States
    Bridget Nugent, PhD, is a Science Policy Analyst who leads regulatory science initiatives for FDA CDER’s Rare Diseases Team (RDT). Dr. Nugent is a neuroscientist with over 16 years of research and mentorship experience with expertise in rare disease drug development, molecular biology... Read More →
    avatar for Ashley Ogawa-Wong

    Ashley Ogawa-Wong

    Medical Writer, Merck Sharp & Dohme LLC, United States
    Ashley is a senior medical writer at Merck & Co., Inc. Since joining medical writing in 2020, Ashley has supported several successful filings to worldwide regulatory agencies. She has authored clinical trial protocols, briefing packages, Investigator’s Brochures, Clinical Study... Read More →
    avatar for Mercy Owusu-Asante

    Mercy Owusu-Asante

    Graduate Student, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
    Mrs Mercy Owusu-Asante is a pharmacist with an MSc in Pharmaceutical Services and Medicines Control obtained from the University of Bradford, UK. In the area of personal professional development, Mercy is pursuing a PhD in Regulatory Science at the University of Herfordshire, UK... Read More →
    avatar for Sydney Ringold

    Sydney Ringold

    Customer Success Manager, Cytel, Inc., United States
    Sydney Ringold is a Customer Success Manager at Cytel. She has a diverse background, having received her B.S. in biology and MBA in operations management from the University of Alabama. She has experience in both commercial and research aspects of clinical trials through cofounding... Read More →
    KR

    Kelly Russell

    Marketing Manager, Forian, Inc., United States
    avatar for Bhavana Tallavajhula

    Bhavana Tallavajhula

    Director, Bristol Myers Squibb, United States
    Bhavana Tallavajhula is a highly accomplished pharmaceutical professional with over 20 years of experience at Bristol Myers Squibb (BMS). She began her career as a Formulation Scientist, gaining expertise in laboratory work. Driven by a desire to make a tangible impact on patient... Read More →
    JV

    Jackie Vanderpuye-Orgle

    Vice President, Advanced Analytics, Parexel International, United States
    Dr. Jackie Vanderpuye-Orgle is a health economist with over 20 years of progressive experience in the application of econometric principles and statistical analysis to both clinical and real-world data. In her role at Parexel, Jackie is responsible for providing technical expertise... Read More →
    avatar for Shruti Vig

    Shruti Vig

    Graduate Student, University of Maryland, College Park, United States
    Shruti Vig is a fifth-year Ph.D. candidate in the Department of Bioengineering at the University of Maryland. Currently under the mentorship of Dr. Huang Chiao Huang and Dr. Graeme F. Woodworth, her research focuses on developing test methodologies for evaluating the phototoxicity... Read More →
    FY

    Felix Yang

    US Regulatory Policy Fellow, Genentech, A Member of the Roche Group, United States
    Felix Yang, PharmD, is a US Regulatory Policy Post-Doctoral Fellow at Genentech, a member of the Roche Group in conjunction with Howard University. Felix obtained his PharmD from the University of Wisconsin-Madison. During his first year at Roche-Genentech, he has conducted projects... Read More →
    avatar for Scarlett Yang

    Scarlett Yang

    Senior Regulatory Affairs Associate, Gilead Sciences, United States
    Scarlett Yang is a Senior Regulatory Affairs Associate at Gilead and supports various regulatory intelligence and policy activities. Scarlett brings partners and stakeholders together across sectors to tackle challenges in drug development. Scarlett holds a PhD in Immunology from... Read More →
    JZ

    Jiewei Zeng

    Associate Director, Abbvie, United States
    Dr. Jiewei Zeng is an Associate Director at AbbVie. She had Ph.D. in mathematics with a major in statistics from the University of Illinois at Chicago, where her research focused on developing optimal designs for compartment models. Dr. Zeng has extensive experience working in the... Read More →


    Monday June 17, 2024 12:15pm - 2:15pm PDT
    Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:45pm PDT

    #122 CH: Digital Transformation: More Than Just Technology - Understanding How to Make it a Reality
    Component Type: Workshop
    Level: Intermediate

    The industry has invested heavily in digital transformation initiatives over the past decade. Despite the promise shown by new technology (e.g. GenAI), many processes are still manual and require significant resourcing. Solutions will be discussed.

    Chair

    Louise Lind Skov, PhD

    Speaker

    Spreaker
    Waheed Jowiya, PhD



    Speakers
    avatar for Waheed Jowiya

    Waheed Jowiya

    Digitalisation Strategy Lead, Novo Nordisk A/S, Denmark
    Waheed is a Digitalisation Strategy Lead at Novo Nordisk. In his role at Novo Nordisk, Waheed has been instrumental in shaping the digitalisation strategy for the company's content creation initiatives. Waheed has played a crucial role in developing the strategy for scaling and deployment... Read More →
    avatar for Louise Lind Skov

    Louise Lind Skov

    Head of Content Digitalisation, Novo Nordisk A/S, Denmark
    Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →


    Monday June 17, 2024 12:45pm - 1:15pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:55pm PDT

    #123 IT: IQVIA Innovation Theater: Evolving Clinical Development Approach Amidst a Digital Transformation Wave
    Component Type: Session

    The rapid transformation of digital edge technologies is fundamentally shifting the solution experience for trial participants, sites, sponsors and clinical research teams. In this presentation, we will share a vision for the future of clinical development processes, that can leverage and drive value generation by maximizing benefits of the ongoing digital transformation wave.

    Chair

    IQVIA

    Speaker

    Speaker
    Rajneesh Patil, DDS, MBA

    Speaker
    George Wu



    Speakers
    avatar for IQVIA

    IQVIA

    United States
    avatar for Rajneesh Patil

    Rajneesh Patil

    Vice President, Clinical Operations, IQVIA, United States
    Rajneesh serves Clinical Operations at IQVIA as Head of Digital Strategy and Analytics Innovation. He is a gold medalist in Dental Surgery from India with Foundations in Public health from Australia and Digital Strategy-Executive from Harvard Business School, USA. At IQVIA, he leads... Read More →
    avatar for George Wu

    George Wu

    Director, Biostatistics, Gilead, United States
    George Wu is a Statistical Advisor in Biostatistics at Gilead. He is passionate about developing innovative approaches to improve drug development using his clinical trial experience and statistical expertise. He works on cross-functional initiatives ranging from innovative trial... Read More →


    Monday June 17, 2024 12:55pm - 1:25pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:55pm PDT

    #124 IT: PPD, part of Thermo Fisher Scientific Innovation Theater: Accelerating Drug Development Through the Convergence of Real-World Data (RWD) and Technology
    Component Type: Session

    The proliferation of real-world data (RWD) sources and advancements in technology (e.g.,artificial intelligence (AI), wearables) have fueled the use of real-world evidence (RWE)in drug development. Globally diverse, trusted data sources and impactful AI and digital technologies provide faster, more comprehensive curated data for optimized study design and analysis. This intersection provides invaluable insights to help decision makers make smarter, faster decisions to advance and optimize product development.

    Chair

    PPD, part of Thermo Fisher Scientific

    Speaker

    Speaker
    Peter Wahl, MS

    Speaker
    Ariel Berger, MPH

    Speaker
    Gino Pirri

    Speaker
    John Van Hoy, MBA



    Speakers
    avatar for Ariel Berger

    Ariel Berger

    Executive Director, Integrated Solutions, Real-World Evidence, Evidera, part of PPD clinical research business of Thermo Fisher Scientific, United States
    Ariel’s focus is database analytics where he designs and advises on various RWE and health economics studies, often involving complex methodologies and hybrid designs and disciplines. He has led numerous outcomes research studies, including retrospective database analyses; developed... Read More →
    avatar for John Van Hoy

    John Van Hoy

    Executive Director, Data Science & Advanced Analytics, PPD, part of Thermo Fisher Scientific, United States
    John has been in the Life Sciences industry for nearly 20 years, with roles that span clinical trial operations, mgmt. consulting, and functional leadership. John has developed a focus on the use of data and analytics to help sponsors and CROs gain a competitive advantage. He has... Read More →
    avatar for Gino Pirri

    Gino Pirri

    VP Head Product & Technology, PPD, part of Thermo Fisher Scientific, United States
    As an executive specializing in eClinical technology, with more than 25-yrs. of experience driving innovation and advancing technology to enhance the clinical trial experience for sites and patients, Gino is at the forefront of spearheading cutting-edge advancements in digital and... Read More →
    avatar for Peter Wahl

    Peter Wahl

    Vice President, Global Head of Scientific Affairs, CorEvitas, part of PPD clinical research business of Thermo Fisher Scientific, United States
    Dr. Wahl leads scientific partnerships for Thermo Fisher multi-sponsor registries and guides strategy on new registries and leveraging RWD to support late phase/post-approval studies, including drug safety. He led programs to drive drug discovery and development, including the ClinicoGenomics... Read More →


    Monday June 17, 2024 12:55pm - 1:25pm PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:55pm PDT

    #125 IT: Box Innovation Theater: From Data Chaos to Digital Clarity - Defining the Next Generation of Life Sciences with AI and eSignatures
    Component Type: Session

    Explore the digital overhaul of life sciences, highlighting the power of AI and unstructured data. Discover how e-signatures and AI are transforming research and patient outcomes. Learn to utilize the 90% unstructured data for better compliance and efficiency. Gain insights on AI applications for innovative, efficient decision-making in life sciences, leading to breakthroughs and a new digital era.

    Chair

    Box, Inc.

    Speaker

    Speaker
    Manu Vohra



    Speakers
    avatar for Box, Inc.

    Box, Inc.

    United States
    avatar for Manu Vohra

    Manu Vohra

    Managing Director, Global Life Sciences, Box, United States
    Manu Vohra is the Global lead for Life Sciences and Go-To-Market strategy for Cloud Content Management at Box.com. After two decades deploying ECM solutions in a regulated industry, he's spending his efforts supporting Life Sciences companies to ride the Digital Transformation wave... Read More →


    Monday June 17, 2024 12:55pm - 1:25pm PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    1:30pm PDT

    #126 CH: AI Enhanced Contact Center: Risks to Consider for Medical and Patient Information Exchange
    Component Type: Workshop
    Level: Basic

    The use of AI is highly praised, but risks must be addressed to protect the public (patients) from unethical influence, incorrect information, and privacy breaches.

    Learning Objectives

    Discuss examples of AI use in Medical Information contact center; Describe the risks associated with AI use and its impact on the public (patients).

    Chair

    Valerie Huh, PharmD, MBA


    Speakers
    avatar for Valerie Huh

    Valerie Huh

    Associate Director, Global Innovation and Implementation, Propharma Group, United States


    Monday June 17, 2024 1:30pm - 2:00pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    1:35pm PDT

    #127 IT: Deloitte Innovation Theater: Turning Vision into Reality - Realizing the Promise of Next-Gen Regulatory Intelligence
    Component Type: Session

    Regulatory Affairs has always had the potential to transform into an insights-driven function capable of enhancing operations and accelerating the approval process. And now, advanced technologies and AI have exponentially accelerated this transformation. How can the regulatory function best help drive your organization toward a future state? Discover real-life solutions and future possibilities enabled by Regulatory Intelligence during this Q&A-style session.

    Chair

    Deloitte

    Speaker

    Speaker
    Mukesh Singhal, MBA

    Speaker
    Norman Elliott



    Speakers
    avatar for Deloitte

    Deloitte

    United States
    avatar for Norman Elliott

    Norman Elliott

    Senior IT Business Relationship Manager - Regulatory Affairs & Quality Assurance, AstraZeneca, United States
    A visionary IT leader, Norm Elliott drives complex business strategy to deliver technical solutions. He has a tech background, supply chain expertise, and broad exposure to a range of business processes. Because he's engaged in multiple business areas, he can help eliminate barriers... Read More →
    avatar for Mukesh Singhal

    Mukesh Singhal

    Principal-Life Sciences Strategy & Analytics, Deloitte, United States
    Mukesh Singhal is a leader in Deloitte’s R&D and Regulatory practices, with over 15 years of industry experience shaping and leading digital transformations across the industry. Mukesh has led a cross-industry Regulatory Intelligence forum since 2018, helping to shape an industry... Read More →


    Monday June 17, 2024 1:35pm - 2:05pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    1:35pm PDT

    #128 IT: Evernorth Health Services Innovation Theater: Analyzing Online Survey Responsiveness and Participation
    Component Type: Session

    Member surveys are a method to collect real-world data not found in the claims data. Such insight can be valuable when combined with electronic medical records and claims data, providing a broader view of the patient. By applying socio-economic and demographic factors of patients likely to participate in virtual study or survey, can lead to increased study efficiency. We will share the common socio-economic and demographic factors of survey responders and non-responders.

    Chair

    Evernorth

    Speaker

    Speaker
    Gene Jay, PharmD



    Speakers
    avatar for Evernorth

    Evernorth

    United States
    avatar for Gene Jay

    Gene Jay

    Head of Sales and Account Management, Evernorth Health Services, United States
    Dr. Gene Jay is the Director of Clinical Trial Solutions at Evernorth Health Services, an organization championing access to clinical trials for a diverse population of Evernorth healthcare members. In his role, Dr. Jay leads a data analytics group that leverages medical, pharmacy... Read More →


    Monday June 17, 2024 1:35pm - 2:05pm PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    1:35pm PDT

    #129 IT: H1 Innovation Theater: Beyond the Numbers - Humanizing Data in Clinical Trials for Inclusive Healthcare Solutions
    Component Type: Session

    This presentation will challenge conventional notions of data-centric approaches in clinical trials by emphasizing the importance of human narratives and lived experiences. We will explore how incorporating qualitative insights alongside quantitative data can enrich decision-making processes, promote empathy-driven healthcare solutions, and ensure that diverse voices are heard and valued.

    Chair

    H1

    Speaker

    Speaker
    Ryan Brown, MPA



    Speakers
    avatar for Ryan Brown

    Ryan Brown

    Regional Vice President, Sales- Trial Landscape, H1, United States
    Ryan Brown is the Regional Vice President of Trial Landscape Sales for H1, a cutting-edge health tech company that utilizes AI and DE&I performance data to enable more diverse and effective clinical trials. With 15+ years of experience driving diversity initiatives, Ryan is a sought-after... Read More →
    avatar for H1

    H1

    United States


    Monday June 17, 2024 1:35pm - 2:05pm PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:15pm PDT

    #132: The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning and Resourcing
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-532-L04-P; CME 1.00; RN 1.00

    Evidence shows that improving diversity in clinical trials requires early planning. The session presents a cost analysis and case examples from an expert panel on the impact of incorporating patient diversity tactics and resources early in the process.

    Learning Objectives

    Discuss how to quantify the cost and resources required to execute tactics that increase clinical trial diversity; Explain how the exclusion of patient diversity tactics in budget planning impacts diversity and overall study milestones; Identify considerations that can influence leadership decision-making around diversity during the budget planning process.

    Chair

    Lloryn Hubbard

    Speaker

    Industry Update
    Ryan Brown, MPA

    Industry Update
    Steve T. Satek, MBA

    Industry Update
    Monica Eason



    Speakers
    avatar for Lloryn Hubbard

    Lloryn Hubbard

    Head of Patient Diversity, PPD Part of Thermo Fisher Scientific, United States
    As head of Patient Diversity at PPD, Lloryn has strategic oversight over the company’s clinical trial health equity efforts and leads a team of specialists focused on optimizing drug development for inclusive patient representation. With 15 years of experience in the pharmaceutical... Read More →
    avatar for Ryan Brown

    Ryan Brown

    Regional Vice President, Sales- Trial Landscape, H1, United States
    Ryan Brown is the Regional Vice President of Trial Landscape Sales for H1, a cutting-edge health tech company that utilizes AI and DE&I performance data to enable more diverse and effective clinical trials. With 15+ years of experience driving diversity initiatives, Ryan is a sought-after... Read More →
    ME

    Monica Eason

    Clinical Operations Portfolio Leader, Genentech, A Member of the Roche Group, United States
    SS

    Steve Satek

    Executive Vice President, Flourish Research, United States


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Session

    2:15pm PDT

    #133: ICH M11 Protocol Template: A Global Solution for Global Drug Development
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-533-L04-P; CME 1.00; RN 1.00

    This session will highlight the latest developments of the ICH M11 Clinical Protocol Template including guidelines,protocol template, and technical specification and how these documents will facilitate more efficient and effective trials.

    Learning Objectives

    Describe the M11 ICH deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification; Describe the types trials and phase that the template encompasses; Discuss the technical specification as a technical representation of the template to facilitate electronic exchange.

    Chair

    Ron Fitzmartin, PhD, MBA

    Speaker

    Global Synergy: Enhancing Patient Outcomes and Advancing Clinical Research Through International Protocol HarmonizationT
    Vada A. Perkins, DrSc, MSc

    The Value of Data: A Regulatory Perspective
    Ana Zanoletty Perez

    Support of Digital Protocol Initiatives
    Chris Decker, MS



    Speakers
    avatar for Ron Fitzmartin

    Ron Fitzmartin

    Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
    Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
    avatar for Chris Decker

    Chris Decker

    President and Chief Executive Officer, CDISC, United States
    Chris is recognized industry wide as a leading technology and standards expert for designing, developing, and implementing complex process and technology solutions. He brings years of experience serving in various executive-level positions across software development, clinical research... Read More →
    avatar for Ana Zanoletty Perez

    Ana Zanoletty Perez

    Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
    Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →
    avatar for Vada Perkins

    Vada Perkins

    Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
    Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session

    2:15pm PDT

    #131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-531-L04-P; CME 1.00; RN 1.00

    The ICH E11A guidance advances use of pediatric extrapolation in three areas: (1) role of exposure-response; (2) statistical implications of using external data; and (3) extrapolation of safety. After an overview, these three areas will be explored.

    Learning Objectives

    Define pediatric extrapolation and three components of extrapolation concept; Describe role of exposure-response in supporting data extrapolation from reference to target pediatric population; Examine the impact of extrapolation on false positive rate of a pediatric clinical trial; Outline impact of pediatric extrapolation on generation of safety data in the target pediatric population.

    Chair

    Robert "Skip" Nelson, MD, PhD

    Speaker

    FDA Update on ICH E11A EWG on Pediartic Extrapolation
    Lynne Yao, MD

    Industry Update
    Forrest Williamson, PhD

    Industry Update on ICH E11A EWG on Pediatric Extrapolation
    Brenda Cirincione, PhD, MS



    Speakers
    avatar for Robert Nelson

    Robert Nelson

    Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
    Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →
    BC

    Brenda Cirincione

    Vice President, Clinical and Quantitative Pharmacology, Vertex, United States
    Brenda Cirincione has over 20 years of research experience in Clinical Pharmacology and Pharmacometrics. She received a PhD in pharmaceutical sciences and a MA in statistics from the University of Buffalo, State University of New York, and has experience working in businesses across... Read More →
    FW

    Forrest Williamson

    Director of Pediatrics, Statistical Innovation Center, Eli Lilly and Company, United States
    avatar for Lynne Yao

    Lynne Yao

    Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
    Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session |   11: Statistics-Data Science, Session |   02: ClinTrials -ClinOps, Session

    2:15pm PDT

    #134: Shifting Medical Writing Value Propositions with the Use of Technology Tools
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-534-L04-P; CME 1.00; RN 1.00

    The explosion of technology and expectations for its use are transforming medical writing. In addition to articulating their value proposition, writers and their managers will have to adapt to this transformation and level-up their skills, in the face of ever-evolving technology and technical challenges. This panel will focus on providing both strategic and tactical considerations for medical writing teams. We will highlight the importance of finding early adopters, developing training for multiple learning styles, building a support network, and surviving the change management process.

    Learning Objectives

    Discuss how the medical writing role is evolving in the face of technology; Outline the new skillset(s) that medical writers will need and how these change the value proposition of medical writing; Discuss strategies for engaging and training teams through this evolution.

    Chair

    Robin Whitsell

    Speaker

    Industry Update
    Joanne Hilton, PhD, MBA

    Industry Update
    Kayla Williams



    Speakers
    avatar for Robin Whitsell

    Robin Whitsell

    President, Whitsell Innovations, Inc., United States
    Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
    JH

    Joanne Hilton

    Executive Director, Medical Writing, GlaxoSmithKline, United Kingdom
    Joanne Hilton joined GSK in July 2023 as Executive Director, Medical Writing. With over 20 years' experience in medical communications, she has a track record of building capabilities, driving strategic growth, delivering operational excellence and leading innovation. Her recent focus... Read More →
    KW

    Kayla Williams

    Director and Head, Oncology Medical Writing, Takeda, United States


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      04: MedAffairs-SciComm, Session

    2:15pm PDT

    #135: Enhancing the Science of Patient Engagement and Patient Input: What's in the Future?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-535-L04-P; CME 1.00; RN 1.00

    This forum discussion focuses on current state, challenges, and opportunities to enhancing the science of patient input. Panel of experts will discuss examples of approaches with partnering with patients, enanging regulators and measuring progress.

    Learning Objectives

    Discuss approaches and best practices for partnering and co-creating with patients; Identify strategies to systematically incorporate patient input into decision making; Describe opportunities to enhance interactions between industry and regulators; Discuss approaches to measure progress in engaging patients and its impact to medical product development.

    Chair

    Pujita Vaidya, MPH

    Speaker

    FDA Perspective
    Michelle Campbell, PhD

    Industry Perspective and Case Example
    Elizabeth Rosenkrands-Lange, MPH, MS



    Speakers
    avatar for Pujita Vaidya

    Pujita Vaidya

    Director, US Patient Engagement, Novartis Pharmaceuticals Corporation, United States
    Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies (e.g., Patient Centricity, Pediatrics, and Innovative Trials). Her work includes partnering with cross-functional colleagues... Read More →
    avatar for Michelle Campbell

    Michelle Campbell

    Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
    Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
    ER

    Elizabeth Rosenkrands-Lange

    Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, United States


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum

    2:15pm PDT

    #138: Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-538-L04-P; CME 1.00; RN 1.00

    This session will discuss regulatory and industry perspectives on building quality into clinical trials by providing updates to agency policy of risk-based monitoring (RBM), quality risk management (QRM), and quality-by-design (QbD) (e.g., ICH E6R3, ICH E8R1, draft and final guidances), including case examples.

    Learning Objectives

    Discuss the importance of building quality into clinical trials; Identify a study’s critical quality (CTQ) factors and the importance of involving all stakeholders in their identification; Describe FDA’s expectations for implementing quality-risk management and developing and executing risk-based monitoring plans to focus on CTQ factors with inspection case examples of sponsors, CROs, service providers and clinical investigators.

    Chair

    Kenneth Getz, MBA

    Speaker

    MHRA Update
    Jason Wakelin-Smith

    FDA Update
    Elena Boley, MD, MBA, FACP

    Industry Update
    Michael Torok, PhD



    Speakers
    avatar for Kenneth Getz

    Kenneth Getz

    Tufts Center for the Study of Drug Development, Center For the Study of Drug Development, United States
    Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
    EB

    Elena Boley

    Senior Physician, OSI, OC, CDER, FDA, United States
    Dr. Boley is a senior physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring... Read More →
    avatar for Michael Torok

    Michael Torok

    Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
    Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
    avatar for Jason Wakelin-Smith

    Jason Wakelin-Smith

    Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Session

    2:15pm PDT

    #139: Comparative Perspectives on Regulating AI in Drug Development: US Versus EU
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-539-L04-P; CME 1.00; RN 1.00

    Explore US and EU AI drug regulation with experts from regulator, industry, and academic perspectives. Learn about principles, data privacy, transparency, and real-world examples. Gain insights into vital regulatory nuances.

    Learning Objectives

    Describe the regulatory frameworks in the US and EU; Discuss the practical necessity of regulation in various AI-driven drug development scenarios.

    Chair

    Jayne Ware, MPH, MSc

    Speaker

    EMA Update
    Steffen Thirstrup, MD, PhD

    FDA Update
    Tala Fakhouri, PhD, MPH

    Industry Perspective
    Rose Purcell, JD, MA



    Speakers
    avatar for Jayne Ware

    Jayne Ware

    Senior Director, Global Regulatory Policy, Merck Sharp & Dohme LLC , United States
    Jayne Ware is a Director for Global Regulatory Policy at Merck. She joined Merck in 2012 after 15 years at the US FDA. Jayne is responsible for coordinating regulatory policy intelligence and advocacy activities for key topic areas at Merck such as digital health issues, safety/pharmacovigilance... Read More →
    avatar for Tala Fakhouri

    Tala Fakhouri

    Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States
    avatar for Rose Purcell

    Rose Purcell

    Director, Global Regulatory Policy and Innovation, Takeda, United States
    avatar for Steffen Thirstrup

    Steffen Thirstrup

    Chief Medical Officer, European Medicines Agency, Netherlands
    Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    2:15pm PDT

    #140: The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-540-L04-P; CME 1.00; RN 1.00

    This session will be a panel discussion with senior leaders from FDA, EMA, and PMDA who are closely involved with real-world evidence (RWE) initiatives within their respective agencies. An open Q&A with leaders in RWE from FDA, EMA, PMDA, will be included.

    Learning Objectives

    Describe current perspectives of regulators from several agencies on the use of real-world evidence (RWE) for regulatory decision-making; Discuss from examples of successful use of RWE in regulatory decision-making and how they can be applied; Identify current initiatives and programs regarding RWE in each regulatory agency.

    Chair

    Charles Lee, MBA, MS

    Speaker

    FDA Update
    Motiur Rahman, PhD, MPharm, MS

    EMA Update
    Sabine Haubenreisser, PhD, MSc

    PMDA Update
    Yuki Ando, PhD



    Speakers
    avatar for Charles Lee

    Charles Lee

    Executive Regulatory Science Director, AstraZeneca, United States
    Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →
    avatar for Yuki Ando

    Yuki Ando

    Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She has over 20 years' experience as Biostatistics Reviewer, and currently she is responsible for the biostatistics review and consultation in the new drug and device... Read More →
    avatar for Sabine Haubenreisser

    Sabine Haubenreisser

    Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
    Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →
    avatar for Motiur Rahman

    Motiur Rahman

    Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States
    Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    2:15pm PDT

    #137: Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-537-L04-P; CME 1.00; PDU 1.00 PMI 2166YE3LVS; RN 1.00

    Review principles of FDA's Project Optimus and discuss the impact on oncology clinical development strategies. Scenario analysis with risk management is needed to balance project cost, timelines, patient centricity and health equity approaches.

    Learning Objectives

    Describe the essential points of FDA's Project Optimus Guidance and how it may impact drug development; Discuss how project managers and oncology development teams gain insight into options to consider in order to balance cost, timelines, and risk during dose finding/dose optimization in new molecular entities and new indications.

    Chair

    Nancy Linda Styple

    Speaker

    Patient Update
    Julia Maues, MA

    Industry Update
    Gary Wilkinson, PhD



    Speakers
    avatar for Nancy Styple

    Nancy Styple

    Project Management Leader, Bayer AG, United States
    Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →
    JM

    Julia Maues

    Patient Advocate, Patient-Centered Dosing Initiative, United States
    Julia Maues spearheads the Patient-Centered Dosing Initiative (PCDI), challenging conventional cancer drug dosing practices and prioritizing patient well-being alongside efficacy. She is co-founder of GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization... Read More →
    GW

    Gary Wilkinson

    Director of Clinical Pharmacology, Ryvu Therapeutics, Poland


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   05: Patient-Focused Drug Dev, Session |   07: ProjectManagement-StrategicPlanning, Session

    2:15pm PDT

    #136: In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-536-L04-P; CME 1.00; RN 1.00

    This session will present on the shifting regulatory landscape on diagnostics, including laboratory developed tests. Discussions will focus on a new proposed rule, the FDA’s oncology diagnostics pilot program, and global development implications.

    Learning Objectives

    Explain recent developments in the In Vitro Diagnostic/Companion Diagnostics (IVD/CDx) regulatory landscape in the US; Discuss regulatory implications of the proposed rule on LDTs; Evaluate the impact of FDA IVD initiatives on global drug development programs

    Chair

    Stephanie Choi, PhD

    Speaker

    Insights into FDA's Proposed Rule and LDT Initiatives
    Cortez McBerry, PhD

    New and Anticipated Trends in IVD and LDT Regulation
    Laura DiAngelo, MPH

    Impact of Changing IVD/LDT Landscape on Global Drug Development Programs
    Megan Doyle, JD, MPH



    Speakers
    avatar for Stephanie Choi

    Stephanie Choi

    Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States
    Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →
    LD

    Laura DiAngelo

    Research Director, AgencyIQ by POLITICO, United States
    Laura DiAngelo is the Director of Regulatory Intelligence for POLITICO's AgencyIQ. She focuses primarily on regulatory intelligence issues impacting the medical device, diagnostics and digital health industries.
    avatar for Megan Doyle

    Megan Doyle

    Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
    Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →
    avatar for Cortez McBerry

    Cortez McBerry

    Partner, NDA Partners, United States


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session

    2:15pm PDT

    #141: Innovation in Manufacturing Globally
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-541-L04-P; CME 1.00; RN 1.00

    There is a rapid increase in the use of advanced manufacturing technologies in medicine. The session will provide an overview of the initiatives regulators take and discussion with industry on learnings and the opportunities ahead.

    Learning Objectives

    Describe the initiatives that regulators take to support the rapid technological growth in medicines manufacture that offers opportunities for better quality of medicines and increased robustness in supply chains leading to increased medicine availability.

    Chair

    Evdokia Korakianiti, PhD, MSc

    Speaker

    EU Perspective on Enabling Innovation in Manufacturing
    Marcel Hoefnagel, DrSc, PhD, MSc

    FDA Perspective on Advanced Manufacturing
    Sau L Lee, PhD

    Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
    Gert Thurau, DrSc, PhD

    Decentralized Manufacturing of ATMPs
    Ursula Busse, PhD, MBA

    Panelist
    Benjamin Stevens, PhD, MPH



    Speakers
    avatar for Ursula Busse

    Ursula Busse

    Head of Regulatory Affairs, Tigen Pharma SA, Switzerland
    Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma... Read More →
    avatar for Marcel Hoefnagel

    Marcel Hoefnagel

    Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
    Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars... Read More →
    avatar for Evdokia Korakianiti

    Evdokia Korakianiti

    Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
    avatar for Sau Lee

    Sau Lee

    Deputy Super Office Director, OPQ, CDER, FDA, United States
    Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS). He is a Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), and the chair of the OPQ Emerging Technology Team. He is leading the effort in advancing OPQ research and... Read More →
    avatar for Benjamin Stevens

    Benjamin Stevens

    Director CMC Policy and Advocacy, GlaxoSmithKline, United States
    Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
    avatar for Gert Thurau

    Gert Thurau

    Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
    Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Session

    2:15pm PDT

    #142: Causal Inference Methodology in Drug Development
    Component Type: Session
    Level: Intermediate

    This session will explore special topics in causal inference. Presenters will describe trial design and analysis issues in drug development, related to both randomized trials and real-world data (RWD), that may benefit from statistical methodology to allow for better and more accurate generation of evidence with respect to drug treatment effects.

    Learning Objectives

    Describe various statistical approaches to handle complex design and analysis issues in drug development. Explain use case examples for illustration for causal inference methods.

    Chair

    Pallavi Mishra-Kalyani, PhD, MS

    Speaker

    Causal Inference in Clinical Drug Development: Industry Update
    Antara Majumdar, PhD

    Methodological Challenges and Potential Solutions When Conducting External Control Studies Intended for Causal Inference
    Shia Kent

    Regulatory Considerations and Case Studies of Externally Controlled Trials
    Pallavi Mishra-Kalyani, PhD, MS



    Speakers
    avatar for Pallavi Mishra-Kalyani

    Pallavi Mishra-Kalyani

    Deputy Division Director, DBV, OB, CDER, FDA, United States
    Pallavi Mishra-Kalyani, Ph.D. is the Deputy Director of the Division of Biometrics V, Office of Biostatistics in the Center for Drug Evaluation and Research (CDER). Since joining the Food and Drug Administration (FDA) in 2015, Dr. Mishra-Kalyani has contributed to the efforts to address... Read More →
    SK

    Shia Kent

    Epidemiologist, Pharmacovigilance Epi and Causal Inference Team, Amgen, United States
    avatar for Antara Majumdar

    Antara Majumdar

    Director, Oncology Statistics, GlaxoSmithKline, United States
    Antara is the Director of Statistics at AcornAI by Medidata. Antara is part of a team responsible for implementation of external controls in clinical drug development. Prior to this, Antara worked for Bristol-Myers Squibb for over a decade. Antara has deep and broad experience in... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Session

    2:15pm PDT

    #130: Interactive Safety Graphics in the Regulatory Decision-Making Process
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-530-L04-P; CME 1.00; RN 1.00

    Different visionary options may lead to a different look and feel to clincial study reports (CSRs) and submissions:
  • Broader use of interactive displays in submissions
  • Sponsor provides interactive package(s)
  • Regulators/sponsors use their own interactive package(s)


  • Let’s continue the discussion on how best to collaborate on interactive safety review strategy and development.

    Learning Objectives

    Identify the impact of interactive displays on submission content and the review process including the clinical study report (CSR) and trial data submission, use of review software, and answering information requests.

    Chair

    Greg Ball, PhD

    Speaker

    Panelist
    Scott Proestel, DrMed, MD

    Panelist
    Y. Veronica Pei, MD, MEd, MPH

    Panelist
    Glen Wright Colopy, PhD, MSc

    Panelist
    David Nahamya



    Speakers
    avatar for Greg Ball

    Greg Ball

    Safety Data Scientist, ASAPprocess, United States
    Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
    avatar for Glen Colopy

    Glen Colopy

    Head of Data Science and Statistics, Wildfell Software, United States
    Glen Wright Colopy is the Head of Data Science & Statistics at Wildfell, a startup specializing in custom software and data science solutions for the biotech and life science industries. Glen's day-to-day work is as a hands-on full stack data science contributor, focused on helping... Read More →
    DN

    David Nahamya

    Secretary to the Authority, Uganda National Drug Authority, Uganda
    David was born in 1967 to Mr. and Mrs. Kihumuro; Ntungamo District, Western Uganda. He is known for being an influential person for positive change and leads with confidence. David is a graduate of MSc. Pharmaceutical Sciences - University of Havana; has PGD in Management - Uganda... Read More →
    avatar for Y. Veronica Pei

    Y. Veronica Pei

    Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States
    Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →
    avatar for Scott Proestel

    Scott Proestel

    Senior Medical Officer, ODES, OND, CDER, FDA, FDA, United States
    Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Forum |   01: ClinSafety-PV, Forum

    2:15pm PDT

    #143: Unveiling the Secrets of Success: An Executive Panel with Insights to Navigating your Career Journey
    Component Type: Forum
    Level: Basic

    This forum is designed to inspire, provide insights for robust career planning, and targeted for anyone interested in further development regardless of the stage of their career. Join industry and executive leaders as they answer your career questions.

    Learning Objectives

    Describe how to approach career planning with a focus on experiences, transferrable skills, and cross-training; Discuss how to use mentoring relationships as a career catapult; Differentiate development from promotion/advancement and use that in career planning; Identify how to mentally deal with uncertainty and benefit from lateral moves and from keeping an open mind.

    Chair

    Leslie Sam

    Speaker

    Panelist
    David Fryrear, MS

    Panelist
    Jeremy Jokinen, PhD, MS

    Panelist
    Paula Walker, MA

    Panelist
    Niam Vora, PharmD



    Speakers
    avatar for Leslie Sam

    Leslie Sam

    President, Leslie Sam and Associates, LLC, United States
    With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
    avatar for David Fryrear

    David Fryrear

    Executive Vice President and Head of Quality Assurance, Astellas, United States
    David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →
    avatar for Jeremy Jokinen

    Jeremy Jokinen

    Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
    Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
    avatar for Niam Vora

    Niam Vora

    Pharmacist, Srx Health Solutions, Canada
    Niam Vora is a PharmD graduate from the University of Illinois Chicago. For the past two years, he has served as the National Student President for DIA Student Chapters across the United States. He has also completed a Schweitzer Fellowship, through which he implemented the United... Read More →
    avatar for Paula Walker

    Paula Walker

    Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
    Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →


    Monday June 17, 2024 2:15pm - 3:15pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Forum

    3:30pm PDT

    #144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-543-L04-P; CME 1.00; RN 1.00

    The current paradigm of repeated safety report transmission to multiple regulators results in greater noise, duplicative effort, more lag time, and diverted focus from protecting patients and building trust through a shared proactive safety science. Might international collaboration evolve in this era of real-world evidence to no longer require such continual circulation of the same adverse event reports? Might newer technologies be leveraged for a more effective modern system? What are the options and the issues that would need to be considered to realize this future state? A panel of regulators and international stakeholders will discuss the issues.

    Learning Objectives

    Identify the issue and extent of international replication of safety reports; Discuss the possibility of leveraging modern processes or technical solutions (e.g., blockchain or decentralized networks) to enable more effective international collaboration; Determine how to move this agenda forward by focusing on patient safety in light of challenges and opportunities.

    Chair

    Andrew Bate, PhD, MA

    Speaker

    Paradigm Shift in Adverse Event Report Management and Sharing: Industry Update
    Mayur A Patel, PharmD

    Regulatory Perspective on AE Report Management and Sharing and Future Directions
    Phil Tregunno



    Speakers
    avatar for Andrew Bate

    Andrew Bate

    Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
    Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
    MP

    Mayur Patel

    Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States
    Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... Read More →
    avatar for Phil Tregunno

    Phil Tregunno

    Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    3:30pm PDT

    #145: Selective Safety Data Collection: As a Tool to Advance Clinical Trial Designs
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-544-L04-P; CME 1.00; RN 1.00

    This session is focused on sharing experience with E19 implementation from multiple stakeholders to identify successes and challenges.

    Learning Objectives

    Describe development of E19 and principles of selective safety data collection; Discuss experiences with E19 implementation from different perspectives; Identify FDA initiatives to promote broader use of E19.

    Chair

    Mary Thanh Hai, MD

    Speaker

    EMA Update
    Priya Bahri, PhD, RPh

    Health Canada Update
    Fannie St-Gelais, PhD

    Industry Update
    Anastasia Lesogor, DrMed

    FDA Update
    Eileen Craig, DrMed

    Implementing Selective Safety Data Collection/E19 More Broadly
    Kevin Bugin, PhD, MS, RAC



    Speakers
    avatar for Priya Bahri

    Priya Bahri

    Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
    Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
    avatar for Kevin Bugin

    Kevin Bugin

    Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
    Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →
    avatar for Eileen Craig

    Eileen Craig

    Clinical Lead , DDLO, OCHEN, OND, CDER, FDA, United States
    Eileen Craig, MD joined the FDA’s Division of Metabolism and Endocrinology Products as a clinical reviewer in 2004 and has been a clinical lead for the Lipid Disorders team in the Division of Diabetes, Lipid Disorders, and Obesity (DDLO) since 2023. She has conducted and supervised... Read More →
    avatar for Mary Thanh Hai

    Mary Thanh Hai

    Deputy Director for Clinical, OND, CDER, FDA, United States
    Dr. Thanh Hai is currently the Deputy Director for Clinical in the Office of New Drugs Immediate Office. She works directly with the OND Director to oversee the development programs of drugs and biologics regulated by the Center of Drug and Evaluation and Research across 27 review... Read More →
    AL

    Anastasia Lesogor

    Senior Global Program Clinical Program Head, Novartis Pharma AG, Switzerland
    Anastasia Lesogor, MD works as Executive Director, Senior Global Program Clinical Head in Global Drug Development at Novartis Pharma. She is responsible for leading the development, registration, approval and life cycle management of RNA-based therapeutics in the atherosclerosis therapeutic... Read More →
    avatar for Fannie St-Gelais

    Fannie St-Gelais

    Manager, Health Product and Food Branch, Health Canada, Canada
    Fannie has been with Health Canada for the past 18 years. She has held various positions in the medical device and drug areas, both as a reviewer and a manager, in premarket evaluation and pharmacovigilance. She has represented Health Canada on the ICH E19 working group. She holds... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    3:30pm PDT

    #147: Data and Technology Influence on ICH Initiatives: M4Q(r2)/Q12 and Global Harmonization
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-546-L04-P; CME 1.00; RN 1.00

    Join industry leaders in this interactive forum to discuss the development of ICH initiatives ICH Q12 and ICH M4Q(r2), how they will impact the product approval lifecycle, and the technology that will manage these processes and the data.

    Learning Objectives

    Describe important initiatives that will have a direct impact on the pharmaceutical product approval lifecycle; Identify how the initiatives will influence changes in our industry for patient-product access and faster approvals; Discuss how technology and data has a major role in bringing these initiatives to reality.

    Chair

    Brooke Casselberry, MS, RAC

    Speaker

    Panelist
    Andrew Chang, PhD

    Panelist
    Ciby Joseph Abraham, PhD

    Panelist
    Alexander Gaffney, MS, RAC

    Panelist
    Lawrence Yu, PhD



    Speakers
    avatar for Ciby Abraham

    Ciby Abraham

    Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States
    Ciby Abraham is a Senior Director and Group Manager, Project and Product Leadership in CMC Regulatory Affairs at AstraZeneca. Prior to his role with AstraZeneca, Ciby worked at the for several years FDA as a Team Leader. In addition, Ciby worked in the industry as a formulator, analytical... Read More →
    avatar for Brooke Casselberry

    Brooke Casselberry

    Vice President, Advisory and Delivery, Epista Life Sciences, United States
    Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →
    avatar for Andrew Chang

    Andrew Chang

    Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States
    Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →
    avatar for Alexander Gaffney

    Alexander Gaffney

    Executive Director, Regulatory Policy And Intelligence, AgencyIQ by POLITICO, United States
    Alexander Gaffney is the Executive Director of Regulatory Policy and Intelligence for POLITICO's AgencyIQ, where he leads a team of more than a dozen regulatory intelligence professionals. Alexander has worked in regulatory for more than a decade, including at the Regulatory Affairs... Read More →
    avatar for Lawrence Yu

    Lawrence Yu

    Director, Office of New Drug Products, OPQ, CDER, FDA, United States
    Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    3:30pm PDT

    #148: Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-547-L04-P; CME 1.00; RN 1.00

    This session delves into the latest guidance on real-world data (RWD) and real-world evidence (RWE), offers insights from case studies in which such data were critical for regulatory decisions, and discusses how to prepare the next generation of medical writers for this complex landscape.

    Learning Objectives

    Analyze the FDA’s current stance and guidance on real-world data (RWD) and real-world evidence (RWE) in regulatory submissions; Compare real-world applications of RWD and RWE, showcased through several case studies; Outline educational strategies for equipping future regulatory and medical writers with the skills and understanding needed to effectively incorporate RWD and RWE into documentation.

    Chair

    Jeanette Towles, MA

    Speaker

    Industry Update
    Craig Ostroff, PharmD

    Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
    Tina Schlecht, PharmD, MBA



    Speakers
    avatar for Jeanette Towles

    Jeanette Towles

    President and CEO, Synterex, Inc., United States
    Jeanette Towles, MA, RAC, is the CEO of Synterex, Inc., a woman-owned, disability-owned clinical and regulatory consulting firm specializing in agile-based project management methodology, automation, and AI-driven technologies. Prior to that, she held in-house consulting and FTE medical... Read More →
    CO

    Craig Ostroff

    Chief Executive Officer, Mill Street Consulting, LLC, United States
    avatar for Tina Schlecht

    Tina Schlecht

    Chief Pharmacy Officer, RxE2, United States
    Tina Schlecht, PharmD, MBA is Chief Pharmacy Officer at RxE2 In. She brings 25 years of experience in pharmacy and industry to RxE2. She began her career at CSM, where she led the growth of CTRP services and went on to be President of Center Point Clinical Services. She also worked... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      04: MedAffairs-SciComm, Session

    3:30pm PDT

    #149: Effective Patient / Industry Collaboration: Valuing Patient Lived Experience To Inform Trial Design
    Component Type: Forum
    Level: Intermediate

    This “talk-show” style forum is driven by the patient voice to collaborate on clinical research through the eyes of patients, advocates, and caregivers. It illuminates barriers and burdens and provides solutions for industry to raise awareness, participation, and retention in clinical trials.

