DIA 2024 Global Annual Meeting: Full Schedule

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6:00am PDT

DIA Fit with F45 Bootcamp Workouts

Component Type: Social Event

Join F45 North Park & F45 Little Italy for a Team Training HIIT Class to jump start your morning! This is a complimentary fitness session to get your day started before DIA 2024 sessions! This session will be on the City Side of the Convention Center Stairs near lobbies C/D.

Chair

Session Information

Monday June 17, 2024 6:00am - 6:45am PDT
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

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7:00am PDT

#OR 1: 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

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

17: Networking Opportunities, Session

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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

17: Networking Opportunities, Social Event

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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

Marwan Fathallah

President & Chief Executive Officer, 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 →

Dean Kamen

Founder, DEKA Research & Development Corp., United States

Serial inventor and the founder of the ARMI-Advance Regeneratve Manufacturing Institute

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 →

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 →

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 →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel , 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 →

Emer Cooke

Chair, ICMRA; Executive Director, 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 →

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.

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 →

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

Featured Topics Artificial Intelligence (AI), Cell and Gene Therapy, Patient Focused, Regulator Perspectives
Feature Topics Artificial Intelligence (AI),Cell and Gene Therapy,Patient Focused,Regulator Perspectives
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10:00am PDT

#SCC: Student Case Competition

Component Type: Session

Each year, DIA hosts a Student Case Competition at our Global Annual Meeting that provides students the opportunity to respond and propose viable solutions to current challenges faced throughout the drug development lifecycle. The competition will be judged by a committee of DIA Fellows and Esteemed Volunteers, who include our most experienced and engaged members that encompass a broad range of expertise.
Student Case Competition featuring presentations from:
Northeastern University: Unveiling ProjectReLife: Revolutionizing Drug Repurposing with Artificial Intelligence (AI)

Rama Doddi, MSRA
Vandana Mandavilli, MSRA
Keerthi Pendri, MSRA
Tejendrasriajith Nalluri, MSRA

Olivia Atkins, MS
Deeksha Surisetty, MS

Ifeoma Njubigbo, PharmD
Bintou Timbiné, PharmD

Chair

Speaker

Competition Judge

Speakers

Joan Chambers

Senior Consultant, Tufts CSDD, United States

As the Chief Operating Officer for CenterWatch, Joan is responsible for the business operations, financial performance, marketing, and sales of the company along with setting strategic direction. Joan's work experience includes: CHI, Tufts CSDD at Tufts University, Thomson CenterWatch... Read More →

Sandra Kweder

Principal, Drug and Biological Products, Greenleaf Health/Elilquent, United States

Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy. As Principal, Drug and Biological Products, with Greenleaf Health, she offers broad expertise accrued through multiple senior leadership... Read More →

Sorcha McCrohan

Specialist, Scientific Programs, DIA, United States

Sorcha McCrohan is a Specialist of Scientific Programs for the Americas Region at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and... Read More →

John Roberts

President and Chief Executive Officer, Vyant Bio, Inc., United States

Jay Roberts, MBA, is President and Chief Executive Officer of Cancer Genetics, Inc., a leader in enabling precision medicine in oncology, where he previously served as Chief Operating Officer and Executive Vice President of Finance. Mr. Roberts also served as Chief Financial Officer... Read More →

Paul Smolenski

Regulatory, DEKA Research & Development Corp., United States

Monday June 17, 2024 10:00am - 10:58am PDT
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

20: Networking Opportunities, Session

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10:00am PDT

#SCC: Student Case Competition

Component Type: Session

Speakers

Olivia Atkins

MS Biotechnology Student, Georgetown University, United States

Rama Doddi

MS Regulatory Affairs Student, Northeastern University, United States

Vandana Mandavilli

MS Regulatory Affairs Student, Northeastern University, United States

Tejendra Sri Ajith Nalluri

MS Regulatory Affairs Student, Northeastern University, United States

Ifeoma Njubigbo

PharmD Student, University of Illinois Chicago, United States

Keerthi Pendri

MS Regulatory Affairs Student, Northeastern University, United States

Deeksha Surisetty

MS Biotechnology Student, Georgetown University, United States

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

17: Networking Opportunities, Session

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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

17: Networking Opportunities, Social Event

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10:00am PDT

DIA Global Annual Meeting Blood Drive

Component Type: Social Event

Make a life saving habit. Did you know 350 blood donations are needed daily? Schedule an appointment with the San Diego Blood Bank and make a difference at DIA 2024. To schedule an appointment for Monday June 17 between 10AM-4PM please sign up below

Chair

Session Information

Monday June 17, 2024 10:00am - 4:00pm PDT
Exhibit Hall B 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event | Blood Drive, Social Event

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10:15am PDT

#101 IT: Taimei Technology Innovation Theater: Transforming Data Management - The Power of AI-Driven Automation

Component Type: Session

Experience the revolution of EDC database creation through automated processes powered by artificial intelligence. This innovation streamlines data management with unparalleled accuracy, optimizing efficiency throughout the study building.

