DIA 2024 Global Annual Meeting: Full Schedule

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6:00am PDT

F45 Workouts

Component Type: Social Event

F45 Training Noth Park offers functional group fitness classes, reimagined. We are more then just a gym. We are total wellness solution for every body.

Monday, June 17 | 6:00 to 6:45am
Wednesday, June 19 | 6:00 to 6:45am

Wednesday June 19, 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

Tags Social Event

7:00am PDT

Coffee and Light Refreshments

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

Wednesday June 19, 2024 7:00am - 8:00am PDT
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

8:00am PDT

#301: Risk Minimization in the EU: New Guidance, New Collaborations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-622-L04-P; CME 1.00; RN 1.00

Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.

Learning Objectives

Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.

Chair

Priya Bahri, PhD, RPh

Speaker

Industry Update
Meredith Smith, PhD, MPA, FISPE

Patient Update
Regina Mariam Kamoga, MPA

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 →

Regina Mariam Kamoga

Executive Director, Community Health And Information Network ( CHAIN), Uganda

She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States

Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

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

8:00am PDT

#303: How Common Data Models Can Address the Challenges in the Use of Clinical Trial and Real-World Data for Evidence Generation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-624-L04-P; CME 1.00; RN 1.00

This panel will discuss different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability.

Learning Objectives

Recognize the different types of data models that exist and their strengths and weaknesses in relation to real-world data (RWD) and interoperability; Discuss the appropriate data models for primary and secondary data and how clinical data managers can potentially help RWD and trial data to meet the evidentiary requirements for regulatory decision-making.

Chair

Jesper Kjær, MS

Speaker

Panelist
Davera Gabriel, RN

Panelist
Jonathan Stuart Chainey

Panelist
Stacy Tegan

Speakers

Jonathan Chainey

Executive Director, Global Head, Data Standards and Governance, Data Sciences, Roche, United States

Jonathan Chainey is an Executive Director and Global Head, Data Standards and Governance within Data Sciences, Product Development at Roche. He leads a global team accountable for the cross-functional governance and adoption of Roche’s CDISC-aligned global data standards across... Read More →

Davera Gabriel

Director of Client Success, Evidentli USA LLC, United States

Davera Gabriel, RN FHL7 FAMIA is the Director of Client Success at Evidentli USA. Widely recognized as one of the world's leaders in accelerating the evolution of healthcare data standards in translational research. She has lead data alignment efforts in groundbreaking, multi-site... Read More →

Jesper Kjaer

Global Director for Public, Private Partnerships, Strat Ops, Global Med Affairs, Novo Nordisk, Denmark

Global Director for Public, Private Partnerships at Novo Nordisk, Global Medical Affaris. Former Director of Data Analytics Centre at the Danish Medicines Agency and co-chair of HMA / EMA Big Data Steering Group. 20 years for life science experience in academia and industry. Been... Read More →

Stacy Tegan

Program Director, Transcelerate Biopharma, Inc., United States

Stacy Tegan is a Program Director at TransCelerate Biopharma, Inc., a non-profit organization with a mission to collaborate across the biopharmaceutical R&D community. In her current role she oversees projects to enable information sharing and harmonization across the clinical development... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

Format Forum
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 Forum

8:00am PDT

#304: Synergizing Large Language Models and Digital Health Technology for Healthcare Transformation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-625-L04-P; CME 1.00; RN 1.00

This discussion will dive into large language models (LLMs) impact on healthcare, their integration with digital health technology, and ethical/regulatory implications.

Learning Objectives

Describe how digital health technologies (DHTs) and generative artificial intelliegence (AI), including large language models (LLMs) are applied to healthcare context; Examine the various integration points between LLMs and DHT and discover how these technologies can work synergistically to revolutionize patient care, telemedicine, remote, and disease progression.