    Learning Objectives

    Describe how empowered patient decision making contributes to increased enrollment and engagement in clinical trials; Discuss value proposition for industry to involve patients early and give examples of metrics to quantify and measure: Idxentify unique challenges and wins in the clinical research space, including pediatric trials.

    Chair

    Aman Khera, MBA

    Speaker

    Panelist
    Stacy Hurt, MBA, MHA



    Speakers
    avatar for Stacy Hurt, MBA, MHA

    Stacy Hurt, MBA, MHA

    Chief Patient Officer, Parexel International, United States
    Stacy Hurt, MHA, MBA is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as... Read More →
    avatar for Aman Khera

    Aman Khera

    Vice President, Regulatory Science & Innovation, Worldwide Clinical Trials, Canada
    Aman Khera has earned her nickname: Rebel Regulator, a clinical research professional, with nearly 3 decades of experience in life sciences clinical research, advising biotech and pharma companies. With a deep foundation in global regulatory affairs and the life sciences industry... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum

    3:30pm PDT

    #150: Building Trust in New Alternative Methods in Investigational New Drug Applications
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-549-L04-P; CME 1.00; RN 1.00

    This forum will discuss practical experiences developing investigational new drug applications (IND) applications with new alternative methods (NAMs). Panelists will share lessons learned on how to build trust in NAMs for regulatory uses.

    Learning Objectives

    Apply strategies to leverage new alternative methods (NAMs) in IND applications; Evaluate successful case studies; Identify gaps and opportunities to advance the use of NAMs for drug development.

    Chair

    Rasika Kalamegham, PhD

    Speaker

    FDA's Perspectives on the Current Use of NAMs in IND Applications
    Paul C. Brown, PhD



    Speakers
    avatar for Paul Brown

    Paul Brown

    Associate Director for Pharmacology and Toxicology, OND, CDER, FDA, United States
    Dr. Brown's responsibilities include development and implementation of guidance and policy related to the nonclinical assessment of human pharmaceuticals. He has been at the FDA since 1996 when he joined the Division of Dermatology and Dental Drug Products as a Pharmacology/Toxicology... Read More →
    RK

    Rasika Kalamegham

    Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
    Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Forum

    3:30pm PDT

    #152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-551-L04-P; CME 1.00; RN 1.00

    This session discusses regulator and industry experience with the use of alternative tools to evaluate GCP compliance during the COVID-19 public health emergency and post-pandemic.

    Learning Objectives

    Discuss the alternative, innovative, risk-based approaches regulators used to evaluate GCP compliance during the COVID-19 public health emergency; Describe the application of these tools in the post-pandemic environment; Explain industry’s perspective on and experiences with regulators' use of alternative approaches to GCP evaluations.

    Chair

    Emily Gebbia, JD

    Speaker

    FDA Update
    Ling Yang, MD, PhD, FAAFP

    Beyond the Pandemic, Sustaining Approaches to GCP Compliance
    Paula Walker, MA

    Health Canada Update
    Jennifer Evans



    Speakers
    avatar for Paula Walker

    Paula Walker

    Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
    Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
    JE

    Jennifer Evans

    Compliance Specialist, Health Canada, Canada
    Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a regulatory... Read More →
    EG

    Emily Gebbia

    Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
    Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →
    LY

    Ling Yang

    Senior Physician, OSI, OC, CDER, FDA, United States
    Ling Yang is a senior physician in the Office of Scientific Investigations in FDA’s Center for Drug Evaluation and Research. She has worked at FDA for over 15 years and has extensive experience in GCP compliance evaluation, clinical review and FDA regulation of new drugs, generic... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Session

    3:30pm PDT

    #153: Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-552-L04-P; CME 1.00; RN 1.00

    Regulatory intelligence is the key to formulating regulatory strategy. We will share the application of AI and critical thinking in developing science and risk-based strategies for the development and lifecycle management of medicinal product.

    Learning Objectives

    Apply skills learned in this session to set up regulatory intelligence frameworks for their team and/or company; Develop critical thinking skills that are imperative to the interpretation and proper utilization of intelligence data; Identify how to setup and manage tools and processes for surveilling and monitoring regulatory changes.

    Chair

    Ana Sengupta, MBA, MS, RAC

    Speaker

    Designing Regulatory Intelligence Framework: Powered by Critical Thinking
    Ana Sengupta, MBA, MS, RAC

    Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
    Susan Carino, MBA, MS, PMP, RAC

    Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
    Aditi Khurana, MBA, PMP, RAC



    Speakers
    avatar for Ana Sengupta

    Ana Sengupta

    Associate Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
    Ana Sengupta is the Associate Director of Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 24 years of pharmaceutical industry experience and 14 years of direct experience in regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she... Read More →
    avatar for Susan Carino

    Susan Carino

    Director, Program Management, Mammoth Biosciences, United States
    Susan Carino is a Director of Program Management with Mammoth Biosciences. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She has led diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →
    avatar for Aditi Khurana

    Aditi Khurana

    Director, Project Management, Summit Therapeutics, Inc., United States
    Aditi Khurana, is the Director of Project Management at Asher Biotherapeutics. She is a Project Management Professional (PMP) and is certified in Global Regulatory Affairs (RAC). She holds a Bachelors in Neuroscience from University of California, Los Angeles (UCLA) and a Masters... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    3:30pm PDT

    #154: Impact of Accelerated Pathways on Patients in Five Countries/Regions
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-553-L04-P; CME 1.00; RN 1.00

    Several global regulatory authorities have similar expedited pathways in which a regulatory approval can be granted that would fulfill an unmet medical need based on preliminary/early data from clinical studies. This session will use a recent Oncology case study comparing the different outcomes resulting from using these five different systems aiming to accelerate development and speed up availability of new treatments to patients. This will be followed by a panel with senior regulators and a patient representative to discuss the regulatory perspective and experience with accelerated approvals. The objective is to identify potential opportunities that could help to achieve more collaboration and equity of access for patients across multiple countries/regions.

    Learning Objectives

    Recognize the differences of accelerated pathways in US, EU, Canada, Japan and Australia; Discuss the impact of these pathways on patient access and treatment outcomes; Identify opportunities to increase global collaboration and international patient equity.

    Chair

    Sunita Zalani, PhD

    Speaker

    EMA Update
    Francesco Pignatti, MD

    Health Canada Update
    Isabelle Rousse, MSc

    PMDA Update
    Yoko Aoi, PhD

    FDA Update
    R. Angelo De Claro, MD



    Speakers
    avatar for Yoko Aoi

    Yoko Aoi

    Deputy Review Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Yoko Aoi is a deputy review director of Office of New Drug V responsible for review and scientific advice on oncology drugs. After joining PMDA, Dr. Aoi was involved in review and scientific advice on new drugs for rheumatoid arthritis, asthma, COPD etc. (2011-2016) and planning... Read More →
    avatar for R. Angelo De Claro

    R. Angelo De Claro

    Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
    Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Scientific Adviser for Oncology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    IR

    Isabelle Rousse

    Associate Director, Bureau of Metabolism, Oncology, Reproductive Sciences, PDD, Health Canada, Canada
    Isabelle Rousse joined Health Canada in 2006. She holds a Bachelor of Science in Biomedical Sciences and a Master of Science in Physiology from University of Montreal. At Health Canada, she has been a Scientific Evaluator in the Marketed Pharmaceuticals Bureau (MPB) within the Marketed... Read More →
    avatar for Sunita Zalani

    Sunita Zalani

    Vice President, Regulatory Affairs, Oncology, Merck & Co., Inc., United States
    Sunita Zalani, PhD is the Vice President and Therapeutic Area Head for Oncology and In-vitro diagnostics in Global Regulatory Affairs and Clinical Safety at Merck. In her current role, she has responsibilities for formulation and execution of global regulatory strategy for the oncology... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    3:30pm PDT

    #155: Health Canada Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-554-L04-P; CME 1.00; RN 1.00

    In this session, leaders from Health Canada will provide an update on regulatory priorities for Canada. The audience will be invited to submit questions of general interest.

    Learning Objectives

    Describe Health Canada’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with the Canadian regulator.

    Chair

    Alysha Croker, PhD

    Speaker

    Panelist
    Sophie Sommerer, MS



    Speakers
    avatar for Alysha Croker

    Alysha Croker

    Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada
    Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
    avatar for Sophie Sommerer

    Sophie Sommerer

    Director, Health Canada, Canada
    Sophie Sommerer is the Director General of Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. She is responsible for regulating biologic drugs (including vaccines), radiopharmaceuticals, blood, cells, tissues and organs, and products for Assisted Human Reproduction... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    3:30pm PDT

    #146: Past, Present, and Future: How Industry and FDA are Handling the Evolving Clinical Trial Diversity Regulatory Landscape
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-545-L04-P; CME 1.00; RN 1.00

    This forum will include discussion among multiple sponsors sharing their first-hand, cross-therapeutic area experience on notable trends and challenges they have faced in preparing these early diversity plan submissions. Panelists will also address how they plan to adapt to more expansive categories enumerated within diversity action plan guidance and share reflections on recently released FDA guidances on this topic (i.e. diversity action plans, post market approaches to obtain data on underrepresented populations, collection of race and ethnicity data). Additionally, panelists will discuss what policy deliverables and clarifications they would like to see reflected in the final guidances. The panel will also include FDA’s perspective and reflections from 2 years of diversity plan submissions as well as any considerations as we look to the future.

    Learning Objectives

    Describe best practices and regulatory feedback on diversity plan submissions.; Compare the perspectives of both FDA and sponsors about the current landscape of trial diversity-related guidances, including the latest diversity action plan guidance.; Discuss how by using an interactive audience feature where we seek others’ experience compiling and feedback from the FDA on diversity plan submissions.

    Chair

    Dylan Bechtle, MS

    Speaker

    Industry Update
    Andrea Doyle

    Industry Update
    Del Smith, PhD, MS

    Industry Update
    Stacy Holdsworth, PharmD

    FDA Update
    Tamy Kim, PharmD



    Speakers
    DB

    Dylan Bechtle

    Associate Director, Regulatory Policy Lead- US, Johnson & Johnson Innovative Medicine, United States
    Dylan is an Associate Director in Johnson and Johnson Innovative Medicine's Global Regulatory Policy and Intelligence (GRPI) group. Dylan leads J&J’s regulatory policy efforts around clinical trial diversity. He is interested in the intersection of novel clinical methodologies (e.g... Read More →
    AD

    Andrea Doyle

    Head, Global Regulatory Affairs, Neurology, Sanofi, United States
    SH

    Stacy Holdsworth

    Associate Vice President, US Regulatory Policy & Strategy, Eli Lilly and Company, United States
    Stacy Holdsworth is the Associate Vice President for U.S. Regulatory Policy & Strategy at Eli Lilly and Company. Her primary responsibilities are to lead a team of regulator professionals in the development and implementation of an external regulatory policy agenda that encourages... Read More →
    avatar for Tamy Kim

    Tamy Kim

    Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
    Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →
    avatar for Del Smith

    Del Smith

    Co-Founder and Chief Executive Officer, Acclinate Inc., United States
    Del is the co-founder and CEO of Acclinate, a trusted digital health company focused on greater health equity through inclusive research. He has built a diverse team and AI/ML platform to help the pharmaceutical and healthcare industry access and engage communities of color so that... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum

    3:30pm PDT

    #156: Data Insight Generation: Leveraging Data Visualization in Study Planning, Monitoring, Exploration, Reporting, and Submission
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-555-L04-P; CME 1.00; RN 1.00

    In this session, we will present various interactive graphics and new concept meetings that can be used to provide informative data insights and to enhance clinical trials execution from planning, monitoring, reporting, and regulatory submission.

    Learning Objectives

    Identify information of interest in an interactive way, which can greatly enhance clinical trials execution from planning, monitoring, reporting, and regulatory submission; Describe how to generate additional, broader, and deeper insights in helping accelerate the understanding of the clinical trial data, and further drive the understanding of disease development and patient journey.

    Chair

    Erya Huang, PhD

    Speaker

    Industry Update
    Melvin Slaighter Munsaka, PhD, MEd, MS

    Industry Update
    Neetu Sangari, PhD, MEd, MS

    Industry Update
    Matthew Kumar, MSc



    Speakers
    avatar for Erya Huang

    Erya Huang

    Associate Director Statistics, Bayer AG, United States
    Dr. Huang is the Associate Director at Bayer U.S. LLC. She has many years of experiences working on global drug developments and registrations. She is also the main contact person of the data visualization app center in Bayer North America since 2016, being passionate about introducing... Read More →
    MK

    Matthew Kumar

    Associate Director, Lead Computational Scientist, Bayer, Canada
    Matthew Kumar is a Lead Computational Scientist at Bayer within the Oncology Digitalization and Computational Sciences group, located in Mississauga, Ontario, Canada. Matthew brings with him over 10 years’ experience as a data scientist and statistician, spanning multiple areas... Read More →
    avatar for Melvin Munsaka

    Melvin Munsaka

    Senior Director, Head Safety Statistics, AbbVie, United States
    Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the... Read More →
    avatar for Neetu Sangari

    Neetu Sangari

    President/CEO, Pragya Tech Leaders, United States
    Dr. Neetu Sangari is an influential Data Analytics Pharma leader, contributing to the Pharma industry, driving change, simplification, and delivering value through innovation. She has over 18 years of Progressive experience in the Pharmaceutical Industry, Clinical Research Organizations... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Session

    3:30pm PDT

    #157: Be Creative and Innovative: A Simple Step-by-Step Process for You and Your Team
    Component Type: Workshop
    Level: Intermediate

    Steve Jobs. Elon Musk. Innovators who create new things or solve problems in new ways. But how do you be creative? How can a team come up with new development plans, trial designs, or enrollment strategies? Learn decision science’s proven process.

    Learning Objectives

    Recognize decision science mindset (expand versus contract, alternative versus value focused); Identify framing and re-framing techniques; Identify and clarify value criteria; Demonstrate value criteria to systematically develop creative solutions.

    Chair

    Tyler Ludlow, MBA


    Speakers
    avatar for Tyler Ludlow

    Tyler Ludlow

    Founder and Chief Decision Scientist, Decision Skills Institute, United States
    Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Workshop

    3:30pm PDT

    #151: Elevate Leadership: Harnessing the Five Superpowers
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-550-L04-P; CME 1.00; PDU 1.00 PMI 2166LI6KQZ; RN 1.00

    Embark on a transformative journey to unlock leadership superpowers! Discover the secrets to excel, empower, and inspire. Challenge perceptions and unleash your inner leadership superhero with engaging discussions, and real-world examples.

    Learning Objectives

    Discuss ethical leadership's impact on culture and success; Describe how to empower teams for self-organization and ownership; Identify how to cultivate a culture of continuous learning and foster team connection, diversity, and inclusion; Determine how to nurture growth for team members' personal and professional thriving.

    Chair

    Vidya Narayanaswamy, MBA, MSc

    Speaker

    Elevate Leadership: Harnessing the Five Superpowers
    Vidya Narayanaswamy, MBA, MSc

    Industry Update
    Sushma D.A. Hallock, MBA



    Speakers
    avatar for Vidya Narayanaswamy

    Vidya Narayanaswamy

    Consultant, IPM, United States
    Vidya Narayanaswamy is a consultant at Integrated Project Management (IPM). She is a seasoned Project Manager with an MBA specializing in Leadership and Management from the University of Laverne and a Specialization in Strategic leadership and Management from University of Illinois... Read More →
    avatar for Sushma D.A. Hallock

    Sushma D.A. Hallock

    Project Management and Operations, Biogen, United States
    Dr. Sushma D.A. Hallock is an expert at The Art of Relationships, believing leadership stems from a balance between the mind, body, and spirit. She holds an MBA in Health Sector Management & Leadership and Organizational Transformation from Questrom School of Business and a Master’s... Read More →


    Monday June 17, 2024 3:30pm - 4:30pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Session |   07: ProjectManagement-StrategicPlanning, Session

    4:45pm PDT

    #158 IT: InSilicoTrials Technologies Innovation Theater
    Component Type: Session



    Chair

    InSilicoTrials


    Speakers

    Monday June 17, 2024 4:45pm - 5:15pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    4:45pm PDT

    #160 IT: Certara Innovation Theater: Technology-Enabled Writing - Use CoAuthor™ as your Fully Integrated GenAI Medical Writing Platform
    Component Type: Session

    CoAuthor™ is the ultimate solution for fast-tracking drug development timelines and improving efficiency in the content generation process. Our AI-powered authoring platform combines the capabilities of Structured Content Authoring and Generative Artificial Intelligence to automate repetitive tasks and streamline the content generation process.
    With CoAuthor, writers can integrate data directly into documents, ensuring consistency and traceability while using a GenAI assistant to accelerate content generation from complex data inputs. The latest enhancements include the ability to create custom document templates and the application of style guides, providing a seamless integrated experience using MS Word. CoAuthor is the ultimate companion tool that can help you achieve your goals with ease and confidence. Trust in CoAuthor to improve your document quality, increase efficiency, and adhere to industry best practices and lean authoring techniques.

    Chair

    Certara

    Speaker

    Speaker
    Demetrius Carter, MBA



    Monday June 17, 2024 4:45pm - 5:15pm PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
     
    Tuesday, June 18
     

    7:00am PDT

    Coffee and Light Refreshments
    Component Type: Social Event




    Tuesday June 18, 2024 7:00am - 8:00am PDT
    Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    8:00am PDT

    #201: Considerations for Identification of Drug-Induced Liver Injury
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-556-L04-P; CME 1.00; RN 1.00

    Identification of drug-induced liver injury (DILI) is hindered by the lack of a structured, standardized approach to its identification and evaluation. This leads to inefficiencies for both sponsors and regulators. Guidance related to data submission for DILI evaluation can improve the efficiency of regulatory review, for example, by reducing the number of information requests sent by the FDA to industry sponsors. Ultimately, improved strategies for DILI data gathering and submission will also improve the accuracy of DILI risk assessment. This session will provide an in-depth discussion of the challenges for reviewing clinical data and suggest potential strategies to improve the DILI identification process. Topics that will be covered include (1) regulatory guidance on structured DILI data submission, (2) how interactive data visualizations tools can enhance the ability to detect potential cases of DILI and (3) the approach to populations with elevated transaminases at baseline and why the modified eDISH (mDISH) approach has important limitations.

    Learning Objectives

    Describe the regulatory guidance for how to submit structured data pertaining to drug-induced liver injury (DILI) data; Discuss how to utilize interactive visualization tools to identify potential cases of DILI; Identify the challenges for detecting DILI when liver tests are abnormal at baseline.

    Chair

    James Buchanan, PharmD

    Speaker

    Regulatory Guidances for Submitting Structured DILI Data
    Y. Veronica Pei, MD, MEd, MPH

    Use of Interactive Visualization Tools to Identify Potential Cases of DILI
    James Buchanan, PharmD

    Addressing the Challenges of DILI Detection in Clinical Trials with Abnormal Baseline Liver Tests
    Paul Hayashi, MD, MPH



    Speakers
    avatar for James Buchanan

    James Buchanan

    President, Covilance LLC, United States
    Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →
    avatar for Paul Hayashi

    Paul Hayashi

    Physician Lead, DILI Team, Division of Hepatology and Nutrition,OND, CDER, FDA, United States
    I am Physician Lead, DILI Team, FDA. I got my BA in microbiology at UCLA and MD at UC San Diego. After residency and gastroenterology training at UC Davis, I completed a research fellowship at the NIH and a transplant fellowship at the University of Colorado. I received an MPH at... Read More →
    avatar for Y. Veronica Pei

    Y. Veronica Pei

    Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States
    Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    8:00am PDT

    #202: Behavioral and Educational Strategies for Avoiding Falsified Medicine Exposure (BE SAFE)
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-557-L04-P; CME 1.00; RN 1.00

    Counterfeit drugs are important public health concern that impact both developed and LMICs. The session is to understand the current landscape and global impact of these and hear from industry, regulators and others on best approaches to address this

    Learning Objectives

    Discuss the significance and current landscape of counterfeit (falsified) medicines; Describe the economic, socio-economic and pervasive health threats to the global population from counterfeit products; Identify the current interventions implemented by regulators, industry, policy makers to combat this; Recognize new approaches to develop more focused programs that address the root cause.

    Chair

    Lubna Merchant, PharmD, MS

    Speaker

    Academic Update
    Saifuddin Ahmed, MD, PhD

    WHO Update
    Rutendo Kuwana, RPh

    FDA Update
    Sangeeta Chatterjee

    Patient Perspective
    Regina Mariam Kamoga, MPA



    Speakers
    avatar for Lubna Merchant

    Lubna Merchant

    Director, Risk Management Center of Excellence, Pfizer Inc , United States
    Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence... Read More →
    SA

    Saifuddin Ahmed

    Professor, Department of Population, Family, and Reproductive Health, Johns Hopkins University, United States
    SC

    Sangeeta Chatterjee

    Deputy Office Director, Office of Drug Security, Integrity, Response, OC, CDER, FDA, United States
    avatar for Regina Mariam Kamoga

    Regina Mariam Kamoga

    Executive Director, Community Health And Information Network ( CHAIN), Uganda
    She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →
    RK

    Rutendo Kuwana

    Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland
    Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Forum
    • Format Forum
    • Level Basic
    • Level Basic
    • Credit Type ACPE, CME, RN
    • Tags Forum

    8:00am PDT

    #203: Feasible Site Feasibility Assessments: Rethinking Business as Usual to Reduce Burden, Timelines, and Costs for Sustainability
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-558-L04-P; CME 1.00; RN 1.00

    In 2021, recommendations to reduce site feasibility assessment burdens was released.. Current industry and CRO methods remain costly and inefficient, and delay trial start-up and patient access to clinical trials.

    Learning Objectives

    Describe the impact of non-standardized study feasibility assessments across the industry; Discuss opportunities and solutions around improvements to the site feasibility assessment process; Apply new methods to streamline feasibility assessments and improve study start-up timelines.

    Chair

    Trevor Joseph Cole, MBA, RN, PMP

    Speaker

    Panelist
    Kristen Ballesteros, PhD, MS

    Panelist
    Suanna S. Bruinooge, MPH

    Panelist
    Ramya Thota



    Speakers
    avatar for Trevor Cole

    Trevor Cole

    Associate Director, WCG, United States
    Trevor Cole is currently an Associate Director at WCG Clinical. Trevor has a bachelor’s degree in health science, an MBA in healthcare management and project management, and is a registered nurse, certified research coordinator, and certified project management professional. Trevor's... Read More →
    KB

    Kristen Ballesteros

    Associate Director, Feasibility Strategy, Thermo Fischer Scientific, PPD, United States
    Dr. Ballesteros is an expert in feasibility strategy, with a focus in hematology and oncology over the last 7 years. Her current role encompasses data curation and analysis to support operational strategy, including a key role in site identification. As PPD's Feasibility SME for diversity... Read More →
    avatar for Suanna Bruinooge

    Suanna Bruinooge

    Chief and Division Director, Research Strategy and Operations Center, American Society of Clinical Oncology, United States
    Suanna Bruinooge, MPH, is the Chief and Division Director of Research Strategies and Collaborations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates and analyzes oncology data to foster innovation in research and patient care and help develop evidence related... Read More →
    avatar for Ramya Thota

    Ramya Thota

    Associate Professor, Intermountain Medical Oncology - IMC, United States
    Dr. Thota is a GI medical oncologist at Intermountain Health, Utah. She finished her subspecialty Hematology and Medical Oncology fellowship training from Vanderbilt University, Nashville, Tennessee. She receives research funding from American Cancer Society Clinician Scientist Development... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum

    8:00am PDT

    #204: Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-559-L04-P; CME 1.00; RN 1.00

    Neurological disorders are complex and multifaceted, with symptoms that can vary widely. Wearable sensors and digital health technologies enable objective collection of data at the patients' home, providing unprecedented ways for tracking diseases.

    This session will include presentations from several NIH-funded and Investigator-initiated studies focused on collecting digital measures of disease progression, including in patients with progressive supranuclear palsy, Parkinson disease, Alzheimer’s and ALS, and their potential impact on clinical trials and care for individuals with neurological disorders.

    Learning Objectives

    Demonstrate innovative wearable sensors and digital technologies capable of accurately detecting and monitoring neurological disease symptoms; Identify methods for seamlessly integrating wearable sensors with existing healthcare systems to ensure continuity of care.

    Chair

    Ashkan Vaziri, PhD

    Speaker

    NIH Update
    Yuan Luo, PhD

    Academic Update
    Bijan Najafi, PhD, MSc

    Industry Update
    Sharon Tamir

    Industry Update
    Ashkan Vaziri, PhD



    Speakers
    AV

    Ashkan Vaziri

    Co-founder and CEO, Biosensics LLC, United States
    Dr. Vaziri is a Founder and CEO of BioSensics, a biomedical firm focused on the development of wearable sensors and digital health platforms for clinical trials and research. Dr. Vaziri’s work presents a unique combination of academic research, product development, and small business... Read More →
    avatar for Yuan Luo

    Yuan Luo

    Program Director, AD/ADRD Biomarkers, Division of Neuroscience, National Institute on Aging, NIH, United States
    Dr. Yuan Luo is a Program Director of the Clinical Interventions and Diagnostics Branch in the Division of Neuroscience at National Institute on Aging, NIH. She oversees the Division’s technology portfolio, such as using wearable, sensors technology for early detection, monitoring... Read More →
    avatar for Bijan Najafi

    Bijan Najafi

    Professor of Surgery; Director, Clinical Research, Baylor College of Medicine, United States
    Dr. Bijan Najafi, Professor of Surgery at Baylor College of Medicine, specializes in digital health and biotechnologies. He's the Director of Clinical Research in Vascular Surgery and Co-Director of Center to Stream Healthcare in Place (C2SHIP). Recognized by Tucson Local Media in... Read More →
    ST

    Sharon Tamir

    Digital Healthcare Innovation, Business and Research Strategy, MT-Pharma, United States
    Sharon Tamir, Leading the Digital Healthcare Innovation team at MT-Pharma since Jan2023. Prior to that she worked as a VP Program Leader of the Neuro-oncology and the Myelofibrosis programs at Karyopharm Therapeutics. Sharon Brings over a decade of experience in drug development... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session

    8:00am PDT

    #205: Data Standards SOS: Reducing Burnout and Navigating Through Fatigue - Part 1
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-560-L04-P; CME 1.00; RN 1.00

    At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

    Learning Objectives

    Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

    Chair

    Venkatraman Balasubramanian, PhD, MBA

    Speaker

    Facilitator
    Sridevi Nagarajan, PhD

    Facilitator
    Norman Schmuff, PhD

    Facilitator
    Hilmar Hamann, PhD

    Facilitator
    Cesar Vinces

    Facilitator
    Vanni Carapetian, MPH

    Facilitator
    Heiner Oberkampf, PhD



    Speakers
    avatar for Venkatraman Balasubramanian

    Venkatraman Balasubramanian

    SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States
    V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →
    avatar for Vanni Carapetian

    Vanni Carapetian

    Director, Regulatory Data, Genentech, A Member of the Roche Group, United States
    Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
    avatar for Hilmar Hamann

    Hilmar Hamann

    Head of Information Management, European Medicines Agency, Netherlands
    Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →
    avatar for Sridevi Nagarajan

    Sridevi Nagarajan

    Head, Digital Regulatory Strategy, AstraZeneca , United Kingdom
    Bringing over two decades of experience, Sridevi Nagarajan is a seasoned strategic portfolio management professional is deeply rooted in data-driven approaches. The expertise lies in successfully steering digital transformations within the Pharmaceutical and Public Health sectors... Read More →
    avatar for Heiner Oberkampf

    Heiner Oberkampf

    CEO, ACCURIDS, Germany
    Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, which is a software for collaborative data standards implementation, that helps pharma companies, e.g., in the implementation of IDMP standards through a federated product data graph. With a group of pharma companies, he has... Read More →
    avatar for Norman Schmuff

    Norman Schmuff

    Associate Director for Science, OPMA, OPQ, FDA, United States
    Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives... Read More →
    avatar for Cesar Vinces

    Cesar Vinces

    EU Interim and International Policy Lead, Accumulus Synergy, United States
    Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Workshop

    8:00am PDT

    #206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-561-L04-P; CME 1.00; RN 1.00

    Integrating patient-experience data (PED) in medicines regulation for better patient-centered outcomes is a priority for medicines regulators, including the FDA and the EU network. The FDA’s program on patient-focused drug development (PFDD) has yielded 4 scientific guidelines on PED, while in the EU work is ongoing to produce a reflection paper outlining pathways for progress, marking an initial step toward smoother PED integration in medicine development. The session will present the US and EU's position in this regard and draw on the experience in applying existing guidance to date.

    Learning Objectives

    Describe the work done by FDA’s Patient-Focused Drug Development (PFDD) program on scientific guidelines on patient-experience data (PED), challenges and future outlook; Describe how work is progressing in the EU to foster the generation and use of patient-experience data in medicines regulatory decision-making.

    Chair

    Steffen Thirstrup, MD, PhD

    Speaker

    US Patient Representative
    Karin Hoelzer, DVM, PhD

    Co-Chair
    Robyn Bent, MS, RN

    EMA Update
    Juan Garcia-Burgos, MD, PhD

    EMA Update
    Rosa Gonzalez-Quevedo

    US Industry Representative
    Maria Apostolaros, JD, PharmD, MS, RPh



    Speakers
    avatar for Maria Apostolaros

    Maria Apostolaros

    Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
    Dr. Maria Apostolaros is currently a Senior Director of Science and Regulatory Advocacy at PhRMA, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to... Read More →
    avatar for Robyn Bent

    Robyn Bent

    Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
    Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →
    avatar for Juan Garcia-Burgos

    Juan Garcia-Burgos

    Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
    Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →
    RG

    Rosa Gonzalez-Quevedo

    Scientific Research Officer, European Medicines Agency, Netherlands
    KH

    Karin Hoelzer

    Senior Director, Policy and Regulatory Affairs, NORD, United States
    Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). She works closely with pharmaceutical and biotech partners to ensure public policy supports innovative approaches and new treatments, and adequately incorporates patient... Read More →
    avatar for Steffen Thirstrup

    Steffen Thirstrup

    Chief Medical Officer, European Medicines Agency, Netherlands
    Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session

    8:00am PDT

    #208: Good Data Governance Practices: Regulatory and Industry Perspectives
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-563-L04-P; CME 1.00; RN 1.00

    In this session, the speakers will emphasize the importance of involving data scientists in the identification of a critical to quality factor’s and will discuss implementation of risk proportionate processes and procedures related to these data governance procedures to address the risks to the critical to quality factors. The speakers will their perspectives related to good data governance practices and provide updates to policy related to data governance (e.g., ICH E6R3, ICH E8R1, 21 CFR part 11) and inspection case examples of clinical trials to illustrate the impact of poor data governance procedures.

    Learning Objectives

    Discuss the importance of good data governance practices; Identify a study’s critical to quality factors related to data governance processes and procedures; Discuss the importance of involving the data scientist in the identification of a study’s critical to quality factors; Describe inspection case examples to illustrate regulatory expectations for data governance and the use of technology in clinical trials.

    Chair

    Kassa Ayalew, MD, MPH

    Speaker

    Update from the Danish Medicines Agency
    Lisbeth Bregnhoj, PhD, MPharm

    Update from Industry
    Prasanna Rao

    Update from the FDA
    Cheryl Grandinetti, PharmD



    Speakers
    avatar for Kassa Ayalew

    Kassa Ayalew

    Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
    Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →
    avatar for Lisbeth Bregnhoj

    Lisbeth Bregnhoj

    Medicines Inspector, GCP, Danish Medicines Agency (DKMA), Denmark
    Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth... Read More →
    avatar for Cheryl Grandinetti

    Cheryl Grandinetti

    Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
    Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
    avatar for Prasanna Rao

    Prasanna Rao

    Global Head, Artificial Intelligence and Machine Learning, Pfizer Inc, United States
    Prasanna Rao is an AI practitioner and Industry Thought Leader whose current role is the Head of Artificial Intelligence and Data Science for Data Management and Monitoring at Pfizer. He has over 25 years of experience in Information technology and Analytics, with 10 years in Healthcare... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Session

    8:00am PDT

    #209: Leveraging New Meeting Opportunities in PDUFA VII: Experiences with Type D and INTERACT
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-564-L04-P; CME 1.00; RN 1.00

    This forum will address experience to date with new meeting types included in PDUFA VII, including Type D and INTERACT. Forum participants will evaluate successes, opportunities for improvement, and discuss how learnings can be shared.

    Learning Objectives

    Evaluate experiences to date with Type D and INTERACT meetings included in PDUFA VII; Identify opportunities to improve implementation of new meeting types to promote innovation and optimize FDA-Sponsor Interactions.

    Chair

    Victoria A. Dohnal, RAC

    Speaker

    Industry Update
    Victoria A. Dohnal, RAC

    FDA Update
    Christy L. Cottrell

    FDA Update
    Adriane Fisher, MBA, MPH

    Industry Update
    Alex May, MS



    Speakers
    avatar for Christy Cottrell

    Christy Cottrell

    Chief, Project Management Staff,, ORO, DROOD, CDER, FDA, United States
    Christy Cottrell is a Chief Project Manager in the FDA's Office of New Drugs, Division of Regulatory Operations for Oncologic Diseases. She co-leads a team of Regulatory Project Managers who support the Division of Oncology 1 which handles the review of drugs and biologics for reproductive... Read More →
    avatar for Victoria Dohnal

    Victoria Dohnal

    Director, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
    Victoria Dohnal is currently Director, Global Regulatory Policy and Intelligence at Johnson and Johnson (J&J) where she is responsible for driving US regulatory intelligence and policy work related to rare diseases, patient focused drug development, cell and gene therapies, and PDUFA... Read More →
    AF

    Adriane Fisher

    Regulatory Project Manager, OTP, CBER, FDA, United States
    Adriane Fisher joined the FDA as a Regulatory Project Manager in September 2018, where she has provided review management throughout the product life cycle, from pre-submission meetings to post-marketing submissions. As an RPM, Adriane also acts as the liaison between FDA and industry... Read More →
    AM

    Alex May

    North America Lead - Regulatory Science, Policy, & Intelligence, District of Columbia, United States
    Alex May leads regulatory policy, science, & intelligence for North America and global regulatory policy efforts on plasma at CSL Behring. He serves as co-chair on BIO's Meetings Task Force and NORD's Regulatory Affairs Working Group. Previously, Alex was a Director of Science & Regulatory... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    8:00am PDT

    #210: Digital Biomarkers as Clinical Endpoints: The Road to Regulatory Acceptability
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-565-L04-P; CME 1.00; RN 1.00

    This forum will review the current regulatory paradigms for the use of digital biomarkers as endpoints in clinical trials in the US and EU. A panel of experts will discuss validation pathways and compare regulatory approaches between regions.

    Learning Objectives

    Describe the V3 process (verification, analytical validation, clinical validation) for validating digital health technologies as fit-for-purpose in a clinical trial; Identify validation pathways in the US and EU; Discuss outstanding challenges to the use of digital health technologies for remote data capture in clinical trials.

    Chair

    Lina AlJuburi, PharmD, MSc

    Speaker

    Enhancing Clinical Research in Europe: Navigating the Regulatory Landscape
    Max Wegner, PharmD, RPh

    Panelist
    Anindita Saha

    Industry Perspective
    Steve Berman, MPH

    Industry Update
    Gul Erdemli, MD, PhD



    Speakers
    avatar for Lina AlJuburi

    Lina AlJuburi

    Head, Global Regulatory Science and Policy - North America, Sanofi, United States
    A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
    avatar for Steve Berman

    Steve Berman

    Deputy Vice President, Science and Regulatory Affairs, BIO, United States
    Steve Berman serves as Deputy VP of Science and Regulatory Strategy for the Biotechnology Innovation Organization (BIO). Steve joined BIO after serving as a Director, Translational Regulatory Affairs, at AstraZeneca. Steve joined AZ after eight years at FDA, working in both CDER and... Read More →
    avatar for Gul Erdemli

    Gul Erdemli

    Global Program Regulatory Director, Novartis Pharmaceuticals Corporation, United States
    Gül Erdemli is a Global Program Regulatory Director at Novartis Regulatory Affairs Early Development. She is a drug development leader with more than 15 years industry experience from target identification to clinical development. She has an MD degree from Hacettepe University, Medical... Read More →
    avatar for Anindita Saha

    Anindita Saha

    Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States
    Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →
    avatar for Max Wegner

    Max Wegner

    Head Regulatory Affairs, Bayer AG, Germany
    After studying pharmacy at the University of Bonn, Max Wegner commenced his PhD in pharmacology at Bayer and started in Regulatory Affairs as a Dossier Manager in 1996 in Wuppertal. Since then, Max has been employed in various functions within Product Development at Bayer and also... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    8:00am PDT

    #211: PMDA Town Hall
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-566-L04-P; CME 1.00; RN 1.00

    PMDA strives and implements various supports to promote regulatory sciences and accelerate product developments based on “4Fs” concept of priorities. In this session, PMDA will share the latest information on its policies and initiatives.

    Learning Objectives

    Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Describe how to develop medical products in Japan; Discuss issues on medical products regulation with senior PMDA officials.

    Chair

    Daisuke Tanaka, PhD

    Speaker

    Panelist
    Daisuke Koga, MSc, RPh

    Panelist
    Yoshiaki Uyama, PhD, RPh



    Speakers
    avatar for Daisuke Tanaka

    Daisuke Tanaka

    Office Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Tanaka joined the Ministry of Health, Labour and Welfare (MHLW) in April 2001 and was involved in orphan drug designation and new drug approval as well as amendment of the Pharmaceutical Affairs Law. Subsequently, he worked in several organisations including European Medicines... Read More →
    avatar for Daisuke Koga

    Daisuke Koga

    Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
    Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices... Read More →
    avatar for Yoshiaki Uyama

    Yoshiaki Uyama

    Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    8:00am PDT

    #212: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-567-L04-P; CME 1.00; RN 1.00

    The session will provide an update on ICMRA's Pharmaceutical Quality Knowledge Management project, including an overview of learnings from the pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities.

    Learning Objectives

    Describe the various workstreams of the ICMRA PQKM project, and their potential to support increased regulatory convergence and reliance with regards to product quality assessments and inspections; Summarise learnings arising from the ICMRA pilots on collaborative assessment of post-approval changes and hybrid inspections; Discuss potential for expansion and operationalization of the pilots.

    Chair

    Theresa Mullin, PhD

    Speaker

    Collaborative Assessment Pilot: Regulators’ Perspective
    Sau L Lee, PhD

    Collaborative Assessment Pilot: Regulators’ Perspective
    Sean Barry, PhD

    Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
    Stelios Tsinontides, PhD, MA

    Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
    Brendan Cuddy, MSc

    Pilot Programs: Industry's Perspective
    Susanne Ausborn, PhD

    Pilot Programs: Industry's Perspectives
    Srivdya Srikant, MS

    Panel Discussion: Pilot Programs
    Evdokia Korakianiti, PhD, MSc

    Panel Discussion: Pilot Programs
    Yasuhiro Kishioka, PhD



    Speakers
    avatar for Susanne Ausborn

    Susanne Ausborn

    Global Head International Regulatory Policy, Roche, Switzerland
    Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
    avatar for Sean Barry

    Sean Barry

    Executive Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
    Dr Barry is an Executive Pharmaceutical assessor at the HPRA and a member of the EMA BMWP and an alternate member of the EMA BWP. His regulatory expertise includes evaluation of quality/CMC data of new product applications, scientific advice, variations and clinical trials for biological... Read More →
    avatar for Brendan Cuddy

    Brendan Cuddy

    Lead Scientific Officer, European Medicines Agency, Netherlands
    Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP... Read More →
    avatar for Yasuhiro Kishioka

    Yasuhiro Kishioka

    Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →
    avatar for Evdokia Korakianiti

    Evdokia Korakianiti

    Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
    avatar for Sau Lee

    Sau Lee

    Deputy Super Office Director, OPQ, CDER, FDA, United States
    Sau (Larry) Lee is a Senior Biomedical Research Scientist (SBRS). He is a Deputy Director of the Office of Testing and Research in the Office of Pharmaceutical Quality (OPQ), and the chair of the OPQ Emerging Technology Team. He is leading the effort in advancing OPQ research and... Read More →
    avatar for Theresa Mullin

    Theresa Mullin

    Associate Center Director - Strategic Initiatives, CDER, FDA, United States
    Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
    avatar for Srivdya Srikant

    Srivdya Srikant

    Director, Global Regulatory Affairs- CMC, Gilead Sciences, United States
    Srividya (Vidya) Srikant is a Director in Regulatory CMC (RA CMC) at Gilead Sciences Inc. Prior to joining Gilead Sciences, Vidya spent over 20 years with other pharmaceutical companies including Genzyme, Takeda, and GSK. She has extensive experience in CMC developing, managing, and... Read More →
    avatar for Stelios Tsinontides

    Stelios Tsinontides

    Office Director, OPMA, OPQ, CDER, FDA, United States
    Dr. Stelios Tsinontides is the Office Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA). OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Session

    8:00am PDT

    #213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-568-L04-P; CME 1.00; RN 1.00

    Advanced cancers pose a dilemma between evidentiary requirements and speedy access to innovative agents. We present the results of a survey with regulators and discuss factors that influence acceptability of real-world data and possible optimal submission strategies.

    Learning Objectives

    Describe the challenges of drug development with evidence using external controls; Discuss regulators’ attitudes about real-world evidence and opportunities for addressing the challenges; Identify strategies using real-world evidence to maximize impact on the regulatory decision.

    Chair

    Francesco Pignatti, MD

    Speaker

    Real-World Data to Support Benefit-Risk Assessment: Regulatory Perspective
    Douwe Postmus, PhD, MSc

    External Comparators Using Real-World Data: Results of a Simulation Study
    Gerd Rippin, DrSc

    The Role and Impact of Real-World Data in Cancer Drug Applications
    Catherine C. Lerro, PhD, MPH



    Speakers
    avatar for Catherine Lerro

    Catherine Lerro

    Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States
    Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Scientific Adviser for Oncology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    avatar for Douwe Postmus

    Douwe Postmus

    Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands
    Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →
    avatar for Gerd Rippin

    Gerd Rippin

    Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany
    Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Session

    8:00am PDT

    #214: Unlocking Artificial Intelligence's Latest Development: Chat GPT for Beginners
    Component Type: Workshop
    Level: Basic

    Join our beginner-friendly Chat GPT workshop! Designed to provide both an overview and hands-on experience, this session will delve into the fundamentals of ChatGPT technology. From understanding its underlying principles to practical applications, participants will gain insight into AI-driven conversations. Through interactive demonstrations and guided exercises, attendees will get firsthand experience in leveraging ChatGPT's capabilities. Whether you're new to AI or seeking practical insights, this session promises to equip you with valuable knowledge and skills

    Learning Objectives

    Describe the basics of artificial intelligence, large language models, and ChatGPT; Identify with using hands-on experience by interacting with ChatGPT through guided exercises; Discuss best practices for interacting with the technology as well get an overview of ethical considerations and potential limitations of ChatGPT technology; Assess the impact its already creating in pharma R&D, and what are the use cases that you can get started with.

    Chair

    Ankush Chandna, MSc

    Speaker

    Facilitator
    Anjali Shah, PharmD

    Facilitator
    Ankush Chandna, MSc



    Speakers
    AC

    Ankush Chandna

    Data Science Lead, Research and Development Excellence, ZS Associates , United States
    avatar for Anjali Shah

    Anjali Shah

    Executive Director, Business Capabilities and Innovation, WWPS, Bristol-Myers Squibb Company, United States
    Anjali Shah, PharmD has 15+ years experience in the biopharmaceutical industry in a variety of therapeutic, operational and leadership roles across Medical Affairs and Patient Safety. Inspired by the opportunity to enable safe and informed use of medicines, Anjali is currently involved... Read More →


    Tuesday June 18, 2024 8:00am - 9:00am PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Workshop

    9:00am PDT

    Coffee Break
    Component Type: Social Event
    Meet with your colleagues to plan your day and/or discuss what you learned the previous day, all while networking with other attendees.