Chair

Taimei Technology, Inc.

Speaker

Speaker
Shou Yuan

Speaker
Gary Ma

Speakers

Taimei Technology, Inc.

United States

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 →

Gary Ma

President, Taimei Technology Inc., United States

Gary Ma, with over 10 years of experience in the biopharmaceutical industry, currently serves as the SVP, Chief Product Officer, and Head of the Overseas BU at Taimei Technology. Before joining Taimei, he worked at both sponsor and CRO companies, including Hengrui Pharmaceuticals... 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

19: InnovationTheaters, Session

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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, along with Brian Dolan from Fortrea, 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

Speaker
Brian Dolan

Speakers

Appian

United States

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 →

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 →

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

19: InnovationTheaters, Session

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10:15am PDT

#103 IT: Mendel AI Innovation Theater: Supercharge Your Clinical Data Workflows

Component Type: Session

Discover how Mendel has built market leading clinical AI that can reason by coupling large language models with a clinical hypergraph. Mendel's product Hypercube leverages the technology to supercharge clinical data warehouses with a 10x increase in efficiency with 90% less errors. Mendel has partnered with the largest life science companies and enabled new business models.

Chair

Mendel.ai

Speaker

Speaker
Karim Galil, MD

Speakers

Mendel.ai

United States

Karim Galil

Co-Founder & CEO, 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

19: InnovationTheaters, Session

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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, MBA, MS

Speakers

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 →

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 →

Subhan Sharief

Senior Director, ArisGlobal LLC, United States

Mr.Sharief is working as a Sr.Director ProServe US at ArisGlobal LLC., He has over 25 years of experience in Technology, Product and Consulting primarily in Pharma. Involved in early dev. of ARISg Safety DB and initial Electronic Submissions. He has progressed into Impl. Consulting... Read More →

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

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
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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

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 →

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 →

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 →

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

Format Forum
Level Intermediate
Featured Topics Risk Management
Level Intermediate
Feature Topics Risk Management
Credit Type ACPE, CME, RN
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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

Digital Twins for Clinical Trials
Andrew Stelzer

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

Speakers

Raviv Pryluk

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 →

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 →

Andrew Stelzer

Head of Business Development, Unlearn.ai, United States

Andrew is a business development expert in the biotechnology and pharmaceutical industries. Most recently, he supported NewCo formation and translational efforts at The Salk Institute for Biological Studies. Prior to Salk, Andrew developed the partnering strategy for InSphero, a Swiss... 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

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulatory Reliance
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulatory Reliance
Credit Type ACPE, CME, RN
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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

Delivering a Data-Driven ICH M11 Clinical Protocol Template
Ron Fitzmartin, PhD, MBA

Cloud-Driven Transformation: Enabling the Ambition of a Global Pharmaceutical Quality Knowledge Management Capability
Hilmar Hamann, PhD

Speakers

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 →

Ron Fitzmartin

Senior 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 →

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 →

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

Format Forum
Level Intermediate
Featured Topics Digital Technology, Regulatory Collaboration
Level Intermediate
Feature Topics Digital Technology,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

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 →

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

Format Session
Level Intermediate
Featured Topics Ethics, Rare Disease, Special Populations
Level Intermediate
Feature Topics Ethics,Rare Disease,Special Populations
Credit Type ACPE, CME, RN
Tags 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

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 →

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research in FDA. Dr. Ayalew oversees the review of integrity of efficacy and safety data submitted to the FDA and the... Read More →

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 →

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation and policy development in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting... 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

Format Session
Level Intermediate
Featured Topics ICH, Regulator Perspectives
Level Intermediate
Feature Topics ICH,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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 two NDRP workstreams: Advisory Committees and Investigational New Drugs

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

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 →

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She is the program manager for the CDER Center for Clinical Trial Innovation and also co-leads the New Drugs Regulatory... Read More →

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 →

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.

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

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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) will present and discuss the latest information on regulation, regulatory science, and drug review and approval. Speakers will also discuss recent development in clinical research in China. 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; Describe the recent update on the progress in drug review, approval and clinical research in China; Identify challenges in drug development and regulation in China.