Chair

Jagdeep Podichetty, PhD, MS

Speaker

Panelist
Qi Liu, PhD

Panelist
Jie Shen, PhD, MBA

Panelist
Sakshi Sardar, PhD

Panelist
Emily Lewis, MS

Speakers

Jagdeep Podichetty

Senior Director of Predictive Analytics, Critical Path Institute, United States

Dr. Jagdeep Podichetty is the Senior Director of Predictive Analytics in the Quantitative Medicine Program at the Critical Path Institute, where he is developing quantitative solutions such as disease progression models, survival models, clinical trial simulation, and artificial intelligence... Read More →

Emily Lewis

Artificial Intelligence and Innovation Lead, Neurology, UCB, United States

Emily Lewis is a trailblazing innovator and leader in the realm of digital health and AI. With nearly two decades of experience, she has made significant contributions to the development and adoption of cutting-edge digital health solutions. Her passion for using technology to improve... Read More →

Qi Liu

Assoc Director for Innovation and Partnerships, OCP, OTS, CDER, FDA, United States

Dr. Qi Liu is the Associate Director for Innovation & Partnership in the Office of Clinical Pharmacology (OCP)/ Office of Translational Sciences, CDER, FDA. She has helped developing OCP’s portfolio on AI, real world evidence and digital health technologies. Qi leads OCP Innovative... Read More →

Sakshi Sardar

Senior Director, Digital and Precision Medicine, Critical Path Institute, United States

Sakshi Sardar is a Senior Director for Digital and Precision Medicine within Quantitative Medicine at the Critical Path Institute. Her focus is on driving the development of essential components for utilizing digital health technologies (DHTs) to meet evidentiary requirements for... Read More →

Jie Shen

Director, Digital Science, AbbVie, United States

Jie Shen is a data science leader with a track record of building innovative solutions for drug discovery and development. Currently he is a Director of Digital Science at AbbVie, leading the digital health technology development, validation, and data analytics. Prior to his current... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

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

8:00am PDT

#305: All the Ways Medical Affairs Supports Product Development: From Clinical Trials to Product Launch

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-626-L04-P; CME 1.00; RN 1.00

Wondering what a medical affairs team does? This session will dive into some of the different roles within medical affairs, their responsibilities, and how these roles support a product over the course of its development.

Learning Objectives

Recognize how the medical affairs function can support a product across all stages of development; Describe different roles within medical affairs and how they connect to each other and to the broader organization.

Chair

Sejal Vora, PharmD

Speaker

All the Ways Medical Affairs Supports Product Development: Field Perspective
Nital Patel, PharmD, MBA

All the Ways Medical Affairs Supports Product Development: Publication Planning
Wendy Tin, PharmD, RPh

Speakers

Sejal Vora

Director, Medical Information, BeiGene, United States

Sejal Vora has over 20 years of industry experience within Medical Affairs, including Medical Information, Publication Planning, Investigator Initiated Research, and serving as a medical reviewer for promotional and medical review committees. She earned her PharmD at the University... Read More →

Nital Patel

Consultant, United States

Nital Patel has over 12 years of experience within Medical Affairs, including Medical Training and Operations, Field Medical, and as Executive Medical Director. She earned both her PharmD and MBA at Drake University in Des Moines, Iowa. Nital completed a 2-year Regulatory Fellowship... Read More →

Wendy Tin

Associate Director, HIV PrEP Scientific Publications, Gilead Sciences, United States

Wendy Tin is a pharmacist by training with more than 6 years of experience in the pharmaceutical industry. After graduating from UC Berkeley with a BA in molecular and cell biology, Wendy attended UCSF and earned her PharmD degree. Prior to industry, Wendy worked as a pharmacist in... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Forum

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

8:00am PDT

#306: Which Clinical Outcome Assessment to Choose: Questionnaire or Sensor? Time to Align an Endpoint Selection Framework

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-627-L04-P; CME 1.00; RN 1.00

Questionnaires, standardized tasks, and DHTs can measure similar outcomes which complicates endpoint selection. This forum discusses a framework to align ontologies for actively-collected and passively-monitored COAs to streamline endpoint strategy

Learning Objectives

Identify biomarkers from actively collected and passively-monitored COAs building upon regulatory definitions; Determine a framework to align ontologies for these measure types enabling rapid, evidence-based, and fit-for-purpose measure selection using case study examples.