    Tuesday June 18, 2024 9:00am - 10:00am PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    9:15am PDT

    #215 IT: Clario Innovation Theater: Responsibly Advancing the Use of Artificial Intelligence (AI) in Clinical Trials - Current Landscape, Common Misconceptions, and Future Opportunities
    Component Type: Session

    AI can help optimize operations, strengthen patient privacy, and improve data quality while reducing risks of human error in clinical trials. However, AI must be used responsibly and governed by the highest ethical principles with regard for data privacy and reducing bias in algorithm performance. Delve into the transformative role of AI in clinical trials: current industry status, common misconceptions, proactively tackling bias and navigating the evolving regulatory landscape.

    Chair

    Clario

    Speaker

    Speaker
    Todd Rudo, MD

    Speaker
    Gaurav Josan

    Speaker
    Lauren Misztal

    Speaker
    Brian Dolan



    Speakers
    avatar for Clario

    Clario

    United States
    avatar for Gaurav Josan

    Gaurav Josan

    Senior Vice President, R&D, Clario, United States
    Gaurav Josan leads the R&D team at Clario as Sr. Vice President focused on innovation and next generation technology solutions including AI capabilities. She has more than 2 decades of experience working in the Clinical Trials space leading strategic technology initiatives. She is... Read More →
    avatar for Lauren Misztal

    Lauren Misztal

    SVP, General Counsel, Clario, United States
    Lauren is a business-oriented and solutions-driven legal advisor who draws on close to two decades of experience successfully resolving complex legal and regulatory issues. As Clario’s General Counsel, Lauren focuses on setting the Company’s global legal strategy and leads teams... Read More →
    avatar for Todd Rudo

    Todd Rudo

    EVP & Chief Medical Officer, Clario, United States
    Dr. Rudo provides medical and scientific leadership at Clario. He is passionate about leveraging scientific resources to support customer success with focused efforts on developing expertise across a range of therapeutic areas. His team provides expert consulting on scientific and... Read More →
    avatar for Brian Dolan

    Brian Dolan

    Vice President Artificial Intelligence and Machine Learning, Fortrea, United States
    Brian is a mathematician, inventor and cyberneticist with decades of experience building enterprise grade artificial intelligence products. Equally comfortable in product, sales and technology roles, he excels at translating complex business problems into tractable mathematical solutions... Read More →


    Tuesday June 18, 2024 9:15am - 9:45am PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    9:15am PDT

    #216 IT: Zelta by Merative Innovation Theater: Revolutionizing Research - The Impact of Machine Learning and Automation in eClinical Platforms
    Component Type: Session

    Getting the most out of AI in clinical data management means deploying it strategically with the goal of maximum, measurable outcomes. This presentation will delve into what these solutions look like when effectively scaled and applied; why traditional machine learning is more suited to driving ROI in your operations than generative AI; and how Zelta’s integrated ML models, analytics, and automation tools are helping to drive new efficiencies in clinical trials.

    Chair

    Merative


    Speakers
    avatar for Merative

    Merative

    United States


    Tuesday June 18, 2024 9:15am - 9:45am PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    9:15am PDT

    #217 IT: Lokavant Innovation Theater: Prescriptive Study Planning: Optimizing Clinical Trials for Time Efficiency, Cost Savings, and Quality
    Component Type: Session

    Explore the power of prescriptive analytics in clinical trial planning and feasibility. Learn how Lokavant's innovative approach can prescribe the next best course of action to help refine and optimize study parameters that predict timelines, control costs, and improve quality.

    Chair

    Lokavant

    Speaker

    Speaker
    Rohit Nambisan



    Speakers
    avatar for Lokavant

    Lokavant

    United States
    avatar for Rohit Nambisan

    Rohit Nambisan

    CEO & Co-Founder, Lokavant, United States
    Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most... Read More →


    Tuesday June 18, 2024 9:15am - 9:45am PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    10:00am PDT

    #218: Long-Term Safety of Approved Medicines: Approaches for Identifying, Characterizing, and Quantifying Delayed Adverse Events
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-569-L04-P; CME 1.00; RN 1.00

    This forum will hear from regulators, industry, vendors, and the academic community on how each has approached the generation of long-term safety data on a hypothetical approved medicine with a risk of delayed adverse events.

    Learning Objectives

    Compare strengths and weaknesses of different approaches for evaluating long-term safety particularly when delayed adverse events are a potential risk; Identify fit-for-purpose, longitudinal data sources to answer regulator research objectives for long-term follow-up studies.

    Chair

    Steven M. Weisman, PhD

    Speaker

    Panelist
    Claudia A Salinas, PhD

    Panelist
    Naomi Boxall, PhD

    Panelist
    Vera Ehrenstein, DrSc, MPH

    Panelist
    Gerald Dal Pan, MD, MHS



    Speakers
    avatar for Steven Weisman

    Steven Weisman

    Global President, Clinical and Regulatory, Lumanity Inc, United States
    Over the years, Dr. Weisman has built a stellar reputation as a regulatory and medical affairs consultant helping clients achieve productive relationships with regulatory authorities in the United States and around the world. Dr. Weisman has played a pivotal role working on important... Read More →
    avatar for Naomi Boxall

    Naomi Boxall

    General Manager, PHARMO Institute, Netherlands
    Naomi is General Manager at PHARMO and INSZO and is accountable for a portfolio of RWE projects using health data from various sources to support drug development and commercialization for global life science sector. With over 20yrs experience from a breadth of epidemiology topics... Read More →
    avatar for Vera Ehrenstein

    Vera Ehrenstein

    Professor, Department of Clinical Medicine, Dept of Clinical Epidemiology, Aarhus University, Denmark
    Vera Ehrenstein is professor of pharmacovigilance at the Department of Clinical Epidemiology, Aarhus University, Denmark. She has more than 20 years' experience as an epidemiologist, including more than 15 years' experience leading multinational postauthorisation safety studies of... Read More →
    avatar for Gerald Dal Pan

    Gerald Dal Pan

    Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
    Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →
    CS

    Claudia Salinas

    Senior Director, GPS Pharmacoepidemiology, Eli Lilly and Company, United States
    Dr. Salinas is a pharmacoepidemiologist, with a doctorate in Epidemiology from the University of Washington, currently working in late stage and postmarketing clinical development at Eli Lilly and Company. She has expertise in real-world data analysis and causal inference focusing... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Forum

    10:00am PDT

    #219: How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-570-L04-P; CME 1.00; RN 1.00

    This workshop will discuss how to combine FDA medical queries (FMQs) and standardized MedDRA queries with study data, as well as how to compare them through interactive figures and tables. It will also discuss how to interpret the algorithmic FMQs.

    Learning Objectives

    Describe how to apply the FDA Medical Queries (FMQs) Excel file and the Standardized Medical Queries (SMQs)ASCII files to a given study trial by combining it with study data; Create interactive figures and tables to analyze the medical queries for a study and compare them for FMQs and SMQs.

    Chair

    Rebecca Lyzinski, MS

    Speaker

    How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics
    Rebecca Lyzinski, MS

    How to Compare FDA Medical Queries and Standardized MedDRA Queries with Interactive Graphics
    Scott Proestel, DrMed, MD



    Speakers
    avatar for Rebecca Lyzinski

    Rebecca Lyzinski

    Senior Software Developer, JMP Statistical Discovery, United States
    Rebecca Lyzinski is a Clinical Research Developer in the JMP Life Sciences group where she develops new reports and analyses for JMP Clinical software. Before joining JMP, Rebecca worked in statistical programming for the pharmaceutical industry. She was a Manager of statistical programming... Read More →
    avatar for Scott Proestel

    Scott Proestel

    Senior Medical Officer, ODES, OND, CDER, FDA, FDA, United States
    Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Workshop

    10:00am PDT

    #220: Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-571-L04-P; CME 1.00; RN 1.00

    Many rare diseases share the same underlying molecular etiology that are therapeutically targetable. Basket trial design based on molecular etiology enables more patients to gain access to clinical trials and accelerate identification of new therpies

    Learning Objectives

    Recognize the potential of basket trial design in rare disease; Apply basket trial design in rare diseases with share molecular etiologies.

    Chair

    David Andrew Pearce, PhD

    Speaker

    Shared Platforms Approaches/Technologies for Rare Diseases
    Philip (P.J.) Brooks, PhD

    Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases
    Christina Waters, PhD, MBA



    Speakers
    avatar for David Pearce

    David Pearce

    President of Innovation and Research/Chair International Rare Disease Research, Sanford Health, United States
    David Pearce is President of Innovation & Research for Sanford Health. He completed his undergraduate Bachelor of Science Degree with honors in biological sciences at Wolverhampton Polytechnic in 1986. He gained his PhD in 1990 at the University of Bath, UK Dr. Pearce has been researching... Read More →
    avatar for Philip (P.J.) Brooks

    Philip (P.J.) Brooks

    Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
    Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →
    CW

    Christina Waters

    Chief Executive Officer and Founder, RARE Science, Inc., United States
    Dr. Christina Waters has been responsible for leading medical research in a broad range of organizations ranging from academia and disease – focused non-profits to biotech and large pharmaceutical companies. Her broad range of experience in basic, translational and clinical research... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum

    10:00am PDT

    #222: External Control Arms at Scale: Multicenter, Multisource Infrastructure for External Control Arms
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-573-L04-P; CME 1.00; RN 1.00

    The speakers will discuss how to enable external control arms (ECAs) at scale. The session will shed light on how to overcome the scalability and quality challenges of real-world data preparation to scale up ECAs from ad hoc projects to enterprise-level machinery for pharmaceutical clinical development function. It will also include ongoing work to create enterprise infrastructure for high-quality evidence generation using ECAs, including selected results from multicenter ECAs in several therapeutic areas.

    Learning Objectives

    Explore strategies to address the inherent challenges of real-world data (RWD) preparation at scale for external control arms (ECAs), including data scalability and quality; Describe how to transition from ad hoc ECA projects to an enterprise-level approach that ensures data quality, processing efficiency, and trustworthiness in analytical results for pharma clinical development.

    Chair

    Mayur Saxena, PhD

    Speaker

    Industry Update
    Jussi Leinonen

    Industry Update
    Victoria Chia, PhD, MPH

    Industry Update
    Weili He, PhD



    Speakers
    avatar for Mayur Saxena

    Mayur Saxena

    Chief Executive Officer, Droice Labs, United States
    As an entrepreneur and scientist, Mayur has concentrated on advancing medicine with high-noise, big data analysis. Before founding Droice, he played key roles in several startups, including co-founding a biotechnology firm in the diabetes space. He earned his BTech at IIT Kanpur and... Read More →
    avatar for Victoria Chia

    Victoria Chia

    Executive Director, Center for Observational Research, Amgen Inc, United States
    Victoria Chia has 15+ years of experience at Amgen Inc as a pharmacoepidemiologist. She currently leads the oncology therapeutic area in the Center for Observational Research. She has worked on oncology and neurology products, supporting multiple products through the product lifecycle... Read More →
    avatar for Weili He

    Weili He

    Volwiler Distinguished Research Fellow; Head, Global Medical Affairs Statistics, AbbVie, United States
    Dr. Weili He is a Senior Director, head of Global Medical Affairs Statistics at AbbVie Inc. Prior to AbbVie, she worked at Merck & Co., Inc. for over 20 years. Weili has published extensively in the areas of adaptive designs (AD), benefit-risk assessment (BRA), and RWE methodology... Read More →
    JL

    Jussi Leinonen

    Strategic Project Lead, Bayer , Finland


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum

    10:00am PDT

    #223: Challenges in Exceeding the Quality of Existing Endpoints and Approaches Using Digital Tools
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-574-L04-P; CME 1.00; RN 1.00

    This forum will discuss how novel technologies provide the means to measure new endpoints and can assess existing endpoints in new ways. Regulatory models are needed to encourage the acceptance of these novel approaches.

    Learning Objectives

    Identify a clear understanding of regulatory frameworks surrounding digital endpoints; Describe the challenges that may arise when a new tool can measure endpoints more effectively than existing tools; Discuss how to build regulator confidence in novel endpoints and tools.

    Chair

    Rob Berlin, JD, MPH

    Speaker

    FDA Perspective
    Jeffrey Nahum Siegel, DrMed, MD

    Industry Perspective
    Julie Tai, PhD

    Industry Perspective
    Lauren Oliva, PharmD, RPh

    Industry Perspective
    Rasika Kalamegham, PhD

    EMA Update
    Steffen Thirstrup, MD, PhD



    Speakers
    avatar for Rob Berlin

    Rob Berlin

    Head, US Regulatory Policy, GlaxoSmithKline, United States
    Rob Berlin is Head of U.S. Regulatory Policy at GlaxoSmithKline (GSK). Rob leads a team focused on driving U.S. regulatory policy, advocacy, and intelligence activities, to ensure optimal advancement and lifecycle management of GSK’s product portfolio. Rob came to GSK from the FDA... Read More →
    RK

    Rasika Kalamegham

    Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
    Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →
    avatar for Lauren Oliva

    Lauren Oliva

    US Lead, Global Regulatory Policy, Biogen, United States
    Lauren Oliva is US lead for Global Regulatory Policy at Biogen. She oversees the development and execution of R&D’s policy roadmap to advance Biogen’s neuroscience and rare disease portfolio. She is passionate about patient centric drug development and the impact of multi-stakeholder... Read More →
    avatar for Jeffrey Siegel

    Jeffrey Siegel

    Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States
    Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →
    JT

    Julie Tai

    Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States
    avatar for Steffen Thirstrup

    Steffen Thirstrup

    Chief Medical Officer, European Medicines Agency, Netherlands
    Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    10:00am PDT

    #224: Data Standards SOS: Reducing Burnout and Navigating through Fatigue - Part 2
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-575-L04-P; CME 1.00; RN 1.00

    At the DIA 2023 a round table on data standards and harmonization discussed “standards fatigue” related to data standards, reference models, consortia, industry groups, and their impact on the industry. We intend to address this topic in a two-part workshop.

    Learning Objectives

    Identify various data standards and harmonization efforts across pharma and biotech industries; Discuss challenges and business impact related to the understanding, implementation, and maintenance of data standards initiatives in light of digital transformation efforts; Describe approaches to identify overlapping/competing initiatives and develop synergistic approaches to reduce fatigue.

    Chair

    Venkatraman Balasubramanian, PhD, MBA

    Speaker

    Facilitator
    Sridevi Nagarajan, PhD

    Facilitator
    Heiner Oberkampf, PhD

    Facilitator
    Vanni Carapetian, MPH

    Facilitator
    Hilmar Hamann, PhD

    Facilitator
    Norman Schmuff, PhD

    Facilitator
    Cesar Vinces



    Speakers
    avatar for Venkatraman Balasubramanian

    Venkatraman Balasubramanian

    SVP and Global Head, Industry Solutions - Healthcare and Life Sciences, Orion Innovation, United States
    V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience... Read More →
    avatar for Vanni Carapetian

    Vanni Carapetian

    Director, Regulatory Data, Genentech, A Member of the Roche Group, United States
    Vanni brings nearly 20 years of life sciences and technology expertise drawn from team and leadership roles at Roche, J&J, and Amgen. Their experience spans clinical development, manufacturing, and regulatory and their principal interest lies in setting and executing strategies that... Read More →
    avatar for Hilmar Hamann

    Hilmar Hamann

    Head of Information Management, European Medicines Agency, Netherlands
    Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →
    avatar for Sridevi Nagarajan

    Sridevi Nagarajan

    Head, Digital Regulatory Strategy, AstraZeneca , United Kingdom
    Bringing over two decades of experience, Sridevi Nagarajan is a seasoned strategic portfolio management professional is deeply rooted in data-driven approaches. The expertise lies in successfully steering digital transformations within the Pharmaceutical and Public Health sectors... Read More →
    avatar for Heiner Oberkampf

    Heiner Oberkampf

    CEO, ACCURIDS, Germany
    Heiner Oberkampf is the CEO and Co-founder of ACCURIDS, which is a software for collaborative data standards implementation, that helps pharma companies, e.g., in the implementation of IDMP standards through a federated product data graph. With a group of pharma companies, he has... Read More →
    avatar for Norman Schmuff

    Norman Schmuff

    Associate Director for Science, OPMA, OPQ, FDA, United States
    Norman R. Schmuff joined the FDA in 1990. For more than 20 years, he has participated in ICH as a member of several Expert Working Groups. He was the Rapporteur for the M4 CTD (eCTD) – Quality Implementation Working Group. He is involved in many FDA electronic submission initiatives... Read More →
    avatar for Cesar Vinces

    Cesar Vinces

    EU Interim and International Policy Lead, Accumulus Synergy, United States
    Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Workshop

    10:00am PDT

    #225: Regulatory Guidance and Papers on Technology Innovations
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-576-L04-P; CME 1.00; RN 1.00

    This session will describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development. The session will discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development. Attendees will hear from industry experts on the topics and their potential implementation and impacts to the field.

    Learning Objectives

    Describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development; Discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development; Describe potential implementation and impacts to the field.

    Chair

    David Meats

    Speaker

    AI and Technology Trends and Regulation Introduction
    David Meats

    Regulation Guidance and Concensus Papers
    Madhavi Gidh-Jain, PhD

    Regulation Guidance
    Louise Lind Skov, PhD



    Speakers
    avatar for David Meats

    David Meats

    Director, Regulatory Services Management, Certara, United States
    David Meats is a Director of Regulatory Services and Medical Affairs at Certara. He has been a medical writer and manager for 23 years working in oncology, immuno-oncology, endocrinology, musculoskeletal, cardiac, hepatic, renal, and infectious disease therapeutic areas on nearly... Read More →
    avatar for Madhavi Gidh-Jain

    Madhavi Gidh-Jain

    Global Medical Writing and Document Management Head, Sanofi, United States
    Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →
    avatar for Louise Lind Skov

    Louise Lind Skov

    Head of Content Digitalisation, Novo Nordisk A/S, Denmark
    Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      04: MedAffairs-SciComm, Session

    10:00am PDT

    #226: Effective Patient Engagement in Patient Experience Data: Practical Insights from Case Studies in Hard-to-Reach Populations
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-577-L04-P; CME 1.00; RN 1.00

    This forum will describe strategies for patient engagement to help design patient experience studies (PED). Case studies will illustrate the critical impact of patient engagement on the design of PED studies.

    Learning Objectives

    Examine the critical role that patient engagement can have on the success of patient experience studies; Implement strategies to overcome challenges associated with patient engagement in hard-to-reach populations.

    Chair

    Ellen Janssen, PhD

    Speaker

    Lessons Learned from Publicly Funded Patient Engagement Activities
    Caroline Vass, PhD

    Industry-Led Case Study
    Bennett Levitan, MD, PhD

    Industry Update
    Brett Hauber, PhD, MA

    FDA Update
    Robyn Bent, MS, RN

    Patient Advocacy Perspective
    Bellinda King-Kallimanis, PhD



    Speakers
    avatar for Ellen Janssen

    Ellen Janssen

    Director, Global Epidemiology, Benefit-Risk Assessment, Janssen Research & Development LLC, United States
    Ellen Janssen in a Director of Benefit-Risk Assessment/Epidemiology at Johnson and Johnson. In her work she lead structured benefit-risk assessments throughout the product lifecycle and conducts patient preferences studies to inform patient-focused decision making. Ellen is passionate... Read More →
    avatar for Robyn Bent

    Robyn Bent

    Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
    Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →
    BH

    Brett Hauber

    Senior Director, Patient Preference Elicitation, Pfizer Inc, United States
    BK

    Bellinda King-Kallimanis

    Senior Director of Patient-Focused Research, LUNGevity, United States
    Bellinda King-Kallimanis is a psychometrician working at the US FDA in the Office of Oncology and Hematology Products in the Office of New Drugs in the Center for Drug Evaluation and Research (CDER). Her work focuses on the use of clinical outcome assessments (COAs) to support patient... Read More →
    avatar for Bennett Levitan

    Bennett Levitan

    Senior Director, Benefit-Risk Assessment, Global Epidemiology, Janssen Research & Development LLC, United States
    Bennett Levitan, MD-PhD is Senior Director, Global R&D Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk (B-R) assessment to Janssen and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development... Read More →
    avatar for Caroline Vass

    Caroline Vass

    Senior Economist, Health Preference Assessment, RTI Health Solutions, United Kingdom
    Caroline Vass, PhD, is a Senior Economist at RTI Health Solutions. Her research focuses on using stated preference methods, particularly discrete choice experiments, to elicit preferences for healthcare. She has expertise in both the qualitative and quantitative components of stated... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum

    10:00am PDT

    #221: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-572-L04-P; CME 1.00; RN 1.00

    Improving access and minimizing burdens are critical to ensuring diverse representation in clinical trials. Panelists will discuss efforts to improve patient access to oncology clinical trials through streamlined protocols and decentralized elements.

    Learning Objectives

    Describe the impact of incorporating decentralized elements (DE) into oncology clinical trials (CTs) on data integrity, patient safety and regulatory approvals; Explain how DE elements increase patient access and recognize opportunities to implement DE; Identify ongoing barriers to implementing DE into CT protocols and solutions to address operational challenges in expanding access to care.

    Chair

    Suanna S. Bruinooge, MPH

    Speaker

    How Sponsors, CROs, and Sites Can Work Together
    Craig H Lipset, MPH

    Meta-Analysis of Trials During COVID
    Joseph Unger, PhD, MS

    Implementing Trials in Large Healthcare System
    Ramya Thota



    Speakers
    avatar for Suanna Bruinooge

    Suanna Bruinooge

    Chief and Division Director, Research Strategy and Operations Center, American Society of Clinical Oncology, United States
    Suanna Bruinooge, MPH, is the Chief and Division Director of Research Strategies and Collaborations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates and analyzes oncology data to foster innovation in research and patient care and help develop evidence related... Read More →
    avatar for Craig Lipset

    Craig Lipset

    Managing Partner, Clinical Innovation Partners, United States
    Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the... Read More →
    avatar for Ramya Thota

    Ramya Thota

    Associate Professor, Intermountain Medical Oncology - IMC, United States
    Dr. Thota is a GI medical oncologist at Intermountain Health, Utah. She finished her subspecialty Hematology and Medical Oncology fellowship training from Vanderbilt University, Nashville, Tennessee. She receives research funding from American Cancer Society Clinician Scientist Development... Read More →
    avatar for Joseph Unger

    Joseph Unger

    Associate Professor, Fred Hutchinson Cancer Center, United States
    Dr. Joseph Unger is a biostatistician and health services researcher. He uses big data to understand more about cancer patients’ treatment outcomes and disparities, especially as they pertain to barriers to participating in clinical trials. He has been at the forefront of efforts... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   02: ClinTrials -ClinOps, Forum

    10:00am PDT

    #227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-578-L04-P; CME 1.00; RN 1.00

    Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.

    Learning Objectives

    Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.

    Chair

    Jason Wakelin-Smith


    Speakers
    EG

    Emily Gebbia

    Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
    Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →
    avatar for Jason Wakelin-Smith

    Jason Wakelin-Smith

    Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Session

    10:00am PDT

    #228: Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-579-L04-P; CME 1.00; RN 1.00

    Results from international industry experience surveys on the Access Consortium and Project Orbis followed by a panel discussion, involving health authorities, to discuss recommendations and next steps to improve and promote these schemes.

    Learning Objectives

    Recognize the benefits and challenges of international collaborative initiatives from both the industry and regulatory authority perspectives; Discuss the recommendations to improve these schemes; Describe how to influence your own organization to adopt or increase usage of these schemes.

    Chair

    Sarah Powell, RAC

    Speaker

    Results of Industry Survey of Orbis Projects
    Sarah Powell, RAC

    Results of Industry Survey on Access Program
    Tse Siang Kang, PhD



    Speakers
    avatar for Sarah Powell

    Sarah Powell

    President, Powell Regulatory Services, United States
    Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 23 years as a consultant, she has assisted clients... Read More →
    avatar for Tse Siang Kang

    Tse Siang Kang

    Head of Regulatory Affairs, North, East, West Asia, Global Regulatory, Pfizer Pte Ltd, Singapore
    Dr. Tse Siang Kang is the Head of Regulatory Sciences in North, East and West Asia cluster, Pfizer Global Regulatory Sciences. In addition to his role in managing a diverse Asia team in Pfizer. Dr Kang also has a particular interest in publishing emerging Regulatory Sciences topics... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    10:00am PDT

    #229: Clinical Trial Enrollment Diversity: Why and How to Engage Community Health Centers
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-580-L04-P; CME 1.00; RN 1.00

    Minority access to clinical trials is an ongoing challenge. Community Health Centers (CHCs) can support linking these populations to studies. This session shares results from a national CHC survey that informs about needs and perceptions that can help increase participation.

    Learning Objectives

    Describe how to distinguish Community Health Centers (CHCs) from other types of healthcare organizations; Discuss results from a grant that surveyed 40 CHCs nationwide about their perceptions and needs related to clinical trials; Evaluate options for CHCs to be involved with supporting clinical trial and diverse enrollment.

    Chair

    Pete Fronte, MBA

    Speaker

    Industry Update
    Karen Correa, PhD

    Community Health Care Update
    James Schultz, MD, MBA, FAAFP

    Patient Update
    Mario DuCre



    Speakers
    avatar for Pete Fronte

    Pete Fronte

    President and Chief Executive Officer, Altura, United States
    Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within health systems and community health centers... Read More →
    avatar for Karen Correa

    Karen Correa

    Vice President, Head of Global Clinical Operations, Takeda, United States
    Dr. Karen Correa is the Vice President, Head of Global Clinical Operations at Takeda; where she is responsible for the advancement of the portfolio and execution of global clinical trials. Her 30 years of clinical research experience cover a large range of settings and venues including... Read More →
    avatar for James Schultz

    James Schultz

    Chief Medical Officer, Neighborhood Healthcare, United States
    MD

    Mario DuCre

    Patient, United States


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      12: Value-Access, Forum

    10:00am PDT

    #230: International Regulatory Convergence: Regulatory Science to Address Challenges Brought by Pharmaceutical Innovation
    Component Type: Forum
    Level: Intermediate

    Innovative approaches have the potential to create new opportunities for patients, but they also bring challenges to regulators, called to evaluate, and supervise products for which traditional regulatory approaches might not be appropriate. Global regulators will discuss how regulatory science is key to develop solutions and how regulators worldwide need to work together to overcome such challenges.

    Learning Objectives

    Explore how to make faster progress with translating regulatory science research outputs into practice, for accelerating and improving medicine development and use; Discuss generalizable success stories and examples with challenges to an efficient translation; Describe and critically review hurdles and success factors.

    Chair

    Antonio Barra Torres, MD

    Speaker

    Promoting International Regulatory Convergence Through Regulatory Science
    Emer Cooke, MBA, MSc

    Path for Future Collaboration Utilizing Regulatory Science
    Yasuhiro Fujiwara, MD, PhD

    ICMRA Summit 2023: Regulators Working Together Towards the Future
    Anthony Lawler, MD, MBA

    Panelist
    Alison Cave, PhD

    Panelist
    Pamela Aung-Thin



    Speakers
    avatar for Pamela Aung-Thin

    Pamela Aung-Thin

    Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada
    Pamela Aung Thin became the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) on March 27, 2023.
    avatar for Alison Cave

    Alison Cave

    Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
    avatar for Emer Cooke

    Emer Cooke

    Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
    Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
    avatar for Yasuhiro Fujiwara

    Yasuhiro Fujiwara

    Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Yasuhiro Fujiwara was previously Director-General, Strategic Planning Bureau of the National Cancer Center, and the Deputy Director of the Hospital (Research), National Cancer Center Hospital. He is a medical oncologist, specializing in breast cancer. Before joining NCCH, he was... Read More →
    avatar for Anthony Lawler

    Anthony Lawler

    Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
    Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →
    avatar for Antonio Barra Torres

    Antonio Barra Torres

    President Director, ANVISA, Brazil
    Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →


    Tuesday June 18, 2024 10:00am - 11:00am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      14: DIAmond, Forum

    11:00am PDT

    #231 CH: Quality in Focus: Diethylene and Ethylene Glycol Challenges
    Component Type: Workshop
    Level: Intermediate

    Participants will delve into the US FDA's regulatory guidance, exploring the testing protocols for high-risk drug components and explore the essential requirements and recommended practices to ensure product safety and compliance.

    Learning Objectives

    Recognize key factors contributing to diethylene glycol (DEG) and ethylene glycol (EG) contamination; Examine the US FDA's regulatory guidance, delving into the testing procedures for high-risk drug components contaminated with DEG and EG; Explore requirements and recommended practices for manufacturers, repackagers, preparers, and distributors.

    Chair

    Chaitanya Koduri


    Speakers
    CK

    Chaitanya Koduri

    Director, International Government and Regulatory Engagement, US Pharmacopeia, United States


    Tuesday June 18, 2024 11:00am - 11:30am PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    #234 RT: Roundtable Discussion: Interactive Safety Graphics in the Regulatory Decision-Making Process
    Component Type: Session

    Join the Clinical Safety & Pharmacovigilance/Statistics & Data Science Community for a follow up round table discussion tied to session: Interactive Safety Graphics in the Regulatory Decision-Making Process (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

    Chair

    Greg Ball, PhD


    Speakers
    avatar for Greg Ball

    Greg Ball

    Safety Data Scientist, ASAPprocess, United States
    Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →


    Tuesday June 18, 2024 11:00am - 12:00pm PDT
    Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    #233 RT: Roundtable Discussion: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA
    Component Type: Session

    Join the Real-World Evidence Community for a follow up round table discussion tied to session: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA (Monday, June 17 | 2:15pm - 3:15 PM PDT). Space is limited.

    Chair

    Jingyu (Julia) Luan, PhD


    Speakers
    avatar for Jingyu (Julia) Luan

    Jingyu (Julia) Luan

    Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D, AstraZeneca, United States
    Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →


    Tuesday June 18, 2024 11:00am - 12:00pm PDT
    Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    #232 RT: Roundtable Discussion: Innovation in Manufacturing Globally
    Component Type: Session

    Join the Digital Acceleration/Regulatory Affairs/Statistics & Data Science Community for a follow up round table discussion tied to session: Innovation in Manufacturing Globally (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

    Chair

    Brett Howard, JD, PhD


    Speakers
    avatar for Brett Howard

    Brett Howard

    Senior Director, US Regulatory Policy, USP, United States
    Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →


    Tuesday June 18, 2024 11:00am - 12:00pm PDT
    Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    Luncheon Service
    Component Type: Social Event




    Tuesday June 18, 2024 11:00am - 1:00pm PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    Community Networking Lunch
    Component Type: Social Evt / Reception

    DIA Community members - this is your dedicated space! Meet up and collaborate with fellow members, participate in roundtable discussions, and/or take a few minutes to reflect on the sessions you've attended.





    Tuesday June 18, 2024 11:00am - 1:30pm PDT
    TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #235 IT: Deloitte Innovation Theater: Drug Safety Unfiltered - Why Isn’t the Needle Moving?
    Component Type: Session

    Technologies such as AI, automation and GenAI have the capability to transform the Safety function. But adoption has been uneven so far. Dive into the issues and explore the “why” behind barriers to adoption. Discover where early adoption pioneers stand now and join a Q&A around what it will take to really move the needle on transformation in Safety.

    Chair

    Deloitte

    Speaker

    Speaker
    Amanda Bowles, MS

    Speaker
    Kelly Traverso



    Speakers
    avatar for Amanda Kirby Bowles

    Amanda Kirby Bowles

    Managing Director, Deloitte, United States
    Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global... Read More →
    avatar for Deloitte

    Deloitte

    United States
    avatar for Kelly Traverso

    Kelly Traverso

    R&D Business Development, Deloitte, United States
    Kelly has more than 20 years’ experience in the areas of Quality, Pharmacovigilance, R&D, and Regulatory Affairs with large, global Biotech and Pharmaceutical companies. She is a Subject Matter Expert on the topics of process assessment and gap analyses, governance model design... Read More →


    Tuesday June 18, 2024 11:15am - 11:45am PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #236 IT: UiPath Innovation Theater: AI Powered Automation - Reducing Time to Market for Life Sciences
    Component Type: Session

    As the cost, complexity and timelines for the development of new drugs and devices continues to grow, AI-powered automation is emerging as a powerful solution to reduce time to market by orchestrating clinical data, simplifying regulatory submissions, eliminating manual and paper-based processes, and automating data and solution testing. AI-powered automation allows organizations to improve time to market while reducing errors, ensuring visibility, and enabling compliance across R&D.

    Chair

    UiPath

    Speaker

    Speaker
    Joe Miles



    Speakers
    avatar for Joe Miles

    Joe Miles

    Industry Director, Life Sciences, UiPath, United States
    As a global Healthcare and Life Sciences industry leader over the past several decades, I have assisted organizations in enabling digital transformation for life sciences organizations across operational, financial and compliance. Most recently, I have led the UiPath Life Sciences... Read More →
    avatar for UiPath

    UiPath

    United States


    Tuesday June 18, 2024 11:15am - 11:45am PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #237 IT: Snowflake Innovation Theater: Secure and Efficient Gen-AI to Accelerate Research and Development
    Component Type: Session

    In the era of AI-enabled research & development, managing and analyzing large-scale data efficiently is crucial, yet traditional systems often fall short in scalability, performance, and collaboration. Learn how Snowflake enables life sciences organizations to build a data foundation, collaborate with the ecosystem and leverage industry-leading AI models safely and cost-effectively. Demo includes use cases around: Protein Similarity & Function Prediction, Gen-AI Clinical Trial Assistant, & more.

    Chair

    Snowflake

    Speaker

    Speaker
    Harini Gopalakrishnan, MS

    Speaker
    Lisa M. Arbogast



    Speakers
    avatar for Lisa Arbogast

    Lisa Arbogast

    Industry Principal, Life Sciences, Snowflake, United States
    Lisa is an accomplished Life Sciences executive with over 35 years of experience in consulting, innovative business models, and global data-driven solutions that solve both technology and business challenges within biopharmaceuticals, diagnostics, and medtech. Her passion is to mobilize... Read More →
    avatar for Harini Gopalakrishnan

    Harini Gopalakrishnan

    Industry Field CTO, Life Sciences, Snowflake, United States
    Harini Gopalakrishnan is the Global Field CTO for Life Sciences for Snowflake, based out of New York and works to contextualize Snowflake and partner solutions for pharma/biotech customers. She has 20 + years experience and worked in leadership roles across both tech and life sciences... Read More →
    S

    Snowflake

    United States


    Tuesday June 18, 2024 11:15am - 11:45am PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #POS 2: Professional Poster Session 2
    Component Type: Session

    Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.


    Speakers
    MA

    Malak Almutairi

    Researcher, Saudi Food and Drug Authority, Saudi Arabia
    I am a researcher specialized in regulatory research with a master's degree in pharmacy and Pharmaceutical Sciences. I have been working in the SFDA (Saudi Food and Drug Authority) for several years now, and my focus has been on ensuring the safety and efficacy of pharmaceutical products... Read More →
    avatar for Daniel Alvarez

    Daniel Alvarez

    Principal Medical Director, Health Equity and Inclusive Research (HEIR), Genentech, A Member of the Roche Group, United States
    Dr. Daniel Alvarez earned his medical degree from the Institute of Medical Science of Havana, Cuba in 2002 and the University of Costa Rica in 2006. He also holds a master's degree in Science of Pharmaceutical Medicine from Hibernia College, Ireland, in 2016 and a Diploma in Pharmacoeconomics... Read More →
    CA

    Celeste Amadei

    Product Manager, PAK Biosolutions, United States
    avatar for Barbara Isquith Arone

    Barbara Isquith Arone

    Vice President, Evidence Generation for Medical Affairs, IQVIA, United States
    Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →
    avatar for Cheng Chi Chen

    Cheng Chi Chen

    Clinical Reviewer, Center For Drug Evaluation, Taiwan
    Cheng Chi Chen, Clinical Reviewer, Division of New Drugs, CDE, Taiwan Cheng Chi Chen has been a Clinical Reviewer in Division of New Drugs at CDE Taiwan for more than 1 years. Cheng Chi Chen is a Pharmacist and holds a Master’s degree in Clinical Pharmacy from National Yang Ming... Read More →
    avatar for Renata Costa

    Renata Costa

    Specialist, LIBBS FARMACEUTICA, Brazil
    Renata Watanabe Costa has a degree in Biomedicine, with a postgraduate degree in Research and Development of Medicines and a Master's in Sciences from the Federal University of Sao Paulo (Brazil). She has 13 years of experience in the pharmaceutical industry in the areas of Medical... Read More →
    avatar for Samantha Cotter

    Samantha Cotter

    Safety Evaluator, FDA, United States
    Dr. Samantha Cotter is a pharmacist and safety evaluator in the Division of Pharmacovigilance within the Office of Surveillance and Epidemiology at the US Food and Drug Administration (FDA). Samantha has over 20 years of clinical pharmacy experience, and 12 years in research at the... Read More →
    avatar for Matt D'Ambrosio

    Matt D'Ambrosio

    Policy Analyst, Duke-Margolis Institute For Health Policy, United States
    Matt D'Ambrosio is a policy analyst with the Duke-Margolis Institute for Health Policy's Biomedical Innovation portfolio. He primarily works with the Institute's Real-World Evidence Collaborative--providing support on workstream deliverables and stakeholder engagement. Matt is based... Read More →
    avatar for Tiffany Dominic

    Tiffany Dominic

    Risk Management Fellow, Pfizer, United States
    Tiffany Dominic is a Post-Doctoral Risk Management Fellow at Pfizer, in conjunction with Rutgers University. She graduated with her Doctor of Pharmacy degree in May 2022 from St. John's University College of Pharmacy and Health Sciences. As a risk management fellow, she takes part... Read More →
    PE

    Pierre Engel

    Senior Director Business Development, CENTOGENE Gmbh, Germany
    With over 15 years of sales and delivery experience in the field of epidemiology and real world evidence (RWE), I am a passionate leader in healthcare innovation and a trusted partner for global pharma accounts. As a Senior Principal Epidemiology at CENTOGENE, I am responsible for... Read More →
    avatar for Emily Epstein

    Emily Epstein

    Clinical Behavioral Health Specialist, Weill Cornell Medicine, United States
    Emily Epstein, LMSW, is a Clinical Behavioral Health Care Specialist at Weill Cornell Medicine's Genetics and Personalized Cancer Prevention Program (GPCP). The GPCP is committed to identifying individuals living at an increased lifetime risk for cancer, conducting research, and creating... Read More →
    SE

    Samuel Ewusie

    Associate Director, Safety Evidence and Science, Bristol-Myers Squibb Company, United States
    A registered pharmacist with a PharmD and an MS in Global Clinical and Pharmacovigilance Regulations, experienced in Clinical Drug Safety and Pharmacovigilance, Risk Management including Risk Evaluation and Mitigation Strategy (REMS), Pharmacoepidemiology and Research Data analys... Read More →
    MA

    Majdi Al Gharsan

    Director, Director of Medical Services, Ministry of Defence, Saudi Arabia
    YG

    Yogesh Gulati

    Senior Safety Physician, Soterius, India
    CH

    Cheryl Hergert

    University of Southern California, United States
    With over 25 years of experience working with small and large companies, Cheryl is familiar with product development for medical devices, pharmaceuticals, and combination products. Her experience ranges from product feasibility testing to product launch. She has held positions in... Read More →
    avatar for Hisahiro Ito

    Hisahiro Ito

    Head of Project Management Office, National Cancer Center Japan, Japan
    avatar for Frank Jaeger

    Frank Jaeger

    Independent Consultant, Nanodose Therapeutics, United States
    Frank Jaeger is an accomplished C-suite leader with over 25 years of biopharmaceutical tenure from seed-stage to large global pharma, in small and large molecules, and from pre-launch to in-market experience. His career spans across R&D, Medical Affairs, Business Development, Commercial... Read More →
    SH

    Sung Hoon Jung

    Professor, The Catholic University of Korea, Korea, Republic of
    avatar for Sarah Kang

    Sarah Kang

    Safety Evaluator, FDA, United States
    Sarah Kang is a safety evaluator in the Division of Pharmacovigilance (DPV) within the Office of Surveillance and Epidemiology at the United States Food and Drug Administration in Silver Spring, Maryland. She has over 9 years of experience as a clinical pharmacist and over 8 years... Read More →
    SK

    Sung-Goo Kang

    Clinical Professor., St.Vincent's Hospital, The Catholic University of Korea, Korea, Republic of
    avatar for Joseph Laudano

    Joseph Laudano

    Medical Director, IQVIA, United States
    Joseph B. Laudano BS Pharm, Pharm D – Medical Director, IQVIA Inc. Joe has over 35 years’ experience in Pharma. Before joining IQVIA, he was VP, Medical Affairs at Pharmaspectra, VP Medical Affairs at Alliqua Biomedical and Senior Director of Medical Affairs & Global Head of Publication... Read More →
    avatar for Christina Mack

    Christina Mack

    Chief Scientific Officer, Real-World Solutions, IQVIA, United States
    Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
    LM

    Laura Magda

    Director of Clinical Trials, SRI International, United States
    AM

    Andrew Marley

    Senior Epidemiologist, Parexel, Spain
    avatar for Hotaka Maruyama

    Hotaka Maruyama

    Division of PharmacoEpidemiology, Office of Pharmacovigilance ?, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    I am a reviewer of pharmacoepidemiology division and have a few years' experience in the office of pharmacovigilance I at Pharmaceuticals and medical devices agency(PMDA).
    avatar for Timothe Menard

    Timothe Menard

    Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
    Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →
    avatar for Mehdi Najafzadeh

    Mehdi Najafzadeh

    Senior Director, Medidata AI, United States
    Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the... Read More →
    avatar for Raphael Pareschi

    Raphael Pareschi

    Patient Safety Lead/ Head of Pharmacovigilance Brazil, Roche, Brazil
    Raphael has more than 16 years of experience in Pharmacovigilance, beginning at Sanofi Brazil, where he acted in roles of increasing responsibility within local PV organization, responsibilities including oversight of case management, PSUR management and RMP management. Raphael also... Read More →
    IP

    Izabela Pedro

    Clinical Research Associate, Hospital Israelita Albert Einstein, Brazil
    avatar for Bruna Sampaio

    Bruna Sampaio

    Manager, Data management, Hospital Israelita Albert Einstein, Brazil
    Bruna has over 14 years of professional experience with technology and data operations. Working in clinical research for almost 10 years, she is experienced in EDC Systems (first as a system analyst and later as an end-user), data management, and data analytics. Currently, she is... Read More →
    CS

    Chris Schneiderman

    Epidemiologist, Abbvie, United States
    SS

    Samantha Seepersad-Nayee

    AD, Excision Biotherapeutics, United States
    avatar for Alexandru Socolov

    Alexandru Socolov

    Senior Data Scientist, Medidata Solutions, United States
    Alexandru is a Senior Data Scientist at Medidata AI focused on building advanced analytical solutions to make clinical trials safer, cheaper and faster. With the background in operations research, mathematical optimization and machine learning, Alexandru applies newest techniques... Read More →
    avatar for Hiroya Taniguchi

    Hiroya Taniguchi

    Department of Clinical Oncology, Aichi Cancer Center Hospital, Japan
    avatar for Brittin Wagner

    Brittin Wagner

    Senior Research Scientist, PointClickCare, Canada
    Brittin Wagner is Senior Research Scientist at PointClickCare. She holds a PhD is in Sociology, PhD Minor in Social Statistics from the University of Washington, with postdoctoral training in health services research & development. She has a longstanding commitment to measurement... Read More →
    avatar for Matt Wampole

    Matt Wampole

    Director, Solution Consulting, Clarivate, United States
    Matt Wampole is the Director of Solution Consulting at Clarivate where he and his team supports clients from discovery to launch of new medical interventions. His 20 years of experience covered a broad range of topics across drug discovery and optimization, clinical trial optimization... Read More →
    avatar for Susan Watson

    Susan Watson

    Associate Director, Bioethics, Eli Lilly and Company, United States
    Susan Briggs Watson, Ph.D. is an Associate Director of Bioethics at Eli Lilly and Company. She received a PhD in clinical psychology from Indiana University-Purdue University at Indianapolis (IUPUI) and completed Georgetown University's Intensive Bioethics Course 38. She has worked... Read More →
    avatar for Susan Watson

    Susan Watson

    Associate Director, Bioethics, Eli Lilly and Company, United States
    Susan Briggs Watson, Ph.D. is an Associate Director of Bioethics at Eli Lilly and Company. She received a PhD in clinical psychology from Indiana University-Purdue University at Indianapolis (IUPUI) and completed Georgetown University's Intensive Bioethics Course 38. She has worked... Read More →
    SW

    Sam Willcox

    Section Manager - Large Molecule Bioanalysis, ACM Global Laboratories, United Kingdom
    Sam graduated from the University of Hull with a BSc in Human Biology in 2009. Since graduating he has worked for the last 15 years in regulated bioanalysis supporting the drug development industry. Expert in the field of bioanalysis of large molecules via ligand binding assays he... Read More →
    avatar for Rebecca Williams

    Rebecca Williams

    Senior Clinical Trials Subject Matter Expert, Essex, Part of Emmes Group, United States
    Rebecca Williams, PharmD, MPH, is a Clinical Trials Subject Matter Expert with Essex, Part of Emmes Group. In this role she supports strategic policy and data initiatives with the National Cancer Institute’s Coordinating Center for Clinical Trials. Prior to this role she was the... Read More →
    avatar for Xiaofeng Xiang

    Xiaofeng Xiang

    Sr. Medical Compliance Manager, Bayer, China
    MV

    Mui Van Zandt

    VP/Global Head, Data Strategy, Access and Enablement, IQVIA, United States
    FZ

    Feng Zhou

    Medical Compliance, Bayer Healthcare Co., Ltd., China


    Tuesday June 18, 2024 11:15am - 1:15pm PDT
    Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:55am PDT

    #238 IT: IQVIA Innovation Theater: An Ecosystem Approach to Site Tech Overload
    Component Type: Session

    With too many systems and not enough staff, research sites are turning down studies they find unworkable. How can we get the clinical trial ecosystem in balance so that everyone benefits, most importantly patients in need?