Chair

Ling Su, PhD

Speaker

Opening Remarks and Introductions
Lili Cao, MS

Initiatives to Bring More New Drugs to Patients, and Faster
Zhimin Yang, MD

Recent Developments in Regulatory Science and Regulation
Jiangyong Yu

Advancing Clinical Research in China: A Clinical Oncologist’s Perspective
Shun Lu

Speakers

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 →

Lili Cao

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

Lili Cao is the Deputy Director-General, China Center for Food & Drug Int’l Exchange (CCFDIE), National Medical Products Administration (NMPA). She received her bachelor degree at Nankai University, and master degree at London School of Economics and Political Science, majoring... Read More →

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 →

Zhimin Yang

Deputy Director, Center for Drug Evaluation, National Medical Products Administration (NMPA), China

Dr. Yang is theDeputy Director-General ,Center for Drug Evaluation of the National Medical Products Administration. Graduated from Peking University Medical Center, majoring in clinical medicine. She used to be a known pediatrician working at Peking University People's Hospital. In... Read More →

Jiangyong Yu

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

Dr. Yu Jiangyong, Doctor of Science, Chief Pharmacist. Currently, he is the consultant and director of division of TCMs and Ethno-Medicines, Department of Drug Registration (Department of TCMs and Ethno-Medicines Regulation) of China's NMPA.

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

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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, RPh

Industry Update
Susanne Ausborn, PhD

Speakers

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 →

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 →

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 →

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 →

Agustin Brito Del Pino

Regional Regulatory Hub Team Lead, Pfizer Inc, Uruguay

Pharmaceutical Chemist based in Montevideo, Uruguay. +10 years of experience on the pharmaceutical industry, part of LatAm Regulatory Affairs in Pfizer since year 2014. Part of the Regional Regulatory Hub for the LatAm Region for the last 8 years. Provided strategic regulatory support... Read More →

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

Level Intermediate
Featured Topics Regulatory Reliance
Level Intermediate
Feature Topics Regulatory Reliance
Credit Type ACPE, CME, RN
Tags 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

Muhammad Ali Hameed

Chief Operating Officer, Population Health Research Institute, Canada

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 →

J. Kyle Wathen

Vice President, Scientific Strategy and Product Innovation, Cytel Inc., United States

J. Kyle Wathen is currently Vice President, Scientific Strategy and Innovation at Cytel. He has previous experience at Gilead Science, Janssen R&D, and M.D. Anderson Cancer Center and has developed a diverse background including industry, academia, statistical innovation, and 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

Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags 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

Virginia Acha

AVP, Global Regulatory Policy, Merck Sharpe & Dohme LLC , 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 →

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 →

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 →

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

Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags 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

The Big Picture: Inclusive Workplaces Benefit Patients
Xoli Belgrave, MSc

Case Study: Recruiting and Hiring, Preparing a Workforce, Evolving a Workforce and its Company
Carlos Orantes, MBA

Case Study: Creating a Culture of Belonging Inside Out
Karen J Wood

Speakers

Xoli Belgrave

Senior Director, Patient Inclusion, Parexel , United States

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 →

Carlos Orantes

Chief Executive Officer, Alcanza Clinical Research, United States

Ruth Gómez Vargas

Senior Medical Writer, MSD, Colombia

Ruth Gómez, M.Sc., is a Regulatory Medical Writer at MSD, 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 MSD, a whole world of diversity exists... Read More →

Karen Wood

Senior Manager Patient Advocacy, Medidata , United States

Karen joined the Patient Insights Team at Medidata, where she champions for patients' rights and well-being. Karen brings a true passion for patients to her role not only because of her professional experience, but from her personal experience as well. It was these experiences that... 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

Level Basic
Featured Topics Diversity Equity and Inclusion (DEI)
Level Basic
Feature Topics Diversity Equity and Inclusion (DEI)
Tags 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

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 →

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 →

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 →

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

Format Forum
Level Intermediate
Featured Topics Artificial Intelligence (AI), Ethics
Level Intermediate
Feature Topics Artificial Intelligence (AI),Ethics
Credit Type ACPE, CME, RN
Tags 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

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 →

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, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... 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

15: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

Level Intermediate
Level Intermediate
Tags Workshop

12:00pm PDT

Luncheon Service

Component Type: Social Event

Station 1: California Turkey Sandwich
Roasted Turkey, Spinach, Sliced Tomatoes, Jack Cheese & Artichoke Aioli on a Squaw Bun

Station 2: Sriracha Chicken Sandwich
Chili Marinated Chicken Breast, Sriracha Infused Slaw & Pepper Jack Cheese on a Pretzel Bun

Station 3: Superfood Salad
Power Greens, Pepitas, Dried Cranberries, Quinoa & Edamame with Balsamic Vinaigrette Vegan & Gluten Free