Chair

Caprice Sassano, MPH

Speaker

Panelist
Roya Sherafat-Kazemzadeh, MD, PhD

Panelist
Megan Parisi, MS

Panelist
Thomas Switzer, MEd

Speakers

Caprice Sassano

Research and Data Products - Applied Sciences, HumanFirst, United States

Roya Sherafat-Kazemzadeh

Scientific Director, Mapi Research Trust, France

Dr. Roya Sherafat is a trained physician and holds dual PhDs in epidemiology and health policy. Roya has over a decade experience in clinical research in the field of obesity and cardiometabolic health specifically on profiling risk factors, adverse cardiometabolic outcomes, and heterogeneity... Read More →

Megan Parisi

Patient Solutions Lead, Syneos Health, United States

Megan Parisi, MS, CCRP, is a Patient Solutions Lead at Syneos Health where she curates patient centric strategies for implementation into clinical trials across all phases of development. She innovates in patient and site focused trial design, focusing on decentralized and digital... Read More →

Thomas Switzer

Principal Digital Health Scientist, Genentech, A Member of the Roche Group, United States

Tom is a Principal Scientist and Digital Health Lead in Genentech's Research and Early Development Informatics group. His current focus is on developing technology platforms supporting molecule teams across the early development portfolio. Tom has over 24 years of clinical development... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum

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

8:00am PDT

#302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-623-L04-P; CME 1.00; RN 1.00

This discussion will provide the setting and background of clinical trials of psychedelics and issues to consider. The session will provide details with a clinical trial participant providing example feedback and insight from that perspective.

Learning Objectives

Discuss the conflicted background of psychedelic clinical trials; Discuss reasonable expectations for clinical trial progression; Identify one participant’s perspective from two clinical trials; compare and contrast the participant perspective with standard clinical outcomes.

Chair

Currien MacDonald, MD

Speaker

Panelist
Sara Reed, MA

Speakers

Currien MacDonald

Medical Chair Director, WCG, United States

Dr. Currien MacDonald has lead the medical chairs at WCG for the past 7 years. Prior to that, Dr. MacDonald served for four years as the medical director for Aspire IRB, another WCG company. After graduating top of his class from the University of Minnesota Medical School, Dr. MacDonald... Read More →

Sara Reed

Video Production, Consultant, United States

Sara Reed holds a MFA in Documentary Media from Northwestern University. With over a decade of freelance video production experience spanning the U.S., Canada, Central/South America, and Africa, she’s contributed to projects for renowned clients such as Discovery, HBO, NASA, and... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 09: Regulatory, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Basic
Featured Topics Ethics
Level Basic
Feature Topics Ethics
Credit Type ACPE, CME, RN
Tags Session

8:00am PDT

#308: Unlocking Innovation: Implementing Future-Focused Risk-Based Quality Management Quality Briefs - A Cross-Functional Challenge

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-629-L04-P; CME 1.00; RN 1.00

Join us as we delve into the cutting-edge realm of risk-based quality management (RBQM) and learn how quality briefs revolutionize compliance reporting both internally and for externally for regulators. Discover how quality briefs offer proactive transparency at the time of filing, incorporating ICH E8/E6(R3) expectations, and focusing on highest risk critical to quality (CtQ) areas. Gain insights from real-world case studies of multi-company implementations, and uncover strategies to collaborate across functions for swift product delivery while maintaining stringent quality standards. Explore how quality briefs drive a paradigm shift in quality management, moving from gatekeeping at the end of the process to proactive involvement from the start, in line with ICH E6 R3 and E8 R1 quality by design principles. Learn how to craft the GCP compliance story of your product's development, with each CtQ factor assessed for compliance status at filing, supported by evidence and data analytics insights. Dive into the 'How' of implementation, with practical guidance for companies keen on adopting this transformative approach, including updates on Health Authority engagement.