    In this panel, leaders across the ecosystem will discuss viable strategies to make a real impact on site tech overload. Learn about One Home for Sites, an initiative that’s bringing the industry together to increase clinical trial capacity and help all stakeholders succeed.

    Chair

    IQVIA Technologies

    Speaker

    Speaker
    Gareth Dabbs

    Speaker
    Michael Rosenblatt

    Speaker
    Aruna Adhikari-Thapa

    Speaker
    Brad Hightower



    Speakers
    avatar for IQVIA Technologies

    IQVIA Technologies

    United States
    avatar for Gareth Dabbs

    Gareth Dabbs

    Vice President, Global Product Strategy, IQVIA, United States
    avatar for Aruna Adhikari-Thapa

    Aruna Adhikari-Thapa

    Senior Director, Product Strategy, IQVIA Technologies, United States
    Aruna Adhikari-Thapa is a seasoned technology strategist with 20+ years of experience in software product management. She excels in leading cross-functional teams, shaping product strategies, justifying investments, and launching innovative solutions to address complex business challenges... Read More →
    avatar for Brad Hightower

    Brad Hightower

    Chief Executive Officer, Hightower Clinical, United States
    Brad has worked at the site-level in clinical research for almost 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his own integrated site network, Hightower Clinical, and hosts the Note to File podcast — a... Read More →
    avatar for Michael Rosenblatt

    Michael Rosenblatt

    Managing Director, Greenhouse Consulting, United States


    Tuesday June 18, 2024 11:55am - 12:25pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:55am PDT

    #239 IT: Fortrea Innovation Theater: Teamwork Makes the Dream Work - How Partnering to Develop Practical Solutions that Address Site and Patient Challenges is Changing the Clinical Trial Landscape
    Component Type: Session

    Without patients, there are no trials. Without the sites to conduct studies, there are no trials. This simple truth drives inclusivity initiatives, and the surge in technology “solutions”. In this panel discussion, we bring together voices from across the clinical trial ecosystem and demonstrate how teamwork comprised of medical expertise, market access insight, patient voice, site advisory boards, and technology partnerships work together with developers and CROs to make teamwork the dream work.

    Chair

    Fortrea

    Speaker

    Speaker
    Elizabeth Seyfert



    Speakers
    avatar for Fortrea

    Fortrea

    United States
    avatar for Elizabeth Seyfert

    Elizabeth Seyfert

    Head of Site Engagement and Patnership Delivery, Fortrea, United States
    Elizabeth has over 18 years of industry experience and has held varying leadership positions across regulatory, start up and clinical delivery functions. Elizabeth currently oversees site partnership and relationship management at Fortrea with a primary focus on supporting clinical... Read More →


    Tuesday June 18, 2024 11:55am - 12:25pm PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:55am PDT

    #240 IT: UBC Innovation Theater: RWD Enrichment Studies - Linking Pre and Post-Trial Data to Inform Product Strategy
    Component Type: Session

    Capturing data on the patient’s healthcare journey prior to and following participation in a clinical trial builds a more complete understanding of their healthcare journey and increases the overall evidence yield. This presentation explores the value and challenges of tokenization and linkage to diverse secondary healthcare data as well as a case study highlighting the real-world application of this approach.

    Chair

    UBC

    Speaker

    Speaker
    Irene Cosmatos, MS

    Speaker
    Jeff Lowry



    Tuesday June 18, 2024 11:55am - 12:25pm PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:30pm PDT

    #241 CH: Practical (and Real) AI and Advanced Automation in New Product Planning and Clinical Development
    Component Type: Workshop
    Level: Basic

    Realizing the value of AI and Advanced Automation tools is no longer hypothetical - real value is being created by the thoughtful application of these tools. We will explore pragmatic examples and opportunities within this working session.

    Learning Objectives

    Create a pragmatic approach for developing and implementing AI and Advanced Automation tools within their organizations; Describe how to develop a plan, implement and calculate and measure ROI for such tools.

    Chair

    Bryan Katz, MBA


    Speakers
    BK

    Bryan Katz

    Chief Strategy Officer, Propharma Group, United States


    Tuesday June 18, 2024 12:30pm - 1:00pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:35pm PDT

    #241.1 IT: Flatiron Health Innovation Theater
    Component Type: Session



    Chair

    Flatiron Health


    Speakers
    avatar for Flatiron Health

    Flatiron Health

    United States


    Tuesday June 18, 2024 12:35pm - 1:05pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:35pm PDT

    #242 IT: PCM Trials Innovation Theater: Mastering the Logistics of Mobile Visits in Global Decentralized Trials
    Component Type: Session

    As the landscape of clinical trials continues to evolve, mobile visits play an increasingly crucial role in ensuring the success of global trials. With more than 80 years of combined experience in logistics and the execution of complex decentralized trials, these industry veterans will share actionable steps to overcome hurdles in distributing supplies, managing samples, and delivering compliant mobile visits to meet the logistical challenges associated with decentralized clinical trials (DCTs).

    Chair

    PCM Trials

    Speaker

    Speaker
    Ellen Weiss

    Speaker
    Kevin Meek

    Speaker
    Mike Sweeney

    Speaker
    Chris Thompson



    Speakers
    avatar for Kevin Meek

    Kevin Meek

    Director, Supply Chain Operations, PCM Trials, United States
    Through expert facilitation, Kevin brings together individual subject matter experts to create cross-functional teams to focus on end-to-end results. He developed these skills in the largest health payer system in the country managing dozens of partner solutions by establishing operational... Read More →
    avatar for Mike Sweeney

    Mike Sweeney

    Global Head of Strategy, CGT & DTP, QuickSTAT, France
    For over three decades Mike has successfully developed and delivered customer-focused solutions in a variety of leadership and cross-functional roles within global life sciences logistics. As a trusted leader, collaborator, and personalized supply chain expert, he has driven innovative... Read More →
    avatar for Chris Thompson

    Chris Thompson

    Senior Operations Manager, Woodley Trial Solutions, United Kingdom
    In his role as Senior Operations Manager, Chris oversees all aspects of solutions and service delivery for clients. This includes rental of laboratory equipment; point-of-care testing devices; Dexcom CGM devices; high-tech connectivity products; plus ancillaries & kitting, all of... Read More →
    avatar for PCM Trials

    PCM Trials

    United States
    avatar for Ellen Weiss

    Ellen Weiss

    Strategy, Decentralized Trials, Emeritus, PCM Trials, United States
    Ellen Weiss is an expert in connecting CROs and sponsors with right-sized hybrid and remote solutions to collect complete data. She has spoken on understanding the logistical support necessary for IMP delivery and dosing, sample collection, logistic options and best use cases. She... Read More →


    Tuesday June 18, 2024 12:35pm - 1:05pm PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:35pm PDT

    #243 IT: ProductLife Group Innovation Theater: Navigating the AI “boom” - A Methodological Framework to Create New Value Streams in your Specific Regulatory Affairs Context
    Component Type: Session

    The publication of Large Language Models has shed light on AI more than ever, and opened new opportunities – and risks. It has been challenging the vendor’s ecosystem. It becomes more and more complex to get a systemic view and define a strategic roadmap in this ever-changing environment. In this session, we will address such challenges by proposing and illustrating a methodological framework stemming from research in complex system engineering and design. The goal is to identify and develop AI value potential that will best fit your needs and context, in a frugal approach to avoid AI and tools “overload”.

    Chair

    Productlife Group

    Speaker

    Speaker
    Gabriele Breda, PhD



    Speakers
    avatar for Gabriele Breda

    Gabriele Breda

    Research & Innovation Director, ProductLife Group, France
    Gabrièle Breda is the Director of Research & Innovation at ProductLife Group (PLG). Graduated from Ecole Normale Supérieure of Paris, with a PhD in Neurosciences, Gabrièle has been managing collaborative Research & Innovation in Healthcare Engineering at Altran and Capgemini Engineering... Read More →
    PG

    Productlife Group

    Productlife Group, France


    Tuesday June 18, 2024 12:35pm - 1:05pm PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    1:15pm PDT

    #244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-582-L04-P; CME 1.00; RN 1.00

    This session will discuss the recent shifts in evidence-based regulatory decision-making, to include types of evidence used to support decisions. Future requirements for evidence generation to support regulatory decision-making will be considered.

    Learning Objectives

    Describe the need for evidence generation to support regulatory decision-making; Discuss the changing evidence landscape supporting regulatory decision-making; Identify what is needed in the future.

    Chair

    Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

    Speaker

    Industry Update
    Andrew Bate, PhD, MA

    Industry Update
    Jeremy Jokinen, PhD, MS

    Trends in Evidence Use During Pharmacovigilance Evaluations
    Samantha Lane, MSc



    Speakers
    avatar for Saad Shakir

    Saad Shakir

    Director, Drug Safety Research Unit, United Kingdom
    Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →
    avatar for Andrew Bate

    Andrew Bate

    Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
    Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
    avatar for Jeremy Jokinen

    Jeremy Jokinen

    Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
    Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
    avatar for Samantha Lane

    Samantha Lane

    Head of Research, Centre of Pharmacovigilance Sciences, Drug Safety Research Unit, United Kingdom
    Samantha Lane is a Senior Research Fellow and the Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit. Samantha leads study design and statistical analysis and has experience with the CPRD electronic health records database. She has a background... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    1:15pm PDT

    #252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-590-L04-P; CME 1.00; RN 1.00

    The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.

    Learning Objectives

    Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.

    Chair

    Cara Alfaro, PharmD

    Speaker

    FDA Update
    Cara Alfaro, PharmD

    Industry Update
    Jonathan Andrus, MS

    MHRA Update
    Jason Wakelin-Smith



    Speakers
    avatar for Cara Alfaro

    Cara Alfaro

    Senior Pharmacologist, OSI, OC, CDER, FDA, United States
    Dr. Alfaro received her B.S. in pharmacy from Purdue University and her Pharm.D. from the Ohio State University. She completed a residency and research fellowship in psychiatric pharmacy at the University of Texas Health Science Center at San Antonio. In 1998, she joined NIH as a... Read More →
    avatar for Jonathan Andrus

    Jonathan Andrus

    President & COO, CRIO, United States
    Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical... Read More →
    avatar for Jason Wakelin-Smith

    Jason Wakelin-Smith

    Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Session |   08: RD Quality-Compliance, Session

    1:15pm PDT

    #247: Bridging Randomized Clinical Trials and Real-World Data Utilizing Data Linkage and Tokenization
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-585-L04-P; CME 1.00; RN 1.00

    Data linkage is a methodology to capture data from patients before, during, and after a clinical trial. The panel will discuss the challenges of conducting randomized clinical trials (RCTs) linked with real-world data (RWD), and will emphasize the data linkage methodologies and current needs.

    Learning Objectives

    Describe the methodology of data linkage, a relatively new method to collect individual patient data before, during, and after a clinical trial outside the randomized clinical trial (RCT) setting; Discuss challenges for different stakeholders involved in utilization of real-world evidence (RWE) and more specifically data linkage, including industry, regulators, and payers/HTA.

    Chair

    Aaron Kamauu, MD, MPH, MS

    Speaker

    Panelist
    Francesco Pignatti, MD

    Panelist
    Kajsa Kvist

    Panelist
    Brian Bradbury, DrSc, MA

    Panelist
    Akshay Vashist



    Speakers
    avatar for Brian Bradbury

    Brian Bradbury

    Vice President, Center for Observational Research, Amgen, United States
    Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →
    avatar for Aaron Kamauu

    Aaron Kamauu

    Managing Director, Ikaika Health LLC, United States
    Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical... Read More →
    avatar for Aaron Kamauu

    Aaron Kamauu

    CEO, Navidence LLC, United States
    Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is the CEO at Navidence. He is a physician entrepreneur and an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to... Read More →
    KK

    Kajsa Kvist

    Scientific Vice President, Novo Nordisk, Denmark
    avatar for Francesco Pignatti

    Francesco Pignatti

    Scientific Adviser for Oncology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    AV

    Akshay Vashist

    Exec Dir, Otsuka Pharmaceutical Development & Commercialization, United States


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    1:15pm PDT

    #248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-586-L04-P; CME 1.00; RN 1.00

    This session will provide perspectives from stakeholders on successes and limitations from practical examples and discuss principles and best practices for maximizing the potential while managing the risks moving forward.

    Learning Objectives

    Describe the current state of the use of artificial intelligence (AI) in the medicinal product lifecycle including its opportunities and challenges; Discuss principles and best practices to maximize potential of AI while managing risks.

    Chair

    Hilmar Hamann, PhD

    Speaker

    EMA Update
    Lorenzo De Angelis, PhD

    Industry Update
    Carlyn Crisotomo , MBA

    Industry Update
    Alexandra (Zan) Cha, PhD, MA

    Industry Update
    Timothe Menard, PharmD, MSc



    Speakers
    LD

    Lorenzo De Angelis

    Platform Architect, European Medicines Agency, Netherlands
    Lorenzo De Angelis studied Physics in Sapienza University of Rome, where he graduated cum laude in July 2014. He then moved to the Netherlands, where he obtained his physics PhD in December 2018, with a thesis entitled "The Singular Optics of Random Light". Afterwards, he joined the... Read More →
    avatar for Alexandra (Zan) Cha

    Alexandra (Zan) Cha

    Principal, Chief Technology Office, Booz Allen Hamilton, United States
    Zan brings 20+ years of experience in health AI / analytics, and IT /product / ops management, applied to medical devices, pharmaceuticals, supply chain, clinical trials, insurance tech, chronic disease management, and population health & wellness. She is currently focused on advancing... Read More →
    CC

    Carlyn Crisotomo

    Vice President, Head of R&D AI Strategy and Execution (RAISE), Amgen, United States
    avatar for Hilmar Hamann

    Hilmar Hamann

    Head of Information Management, European Medicines Agency, Netherlands
    Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →
    avatar for Timothe Menard

    Timothe Menard

    Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
    Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session |   09: Regulatory, Session

    1:15pm PDT

    #249: Topics Related to the Oncology Real-Time Oncology Review Process
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-587-L04-P; CME 1.00; RN 1.00

    This session focuses on the oncology real-time oncology review (RTOR) process and the considerations compared to a standard oncology submission, medical writing processes, and potential time savings.

    Learning Objectives

    Describe Real Time Oncology Review (RTOR) and how RTOR can impact global submission planning; Discuss lessons learned and where plans may not match reality; Define how RTOR best-practices can apply to other submissions and accelerated approval pathways.

    Chair

    Britta Jacobsen, PhD

    Speaker

    Introduction
    Britta Jacobsen, PhD

    Industry Update
    Michael Gyulay

    Industry Update
    Linda Bowen, MSc, RAC

    FDA Update
    Jennifer J. Lee, PharmD, RAC



    Speakers
    avatar for Linda Bowen

    Linda Bowen

    Chief of Staff, Oncology Regulatory Strategy, Pfizer Inc, United States
    Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in... Read More →
    avatar for Michael Gyulay

    Michael Gyulay

    Director, Medical Writing, Oncology and I-Oncology, EMD Serono, United States
    Michael has nearly 20 years of industry experience in Medical Writing and currently is a manager of oncology medical writing leads, leading staff to deliver high quality operational and regulatory documentation and driving best writing and review practices. Prior to his time at EMD... Read More →
    avatar for Britta Jacobsen

    Britta Jacobsen

    Medical Writer and Consultant, Whitsell Innovations, Inc. , United States
    Britta is a scientist and medical writer with 26 years of experience in medical research and oncology. Her postdoctoral training piqued her interest in in steroid hormone receptors and preclinical breast cancer research. The opportunity to work on efficacy testing of novel drug combinations... Read More →
    avatar for Jennifer Lee

    Jennifer Lee

    Sr. Health Scientist, Oncology Center of Excellence, FDA, United States
    Jennifer J. Lee, PharmD, RAC is a Sr. Health Scientist in the Oncology Center of Excellence (OCE) at the US Food & Drug Administration (FDA). In this role, she provides regulatory and strategic support for several of the OCE’s initiatives, including the Pediatric Oncology program... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      04: MedAffairs-SciComm, Session

    1:15pm PDT

    #250: Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-588-L04-P; CME 1.00; RN 1.00

    Increasingly, biopharmas are integrating patient engagement across their corporations in ways that address shared priorities with patient communities. Additionally, they are also increasing the transparency related to delivering on these commitments, including but not limited to, the percent of clinical trials that are informed by patients. This workshop will discuss approaches taken by various companies, the role of advocates, and their perspectives on the importance of achieving meaningful patient engagement, along with the steps necessary to achieve the goals.

    Learning Objectives

    Describe how to bring together key stakeholders to evaluate how, and where, patient engagement can be fully integrated to address what matters most to patients; Describe how to move beyond patients informing select clinical trials to 100% of a portfolio; Identify how to align resources, capabilities and change management needs to deliver on the vision; Discuss how to communicate and monitor the impact of engagement strategies.

    Chair

    Victoria DiBiaso, BSN, MPH, RN

    Speaker

    Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials
    Tracey Robertson, MBA

    Patient Perspective
    Hollie Schmidt, MS



    Speakers
    avatar for Victoria DiBiaso

    Victoria DiBiaso

    Global Head, Patient Informed Development and Health Value Translation, Sanofi, France
    Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
    TR

    Tracey Robertson

    Head of Patient and Site Engagement Capabilities, Boehringer Ingelheim Pharmaceuticals Inc., United States
    As the global CD&O Patient & Site Engagement Capabilities Lead, Tracey's team is responsible for the development the processes, solutions and services supporting all aspects patient and site engagement. She started her career in management consulting with PricewaterhouseCoopers, working... Read More →
    avatar for Hollie Schmidt

    Hollie Schmidt

    Vice President of Scientific Operations, Accelerated Cure Project, United States
    Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Workshop

    1:15pm PDT

    #246: The State of Clinical Trials in 2024: Are We Making the Grade?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-584-L04-P; CME 1.00; RN 1.00

    This forum will present metrics developed and tested to understand progress for improving trials by 2030. A panel will provide work in areas of metrics for assessing progress in improving trials and understanding the state of clinical trials in 2024.

    Learning Objectives

    Discuss current efforts to establish metrics for assessing progress on efforts to improve trials, including improvements to trial design quality and representativeness of trials; Identify areas of trial improvements that may be measured or assessed; Appraise metrics approaches for relevance to improving specific areas of trial operations.

    Chair

    Summer Starling, DrPH, MPH

    Speaker

    Panelist
    Jennifer Miller, PhD

    Panelist
    Linda B Sullivan, MBA



    Speakers
    avatar for Summer Starling

    Summer Starling

    Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
    avatar for Jennifer Miller

    Jennifer Miller

    Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States
    Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →
    avatar for Linda Sullivan

    Linda Sullivan

    Senior Fellow, Tufts Center For the Study of Drug Development, United States
    Ms Sullivan has more than 30 years of experience working in the Healthcare and Clinical Research industries helping organizations optimize processes to improve financial and quality outcomes. She is the founder and served as Executive Director of the Metrics Champion Consortium, an... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   02: ClinTrials -ClinOps, Forum

    1:15pm PDT

    #251: Enabling Patient Access Worldwide Including Japan or Other Countries to Innovative Drugs Through Global Development Strategy
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-589-L04-P; CME 1.00; RN 1.00

    This forum will present the considerations in global development strategy to approach to broader market including Japan for maximizing worldwide patient access and business opportunity. The panelists are from pharma and biotech.

    Learning Objectives

    Describe how to maximize the value of innovative products for the global market and benefit patients worldwide; Discuss how to apply the learnings to the clinical development strategy to expand target market effectively considering patient access to innovative drugs; Identify how to influence to regulators, industry, and trial sites to improve local environment to reduce hurdles and enhance global simultaneous development.

    Chair

    Eri Sekine

    Speaker

    Panelist
    Leyna Mulholland, PharmD, PhD, MS

    Panelist
    Toshiharu Sano, RPh

    Panelist
    Xiaojun (Wendy) Yan, MD, MBA



    Speakers
    avatar for Eri Sekine

    Eri Sekine

    Executive Vice President, CMIC Group, Japan
    Eri Sekine is Executive Vice President of CMIC Co., Ltd. and in charge of Data Business which includes Clinical Data Management, Biostatistics, Statistical Analysis, Pharmacovigilance, Outsourcing Management and Quality Management. Eri Sekine has over 30 years' experience in various... Read More →
    LM

    Leyna Mulholland

    Executive Director, Global Regulatory Affairs, Transent Group, United States
    Leyna is a registered pharmacist in Japan and obtained PharmD, MS/PhD in Toxicology from the University of Michigan. Her career started in academic research focused on gene mutations and carcinogenicity in the Med School at the U of M and graduate courses teaching at Indiana University... Read More →
    avatar for Toshiharu Sano

    Toshiharu Sano

    Associate Vice President, Head of Clinical Operation Area, MSD K.K., Japan
    Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →
    TS

    Toshihiro Sano

    Associate Vice President, Head of Clinical Operations, Merck Sharp & Dohme LLC , United States
    avatar for Xiaojun (Wendy) Yan

    Xiaojun (Wendy) Yan

    Senior Vice President, Chief Regulatory Officer, BeiGene (Beijing) Co., Ltd., China
    Wendy is a pharmacist by training, having graduated from Beijing Traditional Chinese Medicine University (China) and received an MBA from Staffordshire University (UK).  She began her career in Beijing Drug Control Institute, subordinate organization of China NMPA in 1988. Since... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      07: ProjectManagement-StrategicPlanning, Forum

    1:15pm PDT

    #253: Platform Technology Designation: Opportunities and Challenges for Implementation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-591-L04-P; CME 1.00; RN 1.00

    This forum will review the key components of the new FDA Platform Technologies Designation program. A panel of experts will provide their perspectives on the proposal and discuss opportunities and challenges related to its implementation.

    Learning Objectives

    Describe the key attributes of the proposed Platform Technology Designation Program as described by the anticipated FDA draft guidance; Discuss stakeholder perspectives about the new designation program; Describe anticipated opportunities and challenges related to its implementation.

    Chair

    Andrea Doyle

    Speaker

    Panelist
    Rachael Anatol

    Panelist
    Evdokia Korakianiti, PhD, MSc

    Panelist
    Monica Veldman



    Speakers
    avatar for Rachael Anatol

    Rachael Anatol

    Deputy Super Office Director, Office of Therapeutic Products, CBER, FDA, United States
    AD

    Andrea Doyle

    Head, Global Regulatory Affairs, Neurology, Sanofi, United States
    avatar for Evdokia Korakianiti

    Evdokia Korakianiti

    Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
    MV

    Monica Veldman

    Director of Global Regulatory Policy, Alliance for Regenerative Medicine, United States


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    1:15pm PDT

    #254: FDA Rare Disease Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-593-L04-P; CME 1.00; RN 1.00

    Hear from senior FDA leadership about challenges and opportunities in reviewing drugs for rare diseases. Representatives from key Agency Offices/Centers will provide updates on key trends and initiatives, then will discuss hot topic questions.

    Learning Objectives

    Discuss recent trends in the development and FDA review of orphan drugs; Explain new and ongoing FDA policies and initiatives to facilitate the development of drugs for rare diseases; Identify opportunities to further address the challenges associated with rare disease medical product development.

    Chair

    James Valentine, JD, MHS

    Speaker

    Panelist
    Kerry Jo Lee, MD

    Panelist
    Peter W. Marks, MD, PhD



    Speakers
    avatar for James Valentine

    James Valentine

    Director, Hyman, Phelps & McNamara, PC, United States
    James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →
    avatar for Kerry Jo Lee

    Kerry Jo Lee

    Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro, FDA, United States
    Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →
    avatar for Peter Marks

    Peter Marks

    Director, Center for Biologics Evaluation and Research, FDA, United States
    Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    1:15pm PDT

    #245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-583-L04-P; CME 1.00; RN 1.00

    Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.

    Learning Objectives

    Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.

    Chair

    Ana Zanoletty Perez

    Speaker

    FDA Update
    Shari Targum, MD, MPH, FACC, FACP

    Academic Update
    Sara Bristol Calvert, PharmD

    Patient Advocate Perspective
    Deborah Collyar

    WHO Update
    Marion Laumonier, MSc



    Speakers
    avatar for Sara Calvert

    Sara Calvert

    Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States
    Dr. Sara Bristol Calvert is currently the Director of Projects at the Clinical Trials Transformation Initiative (CTTI). Prior to this role, she was a CTTI Senior Project Manager which included leading projects in Diversity in Clinical Trials, Single IRB, Registry Trials, HABP/VABP... Read More →
    avatar for Deborah Collyar

    Deborah Collyar

    President, Patient Advocates In Research (PAIR), United States
    Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →
    avatar for Marion Laumonier

    Marion Laumonier

    Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland
    Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →
    avatar for Ana Zanoletty Perez

    Ana Zanoletty Perez

    Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
    Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →
    ST

    Shari Targum

    Deputy Director, Office of Clinical Policy, OC, FDA, United States
    Dr. Shari Targum has over 30 years of clinical, industry and regulatory experience. She began her FDA career in 1999 as a Medical Officer and then Team Leader in CDER's Division of Cardiovascular and Renal Products and she has held positions of increasing authority in CDER and CBER... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

    1:15pm PDT

    #255: International Harmonization to Support Pharmaceutical Quality and Lifecycle Management
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-594-L04-P; CME 1.00; RN 1.00

    Since establishment in 1990, the International Council for Harmonisation (ICH) has expanded its global footprint to harmonize requirements for the development of medicines and increase patient access to medicines. Importantly, ICH’s quality portfolio serves to support continual improvement and innovation in biopharmaceutical manufacturing. In 2018, ICH published its quality mission to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science.” The Q12 and Q14 Guidelines on Lifecycle Management and Analytical Procedure Development have been instrumental in advancing this mission. Previously, divergent requirements for filing post-approval changes presented challenges and in some cases, led to lengthy timelines for implementing process improvements or incorporating new technologies that may perform more efficiently. The Q12 framework offers a solution to facilitate a globally-aligned risk-based approach to post-approval change management allowing for more efficiency and better serving patient’s interest. Q14 provides additional considerations regarding lifecycle management for analytical procedures. While both of these guidelines are now finalized, there is still work to do to achieve the full benefits envisioned. With ICH’s expansion, it has prioritized the adequate implementation and adherence of guidelines through its work to promote training and periodically conduct a survey to assess guideline implementation by its Members and Observers. This session will provide global regulatory and industry perspective regarding progress made and future opportunities to achieve greater harmonization and encourage the global community to embrace the science and risk-based approaches envisioned by Q12 and Q14. Case studies will be presented highlighting the objectives and work to facilitate a globally aligned approach to implementation of these guidelines.

    Learning Objectives

    Analyze the objectives of ICH Guidelines Q12 Lifecycle Management and Q14 Analytical Procedure Development to promote innovation and facilitate more efficient post-approval change management; Examine status of implementation of Q12 and Q14 Guidelines globally; Investigate opportunities to advance global harmonization and more efficient lifecycle management by using case studies.

    Chair

    Amanda Marie Roache, MS

    Speaker

    Lifecycle Strategies at the Interface Between ICH Q12 and ICH Q14
    Connie Langer, MSc

    ICH Q14: Analytical Procedure Development and Lifecycle Management
    Nina S. Cauchon, PhD

    Update from Japan on Q12
    Satomi Yagi

    Update from EMA
    Evdokia Korakianiti, PhD, MSc



    Speakers
    avatar for Amanda Roache

    Amanda Roache

    Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
    Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →
    avatar for Nina Cauchon

    Nina Cauchon

    Director Regulatory Affairs CMC, Amgen, United States
    Nina S. Cauchon, PhD, leads external engagement activities within RA-CMC. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies... Read More →
    avatar for Connie Langer

    Connie Langer

    Senior Director, Pfizer Inc, United States
    Connie Langer is a Senior Director at Pfizer who leads a team that monitors and advises on regulatory changes and impacts. She collaborates with experts to communicate Pfizer's feedback and position to health authorities on regulations and guidance documents. She also has experience... Read More →
    SY

    Satomi Yagi

    Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA)
    avatar for Evdokia Korakianiti

    Evdokia Korakianiti

    Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum
    • Format Forum
    • Level Intermediate
    • Featured Topics ICH
    • Level Intermediate
    • Feature Topics ICH
    • Credit Type ACPE, CME, RN
    • Tags Forum

    1:15pm PDT

    #256: Successful Strategies for Leading and Influencing Without Authority in an Evolving Digital Landscape
    Component Type: Workshop
    Level: Intermediate

    This workshop will discuss best practices and essential skills for leading without authority. Attendees with go through a real-world case study for leading a cross functional team through a long-term project without formal authority. This workshop will delve into essential strategies for fostering alignment, cultivating open communication, promoting agility, and successfully navigating barriers within organizations.

    Learning Objectives

    Discuss best practices and develop the essential skills needed for leading without authority in a cross functional team environment; Describe influencing stakeholders, negotiation tactics, and relationship building..

    Chair

    Mica Elizalde, RAC

    Speaker

    Facilitator
    Connie Pascual, MSc



    Speakers
    ME

    Mica Elizalde

    Principal Scientist, Regulatory Digital Health, Merck & Co., Inc., United States
    CP

    Connie Pascual

    Principal Scientist, Regulatory Digital Health, Merck & Co., Inc., United States
    Connie is currently a Director of Regulatory Affairs (Digital Health) at Merck. She has worked in the medical device industry in Regulatory Affairs for over 14 years focused on digital health technologies. She has successfully managed, led, and authored domestic and international... Read More →


    Tuesday June 18, 2024 1:15pm - 2:15pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Workshop

    2:15pm PDT

    #259 RT: Roundtable Discussion: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team
    Component Type: Session

    Join the Professional Education, Training & Development/Project Management Community for a follow up round table discussion tied to session: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team (June 17 | 3:30-4:30PM PDT). Space is limited.

    Chair

    Tyler Ludlow, MBA


    Speakers
    avatar for Tyler Ludlow

    Tyler Ludlow

    Founder and Chief Decision Scientist, Decision Skills Institute, United States
    Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →


    Tuesday June 18, 2024 2:15pm - 3:15pm PDT
    Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:15pm PDT

    #257 RT: Roundtable Discussion: Good Data Governance Practices - Regulatory and Industry Perspectives
    Component Type: Session

    Join the Good Clinical Practices & QA Community for a follow up round table discussion tied to session: Good Data Governance Practices and the Importance of Incorporating Input from the Data Scientist in Quality by Design (Tuesday, June 18 | 8:00AM - 9:00AM PDT). Space is limited.

    Chair

    Terry Katz, MS


    Speakers
    avatar for Terry Katz

    Terry Katz

    Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
    Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →


    Tuesday June 18, 2024 2:15pm - 3:15pm PDT
    Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:15pm PDT

    #258 RT: Roundtable Discussion: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
    Component Type: Session

    Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability (Tuesday, June 18 | 8:00am - 9:00AM PDT). Space is limited.

    Chair

    Demetra Macheras, MBA


    Speakers
    avatar for Demetra Macheras

    Demetra Macheras

    Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
    Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →


    Tuesday June 18, 2024 2:15pm - 3:15pm PDT
    Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:15pm PDT

    Refreshment Break
    Component Type: Social Event




    Tuesday June 18, 2024 2:15pm - 3:15pm PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:30pm PDT

    #259.1 IS: Arnold Venture Innovation Session: Better Drug Information for Payers, Physicians, and Patients
    Component Type: Session

    Shared decision-making between patients and their healthcare providers about their treatments is important, and these complex decisions can be facilitated by presenting knowledge in an intuitive manner about the benefit/risk of various therapies based on the insights learned during the clinical investigation. This session will critically consider scientific issues related to communicating drug information advances expeditiously and safely.

    Chair

    Arnold Ventures

    Speaker

    Speaker
    Rita F. Redberg, MD, MSc, FACC

    Speaker
    Steven Woloshin



    Speakers
    avatar for Rita Redberg

    Rita Redberg

    Director, Women's Cardiovascular Services; Professor of Medicine, UCSF Medical Center, United States
    Dr. Redberg is a general Cardiologist and interested in preventive cardiology. Her research interests are in our use of medical procedures and devices. She studies the regulatory process for medical devices and the strength of evidence that supports them, particularly high-risk devices... Read More →
    avatar for Steven Woloshin

    Steven Woloshin

    Professor, Dartmouth Institute, United States
    Dr. Steven Woloshin is co-director of the Center for Medicine and Media at The Dartmouth Institute and a general internist. He and Lisa Schwartz co-created the drug facts box, drug-benefit and harm-data summaries shown in clinical trials to improve consumer decision-making. The FDA's... Read More →
    AV

    Arnold Ventures

    United States


    Tuesday June 18, 2024 2:30pm - 3:00pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:30pm PDT

    #260 IT: Milliman IntelliScript Innovation Theater: Pre-Screening for Clinical Trials - The Revolution Starts in 3, 2, 1…
    Component Type: Session

    Pre-screening trial participants is tough when you don’t have access to full medical records. Instead, collect a HIPAA authorization and let Milliman IntelliScript retrieve and interpret prescription and medical data. Just upload name, zip, and DOB to access our proprietary data on most US residents. Filter by customizable inclusion and exclusion criteria in seconds for easier, more accurate pre-screening. Randomize more participants, realize more revenue, and push more trials to completion.

    Chair

    Milliman IntelliScript

    Speaker

    Speaker
    Alyssa Vincze



    Speakers
    avatar for Alyssa Vincze

    Alyssa Vincze

    Principal and Director, R&D, Milliman IntelliScript , United States
    Alyssa is an actuary serving as Principal and Director of R&D with Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She recently led product development for IntelliScript’s clinical trials solution, adapting... Read More →


    Tuesday June 18, 2024 2:30pm - 3:00pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:30pm PDT

    #261 IT: Parexel Innovation Theater: FSP Partnership - A Foundation for Innovation and Patient-Guided Development
    Component Type: Session

    Optimal outsourcing is not a one-size-fits-all approach. FSP outsourcing has evolved beyond its origins as an efficiency model to manage clinical development labor demands to provide greater control over data, processes and resource allocation. Pfizer recently transitioned from predominately full-service outsourcing to an FSP model while adopting new job roles that prioritize patients and sites. Learn how Pfizer & Parexel created resource efficiencies & agility across a global study portfolio.

    Chair

    Parexel

    Speaker

    Speaker
    Liz Rogers, MSc



    Speakers
    avatar for Parexel

    Parexel

    United States
    LR

    Liz Rogers

    Vice President, Head of Global Site and Study Operations, Pfizer Inc, United States
    As Vice President and Worldwide Head of Global Site and Study Operations at Pfizer, Liz is responsible for leading the management and oversight of global investigator site planning and clinical trial execution. Global Study and Site Operations supports the delivery of the Pfizer portfolio... Read More →


    Tuesday June 18, 2024 2:30pm - 3:00pm PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:30pm PDT

    #262 IT: Weave Innovation Theater: Minutes, Not Months - How to Draft an Efficient IND
    Component Type: Session

    Drafting an effective IND is critical to your organization’s valuation and success. How would being able to do so in minutes rather than months free up you and your team? Learn how you can focus on other key objectives and activities by automating tedious tasks and leveraging your expertise where it matters most: getting therapies to market.

    Chair

    Weave AI

    Speaker

    Speaker
    Brandon Rice



    Speakers
    avatar for Brandon Rice

    Brandon Rice

    CPO, Weave, United States
    I am Brandon and I lead Product at Weave. We are building AutoIND, an AI-powered software platform to streamline every aspect of IND preparation. I am deeply committed to building products that positively impact human lives, create meaningful value for our customers, and are delightful... Read More →


    Tuesday June 18, 2024 2:30pm - 3:00pm PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    3:15pm PDT

    #263: Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-595-L04-P; CME 1.00; RN 1.00

    This session provides an opportunity to pause and reflect on how far we have come and discuss areas for future focus, innovation, and key influential drivers for change from a scientific, technological and patient-centric perspective.

    Learning Objectives

    Describe the evolution in the use of risk management principles in the context of patient safety; Discuss the role of real-time information and collaboration/engagement as the catalyst for action in risk management; Identify current limitations and challenges; List specific case examples from a public health and patient safety perspective; Discuss opportunities for future innovations.

    Chair

    Rania Mouchantaf, PhD

    Speaker

    FDA Update
    Gerald Dal Pan, MD, MHS

    MHRA Update
    Alison Cave, PhD

    Effectiveness of Interventions: Successes and Challenges
    Yola Moride, PhD, FISPE

    Industry Update
    Mamiko Kasho

    EMA Update
    Priya Bahri, PhD, RPh



    Speakers
    avatar for Priya Bahri

    Priya Bahri

    Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
    Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
    avatar for Alison Cave

    Alison Cave

    Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
    avatar for Mamiko Kasho

    Mamiko Kasho

    Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan
    Mamiko Kasho is Executive Director of Global Pharmacovigilance Management in Global Safety HQ of Eisai Co., Ltd, and has been involved in global PV area since she joined the company in 2007. Mamiko has been responsible for PV agreements with licensing partners for 15 years and at... Read More →
    avatar for Yola Moride

    Yola Moride

    President, YolaRX Consultants, Canada
    Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral... Read More →
    avatar for Rania Mouchantaf

    Rania Mouchantaf

    A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
    Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 17 years of experience in the area of pharmacovigilance. Before entering the public service she worked in the private sector, however her interest in pharmacovigilance... Read More →
    avatar for Gerald Dal Pan

    Gerald Dal Pan

    Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
    Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    3:15pm PDT

    #265: Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-597-L04-P; CME 1.00; RN 1.00

    This session will discuss patient advocacy groups and pharmaceutical companies and the co-created the patient advocacy leaders and drug development industry network (PALADIN), a US focused pre-competitive and disease agnostic Consortium, to advance the pace of medicines development.

    Learning Objectives

    Describe progress made by PALADIN (patient advocacy leaders and drug development industry network), a pre-competitive alliance of 20+ organizations formed in 2023; Discuss how the Consortium was established, it’s mission and governance; Identify year one resources created to optimize collaborations; Discuss priority year two activities and long-range plans.

    Chair

    Victoria DiBiaso, BSN, MPH, RN

    Speaker

    Practical Approaches and Resources to Optimize Advocacy Group - Industry Collaborations: An Update on the PALADIN Consortium
    Kenneth Getz, MBA

    Patient Perspective
    Hollie Schmidt, MS



    Speakers
    avatar for Victoria DiBiaso

    Victoria DiBiaso

    Global Head, Patient Informed Development and Health Value Translation, Sanofi, France
    Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
    avatar for Kenneth Getz

    Kenneth Getz

    Tufts Center for the Study of Drug Development, Center For the Study of Drug Development, United States
    Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
    avatar for Hollie Schmidt

    Hollie Schmidt

    Vice President of Scientific Operations, Accelerated Cure Project, United States
    Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum

    3:15pm PDT

    #266: Exploiting Real-World Data From Social Media in Patient-Focused Drug Development
    Component Type: Session
    Level: Basic

    Social media is an important new source of real-world data (RWD) for patient-focused drug development. This session will present a review of considerations from an industry and regulators perspectives when listening to social media from patients.

    Learning Objectives

    Summarize the work done by group of experts from companies’ members; Discuss the challenges and opportunities of exploiting real-world data (RWD) from social media listening for R&D purposes and regulatory submissions; Propose best practices.

    Chair

    Thierry H Escudier, MSc

    Speaker

    Industry Update
    Sarah Lyons

    Academic Update
    Philipp Cimiano, PhD

    Industry Update
    Vishakha Sharma, PhD



    Speakers
    PC

    Philipp Cimiano

    Head of Semantic Computing Group, Director, Joint AI Center, Bielefeld University, Germany
    Philipp is an expert in Artificial Intelligence and Natural Language Processing. He graduated in computer science and obtained his PhD and habilitation from KIT. Since 2009, he is full professor for computer science at Bielefeld University. He leads the Semantic Computing group and... Read More →
    avatar for Thierry Escudier

    Thierry Escudier

    Chairman, Strategic Consulting, DCRIPT, France
    Leader in Clinical Research, with more than 30 year’s experience in Corporate R&D pharma organizations , Thierry has been promoting patient engagement strategy across the Industry. Thierry is now acting as an independent consultant providing strategic consulting and is very much... Read More →
    avatar for Sarah Lyons

    Sarah Lyons

    Vice President, Data Transformation and AI Platforms, DTA and AI, IQVIA, Canada
    avatar for Vishakha Sharma

    Vishakha Sharma

    Senior Principal Data Scientist, Roche, United States
    Vishakha Sharma, senior principal data scientist at Roche Diagnostics Information Solutions, leads NLP and ML initiatives, improving navify product portfolio for enhanced patient care. Vishakha has authored over 50 peer-reviewed publications and given 20+ invited talks. She serves... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session

    3:15pm PDT

    #270: Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-602-L04-P; CME 1.00; PDU 1.00 PMI 2166XALVLX; RN 1.00

    Many project management methodologies, alternative thinking approach and new technologies can be applied to life science project management and bring many benefits. In this session, the adoption of Design Thinking and Generative AI, two of the emerging topics in health care industry, into life science project management will be discussed. The session will also demonstrate, with case studies, the possibilities of implementing new thinking approach for effective project management, team leading and efficient business process development. We will also examine practical applications of Generative AI in project management from optimizing scheduling, resource planning, and risk management. Reflecting on the current adoption efforts, this session provides a platform to explore possibilities to leverage new thinking and technologies to enhance life science project management.

    Learning Objectives

    Critique how many project management methodologies, thinking approaches, and new technologies can be applied to life science projects, and they may bring various benefits into the practice; Implement applicable methodologies and protocol new technologies in real-world practice.

    Chair

    Char Leung

    Speaker

    Industry Update
    Rune Bergendorff, MSc



    Speakers
    avatar for Char Leung

    Char Leung

    Director, Development Program Management, Genmab, United States
    Char Leung is a Director, Development Program Management at Genmab where she leads the operationalization of drug development strategies. Prior to Genmab, Char spent 9 years at Janssen R&D managing biologics discovery and development projects with increasing responsibilities. Char... Read More →
    avatar for Rune Bergendorff

    Rune Bergendorff

    Partner, International Life Sciences, Implement Consulting Group, Denmark
    Rune Bergendorff, Partner at Implement Consulting, boasts two decades of consultancy experience spanning Europe and the US. Educated in IT and business, his focus is centered on delivering sustainable digital transformations that drive business impact and value. Over the past 15 years... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session |   07: ProjectManagement-StrategicPlanning, Session

    3:15pm PDT

    #268: Strategies to Make your Clinical Trials More Inclusive for Patients with Disabilities
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-600-L04-P; CME 1.00; RN 1.00

    This workshop will assist attendees with ways to properly accommodate medically complex and/or rare disease patients through providing accessibility tools and solutions. Soft skills and “person first” language will be discussed.