Chair

Session Information

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

17: Networking Opportunities, Social Event

Tags Social Event

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
Frank Barendregt

Speakers

Frank Barendregt

Technology Sales Director, RWS, Belgium

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

19: InnovationTheaters, Session

Tags Session

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

Datacubed Health

United States

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

19: InnovationTheaters, Session

Tags Session

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

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 →

Castor

Netherlands

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

19: InnovationTheaters, Session

Tags Session

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

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

16: Community Rounds, Session | 02: ClinTrials -ClinOps, Session

Tags Session

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

Salman Alharthi

Head of Formulary Management, Security Forces Hospital, Saudi Arabia

Ashwin Anand

Engagement Manager, Forian, United States

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 →

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 →

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 →

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 →

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 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →

Joan Cheung

Senior Consultant, NNIT, Inc

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 →

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 →

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 →

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 →

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 →

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 →

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.

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 →

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 →

Tapash Ghosh

TL, FDA, United States

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 →

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 →

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 →

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 →

Zarnab Jillani

Medication Error Pharmacovigilance and Risk Management Fellow, FDA, United States

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 →

Yueh-Wen Lan

Senior Project Manager, Center for Drug Evaluation, 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 →

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 →

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.

Jessica Miller

1st-Year Fellow, Global Regulatory Affairs CMC, GlaxoSmithKline, United States

Namosha Mohite

Assistant Director, US Regulatory Affairs Liaison, Bayer, United States

Namosha Mohite, PharmD, is a Assistant Director, US Regulatory Affairs Liaison 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 →

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 →

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 →

Ashley Ogawa-Wong

Associate Director, Regulatory Liaison, 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 →

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 →

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 →

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 →

Jacqueline Vanderpuye-Orgle

Vice President, Parexel, United States

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 →

Stuart Walker

Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom

Professor Stuart Walker, BSC, PhD (London), MFPM, FRSC, FiBiol, FRCPath, is an independent Consultant in Pharmaceutical Medicine and Founder of both the Centre for Medicines Research (CMR) International and the Centre for Innovation in Regulatory Science (CIRS). UK

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 →

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 →

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

18: Posters, Session

Tags Session

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

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 →

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

15: Content Hubs, Workshop | 03: Data-Tech, Workshop

Level Intermediate
Level Intermediate
Tags Workshop

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

IQVIA

United States

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 →

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

19: InnovationTheaters, Session

Tags Session

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

PPD, part of Thermo Fisher Scientific

United States

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 →

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 →

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 →

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

19: InnovationTheaters, Session

Tags Session

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

Speaker
Kirsten Swingle

Speakers

Box, Inc.

United States

Manu Vohra

Managing Director, 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 →

Kirsten Swingle

Manager, Regulatory Submission Project Management, Regeneron, United States

Kirsten Swingle is a Manager at Regeneron Pharmaceuticals, where she leads the Clinical Trial Applications Submission Management Team, a part of the Regulatory Submission Project Management Department. Over the past 5 years, she has been instrumental in transforming the company's... 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

19: InnovationTheaters, Session

Tags Session

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

Valerie Huh

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

Valerie Huh brings over 20 years of expertise in the pharmaceutical, healthcare, and education sectors. She holds a Pharm.D and an MBA, and she is passionate about leveraging advanced technology and new ways of working to improve operational efficiency. In her current role, she is... Read More →

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

04: MedAffairs-SciComm, Workshop | 15: Content Hubs, Workshop

Level Basic
Level Basic
Tags Workshop

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
Camille Chicklis

Speakers

Camille Chicklis

AI Strategy & Delivery Lead, Deloitte, United States

Camille Chicklis is an Artificial Intelligence Leader in Deloitte's Life Sciences & Health Care practice. She spearheads AI strategy and has extensive experience in productionizing AI solutions, connecting business and technical objectives to help organizations realize the true value... Read More →

Deloitte

United States

Mukesh Singhal

Partner, 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

19: InnovationTheaters, Session

Tags Session

1:35pm PDT

#128 IT: Evernorth Health Services Innovation Theater: Analyzing Online Survey Responsiveness by Demographics and SDOH Metrics

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

Speaker
Nicole Keidel

Speakers

Evernorth

United States

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 →

Nicole Keidel

Clinical Trials Senior Advisor, Evernorth Health Services, United States

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

19: InnovationTheaters, Session

Tags Session

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

Ryan Brown

Regional Vice President, 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 →

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

19: InnovationTheaters, Session

Tags Session

1:45pm PDT

Annual Meeting of Members

Component Type: Social Evt / Reception

Monday June 17, 2024 1:45pm - 2:15pm PDT
TBD San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Evt / Reception

Tags Social Evt / Reception

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

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 →

Ryan Brown

Regional Vice President, Trial Landscape, H1, United States

Monica Eason

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

Monica is a Clinical Operations Portfolio Leader (COPL) and Diversity and Inclusion Leader at Genentech, bringing over 30 years of experience in the pharmaceutical industry with Roche and Genentech. She is dedicated to building and coaching diverse teams that transform clinical trial... Read More →

Steve Satek

Executive Vice President, Flourish Research, United States

Steve Satek has more than 35 years of experience in the clinical research industry. He began his career as a bench researcher at the Northwestern University Robert H. Lurie Cancer Center. Since that time, he has held senior leadership positions at the Chicago Center for Clinical Research... Read More →

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

Format Session
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI)
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags 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

Support of Digital Protocol Initiatives
Chris Decker, MS

The Value of Data: A Regulatory Perspective
Ana Zanoletty Perez

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

Speakers

Ron Fitzmartin

Senior Advisor, Office of Regulatory Operations, CBER, FDA, United States

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 →

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 →

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

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

Format Session
Level Intermediate
Featured Topics ICH, Regulator Perspectives
Level Intermediate
Feature Topics ICH,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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 Pediatric Extrapolation
Lynne Yao, MD

Industry Update
Forrest Williamson, PhD, MS

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

Speakers

Robert Nelson

Executive Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States

Robert “Skip” Nelson, MD, MDiv, PhD. is currently Executive 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... Read More →

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 →

Forrest Williamson

Director of Pediatrics, Statistical Innovation Center, Eli Lilly and Company, United States

Forrest Williamson is a Director of Pediatrics within the Global Statistical Sciences organization at Eli Lilly and Company, serves as Adjunct Assistant Clinical Professor of Medicine at the Indiana University School of Medicine, and has Professional Statistician accreditation from... Read More →

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

Format Session
Level Intermediate
Featured Topics Special Populations
Level Intermediate
Feature Topics Special Populations
Credit Type ACPE, CME, RN
Tags 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 life science industry constantly faces the business challenge of delivering safe and effective medicines to patients faster while reducing costs. Accelerated delivery of clinical documents has led to an increased workload for medical writers, which is only exacerbated by the competitive recruitment of talent and the expectation of “perfect” document delivery. These drivers and advancements in automation and AI are transforming medical writing. In addition to articulating their value proposition, writers and their managers will have to adapt to this technical transformation and level-up their skills. This panel will focus on providing both strategic and tactical considerations for medical writing teams. We will highlight the importance of communicating our role as content strategists, 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

Barbenheimer: Medical Writing Can Evolve and Still Be Great in the Face of Technology
Robin Whitsell

SOS! Tech Tools in Medical Writing Communicating your value in the AI age
Kayla Williams

Taking the Robot out of the Medical Writer: A Change Management Approach
Joanne Hilton, PhD, MBA

Speakers

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 →

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 →

Kayla Williams

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

This year, Kayla Williams celebrates 25 years in clinical and regulatory medical writing. She is interested in all aspects of the field, from trial design to registration and beyond, and believes medical writers and simple, intuitive writing processes are key to maximizing the joy... Read More →

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

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Digital Technology
Level Intermediate
Feature Topics Artificial Intelligence (AI),Digital Technology
Credit Type ACPE, CME, RN
Tags 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

Patient Researcher Perspective
Bellinda King-Kallimanis, PhD, MSc

Speakers

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 →

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 →

Bellinda King-Kallimanis

Senior Director of Patient-Focused Research, Lungevity Foundation, United States

Bellinda is Senior Director of Patient-Focused Research at LUNGevity Foundation. In her work at LUNGevity she aims to ensure that patient and caregiver voices are incorporated in decision-making across a wide variety of stakeholders and has built a Citizen Scientist program to aid... Read More →

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, Part of Merck Kgaa, Darmstadt, Germany, United States

Elizabeth Rosenkrands Lange is an experienced regulatory policy leader located in Washington DC. She is an Epidemiologist with a MPH. She has 18+ years of experience working in drug development, regulatory policy and patient advocacy. She began her career at the Danish Medicine Agency... Read More →

Pujita Vaidya

North America Lead, Regulatory Science and Policy, Sanofi, 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

Format Forum
Level Intermediate
Featured Topics Patient Focused
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags 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

Speaker
Linda B Sullivan, MBA

FDA Update
Elena Boley, MD, MBA, FACP

Industry Update
Michael Torok, PhD

Speakers

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 →

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 →

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 →

Linda Sullivan

Senior Fellow, Tufts Center For the Study of Drug Development, United States

Ms Sullivan is a Senior Fellow at the Tufts Center for the Study of Drug Development. She 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 founded... Read More →