    Learning Objectives

    Identify how to expand the definition of diversity; Describe how to have conversations with patients about disabilities; Explore solutions and recommendations for no/low-cost actions you can take to make your facility as accessible as possible for a variety of disabilities; Define resources for support and training for site staff.

    Chair

    Stacy Hurt, MBA, MHA

    Speaker

    Facilitator
    Carlos Orantes, MBA

    Facilitator
    Cecile Gonzalez-Cerimele

    Facilitator
    Mindy Cameron



    Speakers
    avatar for Stacy Hurt, MBA, MHA

    Stacy Hurt, MBA, MHA

    Chief Patient Officer, Parexel International, United States
    Stacy Hurt, MHA, MBA is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as... Read More →
    MC

    Mindy Cameron

    Patient Advocate, Advocacyworks, United States
    Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →
    CG

    Cecile Gonzalez-Cerimele

    Executive Director Diversity and Inclusion in Clinical Trials, Eli Lilly and Company, United States
    Leader with over 30 years in the pharmaceutical sector spanning discovery, New Product Planning, late-stage development, and COVID-19 Ab program. Current focus is on crafting strategies that bolster awareness, education, and availability of CTs for underrepresented groups worldwide... Read More →
    avatar for Carlos Orantes

    Carlos Orantes

    Chief Executive Officer, Alcanza Clinical Research, United States


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Workshop

    3:15pm PDT

    #264: Advancing Innovation in Clinical Trial Design and Conduct
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-596-L04-P; CME 1.00; RN 1.00

    This forum will provide an overview of FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities and an opportunity for stakeholders to share their experiences, perspectives, and priorities to inform FDA’s efforts.

    Learning Objectives

    Discuss key challenges or barriers that hinder the implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

    Chair

    Meghana Chalasani, MHA

    Speaker

    Panelist
    Kevin Bugin, PhD, MS, RAC

    Patient Perspective
    Ella Balasa



    Speakers
    avatar for Meghana Chalasani

    Meghana Chalasani

    Lead, Advisory Committees, Office of New Drugs, CDER, FDA, United States
    Meghana Chalasani leads the Science Strategies program in the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. She also manages the New Drug Regulatory Program’s Advisory Committee modernization effort. Previously, Meghana worked closely on CDER’s Patient-Focused... Read More →
    avatar for Ella Balasa

    Ella Balasa

    Patient Advocate and Engagement Consultant, United States
    A chronic disease patient who advocates research and advisory boards, optimizing clinical trial designs and reviewing protocols, composing lay clinical summaries and op-eds, collaborating on white paper development, moderating patient and industry panel discussions, as well as sharing... Read More →
    avatar for Kevin Bugin

    Kevin Bugin

    Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
    Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum

    3:15pm PDT

    #269: For Whom the Cell Tolls: Ethics in the Era of Precision Medicine
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-601-L04-P; CME 1.00; RN 1.00

    This session will discuss how precision medicine will combine medicine and technology in unique ways to maximize healthcare services and outcomes. At the heart of the issue lie ethical concerns related to privacy, informed consent, and social justice.

    Learning Objectives

    Analyze latest ethical expectations and challenges; Discuss potential future innovation platforms providing significant benefit to be gained from precision medicine; Recognize the bioethical challenges and opportunities ahead.

    Chair

    James Wabby, MHS

    Speaker

    Bioethics Cases and Policy Development
    Terry David Church, DrSc, MA, MS

    Ethical Frontiers: Navigating Transplant and Genetic Ethical Considerations in Patient Care
    Amanda Burkhardt, PhD



    Speakers
    avatar for Amanda Burkhardt

    Amanda Burkhardt

    Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States
    Prior to joining USC Mann faculty, Amanda M. Burkhardt was an adjunct assistant professor at the University of California, Irvine, in the School of Medicine, Department of Physiology & Biophysics; and lecturer in the Department of Biological Sciences at California State University... Read More →
    avatar for Terry Church

    Terry Church

    Assistant Professor, Alfred E Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States
    Dr. Terry David Church is currently an Assistant Professor in Regulatory and Quality Sciences at the University of Southern California, Mann School of Pharmacy and Pharmaceutical Sciences. He is Assistant Director of Pharmacy Undergraduate Programs. Prof. Church's academic focus is... Read More →
    avatar for James Wabby

    James Wabby

    Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
    James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Forum
    • Format Forum
    • Level Basic
    • Featured Topics Ethics
    • Level Basic
    • Feature Topics Ethics
    • Credit Type ACPE, CME, RN
    • Tags Forum

    3:15pm PDT

    #271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-603-L04-P; CME 1.00; RN 1.00

    This session will bring regulators and industry quality experts together to explore how quality management systems can be developed to meet the challenges real-world evidence presents to QA activities and regulatory inspection expectations.

    Learning Objectives

    Evaluate quality challenges associated with the use of real-world evidence as part of regulatory studies; Discuss how to apply proportionate risk-based quality assurance activities which meet regulatory expectations.

    Chair

    Andrew Gray, PhD

    Speaker

    FDA Update
    L'Oreal Walker

    FDA Update
    Lee H. Pai-Scherf, MD

    Industry Perspective
    Abi Seifert, MBA



    Speakers
    avatar for Andrew Gray

    Andrew Gray

    Director, QA Clinical Therapeutic Area Head, Johnson & Johnson, United Kingdom
    Andrew is a member of Johnson and Johnson's R&D Quality organisation where he has responsibility for risk based audit strategy across clinical therapeutic areas. Prior to joining J&J Andrew was a Deputy Director and Head of the Medicines Inspectorate at MHRA. Andrew has led international... Read More →
    avatar for Lee Pai-Scherf

    Lee Pai-Scherf

    Senior Physician, GCP Assessment Branch, DCCE, OSI, OC, CDER, FDA, United States
    Lee H. Pai-Scherf, MD, Senior Physician, OSI, Office of Compliance, CDER, FDA Dr. Pai-Scherf is a Senior Physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory... Read More →
    avatar for Abi Seifert

    Abi Seifert

    Global Head Country Development Quality, Novartis , United States
    Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →
    LW

    L'Oreal Walker

    Supervisory Consumer Safety, OBIMO, ORA, FDA, United States
    L'Oreal Walker is a seasoned professional with over two decades of experience in regulatory compliance and oversight. Currently serving as a Supervisory Investigator in the Office of Bioresearch Monitoring West Division within the Office of Regulatory Affairs at the FDA, L'Oreal leads... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Session

    3:15pm PDT

    #272: This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-604-L04-P; CME 1.00; RN 1.00

    This panel will explore the blue skies of global regulatory pilot programs, including initiatives on real-world evidence (RWE), model-informed drug development (MIDD), innovative trials, and endpoints. Panelists will educate the audience on new opportunities and best practices for future pilot success.

    Learning Objectives

    Critique new opportunities to participate in regulatory pilot programs at FDA and globally; Outline key lessons learned from pilot program case studies and experiences; Identify best practices to increase the likelihood of success for future pilot programs.

    Chair

    Andrew Emmett, MPH

    Speaker

    Moderator
    Danielle Friend Economo, PhD

    PDUFA VII Rare Disease Endpoint Advancement Program
    Mary Jo Salerno, MPH, MS

    Industry Update
    Donna Boyce, MS, RAC

    Industry Update
    Rasika Kalamegham, PhD



    Speakers
    avatar for Danielle Friend Economo

    Danielle Friend Economo

    Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
    Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →
    avatar for Andrew Emmett

    Andrew Emmett

    FDA Liaison | US Regulatory Policy and Global Intelligence, Pfizer Inc, United States
    Andrew Emmett is Pfizer's FDA Liaison and Executive Director for U.S. Regulatory Policy & Global Intelligence. In his role, Andrew develops and advocates for Pfizer policy positions to enhance the regulatory environment for biomedical innovation. He leads key initiatives on real-world... Read More →
    avatar for Donna Boyce

    Donna Boyce

    Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States
    Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
    RK

    Rasika Kalamegham

    Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
    Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →
    MJ

    Mary Jo Salerno

    Science Policy Analyst, ORDPURM, OND, CDER, FDA, United States


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    3:15pm PDT

    #273: How to Provide Necessary Medicinal Products to Children?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-605-L04-P; CME 1.00; RN 1.00

    In this session, speakers share the efficacy of exsiting pediatric regulation and discuss future collaboration to promote pediatric drug development worldwide

    Learning Objectives

    Describe the pediatric regulation of Japan and ASEAN; Discuss collaboration to promote pediatric drug development in these countries.

    Chair

    Junko Sato, PhD

    Speaker

    PMDA Update
    Michiyo Sakiyama, MD

    Industry Upate
    Robert "Skip" Nelson, MD, PhD

    FDA Update
    Gerold Wharton



    Speakers
    avatar for Junko Sato

    Junko Sato

    Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
    avatar for Robert Nelson

    Robert Nelson

    Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
    Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →
    MS

    Michiyo Sakiyama

    Associate Senior Scientist for Clinical Medicine, Office of Vaccines and Blood, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Michiyo Sakiyama, MD is an Associate Senior Scientist for Clinical Medicine of the office of Vaccines and Blood Products at the Pharmaceuticals and Medical Devices Agency (PMDA). She is a pediatrician and currently involved in reviewing vaccines against infectious diseases, blood... Read More →
    GW

    Gerold Wharton

    Program Analyst, Office of Clinical Policy and Programs, OC, FDA, United States


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    3:15pm PDT

    #267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-599-L04-P; CME 1.00; RN 1.00

    This session provides a comprehensive overview of the status/evolution of the concept of electronic product information (ePI) in LATAM from multiple perspectives, including industry, international regulatory bodies, and various stakeholders involving patients and healthcare professionals (HCPs). It also reviews some of the relevant initiatives undertaken in Low to Medium income countries and their benefits and potential.

    Learning Objectives

    Identify the impact of electronic product information (ePI) hybrid pilots and regulatory framework evolution in LATAM countries; Discuss relevant initiatives undertaken in Low to medium income countries; Examine industry motivations and challenges in implementing ePI pilots; Describe the evolving landscape (efforts of HA's based on international standard for ePI, regulatory advancements made to ensure an optimal experience for patients/ HCPs, implications of these challenges on healthcare.

    Chair

    Leonardo Semprun, RPh

    Speaker

    Electonic Product Information Regulatory Evolution in Brazil
    Nélio Cézar de Aquino, SR, MSc

    Electronic Product Information in Low to Middle Income Countries
    Rutendo Kuwana, RPh

    Industry Outlook in Brazil: Exploring eLabeling Perspectives
    Rosana M. Mastellaro, PharmD, RPh



    Speakers
    avatar for Leonardo Semprun

    Leonardo Semprun

    Global Regulatory Policy Lead-LatAm, MSD, Panama
    Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with... Read More →
    avatar for Nélio Cézar de Aquino

    Nélio Cézar de Aquino

    General Manager of Medicines, ANVISA, Brazil
    Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →
    RK

    Rutendo Kuwana

    Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland
    Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →
    avatar for Rosana Mastellaro

    Rosana Mastellaro

    Director, Technical Regulatory Affairs and Innovation, Sindusfarma, Brazil
    Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   03: Data-Tech, Session

    3:15pm PDT

    #274: Regulatory Policy Roundtable: Pharmaceutical Quality, Generics, Innovative Medicines
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-606-L04-P; CME 1.00; RN 1.00

    Industry leaders will discuss how regulatory and industrial policy can support delivering medicines to patients faster, how to assure pharmaceutical quality for innovative and generic medicines, and how regulatory harmonization benefits both sectors and, ultimately, patients.

    Learning Objectives

    Define and discuss policy and program updates from FDA's Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ); Define quality management maturity (QMM) and how the federal government may use it to improve the quality of medicines and resiliency of the supply chain; Identify policy solutions to quality challenges like nitrosamines, PFAS, and related impurities/chemicals that preserve patient access to safe medicines.

    Chair

    Aaron Josephson, MS

    Speaker

    Panelist
    Katherine Wilson, JD, MA

    Quality Policy Priorities of the Canadian Generic Industry
    Kristin Willemsen, MS

    Panelist
    Brett Howard, JD, PhD



    Speakers
    avatar for Aaron Josephson

    Aaron Josephson

    Senior Director, Global Regulatory Policy, Teva Pharmaceuticals, United States
    Aaron develops and advocates for policies that enable more efficient and predictable regulatory systems aligned with Teva’s development programs, business objectives, and patient needs. Prior to joining Teva, Aaron worked at FDA for more than a decade in positions at CDER, CBER... Read More →
    avatar for Brett Howard

    Brett Howard

    Senior Director, US Regulatory Policy, USP, United States
    Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →
    avatar for Kristin Willemsen

    Kristin Willemsen

    Vice President, Scientific and Regulatory Affairs, Canadian Generic Pharmaceutical Association, Canada
    Kristin Willemsen is the Vice President of Scientific & Regulatory Affairs for CGPA. She works with CGPA members advocating for the implementation of regulatory, policy and guidance changes to increase access to safe, effective, and affordable generic medicines for Canadians. A key... Read More →
    avatar for Katherine Wilson

    Katherine Wilson

    Head, Global Regulatory Policy and Intelligence, Viatris, United States
    Katherine (Katie) Wilson, leads Global Regulatory Policy + Intelligence at Viatris, a global healthcare company committed to empowering people worldwide to live healthier at every stage of life. In her current role, Katie provides regulatory support to drive global policy initiatives... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   10: RegCMC-Product Quality, Forum

    3:15pm PDT

    #275: Securing the Chain: US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-607-L04-P; CME 1.00; RN 1.00

    With efforts in the US and Europe to increase supply chain transparency and prevent drug shortages, this forum focuses on recent and pending regulatory updates. We examine actions taken to mitigate product shortages following an unpredicted event impacting product shortages and lack of supply predictability.

    Learning Objectives

    Define the impact of US and European legislation updates on supply chain integrity and efforts to promote domestic manufacturing; Recognize how regulatory actions to prevent and mitigate product shortages are aimed at improving patient access and transparency across the supply chain; Discuss a case study on how the partnership between industry and regulatory can mitigate unpredictability.

    Chair

    Demetra Macheras, MBA


    Speakers
    avatar for Demetra Macheras

    Demetra Macheras

    Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
    Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Session

    3:15pm PDT

    #276: The Promise of Disease Progression Modeling to Bring Treatments to Patients Sooner
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-608-L04-P; CME 1.00; RN 1.00

    The impact of disease progression modeling (DPM) on medical product development has yet to be fully realized. This forum will describe DPM and its current applications in clinical trials and highlight the value of DPM to advance decision making and clinical development efficiency.

    Learning Objectives

    Describe disease progression modeling (DPM) and its current applications in clinical trials; Define the value of DPM to enhance decision making throughout the medical product development lifecycle; Discuss multi-stakeholder effort to advance clinical trial and medical product development efficiency through the increased recognition, value, and consistent use of DPM.

    Chair

    Summer Starling, DrPH, MPH

    Speaker

    Panelist
    Herbert Pang, PhD, MBA

    Panelist
    Karthik Venkatakrishnan, PhD

    Panelist
    Jenny Chien, PhD



    Speakers
    avatar for Summer Starling

    Summer Starling

    Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
    avatar for Jenny Chien

    Jenny Chien

    Associate Vice President, Global PK/PD and Pharmacometrics, Eli Lilly and Company, United States
    Dr. Chien is an associate VP and a scientific lead in the Global PK/PD and Pharmacometrics Department at Eli Lilly and Company. She received her Ph.D. degree in Pharmaceutical Sciences from the University of Washington, Seattle in 1997. Dr. Chien is recognized for her expertise in... Read More →
    avatar for Herbert Pang

    Herbert Pang

    Expert Statistical Scientist, Genentech, A Member of the Roche Group, United States
    Herbert (Herb) Pang is an Expert Statistical Scientist at Genentech/Roche. His research interests include real-world evidence for drug development, machine learning, biomarker discovery, -omics data, and the design and analysis of clinical trials. Herb obtained his PhD in Biostatistics... Read More →
    avatar for Karthik Venkatakrishnan

    Karthik Venkatakrishnan

    Vice President, Global Head of Quantitative Pharmacology, EMD Serono, United States
    Karthik Venkatakrishnan is Vice President and Global Head of Quantitative Pharmacology at EMD Serono, Inc., Billerica, MA, with accountability for leadership of Clinical Pharmacology, Translational M&S, and Pharmacometrics. Previously, he held roles in Clinical Pharmacology at Pfizer... Read More →


    Tuesday June 18, 2024 3:15pm - 4:15pm PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Forum
    • Format Forum
    • Level Basic
    • Level Basic
    • Credit Type ACPE, CME, RN
    • Tags Forum

    4:30pm PDT

    #277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-609-L04-P; CME 1.00; RN 1.00

    This session will introduce a novel FDA approach that harmonizes surveillance for drugs and biologics safety and quality data, creating a cohesive end-to-end review and data management framework to support both safety and quality data regulated by the FDA.

    Learning Objectives

    Describe FDA’s harmonized surveillance process for drugs and biologics safety and quality data with an integrated database approach; Identify the significant gain in efficiencies and effectiveness in drugs and biologics safety and quality reviews at FDA for both pre-market and post-market operations.

    Chair

    Sri Mantha, MBA, MS


    Speakers
    avatar for Sri Mantha

    Sri Mantha

    Director, Office of Strategic Programs, CDER, FDA, United States
    Sridhar (Sri) Mantha is currently Director of the Office of Business Informatics (OBI) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OBI, Sri is charged with leading informatics development to modernize CDER's drug regulatory... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    4:30pm PDT

    #278: Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-610-L04-P; CME 1.00; RN 1.00

    Pregnant individuals are underrepresented in research. This session provides an overview of how the evolving regulatory framework, pharmaco-epidemiology, and clinical trials can advance evidence generation and contribute to pregnancy labeling.

    Learning Objectives

    Discuss important global advances in the collection of data in drugs and biological products used during pregnancy; Identify the evolving regulatory framework, and the value of premarket and postmarketing safety data that can lead to improved labeling information for drugs and biological products used in pregnancy; Describe stakeholder efforts to include pregnant individuals in clinical trials.

    Chair

    Martine Dehlinger-Kremer, PhD

    Speaker

    Assessment of Drugs Used During Pregnancy: Current Status
    Martine Dehlinger-Kremer, PhD

    Safety of Drugs Used During Pregnancy: Regulatory Considerations and Updates
    Lynne Yao, MD

    Post-Marketing Approval Safety Studies: The Role of Pregnancy Registries
    Christina Chambers, PhD, MPH

    Evaluation of Drug Use During Pregnancy: Post-Marketing Surveillance and Beyond - Time for a Paradigm Shift
    Laura Shaughnessy



    Speakers
    avatar for Martine Dehlinger-Kremer

    Martine Dehlinger-Kremer

    Vice President Scientific Affairs, Pediatric Subject Matter Expert, ICON Plc, Germany
    Dr. Dehlinger-Kremer’s has over 30 years experience in research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior joining ICON, she served in executive leadership roles at global CROs, gained experience in global... Read More →
    avatar for Christina Chambers

    Christina Chambers

    Distinguished Professor, Pediatrics, University of California San Diego, United States
    Dr. Christina Chambers is a Professor in the Department of Pediatrics, School of Medicine at UC San Diego. She is Chief of the Division of Environmental Science and Health, and Co-Director of the Center for Better Beginnings. She is the principal investigator of MotherToBaby Pregnancy... Read More →
    LS

    Laura Shaughnessy

    Clinical Program Director, UCB Biosciences, United States
    avatar for Lynne Yao

    Lynne Yao

    Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
    Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    4:30pm PDT

    #284: Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-616-L04-P; CME 1.00; RN 1.00

    Understanding the safety of medicines and the risks imposed by their use is of interest to regulators around the world. This poses challenges for industry who are faced with meeting the regulatory requirements and expectations of multiple Healthcare Agencies from across the globe. This challenge is becoming greater still as more countries start to enter the world of PV.

    This session will focus on how regulators are working together to share information and intelligence and how experienced regulatory agencies are working with nations currently establishing pharmacovigilance regulations to implement these and develop the skills and knowledge required to ensure compliance and establish accepted best practice.

    Learning Objectives

    Describe the challenges faced by industry from a global perspective and gain insight into how regulatory agencies are working together to combat some of these issues; Discuss information and educate countries where PV is an emerging concept; Discuss areas where processes can be improved to make global PV more aligned and less challenging for industry and regulators alike.

    Chair

    Sophie Radicke, MSc

    Speaker

    FDA Update
    Carolyn A Volpe, PharmD, MS

    Update from Ghana
    Adela Ashie

    MHRA Update
    Sarah Vaughan



    Speakers
    avatar for Adela Ashie

    Adela Ashie

    Principal Regulatory Officer, Food and Drugs Authority, Ghana
    Adela Ashie is a pharmacist with over 15 years of experience in Pharmacovigilance. She holds a master’s in international health (MPH IH) from the University of Nottingham, United Kingdom and is currently Head of the Vigilance Unit under the Safety Monitoring Department of the Food... Read More →
    avatar for Sophie Radicke

    Sophie Radicke

    Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
    avatar for Sarah Vaughan

    Sarah Vaughan

    Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
    CV

    Carolyn Volpe

    Team Leader, OSI, OC, CDER, FDA, United States
    CAPT Carolyn Volpe is a licensed pharmacist and serves as the Team Leader for the Pharmacovigilance Compliance Team in FDA’s Center of Drug Evaluation and Research Office of Compliance Office of Scientific Investigations. She has over 14 years’ experience at FDA in post-marketing... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session |   08: RD Quality-Compliance, Session

    4:30pm PDT

    #280: Innovation, Agility, and Accessibility in Trial Execution: Exploring the Roles, Pathways, and Potential for Integration of Embedded Clinics, Pharmacies, and Diagnostic Providers in Clinical Research at Scale
    Component Type: Forum
    Level: Intermediate

    This forum will feature discussion on the challenges and opportunities associated with integrating health care providers in non hospital or physician office settings into the clinical research infrastructure. The forum will have case studies on successful trial execution using complimentary contributions from diagnostic providers, home care providers, pharmacies, and clinics embedded in retail settings.

    Learning Objectives

    Describe the opportunities related to potential trial participant engagement via alternative channels; Identify challenges and barriers to overcome in order to realize value in such innovative solutions; Define situations where optimization of research delivery can be deployed and pathways of doing so.

    Chair

    Earl Seltzer, MBA

    Speaker

    Optimizing Mobile Visits with Technology:Better Geographic, Demographic, and Sociographic Representation
    Josh Rose, MBA

    Supporting Decentralized Clinical Trial Delivery and Diversity in Research Through Partnerships
    Irfan A. Khan, MD

    How Pharmacy and Benefits Management can Support the Clinical Development Continuum
    Krystyna Chmura

    Exploring the Role of Diagnostic Providers in Optimizing Clinical Trial Recruitment
    Kristen Andrews



    Speakers
    avatar for Irfan Khan

    Irfan Khan

    Founder and Chief Executive Officer, Circuit Clinical, United States
    Dr. Khan is a cardiologist and the founder & CEO of Circuit Clinical, one of the fastest growing Integrated Research Organizations in the US. His work is focused on democratizing access to clinical trials.
    avatar for Krystyna Chmura

    Krystyna Chmura

    Senior Clinical Trials Advisor, Life Sciences Data, Evernorth Health Services, United States
    avatar for Earl Seltzer

    Earl Seltzer

    Senior Director, Partnerships and Innovation, CTI, United States
    Earl Seltzer has 19 years of industry experience shared across clinical investigator sites in the United States and working at CROs in the strategic planning and feasibility space. At CTI, Mr Seltzer leads the therapeutic strategy team and supports innovation in trial delivery and... Read More →
    avatar for Josh Rose

    Josh Rose

    Chief Executive Officer, Hawthorne Effect, United States
    Josh Rose, CEO, Hawthorne Effect, is a clinical research industry veteran with more than 20 years of experience. Hawthorne Effect is pioneering the way clinical trials are delivered in the patient’s home or community to drive better study outcomes. Prior Hawthorne, Josh led the... Read More →
    KA

    Kristen Andrews

    Head, Research Site Enablement, Labcorp , United States
    Kristen Andrews, Head of Research Site Enablement at Labcorp, has over 25 years of experience in the clinical trials industry. Starting as a clinical research coordinator, her career has progressed through increasing levels of responsibility and leadership first at research sites... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum

    4:30pm PDT

    #281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-613-L04-P; CME 1.00; RN 1.00

    A rapidly changing landscape has led to an increased use of real-world evidence (RWE) in regulatory decision making, as a complement to randomized clinical trials (RCTs), impacting how medicines are developed and assessed. The session will present where we are and discuss the exciting future ahead.

    Learning Objectives

    Describe how real-world data (RWD) is being leveraged to generate real-world evidence (RWE) in support of regulatory assessment and decision-making processes in Europe; Discuss the progress of DARWIN EU, and a high-level overview of the use of RWE in recent applications in EU and see how the generation of meaningful evidence can support safer and more effective treatments for patients.

    Chair

    Steffen Thirstrup, MD, PhD

    Speaker

    EMA Update
    Sabine Haubenreisser, PhD, MSc



    Speakers
    avatar for Sabine Haubenreisser

    Sabine Haubenreisser

    Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
    Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →
    avatar for Steffen Thirstrup

    Steffen Thirstrup

    Chief Medical Officer, European Medicines Agency, Netherlands
    Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session

    4:30pm PDT

    #282: Shame and Blame: Our Words are a Barrier to Clinical Research are a Care Option
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-614-L04-P; CME 1.00; RN 1.00

    Clinical research creates future clinical care. Let's lead in compassionate communication inviting more participation. Patient, site, and patient-focused drug development (PFDD) experts share and invite your participation in improving access through our words.

    Learning Objectives

    Identify the shame and blame negative words and phrases and their negative impact on patients; Recognize opportunities to improve the patient experience in clinical research as a care option through more compassionate word choice; Describe how to plan and justify optimization of protocol, informed consent, and participant communication language.

    Chair

    Lani Hashimoto

    Speaker

    Panelist
    Jamie Troil Goldfarb

    Panelist
    Eddilisa Martin

    Panelist
    James Duhig, PhD



    Speakers
    avatar for Lani Hashimoto

    Lani Hashimoto

    Associate Director, Patient Engagement, Novartis Pharmaceuticals Corporation, United States
    Lani Hashimoto is dedicated to connecting patients to research. Lani's lived experience as a clinical trial participant and caregiver further inspire her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient engagement. At... Read More →
    avatar for James Duhig

    James Duhig

    Global Head, Office of Health Literacy, AbbVie, United States
    Dr. James (Jay) Duhig, Ph.D., is director of Patient Integration for AbbVie Pharmacovigilance and Patient Safety. Dr. Duhig is an expert in the application of human factors and health literacy in the investigation of medication errors and in the development of drug and device instructional... Read More →
    JG

    Jamie Goldfarb

    Director, Patient Recruitment Strategy, Trialbee, United States
    avatar for Eddilisa Martin

    Eddilisa Martin

    Co-Founder and Chief Executive Officer, M&B Sciences Inc., United States


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum

    4:30pm PDT

    #279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-611-L04-P; CME 1.00; RN 1.00

    In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.

    Learning Objectives

    Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.

    Chair

    Rachele Hendricks-Sturrup, DrSc, MA, MSc

    Speaker

    Panelist
    Mehmet Burcu, PhD, MS

    Panelist
    Christina Mack, PhD, MPH

    Panelist
    Catherine C. Lerro, PhD, MPH



    Speakers
    avatar for Rachele Hendricks-Sturrup

    Rachele Hendricks-Sturrup

    Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States
    Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →
    avatar for Mehmet Burcu

    Mehmet Burcu

    Senior Director, Epidemiology, Merck & Co., Inc., United States
    Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →
    avatar for Catherine Lerro

    Catherine Lerro

    Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States
    Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →
    avatar for Christina Mack

    Christina Mack

    Chief Scientific Officer, Real-World Solutions, IQVIA, United States
    Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   03: Data-Tech, Forum |   11: Statistics-Data Science, Forum |   02: ClinTrials -ClinOps, Forum

    4:30pm PDT

    #285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-617-L04-P; CME 1.00; RN 1.00

    This session will describe the evolution of remote regulatory assessments (RRA’s), FDA’s authority to conduct an RRA in lieu of an inspection, the process for conducting an RRA, and recent RRAs conducted as part of the FY23 BIMO program

    Learning Objectives

    Describe what a remote regulatory assessments is and FDA’s authority to conduct a remote regulatory assessment; Describe the steps taken by the agency and site before, during, and after a remote regulatory assessment is conducted; Discuss FY23 metrics including recently conducted remote regulatory assessments.

    Chair

    Jan Hewett, BSN, JD

    Speaker

    FDA Update
    Kavita C. Dada, PharmD

    Industry Perspective on Remote Assessments
    James Riddle

    Health Canada Update
    Jennifer Evans



    Speakers
    KD

    Kavita Dada

    Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States
    JE

    Jennifer Evans

    Compliance Specialist, Health Canada, Canada
    Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a regulatory... Read More →
    avatar for Jan Hewett

    Jan Hewett

    Regulatory Counsel for Policy, OSI, CDER, FDA, United States
    Jan Hewett joined the U.S. Food and Drug Administration's Center for Drug Evaluation and Research -Office of Compliance- Office of Scientific Investigations office as Regulatory Counsel (Policy) in February 2015. Prior to joining OSI, Jan served as the Director of the Yale University... Read More →
    avatar for James Riddle

    James Riddle

    Senior Vice President, Global Review Operations, Advarra, United States
    JJames Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    4:30pm PDT

    #286: Recent Evolution of Accelerated Approval Pathways: Impacts on the Pathways Use and Implementation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-618-L04-P; CME 1.00; RN 1.00

    Thought leaders will be brought together in a fireside chat to discuss impacts observed due to recent changes to Accelerated Approval as well as current trends in how the pathway is being used and implemented.

    Learning Objectives

    Identify the changes to Accelerated Approval resulting from the passage of FDORA; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of Accelerated Approval; Discuss the impacts of the changes to the Accelerated Approval pathway and how it is currently being implemented.

    Chair

    Danielle Friend Economo, PhD

    Speaker

    Industry Update
    Alexis Miller, JD

    FDA Update
    Peter W. Marks, MD, PhD

    Academic Update
    Edward Neilan, MD, PhD



    Speakers
    avatar for Danielle Friend Economo

    Danielle Friend Economo

    Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
    Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →
    avatar for Peter Marks

    Peter Marks

    Director, Center for Biologics Evaluation and Research, FDA, United States
    Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
    avatar for Alexis Miller

    Alexis Miller

    Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States
    Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →
    avatar for Edward Neilan

    Edward Neilan

    Chief Medical and Scientific Officer, National Organization for Rare Disorders (NORD), United States
    Dr. Ed Neilan is the Chief Medical and Scientific Officer at the National Organization for Rare Diseases (NORD). He is a medical geneticist with experience in both academic medicine and the pharmaceutical industry. His expertise spans laboratory research and medical practice, as well... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    4:30pm PDT

    #287: ANVISA Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-619-L04-P; CME 1.00; RN 1.00

    In this forum, leaders from ANVISA will provide an update on regulatory priorities for Brazil, and inform about local trends, regulatory convergence, and collaboration initiatives. The discussion will also invite questions of general interest from the audience.

    Learning Objectives

    Describe ANVISA’s regulatory initiatives and strategic priorities; Discuss regulatory convergence of Brazilian regulations for medicines and medical devices to international guidelines and standards; Identify trends and opportunities for engagement with the Brazilian regulator.

    Chair

    Cammilla Horta Gomes, MA, MPharm

    Speaker

    Panelist
    Antonio Barra Torres, MD

    Panelist
    Patricia Oliveira Pereira Tagliari, LLM, MPH

    Panelist
    Bianca Zimon



    Speakers
    avatar for Antonio Barra Torres

    Antonio Barra Torres

    President Director, ANVISA, Brazil
    Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →
    avatar for Cammilla Horta Gomes

    Cammilla Horta Gomes

    LATAM Regulatory Policy Lead, Roche, Brazil
    Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator in ANVISA and industry, leading or contributing to bilateral and multilateral negotiations, harmonization... Read More →
    avatar for Patricia Oliveira Pereira Tagliari

    Patricia Oliveira Pereira Tagliari

    Associate Director, ANVISA, Brazil
    Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree... Read More →
    BZ

    Bianca Zimon

    Health Regulation Specialist, ANVISA, Brazil


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    4:30pm PDT

    #289: Post-COVID cGMP Inspections by Global Regulatory Authorities
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-620-L04-P; CME 1.00; RN 1.00

    Unfold real-world post-COVID inspections at global pharmaceutical manufacturing facilities, gaining insights into successes and disappointments within them. Appreciate perspectives on post-COVID inspections from FDA, EMA, Anvisa, and NMPA inspectors.

    Learning Objectives

    Recognize key advances and innovations that regulatory authorities and manufacturing facilities have adopted post-COVID in cGMP inspections;. Identify ongoing challenges that regulatory authorities and manufacturing facilities face in maintaining compliance and ensuring product quality in the post-COVID landscape and their implications in future pharmaceutical developments.

    Chair

    Lan Mu, PhD, RAC

    Speaker

    Industry Update
    Karthik Iyer, MS

    EU Update
    Kheira Hamadi

    Panelist
    Erica Franca Costa, RPh



    Speakers
    avatar for Lan Mu

    Lan Mu

    Senior Vice President, Bio-Thera Solutions, United States
    Dr. Lan Mu has over 25 years of experience in drug discovery, development, and global registration in various therapeutic areas. She was a principal research investigator at Sanofi prior to earning the Regulatory Affairs Certification (RAC). Subsequently, she held roles of increasing... Read More →
    EF

    Erica Franca Costa

    Health Regulation Specialist, ANVISA, Brazil
    Pharmacist, Health Regulation Specialist, Senior GMP Inspector. She has been a member of the Brazilian National Health Surveillance Agency (ANVISA) since 2005, carrying out, among other activities, BPF inspections, medicine and cosmetic products registration, regulatory convergence... Read More →
    KH

    Kheira Hamadi

    GMP Inspector, ANSM, France
    avatar for Karthik Iyer

    Karthik Iyer

    Director, Global Quality, Merck & Co., Inc., United States
    Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Forum

    4:30pm PDT

    #290: Charting the Biosimilars Beat Drop: The Latest Updates in the Biosimilars Landscape, Coverage, and Adoption in the US
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-621-L04-P; CME 1.00; RN 1.00

    This session will provide an overview of today’s biosimilars landscape, explore trends in uptake, describe innovative programs from industry disruptors, and report perspectives from key stakeholders through their primary market research.

    Learning Objectives

    Summarize results of current payer and provider research on barriers to biosimilar coverage and adoption, with a focus on product interchangeability; Describe the challenges and solutions of real-world data (RWD) and real-world evidence (RWE) in decision-making; Identify a framework for operational readiness in biosimilar management.

    Chair

    Charlie Dragovich, RPh

    Speaker

    Industry Update
    Chara Reid, PharmD, RPh

    Industry Update
    Catherine Lockhart, PharmD, PhD, MS



    Speakers
    avatar for Charlie Dragovich

    Charlie Dragovich

    Board of Directors, California Academy of Managed Care Pharmacy, United States
    Charlie Dragovich, BSPharm, is a market access consultant currently serving on the Board of Directors on California AMCP. Mr. Dragovich previously led the development of new programs and services at the Academy of Managed Care Pharmacy (AMCP) to facilitate payer and manufacturer communication... Read More →
    CL

    Catherine Lockhart

    Executive Director, Biologics and Biosimilars Collective Intelligence Consortium, United States
    Cate Lockhart, PharmD, PhD is the Executive Director of the Biologics and Biosimilars Collective Intelligence Consortium where she is responsible for all programs of this multi-stakeholder research collaboration. She is a proven leader in health economics and outcomes research (HEOR... Read More →
    avatar for Chara Reid

    Chara Reid

    Director, Specialty Practice Network, Immunology, Cencora (formerly AmerisourceBergen), United States
    Chara Reid is a National Sales Director for AmerisourceBergen. In this role she leads a national sales team that call on multi-specialty infusion practices. She graduated with her bachelor’s degree in biology in 1998 from Northern Illinois University. Then went on to Midwestern... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      12: Value-Access, Session

    4:30pm PDT

    #283: The Value of Project Management in Driving Drug Discovery Success: A Comparison Between Small Versus Large Pharmaceutical Companies
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-615-L04-P; CME 1.00; PDU 1.00 PMI 2166M3MMI2; RN 1.00

    The session will provide an overview of projct management (PM) in discovery and early development and contrast to the application of PM skills in later stages. The session will include best practices for driving impact with discovery and early development functional areas.

    Learning Objectives

    Describe the value of project management (PM) on discovery teams and early in the drug development lifecycle; Compare adaptations for PM in discovery versus development in both large pharma and smaller biotech settings; Discuss best practices for driving impact with discovery and early development functional areas.

    Chair

    Elizabeth Somers, MS

    Speaker

    The Value of Project Management in Driving Drug Discovery Success - Small Company Perspective
    Stuart Ince, PhD



    Speakers
    avatar for Elizabeth Somers

    Elizabeth Somers

    Executive Director, Global Project and Alliance Management, Merck Sharp & Dohme LLC, United States
    Liz is an Executive Director in Global Project and Alliance Management at Merck focusing on Discovery PM. She manages a team focused on Discovery projects including complex collaborations which leverages her experience managing complex cross functional drug development programs and... Read More →
    avatar for Stuart Ince

    Stuart Ince

    Vice President, Program Leadership, Accent Therapeutics, Inc, United States
    Stuart Ince Ph.D. is a drug discovery and development executive with 22 years of experience in pharmaceutical R&D. He started his career in medicinal chemistry, advancing to a project lead for discovery projects in lead optimization at Bayer AG. Subsequently he progressed to drug... Read More →


    Tuesday June 18, 2024 4:30pm - 5:30pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Session |   07: ProjectManagement-StrategicPlanning, Session
     
    Wednesday, June 19
     

    7:00am PDT

    Coffee and Light Refreshments
    Component Type: Social Event
    Meet with your colleagues to plan your day and/or discuss what you learned the previous day, all while networking with other attendees.



    Wednesday June 19, 2024 7:00am - 8:00am PDT
    Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    8:00am PDT

    #301: Risk Minimization in the EU: New Guidance, New Collaborations
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-622-L04-P; CME 1.00; RN 1.00

    Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.

    Learning Objectives

    Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.

    Chair

    Priya Bahri, PhD, RPh

    Speaker

    Industry Update
    Meredith Smith, PhD, MPA, FISPE



    Speakers
    avatar for Priya Bahri

    Priya Bahri

    Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
    Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
    avatar for Regina Mariam Kamoga

    Regina Mariam Kamoga

    Executive Director, Community Health And Information Network ( CHAIN), Uganda
    She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →
    avatar for Meredith Smith

    Meredith Smith

    Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
    Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    8:00am PDT

    #303: How Common Data Models Can Address the Challenges in the Use of Clinical Trial and Real-World Data for Evidence Generation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-624-L04-P; CME 1.00; RN 1.00

    This panel will discuss different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability.

    Learning Objectives

    Recognize the different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability; Discuss the appropriate data models for primary and secondary data and how clinical data managers can potentially help RWD and trial data to meet the evidentiary requirements for regulatory decision-making.

    Chair

    Jesper Kjær, MS

    Speaker

    Panelist
    Davera Gabriel

    Panelist
    Jonathan Stuart Chainey

    Panelist
    Stacy Tegan



    Speakers
    JC

    Jonathan Chainey

    Executive Director, Global Head, Data Standards and Governance, Data Sciences, Roche, United States
    Jonathan Chainey is an Executive Director and Global Head, Data Standards and Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across... Read More →
    DG

    Davera Gabriel

    Director of Client Success, Evidentli USA LLC, United States
    avatar for Jesper Kjaer

    Jesper Kjaer

    Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark
    Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been... Read More →
    avatar for Stacy Tegan

    Stacy Tegan

    Program Director, Transcelerate Biopharma, Inc., United States
    Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    8:00am PDT

    #304: Synergizing Large Language Models and Digital Health Technology for Healthcare Transformation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-625-L04-P; CME 1.00; RN 1.00

    This discussion will dive into large language models (LLMs) impact on healthcare, their integration with digital health technology, and ethical/regulatory implications.

    Learning Objectives

    Describe how digital health technologies (DHTs) and generative artificial intelliegence (AI), including large language models (LLMs) are applied to healthcare context; Examine the various integration points between LLMs and DHT and discover how these technologies can work synergistically to revolutionize patient care, telemedicine, remote, and disease progression.

    Chair

    Jagdeep Podichetty, PhD, MS

    Speaker

    Panelist
    Qi Liu, PhD

    Panelist
    Jie Shen, PhD, MBA

    Panelist
    Sakshi Sardar, PhD

    Panelist
    Emily Lewis, MS



    Speakers
    avatar for Jagdeep Podichetty

    Jagdeep Podichetty

    Senior Director of Predictive Analytics, Critical Path Institute, United States
    Dr. Jagdeep Podichetty is the Senior Director of Predictive Analytics in the Quantitative Medicine Program at the Critical Path Institute, where he is developing quantitative solutions such as disease progression models, survival models, clinical trial simulation, and artificial intelligence... Read More →
    avatar for Emily Lewis

    Emily Lewis

    Artificial Intelligence and Innovation Lead, Neurology, UCB, United States
    Emily Lewis is a trailblazing innovator and leader in the realm of digital health and AI. With nearly two decades of experience, she has made significant contributions to the development and adoption of cutting-edge digital health solutions. Her passion for using technology to improve... Read More →
    avatar for Qi Liu

    Qi Liu

    Assoc Director for Innovation and Partnerships, OCP, OTS, CDER, FDA, United States
    Dr. Qi Liu is a Senior Science Advisor in the Office of Clinical Pharmacology (OCP), FDA. At FDA, Qi contributed to the review of over 200 NDA/sNDA, 20 BLA/sBLA, and numerous IND. Qi co-authored about 40 manuscripts and presented on many topics at Advisory Committee meetings and scientific... Read More →
    avatar for Sakshi Sardar

    Sakshi Sardar

    Senior Director, Digital and Precision Medicine, Critical Path Institute, United States
    Sakshi Sardar is a Senior Director for Digital and Precision Medicine within Quantitative Medicine at the Critical Path Institute. Her focus is on driving the development of essential components for utilizing digital health technologies (DHTs) to meet evidentiary requirements for... Read More →
    avatar for Jie Shen

    Jie Shen

    Director, Digital Science, AbbVie, United States
    Jie Shen is a data science leader with a track record of building innovative solutions for drug discovery and development. Currently he is a Director of Digital Science at AbbVie, leading the digital health technology development, validation, and data analytics. Prior to his current... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    8:00am PDT

    #305: All the Ways Medical Affairs Supports Product Development: From Clinical Trials to Product Launch
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-626-L04-P; CME 1.00; RN 1.00

    Wondering what a medical affairs team does? This session will dive into some of the different roles within medical affairs, their responsibilities, and how these roles support a product over the course of its development.

    Learning Objectives

    Recognize how the medical affairs function can support a product across all stages of development; Describe different roles within medical affairs and how they connect to each other and to the broader organization.