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 →

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

Format Session
Level Advanced
Featured Topics ICH, Risk Management
Level Advanced
Feature Topics ICH,Risk Management
Credit Type ACPE, CME, RN
Tags 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

Jayne Ware

Senior Director, Global Regulatory Policy, Merck Sharp & Dohme LLC, United States

Jayne is Senior Director for regulatory policy and has been at Merck for over 12 years. She is a senior regulatory policy analyst, responsible for leading surveillance and advocacy on a variety of regulatory policy issues, including artificial intelligence, digital health technologies... Read More →

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, Office of Medic, FDA, United States

Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →

Rose Purcell

Director, Global Regulatory Policy and Innovation, Takeda, United States

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

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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

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 →

Yuki Ando

Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yuki Ando is a Principal 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... Read More →

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 →

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

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Regulator Perspectives,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags 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

Project Management Considerations for Project Optimus
Nancy Linda Styple

Speakers

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 →

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 →

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

Format Session
Level Intermediate
Featured Topics Risk Management
Level Intermediate
Feature Topics Risk Management
Credit Type ACPE, CME, PMI, RN
Tags 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

The LDT Rule and its Impact to CDx
Cortez McBerry, PhD

Top Line Trends in Diagnostics Policy in 2024
Laura DiAngelo, MPH

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

Speakers

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 →

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.

Megan Doyle

Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly & Company, 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 →

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

Format Session
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags 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

This session will focus on the global regulatory frameworks for enabling innovation in manufacturing and quality. Innovation includes the development and manufacture of new types of products, new manufacturing platforms, innovative technologies such as model-based controls, and new analytical technologies. The discussion comes at a critical time as the implementation of new digital tools and manufacturing technologies are key to the evolution of manufacturing. These technologies can be integral to ensuring quality and supporting a robust supply of medicines. The session will also reflect on how Regulators in EU and US are seeking to support the transformation of medicines’ manufacturing and how regional initiatives link to global platforms like ICH, PICs and ICMRA collaborative initiatives under the PQKMS umbrella.

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

Manufacturing Closer to the Patient
Roberto Conocchia, MSc

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

FDA Perspective on Enabling Innovation in 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

Panelist
Benjamin Stevens, PhD, MPH

Speakers

Roberto Conocchia

GMP technical Lead, European Medicine Agency (EMA), Netherlands

Roberto Conocchia is a GMP Technical Lead at the European Medicine Agency (EMA) since March 2018. He obtained a Master degree in Bio-Chemistry from the University of Rome (La Sapienza) and a Post-graduate master’s degree in Natural substances and bio-organic Chemistry. Roberto worked... Read More →

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 →

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States

Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →

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 →

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

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

2:15pm PDT

#142: Causal Inference Methodology in Drug Development

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-542-L04-P; CME 1.00; RN 1.00

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, PhD

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

Speakers

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 →

Shia Kent

Epidemiologist, Pharmacovigilance Epi and Causal Inference Team, Amgen, United States

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

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

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 →

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 →

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

Format Forum
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

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 →

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 →

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

Format Forum
Level Basic
Featured Topics Student Programming
Level Basic
Feature Topics Student Programming
Tags 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

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 →

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 →

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

Format Session
Level Intermediate
Featured Topics Regulator Perspectives, Digital Technology
Level Intermediate
Feature Topics Regulator Perspectives,Digital Technology
Credit Type ACPE, CME, RN
Tags 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

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 →

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States

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 →

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 →

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 →

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

Format Session
Level Intermediate
Featured Topics ICH
Level Intermediate
Feature Topics ICH
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

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 →

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 →

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States

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

Format Forum
Level Intermediate
Featured Topics ICH, Digital Technology
Level Intermediate
Feature Topics ICH,Digital Technology
Credit Type ACPE, CME, RN
Tags 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

Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Clarence L Young, MD

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

Speakers

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 →

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 →

Clarence Young

Senior Vice-President, Clinical, US Regulatory Sciences, Propharma, United States

Clarence Young, MD, is an experienced drug developer with more than 30 years' experience in both Big Pharma (GlaxoSmithkline, Novartis) and emerging pharmaceutical companies (Protez Pharmaceuticals, Iroko Pharmaceuticals, Velicept Therapeutics) where he has led Phase 1-3 clinical... 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

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

3:30pm PDT

#149: Effective Patient / Industry Collaboration: Valuing Patient Lived Experience To Inform Trial Design

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-548-L04-P; CME 1.00; RN 1.00

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

Panelist
Mario Estevez

Panelist
Andrew Schorr

Speakers

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel , United States

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 →

Mario Estevez

Organizer, Patient Caregiver and Racial Equity Institute, United States

Mario Estevez works for The Racial Equity Institute (REI), which seeks to provide a race analysis to systems and institutions. He is currently collaborating on a project with the Chan Zuckerberg Initiative, providing rare disease organizations with REI’s analysis through a two-day... Read More →

Andrew Schorr

Founder, Web-Savvy Health Consultants, LLC, Patient Advocate, United States

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

Format Forum
Level Intermediate
Featured Topics Patient Focused
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags 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

Speaker
Erin Greene, JD

Speakers

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 →

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.