    Chair

    Sejal Vora, PharmD

    Speaker

    All the Ways Medical Affairs Supports Product Development: Field Perspective
    Nital Patel, PharmD, MBA

    All the Ways Medical Affairs Supports Product Development: Publication Planning
    Wendy Tin, PharmD, RPh



    Speakers
    avatar for Sejal Vora

    Sejal Vora

    Director, Medical Information, BeiGene, United States
    Sejal Vora has over 20 years of industry experience within Medical Affairs, including Medical Information, Publication Planning, Investigator Initiated Research, and serving as a medical reviewer for promotional and medical review committees. She earned her PharmD at the University... Read More →
    NP

    Nital Patel

    Consultant, United States
    Nital Patel has over 12 years of experience within Medical Affairs, including Medical Training and Operations, Field Medical, and as Executive Medical Director. She earned both her PharmD and MBA at Drake University in Des Moines, Iowa. Nital completed a 2-year Regulatory Fellowship... Read More →
    avatar for Wendy Tin

    Wendy Tin

    Associate Director, HIV PrEP Scientific Publications, Gilead Sciences, United States
    Wendy Tin is a pharmacist by training with more than 6 years of experience in the pharmaceutical industry. After graduating from UC Berkeley with a BA in molecular and cell biology, Wendy attended UCSF and earned her PharmD degree. Prior to industry, Wendy worked as a pharmacist in... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      04: MedAffairs-SciComm, Forum

    8:00am PDT

    #306: Which Clinical Outcome Assessment to Choose: Questionnaire or Sensor? Time to Align an Endpoint Selection Framework
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-627-L04-P; CME 1.00; RN 1.00

    Questionnaires, standardized tasks, and DHTs can measure similar outcomes which complicates endpoint selection. This forum discusses a framework to align ontologies for actively-collected and passively-monitored COAs to streamline endpoint strategy

    Learning Objectives

    Identify biomarkers from actively collected and passively-monitored COAs building upon regulatory definitions; Determine a framework to align ontologies for these measure types enabling rapid, evidence-based, and fit-for-purpose measure selection using case study examples.

    Chair

    Caprice Sassano, MPH

    Speaker

    Panelist
    Roya Sherafat-Kazemzadeh, MD, PhD

    Panelist
    Megan Parisi, MS

    Panelist
    Thomas Switzer, MEd



    Speakers
    CS

    Caprice Sassano

    Research and Data Products - Applied Sciences, HumanFirst, United States
    RS

    Roya Sherafat-Kazemzadeh

    Scientific Director, Mapi Research Trust, France
    Dr. Roya Sherafat is a trained physician and holds dual PhDs in epidemiology and health policy. Roya has over a decade experience in clinical research in the field of obesity and cardiometabolic health specifically on profiling risk factors, adverse cardiometabolic outcomes, and heterogeneity... Read More →
    avatar for Megan Parisi

    Megan Parisi

    Patient Solutions Lead, Syneos Health, United States
    Megan Parisi, MS, CCRP, is a Patient Solutions Lead at Syneos Health where she curates patient centric strategies for implementation into clinical trials across all phases of development. She innovates in patient and site focused trial design, focusing on decentralized and digital... Read More →
    avatar for Thomas Switzer

    Thomas Switzer

    Principal Digital Health Scientist, Genentech, A Member of the Roche Group, United States
    Tom is a Principal Scientist and Digital Health Lead in Genentech's Research and Early Development Informatics group.  His current focus is on developing technology platforms supporting molecule teams across the early development portfolio.  Tom has over 24 years of clinical development... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum

    8:00am PDT

    #302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-623-L04-P; CME 1.00; RN 1.00

    This discussion will provide the setting and background of clinical trials of psychedelics and issues to consider. The session will provide details with a clinical trial participant providing example feedback and insight from that perspective.

    Learning Objectives

    Discuss the conflicted background of psychedelic clinical trials; Discuss reasonable expectations for clinical trial progression; Identify one participant’s perspective from two clinical trials; compare and contrast the participant perspective with standard clinical outcomes.

    Chair

    Currien MacDonald, MD

    Speaker

    Panelist
    Sara Reed, MA



    Speakers
    avatar for Currien MacDonald

    Currien MacDonald

    Medical Chair Director, WCG, United States
    Dr. Currien MacDonald has lead the medical chairs at WCG for the past 7 years. Prior to that, Dr. MacDonald served for four years as the medical director for Aspire IRB, another WCG company. After graduating top of his class from the University of Minnesota Medical School, Dr. MacDonald... Read More →
    SR

    Sara Reed

    Video Production, Consultant, United States
    Sara Reed holds a MFA in Documentary Media from Northwestern University. With over a decade of freelance video production experience spanning the U.S., Canada, Central/South America, and Africa, she’s contributed to projects for renowned clients such as Discovery, HBO, NASA, and... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

    8:00am PDT

    #308: Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-629-L04-P; CME 1.00; RN 1.00

    Join us as we delve into the cutting-edge realm of risk-based quality management (RBQM) and learn how quality briefs revolutionize compliance reporting both internally and for externally for regulators. Discover how quality briefs offer proactive transparency at the time of filing, incorporating ICH E8/E6(R3) expectations, and focusing on highest risk critical to quality (CtQ) areas. Gain insights from real-world case studies of multi-company implementations, and uncover strategies to collaborate across functions for swift product delivery while maintaining stringent quality standards. Explore how quality briefs drive a paradigm shift in quality management, moving from gatekeeping at the end of the process to proactive involvement from the start, in line with ICH E6 R3 and E8 R1 quality by design principles. Learn how to craft the GCP compliance story of your product's development, with each CtQ factor assessed for compliance status at filing, supported by evidence and data analytics insights. Dive into the 'How' of implementation, with practical guidance for companies keen on adopting this transformative approach, including updates on Health Authority engagement.

    Learning Objectives

    Critique the methodology behind implementing the outcomes-based approach of quality briefs in risk-based quality management (RBQM), illustrating how it demonstrates the compliance status of critical to quality (CtQ) factors; Design effective cross-functional communication strategies within a company to facilitate the implementation of changes required for adopting quality briefs, emphasizing collaboration; Identify the key challenges and successes derived from real-world insights.

    Chair

    Paula Walker, MA

    Speaker

    Panelist
    Cheryl Grandinetti, PharmD

    Panelist
    Jennifer Emerson, PhD, MPH, RN, PMP

    Panelist
    Jamie Bridges, MPH

    Panelist
    Alissa Mun



    Speakers
    avatar for Paula Walker

    Paula Walker

    Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
    Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
    avatar for Jamie Bridges

    Jamie Bridges

    Executive Director, Clinical Quality Assurance, Merck Sharp & Dohme LLC , United States
    Jamie Bridges has 26 years of pharmaceutical experience. She began her career at Pfizer and spent the past 25 years with Merck based out of West Point, PA. Her career has included leadership roles in Data Management, Epidemiology, Operational Excellence and most recently Clinical... Read More →
    avatar for Jennifer Emerson

    Jennifer Emerson

    Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
    Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
    avatar for Cheryl Grandinetti

    Cheryl Grandinetti

    Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
    Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
    AM

    Alissa Mun

    Health Scientist Policy Analyst, OMP, CDER, FDA, United States


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Forum

    8:00am PDT

    #309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-630-L04-P; CME 1.00; RN 1.00

    The FDA Oncology Center of Excellence "Projects" address gaps in oncology drug development and present opportunities as well as challenges for industry. Learn from FDA and industry experts the value of these initiatives and how and when to join in.

    Learning Objectives

    Recognize high-value FDA OCE priorities and projects that impact industry; Identify how and when to engage with these FDA initiatives to produce optimal results for industry, patients, and other stakeholders; Describe how to advance opportunities for harmonization of these high-value OCE Projects with global Health Authorities.

    Chair

    Sabrina Girty, JD

    Speaker

    FDA Overview and Perspective on OCE Projects
    Tamy Kim, PharmD

    From Policy to Practice: Maximizing Collaboration to Support Oncology Innovation
    Mark Stewart, PhD

    Industry Case Study: Project Optimus and Project Orbis
    Vandana Pathak, MS, RAC



    Speakers
    avatar for Megan Doyle

    Megan Doyle

    Global Policy Lead, Digital Health, Diagnostics, Oncology, Amgen, United States
    Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →
    avatar for Sabrina Girty

    Sabrina Girty

    Executive Director, Global Regulatory Affairs, Oncology, Merck & Co., Inc., United States
    Sabrina Girty is an Executive Director in Global Regulatory Affairs, Oncology at Merck & Co. Inc and leads a team of global regulatory strategy professionals across the esophageal, gastric, colorectal and head & neck cancer programs. At Merck, her team secured global marketing authorizations... Read More →
    avatar for Tamy Kim

    Tamy Kim

    Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
    Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →
    VP

    Vandana Pathak

    Global Regulatory Affairs, Amgen, United States
    avatar for Mark Stewart

    Mark Stewart

    Vice President, Science Policy, Friends of Cancer Research, United States
    Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    8:00am PDT

    #310: WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-631-L04-P; CME 1.00; RN 1.00

    This session aims to delve into WHO's pivotal role in the evolving landscape of global regulatory excellence. The discussion will revolve around the transformative impact of WHO-listed Authorities on medical product regulation, emphasizing regulatory reliance as a holistic approach to enhance efficiency and accessibility. Additionally, the session will address the pressing issue of substandard/falsified medical products and their potential threats to global health.

    Learning Objectives

    Describe the significance of WHO-listed Authorities in shaping the future of medical product regulation; Examine the concept of regulatory reliance as a key strategy to enhance access and efficiency in global regulatory practices; Discuss the critical role of regulatory excellence in safeguarding public health against the threats posed by substandard/falsified medical products.

    Chair

    Samvel Azatyan, MD, PhD

    Speaker

    Elevating Regulatory Reliance: The Strategic Impact of WHO-Listed Authorities in Transforming Global Regulatory Landscapes
    Hiiti Sillo, MSc, RPh

    Securing Supply Chains: A Global Imperative
    Rutendo Kuwana, RPh

    EMA Update
    Emer Cooke, MBA, MSc

    Industry Update
    Janis Bernat, MSc

    Moderator for Panel Discussion and Q&A
    Marion Laumonier, MSc



    Speakers
    avatar for Samvel Azatyan

    Samvel Azatyan

    Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
    Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
    avatar for Janis Bernat

    Janis Bernat

    Director, Scientific and Regulatory Affairs, IFPMA, Switzerland
    Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →
    avatar for Emer Cooke

    Emer Cooke

    Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
    Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
    RK

    Rutendo Kuwana

    Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland
    Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →
    avatar for Marion Laumonier

    Marion Laumonier

    Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland
    Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →
    avatar for Hiiti Sillo

    Hiiti Sillo

    Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland
    Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO department of Regulation and Prequalification. Until August 2021, he was the Team Lead, Regulatory Systems Strengthening (RSS), Regulation and Safety Unit. Before joining WHO in January 2018, he was the Director General... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    8:00am PDT

    #311: Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-632-L04-P; CME 1.00; RN 1.00

    Established in 2007, the Access Consortium brings together like-minded regulatory agencies to promote regulatory convergence and foster synergy to address scientific and regulatory issues. In this session, leaders from the Access Consortium will provide an update on achievements using work-sharing initiatives for timely medicines approvals for our populations, enabling industry to bring new, innovative products through Access pathways.

    Learning Objectives

    Discuss pathways and opportunities for industry to bring innovative products through Access; Describe new tools and methodologies to optimize regulatory collaboration under the Access Consortium to support access to medicines.

    Chair

    Pamela Aung-Thin

    Speaker

    Panelist
    June Raine, MD, MSc, FRCP

    Panelist
    Anthony Lawler, MD, MBA

    Panelist
    Mimi May Ling Choong, DrMed, MD

    Panelist
    Jörg Schläpfer, PhD



    Speakers
    avatar for Pamela Aung-Thin

    Pamela Aung-Thin

    Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada
    Pamela Aung Thin became the Assistant Deputy Minister of the Health Products and Food Branch (HPFB) on March 27, 2023.
    avatar for Mimi May Ling Choong

    Mimi May Ling Choong

    Chief Executive Officer, Health Sciences Authority (HSA), Singapore
    Dr Choong was appointed as the Chief Executive Officer of the Health Sciences Authority (HSA) of Singapore on 1 July 2014. She oversees HSA’s wide-ranging public health responsibilities, comprising health products regulation, the national blood service, the national analytical and... Read More →
    avatar for Anthony Lawler

    Anthony Lawler

    Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
    Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →
    avatar for June Raine

    June Raine

    Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of... Read More →
    avatar for Jörg Schläpfer

    Jörg Schläpfer

    Head of Management Services and International Affairs, Swissmedic, Switzerland
    Dr. Jörg Schläpfer, PhD is the Head of Management Services & International Affairs and Member of the Management Board of Swissmedic. He studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    8:00am PDT

    #307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-628-L04-P; CME 1.00; RN 1.00

    Discussion of partnering with regulators to get novel digital health products through the approval processes. Learn insights from industry and regulators for creative, strategic, and flexible thinking on regulation of novel technologies.

    Learning Objectives

    Discuss the challenges of introducing novel digital technologies to FDA; Describe tactics to build better partnerships with regulators.

    Chair

    Rebecca Joy James, MBA, RAC

    Speaker

    Panelist
    Anindita Saha

    Panelist
    James Wabby, MHS

    Panelist
    Adam Cargill, MS

    Panelist
    Wes Gerbig, PhD, MS



    Speakers
    RJ

    Rebecca James

    Director - Advisory, KPMG, LLC, United States
    Rebecca is a Director in the Life Sciences consulting group at KPMG based out of Chicago, IL. She has over 14 years of experience in both consulting and industry roles with companies from pharmaceutical, medical device, and nutritional industries with an emphasis in Regulatory Affairs... Read More →
    AC

    Adam Cargill

    Director, QARACA, MediView XR, Inc., United States
    Adam Cargill, MS RAC, is the Vice President of Quality, Regulatory, and Clinical for MediView XR. In his role he is accountable for the oversight of all regulatory, clinical, and quality functions. Responsibilities include overseeing the company’s global regulatory, clinical, and... Read More →
    WG

    Wes Gerbig

    Director, Global Regulatory Affairs, Drug Delivery and Digital Health, Eli Lilly and Company, United States
    avatar for Anindita Saha

    Anindita Saha

    Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States
    Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →
    avatar for James Wabby

    James Wabby

    Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
    James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session

    8:00am PDT

    #312: Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-633-L04-P; CME 1.00; RN 1.00

    This forum session will explore the transformative potential of Artificial Intelligence (AI) in biotech RA CMC and advanced manufacturing. Discover how AI can optimize processes, improve efficiency, and ensure compliance of your data.

    Learning Objectives

    Define key concepts and principles of artificial intelligence (AI) in the context of biotech industry, regulatory CMC and advanced manufacturing; Identify the potential applications and benefits of AI including how it can automate deviation and change control processes or support strategic decision-making; Discuss the benefits, challenges and cons of AI i.e. data integrity and security.

    Chair

    Grzegorz (Greg) Podrygajlo, PhD

    Speaker

    Application of AI Tools to Support the Decision Process in Regulatory CMC
    Grzegorz (Greg) Podrygajlo, PhD

    Use of AI and ML in Pharmaceutical Manufacturing: Case Studies from the Shop Floor and Regulatory Landscape
    Gert Thurau, DrSc, PhD

    How to Use GenAI in a Smart Way for Now and for the Future
    Hubert Niewiadomski, PhD



    Speakers
    avatar for Grzegorz (Greg) Podrygajlo

    Grzegorz (Greg) Podrygajlo

    GRA CMC Director, Head of Global Manufacturing Support, CSL Behring, Switzerland
    Grzegorz (Greg) Podrygajlo, PhD is Head of Global Manufacturing Support, Global Regulatory Affairs CMC for Biologics at CSL Behring. He obtained Master in Medical Biotechnology and PhD in Neuroscience. Greg leads Global Regulatory Strategy for optimal Change Control Process and Life... Read More →
    avatar for Hubert Niewiadomski

    Hubert Niewiadomski

    Chief Executive Officer, Cledar, United States
    Hubert Niewiadomski is the CEO of Cledar, a Machine Learning and Artificial Intelligence Development company partnering with private and public sectors. Hubert has been the key contributor to more than 100 publications and has been working on neural networks for more than 20 years... Read More →
    avatar for Gert Thurau

    Gert Thurau

    Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
    Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Forum

    8:00am PDT

    #313: The Future of Women’s Health: Do We Really Want Innovation? Policy Ideas To Advance Innovation, Access, and Novel Approaches
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-634-L04-P; CME 1.00; RN 1.00

    There is a critical need for innovation in women’s health, particularly maternal health. What will it take to improve care in this area? How can innovative regulatory, reimbursement and access policies encourage novel approaches to women’s health?

    Learning Objectives

    Identify areas of women’s health which face barriers preventing innovation; Describe disparities in women’s/maternal health and existing regulatory, payment and access policies intended to improve outcomes; Evaluate the types of policy changes needed to encourage innovation

    Chair

    Nancy Bradish Myers, Esq, JD

    Speaker

    Panelist
    Tara Croft, MBA

    Panelist
    Sandy Milligan, JD, MD



    Speakers
    avatar for Nancy Myers

    Nancy Myers

    CEO and Founder, Catalyst Healthcare Consulting, Inc, United States
    Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 19 years and has been active in the DC policy arena for three... Read More →
    avatar for Tara Croft

    Tara Croft

    Chief Executive Officer, Baymatob, Australia
    Tara is a passionate advocate for womens health and technology. A MedTech expert with 20 years industry experience, Tara is the CEO of Baymatob, a female-founded, female-led, early-stage business aiming to improve and save the lives of mothers and their babies, by developing an AI-enabled... Read More →
    avatar for Sandy Milligan

    Sandy Milligan

    Board of Director Member, Gossamer Bio; Principal, Innovex Strategies, United States
    Sandy Milligan is President of Aspira Women's Health, working to transform women’s gynecological health through the development and commercialization of innovative testing options. Previously, Sandy was the head of Research and Development at Organon, focused on improving the everyday... Read More →


    Wednesday June 19, 2024 8:00am - 9:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      12: Value-Access, Forum

    9:00am PDT

    Coffee Break
    Component Type: Social Event
    Meet with your colleagues to plan your day and/or discuss what you learned the previous day, all while networking with other attendees.



    Wednesday June 19, 2024 9:00am - 10:00am PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    9:15am PDT

    #314 IT: IQVIA Innovation Theater: Pre-Approval Access - Strategies for Providing Investigational Product to Patients Beyond Clinical Trials
    Component Type: Session

    This session on Pre-Approval Access (PAA) will address key considerations and challenges for provision of investigational products to patients outside of clinical trials, and before these therapies are approved by regulators. We will focus on key decisions and success factors for organizations to consider when developing their company’s philosophy on this type of access. We will also highlight pragmatic decisions that play into the development of efficient Pre-Approval Access programs.

    Chair

    IQVIA

    Speaker

    Speaker
    Barbara Isquith Arone, MS

    Speaker
    Ana Tediosi



    Speakers
    avatar for IQVIA

    IQVIA

    United States
    avatar for Barbara Isquith Arone

    Barbara Isquith Arone

    Vice President, Evidence Generation for Medical Affairs, IQVIA, United States
    Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →
    avatar for Ana Tediosi

    Ana Tediosi

    Head of Expanded Access Strategy, WEP Clinical, United Kingdom
    With over 10 years of experience in the pharmaceutical industry, Ana is a recognized expert in the field of Expanded Access Programs (EAP). Her expertise lies in oncology, hematology, Rare Diseases, and she has held various roles in the big Pharma (BMS, Roche, Menarini-Stemline... Read More →


    Wednesday June 19, 2024 9:15am - 9:45am PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    9:15am PDT

    #315 IT: ArisGlobal Innovation Theater: Unleashing the Power of Automation and Understanding the Promise of GenAI in Pharmacovigilance and Regulatory Affairs
    Component Type: Session

    In the rapidly evolving life sciences landscape, the integration of next-generation technologies is essential to innovation, improving efficiencies, and ensuring safety, compliance, and efficacy of drugs. In this keynote panel, hear from leaders at ArisGlobal and top pharam, as they discuss tangible automation use cases and their practical implications. Whether you are with a large organization aiming to scale automation and leverage GenAI or a smaller organization looking to begin leveraging automation within your workflows, you’ll find value in hearing the unique journeys our panelists and their organizations have taken - You’ll also learn about the benefits that they are seeing as a result.

    Chair

    ArisGlobal, LLC

    Speaker

    Panelist
    Hans van Leeuwen, PhD

    Panelist
    Claudia Schaffer, RN



    Speakers
    avatar for Art Brown

    Art Brown

    Marketing, ArisGlobal, United States
    HV

    Hans van Leeuwen

    Head of Regulatory Operations, Astellas Pharma Europe BV, Netherlands
    avatar for ArisGlobal, LLC

    ArisGlobal, LLC

    United States
    avatar for Claudia Schaffer

    Claudia Schaffer

    Sr. Director, Head Case and Vendor Management, Merck Healthcare KGaA, Germany
    Claudia Schaffer is the Head Case and Vendor Management at Merck Healthcare – Global Patient Safety and is located in Germany. She has served on TransCelerate's Common SAE Fields and Intelligent Automation Opportunities in Pharmacovigilance initiatives to contribute to the value... Read More →
    avatar for Karthick Sukumaran

    Karthick Sukumaran

    Technology Enablement Director, Roche, United States


    Wednesday June 19, 2024 9:15am - 9:45am PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    9:15am PDT

    #315.1 IT: HCL Innovation Theater
    Component Type: Session



    Chair

    HCL Technologies


    Speakers
    HT

    HCL Technologies

    United States


    Wednesday June 19, 2024 9:15am - 9:45am PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    10:00am PDT

    #317: Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-635-L04-P; CME 1.00; RN 1.00

    This session will explore current progress in pharmacogenomics; the barriers and opportunities it represents for drug safety from the perspective of medicines regulators, industry, the scientific community, healthcare professionals, and patients.

    Learning Objectives

    Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Appraise progress being made in this field internationally; Recognize opportunities for introduction of pharmacogenomic research in your organization.

    Chair

    Alison Cave, PhD

    Speaker

    From Post-Marketing Reports of Side Effects to Pharmacogenomic Research: Can we Reduce the Burden of ADRs?
    Sarah Vaughan

    Patient Perspective
    Christine Von Raesfeld

    Industry Perspective
    Gregory Powell, PharmD, MBA

    Academic Perspective
    Kathleen M. Giacomini, PhD



    Speakers
    avatar for Alison Cave

    Alison Cave

    Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
    avatar for Kathleen Giacomini

    Kathleen Giacomini

    Dean, School of Pharmacy, Professor and Principal Investigator, University of California San Francisco, United States
    Kathleen M. Giacomini, Ph.D. Kathy Giacomini, a professor in the School of Pharmacy at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role... Read More →
    GP

    Gregory Powell

    Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States
    Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing... Read More →
    avatar for Christine Von Raesfeld

    Christine Von Raesfeld

    Founder/SME, Patient Experience, The Light Collective, United States
    Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →
    avatar for Sarah Vaughan

    Sarah Vaughan

    Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Forum

    10:00am PDT

    #319: Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-637-L04-P; CME 1.00; RN 1.00

    This session will discuss how the ISO IDMP standards have a pivotal role in enhancing global pharmacovigilance and improving visibility in the product supply chain. The collaborative efforts of the Global IDMP Working Group reflect the need to advance this critical endeavor.

    Learning Objectives

    Define IDMP standards and explain their benefits when globally implemented; Describe the role of the unique global IDMP identifiers in data exchange of medicinal product information; Discuss the impact of global IDMP identifiers on different use cases in the medicinal product life cycle, for example, pharmacovigilance and drug shortages, supply chain integrity.

    Chair

    Malin Kristina Fladvad, PhD, MSc

    Speaker

    Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
    Ron Fitzmartin, PhD, MBA

    Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
    Hilmar Hamann, PhD



    Speakers
    avatar for Malin Fladvad

    Malin Fladvad

    Portfolio Officer, Uppsala Monitoring Centre, Sweden
    Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts... Read More →
    avatar for Ron Fitzmartin

    Ron Fitzmartin

    Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
    Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
    avatar for Hilmar Hamann

    Hilmar Hamann

    Head of Information Management, European Medicines Agency, Netherlands
    Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session |   03: Data-Tech, Session

    10:00am PDT

    #324: Using Data Analytics for Good Pharmacovigilance Practices
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-642-L04-P; CME 1.00; RN 1.00

    This session will consist of perspectives and case studies of how data-driven solutions are being leveraged to support the development of quality assurance strategies for pharmacovigilance activities and to generate quality evidence in relation to Good Pharmacovigilance Practice (GVP) compliance.

    Learning Objectives

    Investigate the use of data-driven solutions to develop quality assurance strategies for Good Pharmacovigilance Practice (GVP) activities and to generate quality evidence in relation to GVP compliance.

    Chair

    Kiernan Trevett, MSc

    Speaker

    Industry Update
    Michelle Ruiz

    Industry Update
    John Okudjeto, MSc

    MHRA Update
    Sophie Radicke, MSc



    Speakers
    avatar for Kiernan Trevett

    Kiernan Trevett

    Principal Quality Lead, PDQ Quality Assurance Process GVP, Genentech, A Member of the Roche Group, United States
    Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP... Read More →
    JO

    John Okudjeto

    Manager, Pharmacovigilance QA, Janssen Research & Development LLC, United States
    John Okudjeto is a quality assurance professional with over ten years of experience in pharma and medical device manufacturing, supply change management, and pharmacovigilance auditing. John completed a Bachelor of Science in Biology/Chemistry from Georgia State University in 2010... Read More →
    avatar for Sophie Radicke

    Sophie Radicke

    Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
    MR

    Michelle Ruiz

    Principal Quality Data Analyst, Genentech, A Member of the Roche Group, United States
    Michelle is a Principal Quality Data Analyst in Genentech's Product Development Quality organization. In her current role, Michelle focuses on identifying areas in the Pharmacovigilance domain where data analytics can transform business processes, as well as designing and delivering... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session |   08: RD Quality-Compliance, Session

    10:00am PDT

    #320: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-638-L04-P; CME 1.00; RN 1.00

    Join us for a candid tour of three journeys toward integrating AI into key use cases. We share real-world metrics, best practices, and lessons learned as our teams evolve from traditional document development to effective digital solutions. This session focuses on practical ways in which medical writing organizations are using AI technologies to enable new ways of working, achieve business value, and get drugs to market faster.

    Learning Objectives

    Compare approaches to incorporating artificial intelligence (AI) in key use cases; Identify potential solutions to challenges within your organization; Appraise your organization’s plans for AI implementation.

    Chair

    Regina Lynn Preciado

    Speaker

    Evolution of Technology and Exploring Use of Generative AI in Medical Writing
    Madhavi Gidh-Jain, PhD

    Using GenAI to Write First Draft of Clinical Study Reports
    John Henry April, III, MA

    Evolve or Perish: Embracing Automation in Medical Writing
    Waheed Jowiya, PhD



    Speakers
    avatar for Regina Lynn Preciado

    Regina Lynn Preciado

    Senior Director of Content Strategy Solutions, Content Rules, Inc., United States
    Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →
    avatar for John April

    John April

    Senior Director, Adaptive Content Strategy, Global Scientific Communications, Eli Lilly and Company, United States
    Twenty-five years of drug development experience focused on medical writing. Highlights include developing content reuse and generative AI strategies for Lilly, retooling Lilly's medical writing staff to structure its content, leading a medical writing start-up in India, designing... Read More →
    avatar for Madhavi Gidh-Jain

    Madhavi Gidh-Jain

    Global Medical Writing and Document Management Head, Sanofi, United States
    Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →
    avatar for Waheed Jowiya

    Waheed Jowiya

    Digitalisation Strategy Lead, Novo Nordisk A/S, Denmark
    Waheed is a Digitalisation Strategy Lead at Novo Nordisk. In his role at Novo Nordisk, Waheed has been instrumental in shaping the digitalisation strategy for the company's content creation initiatives. Waheed has played a crucial role in developing the strategy for scaling and deployment... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      04: MedAffairs-SciComm, Session

    10:00am PDT

    #321: The ChatBot Will See You Now: Ethical Considerations in Incorporating AI into Informed Consent
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-639-L04-P; CME 1.00; RN 1.00

    Generative AI is gaining traction in trial communications, with goals of expediency and efficiency. New technologies should incorporate patient views and ethical frameworks to keep human interactions that are desirable, necessary, and useful.

    Learning Objectives

    Describe the ethical framework that encompasses informed consent for clinical research; Evaluate goals for the use of artificial intelligence (AI) in clinical trials and how these goals interact with ethical goals for consent; Discuss how to incorporate patient and participant needs and perspective into AI-assisted clinical trial information and communication.

    Chair

    Lindsay McNair, MD, MPH, MS

    Speaker

    Patient Perspective Update
    Deborah Collyar

    Industry Update
    Karla Childers, MS

    Industry Update
    Catina O'Leary, PhD



    Speakers
    avatar for Lindsay McNair

    Lindsay McNair

    Principal Consultant, Equipoise Consulting, United States
    Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
    avatar for Karla Childers

    Karla Childers

    Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
    Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
    avatar for Deborah Collyar

    Deborah Collyar

    President, Patient Advocates In Research (PAIR), United States
    Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →
    CO

    Catina O'Leary

    President and Chief Executive Officer, Health Literacy Media, United States
    Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... Read More →
    avatar for Catina O'Leary

    Catina O'Leary

    President and Chief Executive Officer, Health Literacy Media, United States


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session

    10:00am PDT

    #318: Defining an Inclusive Clinical Trials Approach in Europe
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

    This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

    Learning Objectives

    Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

    Chair

    Ambily Banerjee, PhD

    Speaker

    ACT-EU Efforts from EMA Perspective
    Ana Zanoletty Perez

    Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
    M. Khair ElZarrad, PhD, MPH

    Industry Perspective of Community Engagement in Europe: A Case Study
    Monique Adams, PhD, MS

    CT Network One-Pager v2
    Nicholas Brooke, MBA



    Speakers
    avatar for Ambily Banerjee

    Ambily Banerjee

    Senior Director/Head of Diversity in Clinical Trials, Johnson and Johnson Innovative Medicine, United Kingdom
    After a decade as an academic scientist, following a Ph.D. in Molecular Biology, Ambily moved to GSK Regulatory Affairs, where she held increasingly senior roles in Global Regulatory Affairs and Internal Audit. She also led the race and ethnicity Employee Resource Group, EMBRACE... Read More →
    avatar for Monique Adams

    Monique Adams

    Executive Director, Global Head Diversity and Inclusion in Clinical Trials, Sanofi, United States
    Monique Adams is the Executive Director, Global Head of Diversity and Inclusion in Clinical Trials, or DICT, at Sanofi where she drives the pharmaceutical company’s vision, strategy, and implementation of a holistic framework for DICT. Monique has a Ph.D. in Pharmacology from the... Read More →
    avatar for Nicholas Brooke

    Nicholas Brooke

    Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium
    Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
    avatar for M. Khair ElZarrad

    M. Khair ElZarrad

    Director, Office of Medical Policy, CDER, FDA, United States
    Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
    avatar for Ana Zanoletty Perez

    Ana Zanoletty Perez

    Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
    Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   02: ClinTrials -ClinOps, Forum

    10:00am PDT

    #323: Driving Capacity Building, Equity, and Geographic Expansion in Clinical Trials
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-641-L04-P; CME 1.00; PDU 1.00 PMI 2166PJJJ85; RN 1.00

    90% of trials are performed in higher-income countries. In this session, the audience will learn directly from stakeholders about establishing infrastructure in low and/or middle income countries (LMICs) and how building capacity can improve quality of care and outcomes for patients.

    Learning Objectives

    Describe global research expertise and identifying gaps on a local level; Identify approaches to translate local research expertise to global research excellence; Recognize successful strategies for long-term sustainability and growth.

    Chair

    Muhammad Ali Hameed, CPA, MBA

    Speaker

    Facilitator
    Twanna L Davis, MBA



    Speakers
    avatar for Twanna Davis

    Twanna Davis

    Global Head, Clinical Trial Services, Executive Advisor - Purpose Africa, Purpose Life Science, Canada
    Twanna Davis is the Head of Clinical Trial Solutions at Purpose Life Sciences. In her role, Twanna oversees all functional services necessary to execute full-service global clinical trials. She has over 25 years of experience in clinical operations, directing multiple applicable services... Read More →
    MA

    Muhammad Ali Hameed

    Chief Operating Officer, Population Health Research Institute, Canada


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   07: ProjectManagement-StrategicPlanning, Session

    10:00am PDT

    #326: Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-644-L04-P; CME 1.00; RN 1.00

    In this session, we will discuss international efforts to promote regulatory convergence and expand the use of reliance to bring these highly complex therapies to market earlier, particularly in less developed countries.

    Learning Objectives

    Describe how international harmonization, collaboration, and reliance principles can be effectively applied to the regulation of cell and gene therapies; Discuss the key considerations and regulatory challenges associated with bringing complex, innovative medicines such as cell and gene therapy products to less experienced, emerging markets.

    Chair

    Ginny Beakes-Read, BSN, JD

    Speaker

    FDA Update
    Julia Tierney, JD

    WHO Update
    Samvel Azatyan, MD, PhD

    PMDA Update
    Yasuhiro Kishioka, PhD

    Industry Update
    Maria Antonieta Tony Roman, MPharm

    EMA Update
    Anabela Marcal, PharmD



    Speakers
    avatar for Samvel Azatyan

    Samvel Azatyan

    Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
    Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
    avatar for Ginny Beakes-Read

    Ginny Beakes-Read

    Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
    Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →
    avatar for Yasuhiro Kishioka

    Yasuhiro Kishioka

    Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →
    avatar for Anabela Marcal

    Anabela Marcal

    EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
    avatar for Maria Antonieta Roman

    Maria Antonieta Roman

    Head Regulatory Policy Emerging Markets LATAM, Novartis, Mexico
    Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →
    avatar for Julia Tierney

    Julia Tierney

    Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States
    JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session

    10:00am PDT

    #322: Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-640-L04-P; CME 1.00; RN 1.00

    Precision medicine biomarker testing can be achieved in various formats, harnessing results generated in each patient's treating hospital or in centralized laboratories. We will examine resulting regulatory and technical challenges & opportunities.

    Learning Objectives

    Demonstrate an understanding of different testing models (central vs decentralized); Identify their regulatory consequences for clinical study conduct and approval.

    Chair

    Mike Wierzba, PhD

    Speaker

    Panelist
    Oliver Stoss, PhD

    Panelist
    Amanda Baker, PharmD, PhD

    Panelist
    Ilona Reischl, PhD, MPharm

    Panelist
    Adriana Racolta, PhD, RAC

    Panelist
    Philip Kelly, PhD



    Speakers
    avatar for Mike Wierzba

    Mike Wierzba

    Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States
    Mike Wierzba is a Director within the Precision Medicine & Digital Health, Global Regulatory Affairs team at GSK where he is the diagnostic regulatory lead for multiple development programs and leads efforts related to IVDR. Mike is a participant in EFPIA Precision Medicine Working... Read More →
    AB

    Amanda Baker

    Clinical Development Lead (Director), Pathology Lab, Roche Tissue Diagnostics, United States
    Dr. Baker was a faculty member at the University of Arizona for 13 years where her research focused on the characterization of biomarkers associated with stress signaling pathways activated in response to the tumor microenvironment. She also worked for 8 years as a Research Scientist... Read More →
    PK

    Philip Kelly

    IVDR Project Manager | Assessment and Surveillance, Health Products Regulatory Authority (HPRA), Ireland
    Philip Kelly serves as the IVDR Project Manager for the HPRA. In this role Philip leads work items focused on ensuring compliance with regulatory requirements and facilitating the safe and effective use of IVDs. Recently as part of the COMBINE project Philip aided in the analysis... Read More →
    AR

    Adriana Racolta

    Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States
    avatar for Ilona Reischl

    Ilona Reischl

    Biologics Quality Assessor, Austrian Medicines and Medical Devices Agency (AGES MEA), Austria
    Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality... Read More →
    avatar for Oliver Stoss

    Oliver Stoss

    Senior Vice President of Operations, Discovery Life Sciences Biomarker Services GmbH, Germany
    Dr. Stoss is leading the clinical trial operations at Discovery Life Sciences in his function as Senior Vice President Operations. Since 2004, he served in different leadership roles in both the USA and Europe and did oversee more than 600 phase I to phase III biomarker driven clinical... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Forum

    10:00am PDT

    #328: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products
    Component Type: Forum
    Level: Intermediate

    Advanced Therapies and combined advanced therapies emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. When developing an advanced therapy product, there are many things to be considered – relationships between tissue, biologic, and device development as well as early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation. With the dawn of a new millennium and the rapidly aging baby-boomer population, the pressure for companies to create safer and more effective treatments is growing. Advanced therapies are one of the solutions that have emerged to meet the more rigorous demands of patients. Drug-enhanced devices, including drug eluting stents and antimicrobial-coated catheters, have already proven themselves on the market. Pre-filled syringes and transdermal patches, which are novel drug delivery systems, have also been widely used treatments. However, advanced therapies and combined advanced therapies are innovative products and could provide solutions as well as cures for previously untreatable conditions, which can truly change the face of the industry. Speakers will be FDA and industry leaders and FDA illustrating hot topics and example case studies in a panel discussion for us to navigate the future regulatory framework for unmet medical needs and next generation of medical products.

    Learning Objectives

    Analyze latest regulatory expectations and challenges; Identify potential future innovation platforms; Acknowledge potential and future global convergence/harmonization initiatives for combination products; Describe the regulatory challenges and opportunities ahead.

    Chair

    James Wabby, MHS

    Speaker

    FDA Update
    Andrea Gray, PhD

    Panelist
    Rob Schulz

    Panelist
    William Daunch, PhD

    Panelist
    Michael Lehmicke, MSc



    Speakers
    avatar for James Wabby

    James Wabby

    Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
    James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
    avatar for William Daunch

    William Daunch

    Chief Technology Officer, Focal Medical, Inc., United States
    Professionally trained polymer scientist + analytical chemist. Began career as an industrial chemist/materials scientist in Belgium (ICI). Moved to Scotland and applied skills to helping early stage company (Aortech) develop the first fully synthetic heart valve (now commercialized... Read More →
    avatar for Andrea Gray

    Andrea Gray

    Biomedical Engineer Advisor, CBER, FDA , United States
    Andrea Gray is a Biomedical Engineer Advisor in the Regulatory Operations Branch of the Division of Regulatory Operations and Programs (DROP) in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER). She specializes in regulatory review of... Read More →
    ML

    Michael Lehmicke

    Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine, United States
    Michael has over 20 years of R&D experience in biomaterials, medical devices and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple... Read More →
    avatar for Rob Schulz

    Rob Schulz

    President and COO, Suttons Creek, Inc., United States


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Forum |   09: Regulatory, Forum |   14: DIAmond, Forum

    10:00am PDT

    #325: A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-643-L04-P; CME 1.00; RN 1.00

    Expert presentations and panel discussion on the regulatory agilities which decreased review times for SARS-COV-2 vaccines and incorporation of these agilities in the new US Platform Tech Designation and EFPIA-proposed Dynamic Regulatory Assessment.

    Learning Objectives

    Discuss regulatory agilities and reliance approaches which significantly decrease review times internationally; Discuss the potential impact of recent US legislative initiatives including Platform Technology Designation and the EFPIA-proposed Dynamic Regulatory Assessment on drug development timelines as well as the opportunities and risks of these new initiatives.

    Chair

    Helen Bayes Hartman, PhD

    Speaker

    Preparedness: Challenging the Traditional Regulatory Paradigms to Address Public Health Emergencies
    Debra A Yeskey

    Panelist
    Khushboo Sharma, MBA

    Panelist
    David C. Kaslow, MD



    Speakers
    HH

    Helen Hartman

    Director, Global Regulatory Sciences, Pfizer Inc, United States
    Helen has over 15 year of drug development experience as a global regulatory strategist and regulatory intelligence/policy professional across multiple therapeutic areas.
    avatar for David Kaslow

    David Kaslow

    Director, Vaccines Research and Review (OVRR), CBER, FDA, United States
    David is director of the Office of Vaccines Research and Review, CBER, US FDA, where he oversees regulation of vaccines, allergenics, live biotherapeutics and bacteriophage. His 35+ years of experience in use-inspired research, product development, and product introduction include... Read More →
    avatar for Khushboo Sharma

    Khushboo Sharma

    Chief Regulatory Innovation Officer, Accumulus Synergy, United States
    Khushboo Sharma is the Chief Regulatory Innovation Officer for Accumulus. Sharma joined Accumulus Synergy in 2022 from BIO, where she focused on major regulatory policy initiatives to build the appropriate regulatory framework. Prior to BIO, Sharma spent 11 years in various roles... Read More →
    DY

    Debra Yeskey

    Head of Regulatory Policy and Intelligence, CEPI, United States


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    10:00am PDT

    #327: Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-645-L04-P; CME 1.00; RN 1.00

    This session will include the regulator and industry perspective on the Green Deal initiative and chemical agenda and will have discussions on identified case study areas of expected heavy impact where panelists from industry, SMEs, and regulators will come together to share concerns and discuss opportunities and solutions on how to manage a more sustainable and environmentally future – for example through regulatory tools which enable innovation to address the challenges.

    Learning Objectives

    Identify insights into how manufacturers and regulators can collaborate to deliver a revolution without risks to the supply of medicines.

    Chair

    Ana Padua, MSc, RPh

    Speaker

    EMA Update
    Veronika Jekerle, PhD, RPh

    Sustainability and CMC (Chemistry, Manufacturing and Controls)
    Benjamin Stevens, PhD, MPH



    Speakers
    avatar for Ana Padua

    Ana Padua

    Director EU Global Regulatory and Scientific Policy, EMD Serono, Switzerland
    Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory... Read More →
    avatar for Veronika Jekerle

    Veronika Jekerle

    Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
    Veronika Jekerle hold the position as Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division at European Medicines Agency. The office manages pharmaceutical quality aspects for all human medicines across the lifecycle from early development to post-authorisation... Read More →
    avatar for Benjamin Stevens

    Benjamin Stevens

    Director CMC Policy and Advocacy, GlaxoSmithKline, United States
    Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →


    Wednesday June 19, 2024 10:00am - 11:00am PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      10: RegCMC-Product Quality, Session

    11:00am PDT

    #329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
    Component Type: Session

    Join the Regulatory Affairs Community for a follow up round table discussion tied to session: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle (Tuesday, June 18 | 1:15PM - 2:15 PM PDT). Space is limited.

    Chair

    Brooke Casselberry, MS, RAC


    Speakers
    avatar for Brooke Casselberry

    Brooke Casselberry

    Vice President, Advisory and Delivery, Epista Life Sciences, United States
    Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →


    Wednesday June 19, 2024 11:00am - 12:00pm PDT
    Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    #330 RT: Roundtable Discussion: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases
    Component Type: Session

    Join the Medical Writing Community for a follow up round table discussion tied to session: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases (Wednesday, June 19 | 10:00AM-11:00AM PDT). Space is limited.

    Chair

    Regina Lynn Preciado


    Speakers
    avatar for Regina Lynn Preciado

    Regina Lynn Preciado

    Senior Director of Content Strategy Solutions, Content Rules, Inc., United States
    Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →


    Wednesday June 19, 2024 11:00am - 12:00pm PDT
    Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    #330 RT: Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
    Component Type: Session

    Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation (Tuesday, June 18 | 3:15 PM - 4:15 PM PDT). Space is limited.

    Chair

    Chaitanya Koduri


    Speakers
    CK

    Chaitanya Koduri

    Director, International Government and Regulatory Engagement, US Pharmacopeia, United States


    Wednesday June 19, 2024 11:00am - 12:00pm PDT
    Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:00am PDT

    Luncheon Service
    Component Type: Social Event




    Wednesday June 19, 2024 11:00am - 1:00pm PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #331 CH: Emerging Standards for Novel Excipients
    Component Type: Workshop
    Level: Intermediate

    Participants will delve into the challenges of applying novel excipients to pharmaceutical formulations and conducting safety assessment, while also gaining insights into the crucial regulatory requirements needed to ensure product compliance and safety.
    Moreover, the rationale behind the development of emerging standards, their potential impact, and the ways in which they can contribute to elevating the standard of excellence with novel excipients will be presented. Attendees will also learn about emerging standard approaches that will help remove the current barriers to using novel excipients in new therapeutics/advanced formulations.

    Learning Objectives

    Explore challenges of using novel excipients in drug formulations; Gain insights into emerging standard approaches and possible pathways for novel excipients development.

    Chair

    Tong (Jenny) Liu, PhD


    Speakers
    TJ

    Tong (Jenny) Liu

    Principal Scientist, United States Pharmacopeia (USP), United States
    Jenny holds a PhD in Chemistry from Boston University and has more than 20 years of experience in analytical method development and validation for pharmaceutical products. After postdoctoral research at Rutgers university (New Jersey) and work at AustarPharma and Catalent Pharma Solutions... Read More →


    Wednesday June 19, 2024 11:15am - 11:45am PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #331.1 IT: Syneos Health Innovation Theater
    Component Type: Session



    Chair

    Syneos Health


    Speakers
    avatar for Syneos Health

    Syneos Health

    United States


    Wednesday June 19, 2024 11:15am - 11:45am PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #331.2 IT: OM1 Innovation Theater
    Component Type: Session



    Chair

    OM1


    Speakers
    avatar for OM1

    OM1

    United States


    Wednesday June 19, 2024 11:15am - 11:45am PDT
    Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:15am PDT

    #331.3 IT: N-Power Medicine Innovation Theater
    Component Type: Session



    Chair

    N-Power Medicine


    Speakers
    NM

    N-Power Medicine

    United States


    Wednesday June 19, 2024 11:15am - 11:45am PDT
    Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    11:45am PDT

    #332 CH: Informing Clinical Trials with Patient Feedback Through Simulations: An Innovative Methodology
    Component Type: Workshop
    Level: Intermediate

    Clinical trial simulations are a valuable and insightful methodology in understanding the patient experience during a clinical trial. Discussion will focus on strategies in operationalizing clinical trial simulations to inform clinical trial design.

    Learning Objectives

    Discuss how to derive and operationalize insights from patients and caregivers from clinical trial simulations; Explain strategies on how insights can impact clinical trial design and operation.

    Chair

    Wesley D Peters, MS


    Speakers
    avatar for Wesley Peters

    Wesley Peters

    Research Specialist II, Patient Experience, Evidera/Thermo Fisher Scientific, United States
    Wes Peters is a public health professional with over 7 years of experience in the Life Science industry. Wes received his Master of Science in Public Health (MSPH) from the Johns Hopkins Bloomberg School of Public Health with a focus in Health Education and Health Communication. Currently... Read More →


    Wednesday June 19, 2024 11:45am - 12:15pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    12:30pm PDT

    #333 CH: Real-World Evidence (RWE) for Regulatory and Health Technology Assessment (HTA) Decision Making – Where are we?
    Component Type: Workshop
    Level: Intermediate

    While the use of Real-World Data (RWD) in the post-marketing surveillance setting has increased in recent years, RWD use for decision-making in the pre-licensing is currently the focus of all stakeholders through various initiatives, including at the global level.

    Learning Objectives

    Discuss the value and importance of various multi-stakeholder collaborations to agree what and how real-world data (RWD) can be collected in order to generate real-world evidence (RWE) to support and optimise drug development; Understand the initiatives and recommendations on the use of RWE to inform decisions by healthcare systems (HTA/payers and regulators).

    Chair

    Solange Corriol-Rohou, DrMed, MD, PhD

    Speaker

    Facilitator
    David Sidney Ross, MBA, MSc, PMP, RAC



    Speakers
    avatar for Solange Corriol-Rohou

    Solange Corriol-Rohou

    Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
    Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines... Read More →
    avatar for David Ross

    David Ross

    Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
    David Ross has led enterprise projects at AstraZeneca and Abbott Labs. He implemented enterprise solutions at AZ for cross-functional CSR Initiative, led the PQ/CMC pilot for AZ, developed roles for Early Clinical Authoring and leads Clinical Study Start up improvements in alignment... Read More →


    Wednesday June 19, 2024 12:30pm - 1:00pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    1:15pm PDT

    #344: Leveraging Point of Care Technologies for Near Real Time, Interactive Safety Surveillance: Opportunities and Challenges
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-647-L04-P; CME 1.00; RN 1.00

    Forum will summarize a study that demonstrated the ability of healthcare provides (HCPs) and pharmacovigilance (PV) staff to have near real-time adverse event communications. Panelists will discuss opportunities and challenges for extending this new, potentially transformative capability.

    Learning Objectives

    Discuss how digital technologies can facilitate the near real time, interactive exchange of adverse drug information between healthcare providers (HCPs) and pharmacovigilance (PV) experts in a trusted, compliant, and transparent manner; Identify the opportunities and challenges with such an approach.

    Chair

    Gregory Powell, PharmD, MBA

    Speaker

    MHRA Update
    Phil Tregunno

    Patient Update
    Dave deBronkart

    Physician/EHR update
    Auren Weinberg, MD, MBA



    Speakers
    GP

    Gregory Powell

    Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States
    Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing... Read More →
    avatar for Dave deBronkart

    Dave deBronkart

    Patient Advocate, E-Patient Dave, LLC, United States
    "e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →
    avatar for Phil Tregunno

    Phil Tregunno

    Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →
    AW

    Auren Weinberg

    Chief Medical Officer, Veradigm, United States


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Forum

    1:15pm PDT

    #348: Challenges and Solutions to Building the Right Patient-Centered Evidence to Support Fit-For-Purpose Sensor-Based Outcomes
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-651-L04-P; CME 1.00; RN 1.00

    Challenge areas for developing patient-centered sensor-based outcomes (SBOs) will be identified, along with solutions and key considerations using real-world examples of SBO development.

    Learning Objectives

    Describe key challenges to leveraging the patient-focused drug development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product development and decision making; Identify potential solutions to inform development of fit-for-purpose, patient-centered SBOs.

    Chair

    Katelyn R Keyloun, PharmD, MS

    Speaker

    Sensor-Based Outcome Measure Development: Challenge Areas for Concept Elicitation and Interpretation of Endpoints
    Bill Byrom, PhD

    FDA Update
    Michelle Campbell, PhD



    Speakers
    KK

    Katelyn Keyloun

    Director, R&D Digital and Data Strategy, AbbVie, United States
    Kate has spent the last 10 years in the HEOR space, supporting evidence generation and the intersection of Patient Centered Outcomes Research and Digital Health. She started her career researching a cure for malaria, which fostered her strong desire to study medicine and gain a 360... Read More →
    avatar for Bill Byrom

    Bill Byrom

    Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom
    Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →
    avatar for Michelle Campbell

    Michelle Campbell

    Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
    Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Workshop |   03: Data-Tech, Workshop

    1:15pm PDT

    #345: Regulatory Considerations in Trial Design for Cell and Gene Therapies
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-648-L04-P; CME 1.00; RN 1.00

    Cell and gene therapies have enormous potential to address unmet medical need. The application of validated clinical trials design tools along with biomarkers to assess safety and endpoints can help address regulatory uncertainty.

    Learning Objectives

    Discuss regulatory considerations for cell and gene therapies including the use of data modeling in clinical trial design and the application of biomarkers both for safety assessment and measures of outcome; Discuss how to plan for meeting regulatory requirements and be able to incorporate these plans into your company’s drug development plans.

    Chair

    Kanwaljit Singh, MD, MBA, MPH

    Speaker

    Regulatory Considerations for Development of Pediatric Cell and Gene Therapies: FDA Update
    Najat Bouchkouj, MD

    Regulatory Consideration for Pediatric Cell and Gene Therapies - Industry Perspective
    Paulla Dennis

    Path from Bench-to-Bedside for a Cell and Gene Therapy Drug Product
    Stephanie Cherqui



    Speakers
    avatar for Najat Bouchkouj

    Najat Bouchkouj

    Associate Director for Pediatrics (Acting), Office of Clinical Evaluation, Offic, FDA, United States
    Dr. Najat Bouchkouj is the Acting Associate Director for Pediatrics in the Office of Clinical Evaluation, OTP, CBER, FDA. Dr. Bouchkouj joined the FDA in 2016. She earned her medical degree from Damascus University, Syria and completed a residency in Pediatrics at the State University... Read More →
    SC

    Stephanie Cherqui

    Director, UC San Diego Gene Therapy Initiative, University of California San Diego, United States
    PD

    Paulla Dennis

    Senior Director, Rare Diseases, Advanced Therapies, and Pediatrics, Fortrea, United States
    • Paulla Dennis, Senior Director, is a leading member of the Rare Disease, Advanced Therapies, and Paediatric Team (RAPT) with over 20 years in the clinical research industry. Paulla has expertise in global phase I through IV pediatric and rare disease operational strategy and planning... Read More →
    avatar for Kanwaljit Singh

    Kanwaljit Singh

    Executive Director, International Neonatal Consortium, Critical Path Institute, United States


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      06: TranslationalDelivery Tech-PrecMedicine, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

    1:15pm PDT

    #346: A Clinical Research Workforce in Crisis: Imperatives for a Sustainable Staffing Model
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-649-L04-P; CME 1.00; RN 1.00

    The clinical research workforce crisis threatens to undermine the entire drug development ecosystem. This session will discuss the glaring disconnect between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. It will feature a variety of industry leaders who will frame the issue and share lessons, solutions, and workforce development models that can be emulated globally to help build the next generation of clinical researchers--diverse and research ready.

    Learning Objectives

    Discuss the extent of the clinical research workforce crisis, including a diminishing pool of experienced clinical research professionals a ‘war for talent’ that is driving high and unsustainable turnover; Identify factors contributing to this crisis; Describe promising steps that can help with future workforce development.

    Chair

    Susan Landis

    Speaker

    Industry Update
    Jimmy Bechtel, MBA

    Industry Update
    Meghan McKenzie, MA

    Academic Update
    Jonathan Watanabe, PharmD, PhD



    Speakers
    avatar for Susan Landis

    Susan Landis

    Executive Director, Association of Clinical Research Professionals (ACRP), United States
    Susan Landis serves as the Executive Director for the Association of Clinical Research Professionals. Prior to joining the Association, Susan led Strategic Engagement & Marketing Communications for the Duke Clinical Research Institute (DCRI). While at Duke, Susan established and led... Read More →
    avatar for Jimmy Bechtel

    Jimmy Bechtel

    Vice President, Site Engagement, Society for Clinical Research Sites (SCRS), United States
    Jimmy brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum as a data specialist, patient recruiter and operations manager. On the pharma side where he worked... Read More →
    avatar for Meghan McKenzie

    Meghan McKenzie

    Patient Inclusion and Head, Equity, Chief Diversity Office, Genentech, A Member of the Roche Group, United States
    Meghan McKenzie works in Patient Inclusion and Health Equity in Genentech’s Chief Diversity Office (CDO). She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity. Genentech’s... Read More →
    avatar for Jonathan Watanabe

    Jonathan Watanabe

    Associate Dean, Pharmacy Assessment and Quality | Prof, Clinical Pharmacy, University of California Irvine, United States


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    1:15pm PDT

    #351: Revolutionizing Quality Management: Harnessing the Power of AI for Enhanced Decision Making and Continuous Improvement
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-654-L04-P; CME 1.00; RN 1.00

    This session explores four use cases of AI's potential to revolutionize quality management (QM) decision making and enhance organizational processes. Discover how AI is being implemented within QM and AI's role in identifying trends and driving improvement initiatives.

    Learning Objectives

    Describe the role of AI for quality management (QM) decision making, with a focus on advanced data analysis and pattern recognition, quality risk management, inspection readiness and drive continuous improvement initiatives; Identify practical use cases of AI in enterprise QMS, metadata extraction, risk assessment, and knowledge management systems, showcasing the benefits of AI integration.

    Chair

    Oliver Fink, MS

    Speaker

    AI Embedded Capabilities in an Enterprise Quality Management System
    Michael Pelosi, MA, MBA, MSc

    Augmenting Quality Assurance Activities with AI
    Oeystein Kjoersvik, MS, MSc

    AI Use Cases in Regulatory Monitoring
    Haleh Valian, PhD



    Speakers
    OF

    Oliver Fink

    Head Learning, Processes and Digitalization, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
    avatar for Oeystein Kjoersvik

    Oeystein Kjoersvik

    Technology Auditor and Quality Projects Lead, Merck Sharp & Dohme LLC, Czech Republic
    Oeystein Kjoersvik is currently a Technology Auditor and Quality Projects lead at Merck, one of his focuses is AI within QA. Oeystein also served as a Machine Learning SME for TransCelerate's Intelligent Automation team. Prior to his current role, he held the role of Product Owner... Read More →
    MP

    Michael Pelosi

    Director, Quality Analytics, Astellas, United States
    HV

    Haleh Valian

    Head of Decision Quality Analytics and Innovation, Biogen, United States
    Haleh is the Biogen's Head of R&D Decision, Quality Analytics and innovations. She has more than 21 years of expertise utilizing advanced analytics to solve challenging business problems relating to process optimization in a variety of industries, including pharma, healthcare, and... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      08: RD Quality-Compliance, Session

    1:15pm PDT

    #352: Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA)
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-655-L04-P; CME 1.00; RN 1.00

    This will be an interactive panel discussion with experts sharing examples how AI/ML can be used to create solutions for better regulatory decision-making and predicting regulatory success. Risks and benefits of using this approach will be discussed.

    Panelists will include world-renowned experts on drug development, drug regulations, decision science and data analytics.

    Learning Objectives

    Evaluate how AI/ML can be used to help with regulatory decision making; Analyze scenarios using case studies by world’s leading expert on drug development, cloud computing, and predicting regulatory success; Compare risks and benefits for using this evolving technology.

    Chair

    Romi Singh, PhD

    Speaker

    Panelist
    Kilian Weiss

    Panelist
    Subha Madhavan, PhD, FACMI

    Panelist
    Lily Li, JD



    Speakers
    avatar for Romi Singh

    Romi Singh

    Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States
    Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →
    LL

    Lily Li

    Founder and President, Metaverse Law, United States
    Lily Li is the founder and president of Metaverse Law, a firm that focuses exclusively on privacy, AI, and cybersecurity law. She advises mid-sized, public, and multinational clients on a broad range of AI and data protection matters, such as the CCPA, GDPR, NIST AI Framework, Biden... Read More →
    avatar for Subha Madhavan

    Subha Madhavan

    Vice President and Head of AI/ML, Global Biometrics and Data Management, Pfizer Inc, United States
    Subha Madhavan heads up AI/ML, Quantitative and Digital Sciences within Global Product Development at Pfizer. Prior to joining Pfizer, she was Head of Data Science and AI within Oncology R&D Strategy at AstraZeneca Pharmaceuticals. She has initiated and successfully directed several... Read More →
    KW

    Kilian Weiss

    General Manager, Veeva Link, Veeva, Germany
    As general manager of Veeva Link, Kilian is responsible for the strategic direction, growth, and customer success of Veeva’s global Link Platform. He is also responsible for Veeva’s European Data business and commercial strategy. Before joining Veeva, Kilian founded Mederi, a... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    1:15pm PDT

    #353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-656-L04-P; CME 1.00; RN 1.00

    Model Informed Drug Development (MIDD) can enhance the efficiency of drug development and regulatory decision-making. The ICH M15 guideline aims to enable the further integration and consistent use of MIDD. This session will cover the draft guideline in greater detail.

    Learning Objectives

    Discuss the draft guideline and what may be new to drug developers and the regulatory community, including the concept of a risk-based assessment, the value of multidisciplinary team alignment on MIDD strategy, and early alignment with regulators; Identify current approaches, best practices, and future opportunities to enhance development and decision-making.

    Chair

    Erin Greene, JD

    Speaker

    Industry Perspective
    Malidi Ahamadi

    Industry Perspective
    Mark C. Peterson, PhD



    Speakers
    avatar for Erin Greene

    Erin Greene

    US Lead, Global Regulatory Policy and Innovation, Takeda, United States
    Experienced leader in Global Regulatory Policy and Intelligence with a demonstrated history of working in the pharmaceutical and healthcare industries. Graduated from American University, Washington College of Law with an emphasis on FDA regulation and health law and policy.
    MA

    Malidi Ahamadi

    US Head, Modeling and Simulation, Sanofi, United States
    MP

    Mark Peterson

    Senior Director, Modeling and Simulation, Vertex Pharmaceuticals, United States
    Dr. Mark C. Peterson works at Vertex Pharmaceuticals as a Senior Director in Clinical & Quantitative Pharmacology. Prior to that, he was at Pfizer (9 years), Biogen (2 years) and Amgen (8 years). Dr. Peterson received a Bachelor of Sciences in Pharmacy (1992) and a Doctorate in Pharmaceutical... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    1:15pm PDT

    #354: ICMRA Post-Pandemic: Regulators Looking into the Future
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-657-L04-P; CME 1.00; RN 1.00

    ICMRA regulators will share their views on the opportunities and challenges brought by some of the main innovative concepts and technologies they are facing, including artificial intelligence, evolving clinical trials, and real-world evidence in the authorization of advanced therapy medical products (ATMPs).

    Learning Objectives

    Identify how regulators are working on maximizing the opportunities offered by artificial intelligence while minimizing the risks; Discuss new concepts for enhanced clinical trials (e.g.: platform CTs, decentralized CTs); Describe opportunities and challenges brought by the use of real-world evidence data for authorization of advanced therapy medical products.

    Chair

    Emer Cooke, MBA, MSc

    Speaker

    Panelist
    Anthony Lawler, MD, MBA

    Panelist
    Antonio Barra Torres, MD

    Panelist
    Lorraine Nolan, PhD

    Panelist
    Daisuke Koga, MSc, RPh



    Speakers
    avatar for Emer Cooke

    Emer Cooke

    Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
    Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
    avatar for Anthony Lawler

    Anthony Lawler

    Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
    Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →
    avatar for Antonio Barra Torres

    Antonio Barra Torres

    President Director, ANVISA, Brazil
    Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →
    avatar for Lorraine Nolan

    Lorraine Nolan

    Chief Executive, Health Products Regulatory Authority , Ireland
    Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
    avatar for Daisuke Koga

    Daisuke Koga

    Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
    Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    1:15pm PDT

    #349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-652-L04-P; CME 1.00; RN 1.00

    This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.

    Learning Objectives

    Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.

    Chair

    Yao-Yao Zhu, MD, PhD

    Speaker

    Panelist
    Katherine A. High, MD

    Panelist
    Vaishali Popat, MD, MPH

    Clinical Considerations for Oncology Cell and Gene Therapy Trials
    Ke Liu, MD, PhD



    Speakers
    avatar for Yao-Yao Zhu

    Yao-Yao Zhu

    Regulatory Affairs Director, AstraZeneca, United States
    Yao-Yao Zhu, MD, PhD, has over 15 years of regulatory experience. She is currently a Regulatory Affairs Director for cardiovascular, renal, and metabolic diseases at AstraZeneca (AZ). Prior to AZ, she was a head of Global Regulatory Affairs at Biosion for antibody products in oncology... Read More →
    avatar for Katherine High

    Katherine High

    Co-Founder and Former President, Sparks Therapeutics; Visiting Professor, Rockefeller University, United States
    Dr. Katherine High is the former President at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High... Read More →
    avatar for Ke Liu

    Ke Liu

    Chief Development Officer, Marengo Therapeutics, United States
    As Chief Development Officer of Marengo Therapeutics, Ke Liu joins Marengo with over 20 years of experience in the field of oncology, immuno-oncology, and cell and gene therapy, most recently serving as Senior Vice President and led the key regulatory activities at Sana Biotechnology... Read More →
    avatar for Vaishali Popat

    Vaishali Popat

    Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States
    Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   02: ClinTrials -ClinOps, Forum |   04: MedAffairs-SciComm, Forum

    1:15pm PDT

    #347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-650-L04-P; CME 1.00; RN 1.00

    This panel will discuss opportunities and challenges of leveraging artificial intelligence (AI) in the drug development lifecycle, especially in regulatory operations. The panel will include representation from regulatory, and industry.

    Learning Objectives

    Identify the impact of artificial intelligence (AI) in the drug development lifecycle from health authorities' and, industry's perspectives; Recognize opportunities for the regulators and industry to leverage rapid advancement of AI to the drug development lifecycle; Discuss challenges to implement changes from policy, technology, standard, data security in regulatory operations.

    Chair

    Ethan Chen, MBA, MS, PMP

    Speaker

    The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
    Hilmar Hamann, PhD

    Panelist
    Tala Fakhouri, PhD, MPH

    Panelist
    Nicole Mahoney, PhD



    Speakers
    avatar for Ethan Chen

    Ethan Chen

    Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States
    Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →
    avatar for Tala Fakhouri

    Tala Fakhouri

    Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States
    avatar for Hilmar Hamann

    Hilmar Hamann

    Head of Information Management, European Medicines Agency, Netherlands
    Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →
    avatar for Nicole Mahoney

    Nicole Mahoney

    Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States
    Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   03: Data-Tech, Forum

    1:15pm PDT

    #350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-653-L04-P; CME 1.00; RN 1.00

    Discussion of ICH work to harmonize recommendations for inclusion of patient’s perspective in drug development. Patient group representatives will also highlight key considerations for clinical research and development of international standards.

    Learning Objectives

    Discuss ICH’s portfolio for inclusion of patient’s perspective in drug development and outline specific case examples; Describe the patient perspective in clinical research and identify key considerations that may be relevant for the international community in developing standards; Evaluate linkages between ICH’s mission and key interests of patient, health care professional, and life science communities.

    Chair

    Amanda Marie Roache, MS

    Speaker

    Moderator
    Theresa Mullin, PhD

    ICH E22 Patient Preference Studies
    Brett Hauber, PhD, MA

    ICH Patient Engagement
    Francesco Pignatti, MD

    Patient Perspective on Engagement to Inform Drug Development
    Nicholas Brooke, MBA



    Speakers
    avatar for Nicholas Brooke

    Nicholas Brooke

    Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium
    Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
    BH

    Brett Hauber

    Senior Director, Patient Preference Elicitation, Pfizer Inc, United States
    avatar for Theresa Mullin

    Theresa Mullin

    Associate Center Director - Strategic Initiatives, CDER, FDA, United States
    Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Scientific Adviser for Oncology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    avatar for Amanda Roache

    Amanda Roache

    Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
    Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   05: Patient-Focused Drug Dev, Session

    1:15pm PDT

    #355: Unlocking the Puzzle of Borrowing Adult Data for Designing Innovative Hybrid Pediatric Trials
    Component Type: Workshop
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-658-L04-P; CME 1.00; RN 1.00

    Recruiting pediatric patients is a challenge and one of the solutions is to carefully design the study in an hybrid way to borrow adult data for pediatric study using innovative statistical techniques. The workshop discusses the recruitment challenges involved and then attendees will play a role of providing their thoughts on pediatric recruitment challenges. The workshop explains how well a study can be designed in an innovative way with appropriately utilizing the statistical techniques with case study to overcome recruitment challenges.

    Learning Objectives

    Discuss how to borrow historical adult data for pediatric study where recruiting pediatric patients is a huge challenging task.

    Chair

    Rajesh Kumar Gajendran, SR, MSc


    Speakers
    RK

    Rajesh Kumar Gajendran

    Senior Principal Biostatistician, Navitas Life Sciences, India
    With 15 years of comprehensive experience in the Medical & Clinical research sector, I have established myself as a proficient Biostatistician. Currently serving as the Senior Principal Biostatistician at Navitas Life Sciences, my role encompasses a broad spectrum of responsibilities... Read More →


    Wednesday June 19, 2024 1:15pm - 2:15pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Workshop

    2:15pm PDT

    #356 RT: Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent
    Component Type: Session

    Join the Bioethics Community for a follow up round table discussion tied to session: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

    Chair

    Karla Childers, MS


    Speakers
    avatar for Karla Childers

    Karla Childers

    Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
    Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →


    Wednesday June 19, 2024 2:15pm - 3:15pm PDT
    Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      16: Community Rounds, Session |   05: Patient-Focused Drug Dev, Session

    2:15pm PDT

    #357 RT: Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience
    Component Type: Session

    Join the Digital Acceleration Community for a follow up round table discussion tied to session: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

    Chair

    Cesar Vinces


    Speakers
    avatar for Cesar Vinces

    Cesar Vinces

    EU Interim and International Policy Lead, Accumulus Synergy, United States
    Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →


    Wednesday June 19, 2024 2:15pm - 3:15pm PDT
    Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:15pm PDT

    Refreshment Break
    Component Type: Social Event




    Wednesday June 19, 2024 2:15pm - 3:15pm PDT
    Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:30pm PDT

    #358 CH: RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room?
    Component Type: Workshop
    Level: Intermediate

    Critical-to-Quality (CtQ) factors are key to determining which protocol-related processes and variables matter. These should be defined cross-functionally during risk assessment and built into all functional plans to have a common focus and approach.

    Learning Objectives

    Define Critical-to-Quality (CtQ) variables; Streamline CtQ to all functional plans for common approach; Understand the benefits from reduced SDR/SDV by focusing on CtQ as variables that matter.

    Chair

    Terry Katz, MS


    Speakers
    avatar for Terry Katz

    Terry Katz

    Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
    Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →


    Wednesday June 19, 2024 2:30pm - 3:00pm PDT
    Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    2:30pm PDT

    #358.1 IT: DIA Innovation Theater: The 2024 DIA Science Priorities - Inspired by the Original Olympic Games Motto "Faster, Higher, Stronger"
    Component Type: Session

    Discussion of the new DIA Science Priorities and our approach for establishing new avenues for collaborative research and regulatory harmonization through information sharing and multi-stakeholder consensus building, with patients in the center of our agenda.

    Chair

    Maria Vassileva, PhD


    Speakers
    avatar for Maria Vassileva

    Maria Vassileva

    Global Head of Science & Scientific Strategy, DIA, United States
    Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →


    Wednesday June 19, 2024 2:30pm - 3:00pm PDT
    Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    3:15pm PDT

    #359: A Safety Surveillance Plan for Serious Anticipated Events
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-659-L04-P; CME 1.00; RN 1.00

    A number of questions remain about Safety Surveillance Plans (SSPs). The proposed panel discussion will include persons from multiple sponsors who have experience with developing processes to address the FDA’s recommendations in the 2021 guidance.

    Learning Objectives

    Discuss when a safety surveillance plan (SSP) is warranted; Describe specifics on implementation of the trigger method; Evaluate a product in different patient populations and ensure study integrity; Identify clarity on roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting.

    Chair

    Greg Ball, PhD

    Speaker

    Panelist
    Susan Talbot

    Panelist
    Ranjeeta Sinvhal, MD

    Panelist
    Susan Kindig, JD, MD



    Speakers
    avatar for Greg Ball

    Greg Ball

    Safety Data Scientist, ASAPprocess, United States
    Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →
    avatar for Susan Kindig

    Susan Kindig

    Prior Executive Director, Medical and Drug Safety, United States
    Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience... Read More →
    avatar for Ranjeeta Sinvhal

    Ranjeeta Sinvhal

    Executive Medical Director, Medical Safety, AbbVie, United States
    Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Instructor in Loyola PV Certificate Course. Co-chair of Cardiovascular Internal Safety... Read More →
    ST

    Susan Talbot

    Director Biostatistics, Amgen, United States


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Forum

    3:15pm PDT

    #362: Streamlining Processes and Data Exchange Across R&D Functions to Improve Performance and Facilitate Automation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-662-L04-P; CME 1.00; RN 1.00

    In this interactive forum, panelists share how they are working across R&D to improve processes and data flows, govern their data, move toward more data-driven processes, and facilitate the use of artificial intelligence (AI) and advanced technologies.

    Learning Objectives

    Identify how sponsor companies are optimizing their business processes and getting more value from their data across R&D; Discuss approaches for process optimization, data governance and standardization; Describe ways to move towards data-driven business processes and how to enable greater automation and business efficiency across product development.

    Chair

    Cary Smithson, MBA

    Speaker

    Panelist
    Linda Chong, MBA

    Panelist
    Rayna Venook, PhD



    Speakers
    avatar for Cary Smithson

    Cary Smithson

    Senior Director, Business Transformation & Systems Management, Cencora Pharmalex, United States
    Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory... Read More →
    avatar for Linda Chong

    Linda Chong

    Director, Regulatory Information Management, Daiichi Sankyo, United States
    Linda Chong has overall 20 years of experience within the Pharmaceutical industry specifically Regulatory Information Management, Global Submission Management, and Data Governance including organization change management. She is currently the Director of Regulatory Information Management... Read More →
    avatar for Rayna Venook

    Rayna Venook

    Team Lead, Pharma Development Regulatory, Genentech, A Member of the Roche Group, United States
    Rayna Venook is a Team Lead within the Regulatory Information Management organization at Roche. In this capacity, she focuses on facilitating the development and delivery of solutions to enhance data interoperability to enable integrated solutions across Roche. She has 17 years of... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    3:15pm PDT

    #360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-660-L04-P; CME 1.00; RN 1.00

    Unlocking AI's potential to facilitate diversity in clinical trials demands inclusive images capturing skin manifestations of internal diseases across races and ethnicities. Join our panel to learn more about inclusive innovation in AI solutions.

    Learning Objectives

    Discuss the importance of photographs and images in AI algorithms to identify internal diseases impacting patients of color and how that supports clinical trial enrollment; Identify the questions to ask of AI solution providers to ensure imagery is inclusive; Describe what’s being done to improve imagery in AI learning to drive clinical trial diversity.

    Chair

    Pamela Simpkins, MBA

    Speaker

    Patient Update
    Tricha Shivas, MS

    Industry Update
    Lionel Phillips, MBA

    Industry Update
    Brian H Johnson



    Speakers
    avatar for Pamela Simpkins

    Pamela Simpkins

    Managing Partner, Mezzopointe. LLC, United States
    Biopharma R&D executive with 26+ years in the industry and nearly a decade as an institutional investor. Expert in R&D Finance with a proven track record in accelerating development of key pipeline assets to achieve regulatory approval and market authorization. Built, led and sold... Read More →
    BJ

    Brian Johnson

    Vice President, R&D Technology, Takeda, United States
    avatar for Lionel Phillips

    Lionel Phillips

    President, Inside Edge Consulting, United States
    avatar for Tricha Shivas

    Tricha Shivas

    Chief of Staff and Strategy, Foundation For Sarcoidosis Research, United States
    Tricha Shivas joined the Foundation for Sarcoidosis Research (FSR) in December of 2020. As the Chief of Staff and Strategy, she works with various stakeholders including individuals living with sarcoidosis. Through her career she has built strong stakeholder relations, created comprehensive... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session |   11: Statistics-Data Science, Session |   02: ClinTrials -ClinOps, Session

    3:15pm PDT

    #366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-666-L04-P; CME 1.00; RN 1.00

    This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.

    Learning Objectives

    Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.

    Chair

    Allison Martin, MS

    Speaker

    The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
    Michelle Campbell, PhD

    The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
    Francesco Pignatti, MD

    The Intersection of Patient-Experience Data and Benefit-Risk Analysis: Industry Update
    Jill Yersak

    The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
    Hollie Schmidt, MS



    Speakers
    avatar for Allison Martin

    Allison Martin

    Director, Regulatory Science and Policy, North America, Sanofi, United States
    As a Director on Sanofi’s Regulatory Science and Policy North America team, Allison is responsible for advancing regulatory science and strategically engaging in regulatory policy efforts. In this role, Ms. Martin collaborates with internal and external stakeholders to identify... Read More →
    avatar for Michelle Campbell

    Michelle Campbell

    Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
    Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Scientific Adviser for Oncology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    avatar for Hollie Schmidt

    Hollie Schmidt

    Vice President of Scientific Operations, Accelerated Cure Project, United States
    Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →
    JY

    Jill Yersak

    Head, US ALS Patient Advocacy and Engagement, Amylyx Pharmaceuticals, United States


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session

    3:15pm PDT

    #364: Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-664-L04-P; CME 1.00; PDU 1.00 PMI 21668FZSM7; RN 1.00

    In this session, we will provide an overview of lifecycle management for an asset from patent filing to loss of exclusivity. Critical success factors require early planning, rigorous prioritization, organizational alignment, cross-functional buy-in and collaboration, and retention of enterprise memory over the long lifecycle of an asset. Program managers will gain insight into their unique role as champions of process and people, ensuring therapies reach patients faster. Proven strategies from case study examples will outline key decision points at each stage of product development, identify tools for strengthening cross-functional team planning, ensure quality oversight, and enhance successful delivery of the product lifecycle strategy.

    Learning Objectives

    Identify the concept of pharmaceutical lifecycle management and its role in bringing lifesaving therapies to patients efficiently; Discuss the challenges of pharmaceutical lifecycle management, such as siloed department planning and lack of resources; Describe the role of project management in ensuring continuity of lifecycle management and the execution of the product strategy.

    Chair

    Susan Carino, MBA, MS, PMP, RAC

    Speaker

    Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey: Industry Update
    Aditi Khurana, MBA, PMP, RAC



    Speakers
    avatar for Susan Carino

    Susan Carino

    Director, Program Management, Mammoth Biosciences, United States
    Susan Carino is a Director of Program Management with Mammoth Biosciences. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She has led diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →
    avatar for Aditi Khurana

    Aditi Khurana

    Director, Project Management, Summit Therapeutics, Inc., United States
    Aditi Khurana, is the Director of Project Management at Asher Biotherapeutics. She is a Project Management Professional (PMP) and is certified in Global Regulatory Affairs (RAC). She holds a Bachelors in Neuroscience from University of California, Los Angeles (UCLA) and a Masters... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      07: ProjectManagement-StrategicPlanning, Session

    3:15pm PDT

    #365: Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-665-L04-P; CME 1.00; RN 1.00

    Adequate enrollment of underrepresented groups continues to be a challenge in a complex, global regulatory and research ecosystem. Review and assess evolving expectations and processes in the US, Canada, and other regulatory systems, what has been implemented, what adjustments have been made, what has worked, and what hurdles or differences remain.

    Learning Objectives

    Describe the background and underlying requirements to FDA’s and other health authorities’ diversity and inclusion policies and guidance; Discuss how different stakeholders have implemented and reacted to implementation of new and evolving policies; Identify areas where views or expectations diverge; Discuss and describe what has worked, what has not; Identify how this area might change in future.

    Chair

    Alexis Miller, JD

    Speaker

    FDA Update
    Karen Hicks, DrMed

    Health Canada Update
    Alysha Croker, PhD

    UK Update
    Naho Yamazaki, PhD

    Patient Update
    Loriana Hernandez-Aldama



    Speakers
    avatar for Alexis Miller

    Alexis Miller

    Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States
    Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →
    avatar for Alysha Croker

    Alysha Croker

    Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada
    Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →
    avatar for Loriana Hernandez-Aldama

    Loriana Hernandez-Aldama

    Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup For Life, United States
    Loriana is a 2x cancer survivor, international motivational speaker, award-winning journalist, podcast host, and author of "Becoming the Story: The Power of Prehab." Bold, transparent, and honest, Loriana has emerged as a game-changer in healthcare, advocating globally for transformative... Read More →
    avatar for Karen Hicks

    Karen Hicks

    Deputy Director, Office of Medical Policy, CDER, FDA, United States
    Dr. Hicks is the Deputy Director of the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). She oversees regulation and policy development for CDER and participates in cross-cutting agency initiatives... Read More →
    avatar for Naho Yamazaki

    Naho Yamazaki

    Deputy Director, Policy and Partnerships, Health Research Authority, United Kingdom
    Naho is Deputy Director, Policy and Partnerships at the Health Research Authority (HRA), where she is leading on a range of policy and engagement initiatives for the HRA to make it easy to do research that people can trust. This includes pushing for change to increase diversity and... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    3:15pm PDT

    #367: EMA Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-667-L04-P; CME 1.00; RN 1.00

    The European Forum will explain our various platforms and ways to engage to support innovation, illustrated on an example of an Advanced Therapy Medicinal Product (ATMP).

    Learning Objectives

    Describe the assessment procedure and the role of CHMP and rappoteur; Describe platforms to support developers; Discuss a successful submission of an ATMP.

    Chair

    Steffen Thirstrup, MD, PhD

    Speaker

    Panelist
    Sabine Haubenreisser, PhD, MSc

    Panelist
    Anabela Marcal, PharmD

    Panelist
    Evdokia Korakianiti, PhD, MSc



    Speakers
    avatar for Sabine Haubenreisser

    Sabine Haubenreisser

    Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
    Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →
    avatar for Evdokia Korakianiti

    Evdokia Korakianiti

    Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
    avatar for Anabela Marcal

    Anabela Marcal

    EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
    avatar for Steffen Thirstrup

    Steffen Thirstrup

    Chief Medical Officer, European Medicines Agency, Netherlands
    Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    3:15pm PDT

    #363: Implementing Changes To Drug-Device Combination Products Globally
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-663-L04-P; CME 1.00; RN 1.00

    Industry and regulators will collaborate to discuss current challenges and future opportunities to streamline post approval changes to combination products.

    Learning Objectives

    Describe current regulatory frameworks for lifecycle management changes to combination products; Compare differences in expectations for submissions of post-approval changes globally; Discuss the utilization of harmonized guideline, ICH Q12, for management of post approval changes to combination products globally.

    Chair

    Chelsea O'Connell, MS, RAC

    Speaker

    FDA CBER Perspective on Postmarket Changes to CBER-Led Combination Products
    Andrea Gray, PhD

    Industry Perspective on the Latest ICH Q12 Training Module 8
    Andrew Chang, PhD

    Industry Perspective on Postmarket Changes to Combination Products: Global
    Amy Wise, MBA

    PMDA Update: Postmarket Changes to Combination Products in Japan
    Keisuke Tanaka, PhD

    Industry Perspective on Postmarket Changes to Combination Products: US
    Lori-Anne Boville



    Speakers
    avatar for Chelsea O'Connell

    Chelsea O'Connell

    Director, Global Regulatory and R&D Policy, Amgen, United States
    Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →
    avatar for Andrew Chang

    Andrew Chang

    Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States
    Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →
    AW

    Amy Wise

    Associate Director, RA Device and Combination Products, AbbVie, United States
    Amy Wise is an Associate Director Regulatory Affairs Device and Combination Products at AbbVie. Amy has been in the pharmaceutical industry for 25 years with 15 years in regulatory affairs, 5 years in quality and 5 years in pharmaceutical sciences. She has successfully provided the... Read More →
    avatar for Andrea Gray

    Andrea Gray

    Biomedical Engineer Advisor, CBER, FDA , United States
    Andrea Gray is a Biomedical Engineer Advisor in the Regulatory Operations Branch of the Division of Regulatory Operations and Programs (DROP) in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER). She specializes in regulatory review of... Read More →
    KT

    Keisuke Tanaka

    Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Tanaka is Reviewer of the Office of Cellular and Tissue-based Products, PMDA. He received his Ph, D. from Osaka University in Bioorganic chemistry with emphasis in nucleic acid therapy. Since joining PMDA in 2021, he has worked in the Office of Cellular and Tissue-based Products... Read More →
    avatar for Lori-Anne Boville

    Lori-Anne Boville

    Group Director, Pharma Technical Regulatory, Device and Combination Products, Genentech, A Member of the Roche Group, United States
    She is a Regulatory Affairs Expert in Biologics products, Medical Devices & Combination Products at Genentech. Lori has over 20 years of Biopharmaceutical product development, analytical testing, commercial quality, regulatory affairs and medical device experience. She has successfully... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session

    3:15pm PDT

    #368: Harnessing the Power of Artificial Intelligence (AI) in Clinical Research From Knowledge Graphs to Generative AI
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-668-L04-P; CME 1.00; RN 1.00

    This session discusses usage of a variety of artificial intelligence (AI) solutions (knowledge-based expert systems, generative AI, machine learning) across the clinical research lifecycle from drug discovery to patient recruitment, data quality management, and submission. We will go over specific problems that lend themselves to AI and how we go about building scalable solutions with emphasis on explainability, reliability, and validity.

    Learning Objectives

    Discuss the use of generative artificial intelligence (AI) and machine learning in clinical research and measures taken to insure validity and reliability; Describe the role of knowledge graph (KG) in building AI systems.

    Chair

    Katy Ghantous, PhD, MS

    Speaker

    Industry Update
    John Overington

    Industry Update
    Joe Mullen

    Academic Update
    Ramona Lynn Walls, PhD



    Speakers
    KG

    Katy Ghantous

    Senior Director, Data Science, Medidata Solutions, United States
    avatar for Joe Mullen

    Joe Mullen

    Head of Data Science and Professional Services, SciBite, United Kingdom
    avatar for John Overington

    John Overington

    Chief Data Officer, Exscientia, United Kingdom
    John Overington is Chief Data Officer at Exscientia & has over 35 years experience of drug discovery & design, data science & machine learning; encompassing innovation and leadership positions in pharma, academia & biotech sectors. After a degree in Chemistry, a PhD in protein structure... Read More →
    RW

    Ramona Walls

    Executive Director of Data Science, Data Collaboration Center, Critical Path Institute, United States
    Ramona Walls, Ph.D. is Executive Director of Data Science at the non-profit Critical Path Institute (C-Path). She oversees multiple efforts including C-Path’s Data and Analytics Platform, development of a rare disease knowledge graph, and expansion and modernization of C-Path’s... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Session

    3:15pm PDT

    #361: Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-661-L04-P; CME 1.00; RN 1.00

    Recruitment is a significant building block of clinical trials and also one of the greatest challenges, often having a direct influence on trial success or failure. In-efficiencies associated with patient recruitment may lead to prolonged trial durations, increased costs, and delays in bringing effective treatments to market. This session will explore methods for predicting the effect of different recruitment patterns on trial progression, outcomes and likelihood of the trial to meet its goals and present newly available technologies and trial design measures for successfully advancing recruitment.

    Learning Objectives

    Describe the considerations of recruitment rate optimization in clinical trials and adaptive trials in particular; Discuss the available technologies and methodologies for optimizing recruitment via dedicated software, patient advocacies, databases and registries and the evaluation of trade-offs between trial duration and sample size requirements within a variety of adaptive trial designs as compared with standard fixed designs.

    Chair

    Raviv Pryluk, PhD

    Speaker

    Time is Life: Leveraging Innovation in Clinical Trials for Rapid Recruitment
    Tanya Russell, PhD, MS, RPh

    Potential for Leveraging AI/ML in Pre-Trial Recruitment Modelling
    Jenny Higley, MS

    Demystifying Site Engagement: Leveraging an Omnichannel Approach with Data-Driven Clinical Analytics
    Sanghita Bhattacharya, PhD

    Optimizing Clinical Trial Site Selection: Balancing Recruitment Efficiency and Population Diversity
    Raviv Pryluk, PhD



    Speakers
    avatar for Raviv Pryluk

    Raviv Pryluk

    CEO & Co-founder, PhaseV, United States
    Raviv is the co-founder & CEO of PhaseV, a technology company that leverages causal-ML and advanced software capabilities to support advanced & innovative clinical trials. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion (Cum Laude) and Ph.D. in computational neuroscience... Read More →
    avatar for Sanghita Bhattacharya

    Sanghita Bhattacharya

    Associate Director Data Science , Feasibility and Analytics, Clinical Operations, Johnson & Johnson Innovative Medicine, United States
    Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as... Read More →
    JH

    Jenny Higley

    Director, Head of Feasibility CoE, Biogen, United States
    Jenny has 20 years of clinical research experience and is currently the Director of the Feasibility Center of Excellence at Biogen, where she has worked for the past four years. Jenny’s career also includes CRO and ARO experience from IQVIA, Syneos Health, and the Duke Clinical... Read More →
    TR

    Tanya Russell

    Vice President, Integration Lead, Pfizer Inc, United States
    Tanya Russell recently moved into a new role as Vice President, CD&O Integration Lead supporting the R&D integration of Seagen and Pfizer into one Pfizer Oncology department. For the last 3+ years, Tanya was Pfizer’s Oncology and Rare Disease Clinical Operations Head with accountability... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    3:15pm PDT

    #369: Improving Communication Across Differences in Drug Development Teams
    Component Type: Workshop
    Level: Intermediate

    The interactive workshop will provide an opportunity for participants to discuss common barriers that hinder effective communication in cross-cultural, diverse teams. Discussion will draw from the management, psychology, and drug development literature to help contextualize communication and feedback giving.

    Learning Objectives

    Identify and discuss common interactions and patterns that can hinder effective communication in diverse and cross-cultural teams in drug development; Describe common pitfalls and fallacies related to feedback and learn how to avoid them; Identify evidence-based solutions on how to reduce barriers to communication.