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 →

Christine Mayer-Nicolai

Vice President, Regulatory and Scientific Policy, Merck Healthcare 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 →

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

Format Forum
Level Intermediate
Level Intermediate
Credit Type ACPE, CME, RN
Tags Forum

3:30pm PDT

#157: Be Creative and Innovative: Top 5 Secrets from Decision Science for You and Your Team

Component Type: Session
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

Speaker

Creativity and Innovation within Clinical Drug Development
Candice Junge, PhD

Speakers

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 →

Candice Junge

Executive Director, Neurology Program and Clinical Lead, Ionis Pharmaceuticals, Inc., United States

Candice Junge has over 20 years experience in drug development including preclinical research, clinical development and commercial readiness. She is currently an Executive Director, Neurology Program and Clinical Lead at Ionis Pharmaceuticals and is responsible for end-to-end drug... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjectManagement-StrategicPlanning, Session | 13: ProfDevelopment, Session

Format Workshop
Level Intermediate
Featured Topics Student Programming
Level Intermediate
Feature Topics Student Programming
Tags Session

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

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom

Jennifer Evans

Compliance and Enforcement 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 compliance... Read More →

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 →

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

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

Aditi Khurana

Director, Project Management, Summit Therapeutics, Inc., United States

Aditi is an experienced Program & Alliance executive in the Pharma industry specializing in the oncology and neuroscience therapeutic areas. She started her career as an ASCP & state licensed Clinical Cytogenetics & Molecular Biology scientist, and later transitioned into leadership... 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

Format Session
Level Advanced
Featured Topics Artificial Intelligence (AI)
Level Advanced
Feature Topics Artificial Intelligence (AI)
Credit Type ACPE, CME, RN
Tags 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

Industry Update
Kathleen Winson, MPH, MS

Speakers

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 →

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 →

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 →

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 →

Kathleen Winson

Executive Group Director, Product Development Regulatory, Genentech, A Member of the Roche Group, United States

Kathleen Winson is an Executive Group Director in Regulatory at Genentech/Roche. In her role, she oversees regulatory strategy for Oncology Lung and pan-tumor development. With over 25 years of experience in clinical research and drug development, Kathleen has garnered extensive expertise... Read More →

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

Format Session
Level Intermediate
Featured Topics Patient Focused, Patient Focused
Level Intermediate
Feature Topics Patient Focused,Patient Focused
Credit Type ACPE, CME, RN
Tags 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

Speakers

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 →

Sophie Sommerer

Director General, 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

Format Session
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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

Dylan Bechtle

Associate Director, Regulatory Policy Lead- US, Johnson & Johnson, 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 →

Andrea Doyle

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

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 →

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States

Tamy Kim is the Director for Regulatory Affairs and Policy at FDA's Oncology Center for Excellence and the Associate Director for Regulatory Affairs in the Office of Oncologic Diseases (OOD). Dr. Kim is responsible for developing policies and procedures affecting the review of products... Read More →

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

Format Forum
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI), Regulator Perspectives
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI),Regulator Perspectives
Credit Type ACPE, CME, RN
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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

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 →

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 →

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 →

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

Format Session
Level Intermediate
Featured Topics Digital Technology
Level Intermediate
Feature Topics Digital Technology
Credit Type ACPE, CME, RN
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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 compassionate 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

Elevate Leadership: Harnessing the Five Superpowers
Sushma D.A. Hallock, MBA

Speakers

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 →

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

Format Session
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI), Student Programming
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI),Student Programming
Credit Type ACPE, CME, PMI, RN
Tags Session

4:30pm PDT

Opening Reception

Component Type: Social Event

We look forward to welcoming you to this remarkable event and celebrating the opening of our Exhibit Hall with you. Thank you for your support and enthusiasm. See you at the reception!

Monday June 17, 2024 4:30pm - 6:30pm PDT
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

4:45pm PDT

#158 IT: InSilicoTrials Technologies Innovation Theater: Are Human Patients Needed for Clinical Trials, Tomorrow?