    Chair

    Jennifer Kim, PhD

    Speaker

    Empirical Perspective: What the Research on Team Communication in Drug Development Reveals
    Emily Botto

    Learning and Development Perspective: Best Practices for Training and Implementation
    Tamei Elliott, MS

    Case Perspective: Learnings from the Field
    Christine Mayer-Nicolai, PharmD



    Speakers
    avatar for Jennifer Kim

    Jennifer Kim

    Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
    I'm a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining how diversity, equity and inclusion dynamics impact individual, group, and organizational outcomes... Read More →
    avatar for Emily Botto

    Emily Botto

    Research Analyst, Tufts Center for the Study of Drug Development, United States
    Emily Botto joined the Tufts Center for the Study of Drug Development (Tufts CSDD) as a Research Analyst in October 2020 after graduating from Brandeis University. Her work focuses on studies relating to clinical research execution strategies and practices as well as clinical trial... Read More →
    avatar for Tamei Elliott

    Tamei Elliott

    Associate Director, Scientific Programs, DIA, United States
    Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →
    avatar for Christine Mayer-Nicolai

    Christine Mayer-Nicolai

    Vice President, Regulatory and Scientific Policy, Merck Healtcare KGaA, Germany
    Dr. Christine Mayer-Nicolai, VP, Regulatory & Scientific Policy at Merck Healthcare KGaA, Germany is based in Darmstadt and Washington, DC. She is leading the development of Merck Healthcare regulatory policy priorities, identifying, and responding to global regulatory and legislative... Read More →


    Wednesday June 19, 2024 3:15pm - 4:15pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Workshop

    4:30pm PDT

    #370: Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-669-L04-P; CME 1.00; RN 1.00

    Artificial intelligence solutions may support and enhance human decision-making and information processing throughout pharmacovigilance. This session aims to outline best practices and potential pitfalls in their use.

    Learning Objectives

    Recognize key challenges in assessing artificial intelligence solutions and interpreting evaluations of their performance; Describe some best practices for critical appraisal of artificial intelligence solutions; Identify the need for consideration of human computer interactions.

    Chair

    Jim Barrett, PhD, MSc

    Speaker

    MHRA Update
    Phil Tregunno

    FDA Update
    Monica Munoz, PharmD, PhD

    Industry Update
    Andrew Bate, PhD, MA



    Speakers
    JB

    Jim Barrett

    Senior Data Scientist, Upsala Monitoring Centre (UMC), Sweden
    Jim is a senior data scientist at Uppsala Monitoring Centre (UMC), where he has worked for the past 4 years. In that time, Jim has worked on several projects including advanced signal detection methods, tools to facilitate analysis of large case series and NLP methods for mining structured... Read More →
    avatar for Andrew Bate

    Andrew Bate

    Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
    Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
    avatar for Monica Munoz

    Monica Munoz

    Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
    CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →
    avatar for Phil Tregunno

    Phil Tregunno

    Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
    Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    4:30pm PDT

    #374: Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-673-L04-P; CME 1.00; RN 1.00

    The forum will consist of regulators and industry experts who were the authors of the ICH E17 guidelines. As regulators and sponsors, they will provide first-hand narrative on their experiences in implementing the ICH E17 guidelines.

    Learning Objectives

    Discuss the status of adoption of ICH E17 guidelines on conduct of multiregional clinical trials (MRCT) by the regulators and industry. • Identify reasons behind slow uptake of the ICH E17 guidelines. • Discuss points for increasing usage of E17 for conduct of MRCT and simultaneous global development.

    Chair

    Yoshiaki Uyama, PhD, RPh

    Speaker

    PMDA Perspective
    Yoko Aoi, PhD

    Pharmaceutical Industry Perspective
    Romi Singh, PhD

    FDA Update
    Douglas D. Pratt

    Taiwan Perspective
    I-Chun Lai, MD, MS

    China Perspective
    Yangfeng Wu, MD, PhD



    Speakers
    avatar for Yoshiaki Uyama

    Yoshiaki Uyama

    Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
    avatar for Yoko Aoi

    Yoko Aoi

    Deputy Review Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    Dr. Yoko Aoi is a deputy review director of Office of New Drug V responsible for review and scientific advice on oncology drugs. After joining PMDA, Dr. Aoi was involved in review and scientific advice on new drugs for rheumatoid arthritis, asthma, COPD etc. (2011-2016) and planning... Read More →
    avatar for I-Chun Lai

    I-Chun Lai

    Director, Consultation Division, Center for Drug Evaluation, Taiwan
    Dr. I-Chun Lai graduated with her medical degree from Taipei Medical University in Taiwan in 2001 and worked as a physician until 2007, when she joined the Center for Drug Evaluation (CDE) in Taiwan. In 2013, she received her Master of Science from the Institute of Health Policy and... Read More →
    DP

    Douglas Pratt

    Supervisory Medical Officer, OVRR, CBER, FDA , United States
    avatar for Romi Singh

    Romi Singh

    Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States
    Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →
    YW

    Yangfeng Wu

    Executive Director, Peking University Clinical Research Institute, China
    Professor Wu is the Executive Director of Peking University Clinical Research Institute. He has been principal investigators of tens of research projects sponsored by national and international founding agencies including China Ministry of Science and Technology, China Natural Science... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum |   09: Regulatory, Forum
    • Format Forum
    • Level Intermediate
    • Featured Topics ICH
    • Level Intermediate
    • Feature Topics ICH
    • Credit Type ACPE, CME, RN
    • Tags Forum

    4:30pm PDT

    #372: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-671-L04-P; CME 1.00; RN 1.00

    This forum will discuss regulatory activities and technology to enable global convergence and reliance for post-approval changes (PAC). Diverse panelists will share examples of efficient collaboration and information exchange to reduce the PAC process cycle times.

    Learning Objectives

    Recognize the importance of global collaboration to support sovereign decision making; Discuss how building in reliance practices into cloud-based solutions could accelerate the post-approve changes (PAC) process globally; Explain how cloud solutions support transparency, trust, regulatory convergence, and information exchange, and collaboration to increase patient access to therapies.

    Chair

    Dominique Lagrave, PharmD

    Speaker

    Panelist
    Samvel Azatyan, MD, PhD

    Panelist
    David Mukanga, PhD, MPH

    Panelist
    Susanne Ausborn, PhD

    Panelist
    Cynthia Ban



    Speakers
    avatar for Dominique Lagrave

    Dominique Lagrave

    Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States
    Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
    avatar for Susanne Ausborn

    Susanne Ausborn

    Global Head International Regulatory Policy, Roche, Switzerland
    Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
    avatar for Samvel Azatyan

    Samvel Azatyan

    Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
    Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
    avatar for Cynthia Ban

    Cynthia Ban

    Global Head, Regulatory Affairs CMC, Vaccines, Sanofi, Canada
    Cynthia Ban is the Global Head Regulatory CMC & Devices for Vaccines at Sanofi. Senior Global Leader in the pharmaceutical industry specializing in Regulatory Affairs. Worked for small biotech and large multinational companies. Led and developed teams across multiple geographies and... Read More →
    avatar for David Mukanga

    David Mukanga

    Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States
    Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Forum

    4:30pm PDT

    #373: Patient-Centric Approaches in Summaries and Data Return
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-672-L04-P; CME 1.00; RN 1.00

    Join us for a multi-stakeholder discussion to learn more about the practical tools and considerations available to help sponsors get started or improve their participant communications including lay protocol synopses, lay summaries, and participant data return.

    Learning Objectives

    Recognize the problems in explaining benefit and risk to patients and lay audiences; Define meaningful communication of information to research participants; Identify how evolving collaborations, proactive planning, interoperability, digital health advancements, and secure data management enable participant data return options that do not compromise data integrity, confidentiality, or submission timelines.

    Chair

    Jean Sposaro, MHS, LLM

    Speaker

    Individual Participant Data Return: Feasible, Personal, and Actionable Options to Support Informed Decision-Making
    Jean Sposaro, MHS, LLM



    Speakers
    avatar for Jean Sposaro

    Jean Sposaro

    Director, Global Drug Development Operations,Industry Collaborations, Bristol-Myers Squibb Company, United States
    Healthcare Provider, Researcher, Patient Advocate, Bioethics, Pharmaceutical Law & Policy Professional advancing science through impactful collaboration with stakeholders across the R&D ecosystem to "co-create a healthier future". Optimizing global collaborations as enablers of innovation... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session

    4:30pm PDT

    #371: Using Influencers to Recruit Hard-to-Engage Populations
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-670-L04-P; CME 1.00; RN 1.00

    Influencers are community connectors that can be leveraged to expand patient recruitment, particularly for hard-to-engage populations. We will discuss how influencers can engage patient audiences for clinical trial participation.

    Learning Objectives

    Discuss the power of influencer marketing to improve clinical trial participation, including among diverse populations; Describe how to build an effective influencer campaign — matching the right influencer to your objectives; Develop effective digital assets; Identify how to maximize exposure among a captivated audience.

    Chair

    Sarah McKeown-Cannon

    Speaker

    Industry Update
    Lara Lane



    Speakers
    LL

    Lara Lane

    Director, Clinical Operations, Ironwood Pharmaceuticals, United States
    As Director of Clinical Operations at Ironwood, Lara is responsible for developing and executing clinical operations program strategies, ensuring the delivery of high-quality results. With 20+ years of expertise in the industry, her work experience has spanned across clinical sites... Read More →
    SM

    Sarah McKeown-Cannon

    Vice President, Growth, Publicis Health, United States
    Sarah McKeown-Cannon (she/her/hers) provides innovative patient recruitment and engagement solutions that enrich study experiences and deliver measurable results. She is driven by her commitment to making a difference in people's lives, by understanding all the dimensions that make... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   02: ClinTrials -ClinOps, Session

    4:30pm PDT

    #375.1: Middle East Emerging Opportunities
    Component Type: Forum
    Level: Intermediate

    In this forum, regulatory authorities from the Middle East region will share updates, success stories, lessons learned and plans for the future.

    Learning Objectives

    Identify the regulatory authorities' representatives from the Middle East region; Discuss new developments and opportunities in the region.


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    4:30pm PDT

    #375: Sustainability of Rare Disease Drug Development
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-674-L04-P; CME 1.00; RN 1.00

    Panelists will reflect on the past forty years of the orphan drug act including advancements and impediments. The panel will discuss what is needed in the future to continue to advance rare disease drug development to treat as many patients as possible.

    Learning Objectives

    Discuss the outcomes, challenges, and opportunities in the next forty years of the Orphan Drug Act; Identify policy advancements that need to be made to continue innovative rare disease drug development.

    Chair

    Darcy Frear, PhD

    Speaker

    Panelist
    Katherine Donigan, PhD

    Panelist
    Patroula Smpokou, MD

    Panelist
    Karin Hoelzer, DVM, PhD

    Panelist
    Julia Tierney, JD



    Speakers
    avatar for Darcy Frear

    Darcy Frear

    Associate Director, Bridgebio, United States
    Dr. Darcy Frear is currently the associate director for Regulatory Policy and Intelligence at BridgeBio. Prior to joining BridgeBio in 2022, Darcy began her regulatory career at Genentech supporting program management in oncology and US regulatory policy. Subsequently, she joined... Read More →
    KD

    Katherine Donigan

    Senior Director, Science and Regulatory Policy, Sarepta, United States
    Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory Policy at Sarepta Therapeutics. Prior to joining Sarepta, Dr. Donigan was a Senior Director of Science and Regulatory at Biotechnology Innovation Organization (BIO) and spent 7 years in regulatory policy... Read More →
    KH

    Karin Hoelzer

    Senior Director, Policy and Regulatory Affairs, NORD, United States
    Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). She works closely with pharmaceutical and biotech partners to ensure public policy supports innovative approaches and new treatments, and adequately incorporates patient... Read More →
    avatar for Patroula Smpokou

    Patroula Smpokou

    Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER, FDA, United States
    Patroula Smpokou, MD, is a board-certified pediatric clinical geneticist working in the Division of Rare Diseases and Medical Genetics at CDER. Her work involves the clinical review and regulation of products intended for rare genetic diseases. Prior to joining FDA, she was a practicing... Read More →
    avatar for Julia Tierney

    Julia Tierney

    Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States
    JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    4:30pm PDT

    #376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-675-L04-P; CME 1.00; RN 1.00

    This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.

    Learning Objectives

    Identify the key current challenges in quality control for cell and gene therapy development; Explain global regulators’ perspectives on quality control, including raw material selection, control, and qualification; Discuss best practices, including standards and reference materials, to support the development and manufacture of cell and gene therapies.

    Chair

    Fouad Atouf, PhD

    Speaker

    Qualification and Selection of Raw Materials During Early Stage of Development
    Mo Heidaran, PhD

    Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
    Haritha Vallabhaneni, PhD

    Cell and Gene Therapy Products: Global Regulatory Perspective
    Alexandra Beumer Sassi, PharmD, PhD, RAC



    Speakers
    avatar for Fouad Atouf

    Fouad Atouf

    Senior Vice President, Global Biologics, United States Pharmacopeia (USP), United States
    Dr. Atouf has over 20 years’ experience in research, product development, characterization and quality assessment of biologics including cell and gene therapies (CGT). At USP, he heads the Biologics program and oversees standards development, stakeholder engagement and external... Read More →
    avatar for Mo Heidaran

    Mo Heidaran

    Chief Regulatory Scientist, Cellx Inc., Consulting, United States
    Dr. Mo Heidaran is currently Chief Regulatory Scientist at Cellx Inc. He previously worked as Head of Translational and Regulatory Strategy at GCTx (GC Therapeutics). He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the... Read More →
    avatar for Alexandra Beumer Sassi

    Alexandra Beumer Sassi

    Global Head of CMC&QA, Voisin Consulting Life Sciences, United States
    Dr. Beumer Sassi is a Senior Director, CMC at Voisin Consulting Life Sciences with over 22 years of experience in biopharmaceutical industry and consulting. She is responsible for the strategy and technical content of projects involving the development of Biologics, Cell and Gene... Read More →
    avatar for Haritha Vallabhaneni

    Haritha Vallabhaneni

    Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER, FDA, United States
    Dr. Vallabhaneni is a CMC Reviewer in the Division of Cell Therapy 1, CBER, FDA. She is involved in CMC review of regulatory applications involving cellular therapy products. She has extensive research experience in stem cells previously working on multiple research projects investigating... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session |   10: RegCMC-Product Quality, Session

    4:30pm PDT

    #377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-676-L04-P; CME 1.00; RN 1.00

    This session will include a case study in a short-term depression trial with repeated measurements of continuous outcomes and two types of intercurrent events, and evaluate the four developed data-generating models. Can we jointly generate outcomes and intercurrent events that are associated for a generic phase 3 trial in simulation studies? What data-generating models can be used to achieve this?

    Learning Objectives

    Describe phase 3 randomized controlled trial data (clinical outcomes and intercurrent events) and model the association between efficacy outcomes and intercurrent events; Discuss how this research is needed to enable analytical or simulation studies that can investigate estimands and strategies on datasets generated under the same data-generating models; Identify how to implement the E9(R1) estimand framework.

    Chair

    Marian Mitroiu, PhD

    Speaker

    EMA Update
    Francesco Pignatti, MD

    MEB Update
    Laura Rodwell, PhD



    Speakers
    avatar for Marian Mitroiu

    Marian Mitroiu

    Associate Director Biostatistics, Biogen, Switzerland
    Marian is from Romania. In 2015-2016 he did a traineeship at EMA in London at the Biostatistics and Methodology Office. In 2017, he started his doctoral studies at Julius Center, UMC Utrecht and Utrecht University. He worked in parallel at CBG-MEB, being part of the Methodology Working... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Scientific Adviser for Oncology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    avatar for Laura Rodwell

    Laura Rodwell

    Statistical Assessor, Dutch Medicines Evaluation Board, Netherlands
    Laura has been working in research and biostatistics in one way or another for the past 20 years. After starting her career in crime research she became more interested in medical research and clinical trials. She completed her Master of Biostatistics in 2010 and a PhD in Biostatistics... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      11: Statistics-Data Science, Session

    4:30pm PDT

    #378: From X to Z: Unleashing the Power of Multigenerational Collaboration in Life Sciences – The Basics for All
    Component Type: Workshop
    Level: Basic

    Unlock the secrets of workplace success! Learn to harness the strengths of each generation and build a cohesive and successful team. Don't miss out on the opportunity to learn valuable insights and strategies for managing a diverse workforce.

    Learning Objectives

    Explore the unique characteristics and differences among different generations in the workplace; Discuss practical ideas on how to effectively manage and create a harmonious and productive work environment; Describe how to dispel the myths and stereotype of each generation.

    Chair

    Tywnia Brewton

    Speaker

    Facilitator
    Leslie Sam



    Speakers
    avatar for Tywnia Brewton

    Tywnia Brewton

    Executive Director, Human Resources, Astellas , United States
    Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →
    avatar for Leslie Sam

    Leslie Sam

    President, Leslie Sam and Associates, LLC, United States
    With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →


    Wednesday June 19, 2024 4:30pm - 5:30pm PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      13: ProfDevelopment, Workshop
     
    Thursday, June 20
     

    7:00am PDT

    Coffee and Light Refreshments
    Component Type: Social Event




    Thursday June 20, 2024 7:00am - 8:00am PDT
    Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    8:00am PDT

    #401: Harnessing Real-World Data to Generate Real-World Evidence for Regulatory Grade Safety Studies
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-677-L04-P; CME 1.00; RN 1.00

    Session will focus on considerations with successful as well as unsuccessful use cases for generating regulatory grade safety studies using secondary data under new FDA Guidance.

    Learning Objectives

    Describe considerations when using secondary data to generate real-world evidence for regulatory-grade post-marketing studies; Describe key elements to consider when implementing feasibility assessment to identify real-world data sources.

    Chair

    Alicia Gilsenan, PhD, MS, RPh, FISPE

    Speaker

    FDA Update
    Marie Bradley, PhD, MPH, MPharm

    Value of Real-World Data/Real-World Evidence to Assess Potential Safety Signal: Use Case- Ophthalmology
    Angelika Manthripragada, PhD, MPH



    Speakers
    avatar for Alicia Gilsenan

    Alicia Gilsenan

    Vice President, Epidemiology, RTI Health Solutions, United States
    Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →
    MB

    Marie Bradley

    Senior Advisor Real-World Evidence Analytics, OMP, CDER, FDA, United States
    Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as technical lead for externally conducted... Read More →
    AM

    Angelika Manthripragada

    Director, Pharmacoepidemiology, Global Patient Safety, Regeneron, United States
    Angelika Manthripragada is a Director in the Pharmacoepidemiology group in Global Patient Safety at Regeneron, where she leads the epidemiological strategy and support in the areas of Neurology/Pain and Ophthalmology. Prior to joining Regeneron, she worked in the observational research... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session

    8:00am PDT

    #407: Leveraging Statistical Approaches in Drug Safety Analysis
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-683-L04-P; CME 1.00; RN 1.00

    Safety analyses play a pivotal role in drug development, ensuring the protection of patients while advancing innovative pharmaceuticals to market. This statistical session will discuss the critical aspects of safety analysis including the shortcomings of the way we estimate safety signals today focusing on the incorporation of advanced statistical methodologies for signal detection and wider evaluation of specific events such as adverse events of special interest. Additionally, the session will delve into regulatory considerations and best practices for presenting safety analyses to regulatory agencies. Understanding the expectations and requirements of regulatory bodies is essential for successful drug development, and the session will provide valuable guidance in this regard.

    Learning Objectives

    Describe key aspects in planning safety analyses, and their pivotal role in ensuring the safety of pharmaceutical products; Discuss regulatory considerations and best practices for presenting safety analyses to regulatory agencies; Identify quantitative assessment and characterization of adverse events of special interest (AESIs) in the drug lifecycle; Discuss the shortcomings of the way we currently estimate safety outcomes and a call to action to change that.

    Chair

    George Kordzakhia, PhD

    Speaker

    Industry Update
    Melvin Slaighter Munsaka, PhD, MEd, MS

    Industry Update
    Michael A. Fries, PhD, MA

    FDA Update
    Cesar Daniel Torres, PhD, MS



    Speakers
    GK

    George Kordzakhia

    Statistical Sciences Senior Director, AstraZeneca, United States
    M.S Applied Mathematics, Purdue University, 1998 Ph.D. Statistics, University of Chicago, 2003 VIGRE Assistant Professor, UC Berkeley, 2003-2006 Mathematical Statistician, FDA, 2006-2021 Statistical Sciences Senior Director, Astra Zeneca, 20022-2024
    MF

    Michael Fries

    Head, Biostatistics, CSL Behring, United States
    Michael has been the head of biostatistics at CSL Behring since 2022. He has worked in the industry since 1999. He has also held several academic appointments, including a Visiting Assistant Professor at the School of Computer Science and DePaul University. Michael is a workstream... Read More →
    avatar for Melvin Munsaka

    Melvin Munsaka

    Senior Director, Head Safety Statistics, AbbVie, United States
    Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the... Read More →
    avatar for Cesar Torres

    Cesar Torres

    Senior Mathematical Statistician, OB, OTS, CDER, FDA, United States
    Cesar received his B.S. in Probability & Statistics at the University of California, San Diego, before completing his graduate studies at the University of Washington’s Department of Biostatistics. He now works at the FDA’s Center for Drug Evaluation and Research as a reviewer... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      01: ClinSafety-PV, Session |   11: Statistics-Data Science, Session

    8:00am PDT

    #404: Meeting in the Middle: Best Practices for Collaboration Between Medical Affairs and Clinical Development
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-680-L04-P; CME 1.00; RN 1.00

    Medical affairs and clinical development enhance the scientific credibility of the company (and its products) with established and emerging clinical investigators These collaborations may also improve study recruitment techniques.

    Learning Objectives

    Design new activities which require participation from both medical affairs and clinical development; Demonstrate how the medical affairs team can provide real-world data to help inform study designs and execution; Critique case studies of successful collaborations.

    Chair

    J. Lynn Bass, PharmD, RPh

    Speaker

    Industry Update
    J. Lynn Bass, PharmD, RPh

    Industry Update
    Rebecca A. Vermeulen, RPh

    Industry Update
    Gwendolyn Shang

    Industry Update
    Sonja Wesley Hokett, PharmD, MS, MSc



    Speakers
    avatar for J. Lynn Bass

    J. Lynn Bass

    Senior Director, Medical Science Liaisons, BridgeBio, United States
    In her 25+ years of industry experience, Lynn has served in both individual and leadership positions within Medical Affairs at both large and start-up companies. She is currently Sr. Director, Medical Science Liaisons at BridgeBio, where she is building and leading a field medical... Read More →
    avatar for Sonja Hokett

    Sonja Hokett

    Executive Director/Head of Medical Managed Care, BioXcel Therapeutics, United States
    Residing in Branson, Missouri, Sonja holds PharmD degree from the University of Louisiana Monroe, Master of Science degree in Hospital Pharmacy Administration from the University of Houston, and Executive Master's degree Health Economics, Policy & Management from the London School... Read More →
    GS

    Gwendolyn Shang

    Senior Director, Medical Affairs, Day One Pharma, United States
    avatar for Rebecca Vermeulen

    Rebecca Vermeulen

    Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States
    Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      02: ClinTrials -ClinOps, Forum |   04: MedAffairs-SciComm, Forum

    8:00am PDT

    #403: Achieving Diversity in Clinical Research Using Digital Health Technologies
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Application UAN: 0286-0000-24-679-L04-P; CME 1.00; RN 1.00

    This session will explore, from three complementary perspectives, how to improve diversity in clinical research by actively addressing accessibility, equity, and inclusion throughout the design and implementation of digital health technologies.

    Learning Objectives

    Summarize the current state and define industry goals related to diversity, equity, and inclusion (DEI) in clinical research; Outline the role of digital solutions in achieving these diversity, equity, and inclusion goals in clinical research; Apply core principles for digital design and implementation with case studies.

    Chair

    Lindsay Hughes, PhD, MS


    Speakers
    LH

    Lindsay Hughes

    Principal, Patient Experience Solutions and Patient Centered Solutions, IQVIA, United States
    Dr. Hughes is a scientist and leader with nearly 20 years of experience in behavioral and life sciences, focusing particularly on the role of access to information in human behavior and health outcomes. She is a former advisor to national governments on stigma in healthcare and clinical... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   03: Data-Tech, Forum

    8:00am PDT

    #405: The FDA's Commitment to Patient-Centric Research: Key Themes from Decentralized Trial Draft Guidance
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-681-L04-P; CME 1.00; RN 1.00

    This interactive forum will explore the key themes and industry feedback from the decentralized trials alliance members’ response to the FDA draft guidance on decentralized clinical trials.

    Learning Objectives

    Examine how the FDA draft guidance reflects a commitment to patient-centric decentralized clinical trials; Identify key themes and industry feedback provided in the alliance's response to the draft guidance; Discuss the next steps needed to enable adoption of decentralized trials under the draft framework.

    Chair

    Rasika Kalamegham, PhD

    Speaker

    Collaboration Perspective
    Jane Elizabeth Myles, MSc

    FDA Perspective
    M. Khair ElZarrad, PhD, MPH

    Industry Perspective
    Dylan Bechtle, MS



    Speakers
    DB

    Dylan Bechtle

    Associate Director, Regulatory Policy Lead- US, Johnson & Johnson Innovative Medicine, United States
    Dylan is an Associate Director in Johnson and Johnson Innovative Medicine's Global Regulatory Policy and Intelligence (GRPI) group. Dylan leads J&J’s regulatory policy efforts around clinical trial diversity. He is interested in the intersection of novel clinical methodologies (e.g... Read More →
    avatar for M. Khair ElZarrad

    M. Khair ElZarrad

    Director, Office of Medical Policy, CDER, FDA, United States
    Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
    RK

    Rasika Kalamegham

    Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
    Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →
    avatar for Jane Myles

    Jane Myles

    Program Director, Decentralized Trials and Research Alliance (DTRA), United States
    Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   09: Regulatory, Forum

    8:00am PDT

    #406: More Nuanced Clinical Outcomes from Person-Generated Health Data: The New Frontier
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-682-L04-P; CME 1.00; RN 1.00

    Person-generated data offers nuanced effectiveness measures for clinical and regulatory decision-making for new medical products, like the wearable-derived digital clinical outcome assessment for Duchenne muscular dystrophy. What's next?

    Learning Objectives

    Describe practical applications of person-generated health data, and key business and regulatory perspectives on opportunities and challenges; Explain the value of this type of information to patients, clinicians, and colleagues to help inform decision-making.

    Chair

    Nancy A Dreyer, PhD, MPH, FISPE

    Speaker

    Panelist
    Christina Mack, PhD, MPH

    Panelist
    Paul Strijbos, PhD

    Panelist
    Jeffrey Nahum Siegel, DrMed, MD

    Panelist
    Martha Azer, PharmD, RPh



    Speakers
    avatar for Nancy Dreyer

    Nancy Dreyer

    Founder, Dreyer Strategies LLC, United States
    Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing... Read More →
    avatar for Christina Mack

    Christina Mack

    Chief Scientific Officer, Real-World Solutions, IQVIA, United States
    Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
    avatar for Paul Strijbos

    Paul Strijbos

    Senior Principal Neurotech Innovation Leader, F. Hoffmann-La Roche Ltd, Switzerland
    Paul is a PhD neuroscientist with over 25 years of clinical development experience across the product lifecycle. He works as Neurotechnology Innovation Leader in the late stage Neuroscience organization of F. Hoffmann-La Roche in Basel and focusses on the development, validation and... Read More →
    avatar for Martha Azer

    Martha Azer

    Associate Director, Global Regulatory Policy & Intelligence, Johnson & Johnson, United States
    Martha Azer is an Associate Director of Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the US policy work on Digital Health and Artificial Intelligence & Machine Learning as well as Precision Medicine to help shape the regulatory policy landscape to provide... Read More →
    avatar for Jeffrey Siegel

    Jeffrey Siegel

    Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States
    Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   09: Regulatory, Forum

    8:00am PDT

    #408: Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-684-L04-P; CME 1.00; RN 1.00

    This session provides new thinking and examples of how to design and implement qualitative research around genetic testing and precision medicine for oncology patients.

    Learning Objectives

    Discuss approaches to designing, executing, and analyzing qualitative research around patient perceptions of genetic testing and precision medicine; Discuss unmet needs around patient education and the integration of genetic counselor into care team; Examine the application of a behavioral framework to understand decision to get a genetic testing for oncology patients.

    Chair

    Wesley D Peters, MS

    Speaker

    Measuring Value in Oncology: Are we Keeping Pace with Science?
    Solange Corriol-Rohou, DrMed, MD, PhD

    Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine
    Jennifer Malinowski, PhD



    Speakers
    avatar for Solange Corriol-Rohou

    Solange Corriol-Rohou

    Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
    Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines... Read More →
    avatar for Wesley Peters

    Wesley Peters

    Research Specialist II, Patient Experience, Evidera/Thermo Fisher Scientific, United States
    Wes Peters is a public health professional with over 7 years of experience in the Life Science industry. Wes received his Master of Science in Public Health (MSPH) from the Johns Hopkins Bloomberg School of Public Health with a focus in Health Education and Health Communication. Currently... Read More →
    JM

    Jennifer Malinowski

    Director, Access and Policy Research, Johnson & Johnson Innovative Medicine, United States
    Dr. Malinowski is a sought-after expert for precision medicine and genomics, bioethics, health economics and outcomes research, and is a certified clinical guideline methodologist. A proven leader, she has substantial experience building a culture of engagement and inclusion across... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   12: Value-Access, Session

    8:00am PDT

    #409: Dive into the Power of Diversity: Leveraging Transferable Skills from Regulated Industries to Regulatory Agencies in Medicines Development
    Component Type: Forum
    Level: Intermediate

    Curious about who shapes the decisions behind medicines approval and inspection? Wondering about the diversity in backgrounds and perspectives within regulatory agencies? Join us for an insightful session delving into the critical role of diversity in medicines development and regulatory decision-making. Ever pondered if your skills could transition you from being regulated to a regulator, or vice versa? Explore how transferable skills can bridge the gap between industry and regulatory roles, fostering diverse thinking essential for patient-centric outcomes. Discover career pathways in both sectors and learn how breadth of experience in seemingly unrelated roles can enrich regulatory processes, including patient advocacy. Don't miss this opportunity to uncover the less trodden path between regulators, the regulated, and patient advocacy. Join us to pave the way for a more inclusive and impactful medicines development landscape.

    Learning Objectives

    Recognize transferable skills from industry to regulatory roles, fostering diversity crucial for innovation; Assess the panelists' career trajectories transitioning between sectors, gaining strategies for professional growth; Identify the patient advocacy's role, understand how similar transferable skills are utilized to support patient-centric approaches.

    Chair

    Paula Walker, MA

    Speaker

    Panelist
    Sophie Radicke, MSc

    Panelist
    Patroula Smpokou, MD



    Speakers
    avatar for Paula Walker

    Paula Walker

    Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
    Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
    avatar for Sophie Radicke

    Sophie Radicke

    Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
    Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
    avatar for Patroula Smpokou

    Patroula Smpokou

    Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER, FDA, United States
    Patroula Smpokou, MD, is a board-certified pediatric clinical geneticist working in the Division of Rare Diseases and Medical Genetics at CDER. Her work involves the clinical review and regulation of products intended for rare genetic diseases. Prior to joining FDA, she was a practicing... Read More →


    Thursday June 20, 2024 8:00am - 9:00am PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Forum |   13: ProfDevelopment, Forum

    9:15am PDT

    #411: Generative AI-Driven Clinical Data Management: A Myth or a Reality?
    Component Type: Session
    Level: Advanced
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-686-L04-P; CME 1.00; RN 1.00

    This session will discuss use of generative AI to transform clinical data operations across the clinical trials lifecycle across use cases such as integration, summarization, translation, content generation, and knowledge extraction. The use of generative AI will be discussed for applications such as smart data review and edit checks, workflow automation, and real-time data transformation.

    Learning Objectives

    Discuss the challenges associated with existing clinical data platforms; Identify specific uses cases where such challenges exist in study startup, study conduct, and study closeouts; Describe how generative AI will transform the clinical data platform to operate seamlessly driving faster patient recruitment and efficient site selection or trial conduct.

    Chair

    Lichen Shen

    Speaker

    Creating Production Grade (Gen)AI-Powered Software for Clinical Trials
    Lichen Shen

    Industry Update
    Sharmin Nasrullah, MS



    Speakers
    SN

    Sharmin Nasrullah

    General Manager, Life Sciences, Clinical, Salesforce, United States
    avatar for Lichen Shen

    Lichen Shen

    Senior Director of Product R&D, Medidata, United States
    Lichen imagines a world without diseases and monsters. He innovates in commercial tech, national defense intelligence, and life sciences industry. One of his current roles is co-leading the (Generative) AI Platform as a Service and the next generation clinical trial data platform... Read More →


    Thursday June 20, 2024 9:15am - 10:15am PDT
    Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      03: Data-Tech, Session

    9:15am PDT

    #410: The Impact of Racial Discrimination on the Patient Clinical Trial Experience
    Component Type: Session
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-685-L04-P; CME 1.00; RN 1.00

    The session will share findings from a recent mixed-method study that examined the different types of racial microaggressions patients experience while participating in clinical trials and how these interactions affect their experience.

    Learning Objectives

    Describe findings from a recent study examining common forms of racial discrimination experienced by patients in clinical trials; Discuss the impact that these interactions can have on patient-reported outcomes, including patient trust and willingness to participate in another study at that site or location; Discuss evidence-based solutions that can reduce exclusion in clinical trials.

    Chair

    Jennifer Kim, PhD

    Speaker

    How Microaggressions Can Impact the Patient Experience in Clinical Trials
    Sharon Rivera Sanchez

    Research Perspective: The Science of Exclusion in Clinical Trials
    Ruby Madison Ford, MPH

    Amplifying the Patient Voice: Incorporating the Patient Experience
    Perla Nunes

    Industry Update
    Rodney Winley

    Industry Update
    Elizabeth Rosenkrands-Lange, MPH, MS



    Speakers
    avatar for Ruby Ford

    Ruby Ford

    Research Analyst, Tufts School of Medicine, United States
    avatar for Jennifer Kim

    Jennifer Kim

    Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
    I'm a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining how diversity, equity and inclusion dynamics impact individual, group, and organizational outcomes... Read More →
    avatar for Sharon Rivera Sanchez

    Sharon Rivera Sanchez

    Patient Advocate and Founder, Trials of Color, United States
    I am Sharon Rivera-Sanchez, founder & CEO of Trials of Color and Saving Pennies 4 A Cure, non-profits 501-C3 organizations founded in 2018, & Trials of Color in 2022. The mission is to educate, advocate, and empower cancer patients with a primary focus on Diversity in Clinical trials... Read More →
    avatar for Perla Nunes

    Perla Nunes

    Patient Advocate, Community Outreach and Clinical Research DEI Consultant, United States
    Ms. Nunes' research career began at Hoffmann-LaRoche, where she worked in drug discovery. In NC she worked in at at the Cannon Research Center of Atrium Health focusing on preclinical and clinical research areas related to oncology and immunology. She worked at Duke University's CTSI... Read More →
    ER

    Elizabeth Rosenkrands-Lange

    Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, United States
    RW

    Rodney Winley

    Senior Director, R&D Patient Partnerships, CSL Behring, United States


    Thursday June 20, 2024 9:15am - 10:15am PDT
    Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      05: Patient-Focused Drug Dev, Session |   02: ClinTrials -ClinOps, Session

    9:15am PDT

    #412: Unleashing Biopharma Potential: Maximizing Consortia Engagement with Strategic Change Management
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-687-L04-P; CME 1.00; PDU 1.00 PMI 21664WZFGG; RN 1.00

    Through strong sponsorship, stakeholder management, and communication practices, many companies have been more effective at bringing innovation and new learnings from external organizations and consortia back into their respective companies.

    Learning Objectives

    Recognize how dedicating resources can enable your organization to enhance talent and innovation, increase value, and maximize your investment in consortia participation; Discuss the application of best practices around communicating new solutions/tools and events to the right internal stakeholders to maximize uptake; Describe building a coalition of internal champions to support collaboration.

    Chair

    John Richard Dobbins, MEd

    Speaker

    Industry Update
    Sarah McKay Tremethick

    Industry Update
    Toni Spears, BSN

    Industry Update
    John Z. Sun, PhD, MBA, PMP



    Speakers
    avatar for John Dobbins

    John Dobbins

    Program Manager, Portfolio Change Management, Transcelerate Biopharma Inc., United States
    John Dobbins is an experienced change management practitioner and former educator. For the past two and half years, John has been the Program Manager of Portfolio Change Management at TransCelerate BioPharma Inc., a collaborative biopharma consortium. Within TransCelerate, he supports... Read More →
    avatar for Toni Spears

    Toni Spears

    Program Lead, Industry Collaborations, Sanofi, United States
    Toni Spears is an industry leader whose passion for clinical research was ignited while treating patients in the hospital setting. With over 21 years at Sanofi, Toni’s early experience managing global studies & leading clinical teams built the foundation for involvement in external... Read More →
    avatar for John Sun

    John Sun

    Program Lead, Global Clinical Operation, Development, Novartis Pharmaceuticals Corporation, United States
    John is a Program Lead at Novartis, and had served as Global Analytics Project Manager and Global Program Team Director in different franchises. Before Novartis, he held positions at Whitehall-Robins, Kos Pharmaceuticals, Schering-Plough, and Sanofi-Aventis. John has actively volunteered... Read More →
    avatar for Sarah Tremethick

    Sarah Tremethick

    Global Consortia Program Lead, Product Development Industry Collaborations, Roche Products Limited
    Sarah is a catalyzer for change who connects like-minded people across the biopharmaceutical community to solve common challenges. She’s a Roche leader responsible for mobilizing a diverse team of innovators from across the organization, passionate to solve problems and disrupt... Read More →


    Thursday June 20, 2024 9:15am - 10:15am PDT
    Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      07: ProjectManagement-StrategicPlanning, Session

    9:15am PDT

    #413: What is the Value of Reference Agency Assessment Reports in Enabling Reliance and What do Relying Agencies Require?
    Component Type: Session
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-688-L04-P; CME 1.00; RN 1.00

    Challenges remain in the implementation of reliance. This session will bring together stakeholders to discuss the utilisation of assessment reports, and recommend ways to ensure effective and efficient systems in the future.

    Learning Objectives

    Recognize the value of assessment reports in enabling reliance; Describe current use of public and non-public information for enabling regulatory reviews; Discuss how documentation and information sharing could improve to ensure reliance becomes successful.

    Chair

    Magda Bujar, PhD, MSc

    Speaker

    Reference Agency Viewpoint
    Emer Cooke, MBA, MSc

    Relying Agency Viewpoint
    Patricia Oliveira Pereira Tagliari, LLM, MPH

    Industry Viewpoint
    Susanne Ausborn, PhD



    Speakers
    avatar for Magda Bujar

    Magda Bujar

    Senior Manager, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
    Dr Magda Bujar is Senior Manager, Regulatory Programme and Strategic Partnerships and has over 8 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of... Read More →
    avatar for Susanne Ausborn

    Susanne Ausborn

    Global Head International Regulatory Policy, Roche, Switzerland
    Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
    avatar for Emer Cooke

    Emer Cooke

    Executive Director, Chair, ICMRA, The European Medicines Agency, Netherlands
    Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
    avatar for Patricia Oliveira Pereira Tagliari

    Patricia Oliveira Pereira Tagliari

    Associate Director, ANVISA, Brazil
    Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree... Read More →


    Thursday June 20, 2024 9:15am - 10:15am PDT
    Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Session

    9:15am PDT

    #414: Regulatory Affairs of the Future: Is Now
    Component Type: Forum
    Level: Basic
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-689-L04-P; CME 1.00; RN 1.00

    Global regulatory affairs is a critical function at the key interface between the innovation from our pipelines and patients. The world around us is changing very rapidly leading to implications and opportunities for regulatory affairs. We must evolve. But how?

    Learning Objectives

    Identify what global changes are leading to an evolved regulatory affairs organization; Discuss what skillset global regulatory affairs professionals of the future will need.

    Chair

    Lina AlJuburi, PharmD, MSc

    Speaker

    FDA Update
    M. Khair ElZarrad, PhD, MPH

    Academic Update
    Maria Florez, MA

    Industry Update
    Nicole Mahoney, PhD



    Speakers
    avatar for Lina AlJuburi

    Lina AlJuburi

    Head, Global Regulatory Science and Policy - North America, Sanofi, United States
    A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →
    avatar for M. Khair ElZarrad

    M. Khair ElZarrad

    Director, Office of Medical Policy, CDER, FDA, United States
    Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →
    avatar for Maria Florez

    Maria Florez

    Senior Consultant, Tufts Center For the Study of Drug Development, Tufts Univers, United States
    Maria Florez studies the practices, strategies, attitudes, and incentives driving innovation in the pharmaceutical R&D process, as well as the impact of digital transformation in clinical research. Maria has been a researcher, consultant, and advisor in the healthcare sector for over... Read More →
    avatar for Nicole Mahoney

    Nicole Mahoney

    Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States
    Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →


    Thursday June 20, 2024 9:15am - 10:15am PDT
    Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum

    9:15am PDT

    #415: EMA-FDA Question Time
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-690-L04-P; CME 1.00; RN 1.00

    In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

    Learning Objectives

    Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

    Chair

    Anabela Marcal, PharmD
    Katherine Tyner, PhD

    Speaker

    Panelist
    Kerry Jo Lee, MD

    Panelist
    Adam C Fisher, PhD

    Panelist
    R. Angelo De Claro, MD

    Panelist
    Evdokia Korakianiti, PhD, MSc

    Panelist
    Steffen Thirstrup, MD, PhD

    Panelist
    Francesco Pignatti, MD



    Speakers
    avatar for Anabela Marcal

    Anabela Marcal

    EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
    Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
    avatar for Katherine Tyner

    Katherine Tyner

    FDA Liaison to the EMA, Office of Global Policy and Strategy, OC, FDA, United States
    Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical... Read More →
    avatar for R. Angelo De Claro

    R. Angelo De Claro

    Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
    Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
    avatar for Kerry Jo Lee

    Kerry Jo Lee

    Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro, FDA, United States
    Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →
    AF

    Adam Fisher

    Director, Enterprise Project Staff, OQA, OPQ, CDER, FDA, United States
    Adam Fisher, PhD., is the Director of Enterprise Project Staff in the Office of Pharmaceutical Quality and lead of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative at the U.S. FDA. He has been a primary and secondary reviewer of generic drug applications... Read More →
    avatar for Francesco Pignatti

    Francesco Pignatti

    Scientific Adviser for Oncology, European Medicines Agency, Netherlands
    Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
    avatar for Steffen Thirstrup

    Steffen Thirstrup

    Chief Medical Officer, European Medicines Agency, Netherlands
    Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →
    avatar for Evdokia Korakianiti

    Evdokia Korakianiti

    Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
    Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →


    Thursday June 20, 2024 9:15am - 10:15am PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   14: DIAmond, Forum

    10:15am PDT

    Coffee Break
    Component Type: Social Event




    Thursday June 20, 2024 10:15am - 10:45am PDT
    Ballroom 6 Lobby San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

    10:45am PDT

    #416: FDA Town Hall
    Component Type: Forum
    Level: Intermediate
    CE: ACPE 1.25 Knowledge UAN: 0286-0000-24-691-L04-P; CME 1.25; RN 1.25

    The FDA Town Hall is the forum to hear from FDA leadership about Center priorities. The audience will be invited to submit questions of general interest.

    Learning Objectives

    Discuss FDA Center priorities.

    Chair

    Kim Quaintance-Lunn

    Speaker

    Panelist
    Kevin Bugin, PhD, MS, RAC

    Panelist
    Julia Tierney, JD

    Panelist
    Anindita Saha

    Panelist
    Tamy Kim, PharmD



    Speakers
    avatar for Kim Quaintance-Lunn

    Kim Quaintance-Lunn

    Vice President, Regulatory Affairs Americas, Bayer AG, United States
    Kim Quaintance-Lunn is the Vice President, Regulatory Affairs Americas and a Distinguished Science Fellow at Bayer, a Director at Large for the FDA Alumni Association, and Chair of DIA's Americas Regional Advisory Council. At Bayer, Kim serves in a leadership capacity for US Regulatory... Read More →
    avatar for Kevin Bugin

    Kevin Bugin

    Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
    Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →
    avatar for Julia Tierney

    Julia Tierney

    Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States
    JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →
    avatar for Anindita Saha

    Anindita Saha

    Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States
    Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →
    avatar for Tamy Kim

    Tamy Kim

    Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
    Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including... Read More →


    Thursday June 20, 2024 10:45am - 12:00pm PDT
    Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
      09: Regulatory, Forum |   14: DIAmond, Forum
     

    Filter sessions
    Apply filters to sessions.