Component Type: Session

Chart your new horizons by pioneering on the edge of Gen AI-powered In Silico Data Modeling. Proven case studies will be shared in a panel session from regulatory, sponsor and CRO perspectives. Learn how InSilicoTrials has enhanced drug dosing, trial performance, and patient safety across targeted populations. Discover significant reductions in time and costs—achieving up to a 90% efficiency in specific R&D activities—while upholding the highest standards of patient safety.

Don't miss the chance to receive an autographed complimentary copy of the publication "Toward Good Simulation Practice," co-authored by our CEO, Luca Emili, with the contribution of 13+ FDA leaders. This book is a cornerstone in promoting reliable and efficient In Silico Trials solutions, reflecting a major stride in medical research and development.

Chair

InSilicoTrials

Speaker

Moderator
MaryAnne Rizk, PhD

Panelist
Jonathan Solomon Helfgott, MS

Panelist
Luca Emili

Panelist
Adam Kaplin

Speakers

Luca Emili

CEO, InSilicoTrials, United States

Luca Emili is founder & CEO of InSilicoTrials, a platform for modeling and simulation in healthcare & life sciences. He was the CEO of Emaze, a cybersecurity firm specializing in automated security analysis. He holds advisory roles, including at EMA's Cloud Security Consultative Group... Read More →

Jonathan Helfgott

Senior Lecturer, Faculty, & Program Coordinator,, Johns Hopkins University, United States

Jonathan Helfgott is an FDA regulatory, clinical, and market access expert, specializing in medical products’ commercialization. He has overseen global clinical research & regulatory activities such as product development, approvals, clinical trial design & communications with health... Read More →

InSilicoTrials

Italy

Adam Kaplin

Chief Scientific and Clinical Innovation Officer, Miralogx, United States

Dr. Adam Kaplin completed his undergrad at Yale and his MD/PhD at Johns Hopkins. He trained with two Nobel Laureates and in Solomon Snyder's lab. Dr. Kaplin was Chief Psychiatric Consultant to the Johns Hopkins Multiple Sclerosis and Transverse Myelitis Centers, researching the immune... Read More →

MaryAnne Rizk

Chief Executive Officer, Rizk Management Advisors, United States

Dr. MaryAnne Rizk builds large-scale partner ecosystems at the intersection of science & technology. A PharmaVoice™ 100 Award Recipient, she champions change and collaboration, accelerating scientific breakthroughs from pipeline to patient. With 25 years in digital transformations... Read More →

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

19: InnovationTheaters, Session

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4:45pm PDT

#159 IT: Infosys Innovation Theater: Gen AI Led Innovations for Clinical and Regulatory Landscape

Component Type: Session

How Infosys partnered with clients to drive productivity, improved outcomes, phenomenal breakthroughs for protocol design, patient recruitment/management, trial operations, document generation, and submission.

Chair

Infosys Technologies Ltd.

Speaker

Speaker
Subhro Mallik

Speaker
Henry Hofmann

Speaker
Naeiry Vartevan

Speaker
Sunil Agarwal, MS

Speaker
Anne Bichteler

Speakers

Sunil Agarwal

Associate Partner – Life Sciences NAM Lead Infosys Consulting, Infosys, United States

Strategic data science leader enhancing pharmaceutical business outcomes through advanced analytics and management. Expert in global team leadership and transformative program development.

Anne Bichteler

Senior Principal, Infosys, Germany

Henry Hofmann

Senior Vice President R&D, BASE Life Sciences, Switzerland

Infosys Technologies Ltd.

United States

Subhro Mallik

EVP - Global Head of Life Sciences, Infosys, United States

Subhro Mallik is EVP and Head of the Life Sciences business unit at Infosys. He leads a team of client partners and sales executives to grow Infosys business in existing and new clients. He brings rich experience of growing new businesses, building teams, and ensuring profitable growth... Read More →

Naeiry Vartevan

VP, US R&D, BASE Life Sciences, United States

With over 17 years of experience, she is a highly energetic, entrepreneurial and enthusiastic business development professional. She has helped small companies/ startups in the healthcare/life sciences space grow over the last decade.

Monday June 17, 2024 4:45pm - 5:15pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

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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

Speaker
Christopher Bouton, PhD

Speakers

Christopher Bouton

Senior Vice President, Head of AI, Certara, United States

Christopher Bouton is Senior Vice President and Head of AI at Certara. Prior to Certara, Bouton was the Founder & CEO of Vyasa Analytics (acquired by Certara in 2022), an AI analytics company. Bouton previously founded Entagen, which was acquired by Thomson Reuters. Before those... Read More →

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

19: InnovationTheaters, Session

Tags Session