Learning Objectives

Critique the methodology behind implementing the outcomes-based approach of quality briefs in risk-based quality management (RBQM), illustrating how it demonstrates the compliance status of critical to quality (CtQ) factors; Design effective cross-functional communication strategies within a company to facilitate the implementation of changes required for adopting quality briefs, emphasizing collaboration; Identify the key challenges and successes derived from real-world insights.

Chair

Paula Walker, MA

Speaker

Panelist
Cheryl Grandinetti, PharmD

Panelist
Jennifer Emerson, PhD, MPH, RN, PMP

Panelist
Jamie Bridges, MPH

Panelist
Alissa Mun, MS

Speakers

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 →

Jamie Bridges

Executive Director, Clinical Quality Assurance, Merck Sharp & Dohme LLC , United States

Jamie Bridges has 26 years of pharmaceutical experience. She began her career at Pfizer and spent the past 25 years with Merck based out of West Point, PA. Her career has included leadership roles in Data Management, Epidemiology, Operational Excellence and most recently Clinical... Read More →

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →

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 →

Alissa Mun

Health Scientist Policy Analyst, OMP, CDER, FDA, United States

Alissa Mun is a Health Scientist Policy Analyst in the Division of Clinical Trial Quality of the Office of Medical Policy in CDER/FDA. She provides scientific and technical input for ongoing policy initiatives such as risk-based monitoring, quality by design, and risk management with... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Forum

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

8:00am PDT

#309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-630-L04-P; CME 1.00; RN 1.00

The FDA Oncology Center of Excellence "Projects" address gaps in oncology drug development and present opportunities as well as challenges for industry. Learn from FDA and industry experts the value of these initiatives and how and when to join in.

Learning Objectives

Recognize high-value FDA OCE priorities and projects that impact industry; Identify how and when to engage with these FDA initiatives to produce optimal results for industry, patients, and other stakeholders; Describe how to advance opportunities for harmonization of these high-value OCE Projects with global Health Authorities.

Chair

Sabrina Girty, JD

Speaker

FDA Overview and Perspective on OCE Projects
Tamy Kim, PharmD

From Policy to Practice: Maximizing Collaboration to Support Oncology Innovation
Mark Stewart, PhD

Industry Case Study: Implementing OCE Projects in Drug Development
Vandana Pathak, MS, RAC

Speakers

Sabrina Girty

Executive Director, Global Regulatory Affairs, Oncology, Merck & Co., Inc., United States

Sabrina Girty is an Executive Director in Global Regulatory Affairs, Oncology at Merck & Co. Inc and leads a team of global regulatory strategy professionals across the esophageal, gastric, colorectal and head & neck cancer programs. At Merck, her team secured global marketing authorizations... Read More →

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 →

Vandana Pathak

Director Global Regulatory Affairs, Amgen, United States

Vandana Pathak, MS, RAC is a Director, Global Regulatory Affairs - Oncology at Amgen Inc. She leads global regulatory teams to drive global regulatory strategy and provides regulatory leadership to cross-functional teams to develop and execute global regulatory product strategies... Read More →

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States

Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

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

8:00am PDT

#310: WHO Town Hall: Safeguarding Public Health - WHO's Vision for Global Regulatory Excellence

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-631-L04-P; CME 1.00; RN 1.00

This session aims to delve into WHO's pivotal role in the evolving landscape of global regulatory excellence. The discussion will revolve around the transformative impact of WHO-listed Authorities on medical product regulation, emphasizing regulatory reliance as a holistic approach to enhance efficiency and accessibility. Additionally, the session will address the pressing issue of substandard/falsified medical products and their potential threats to global health.

Learning Objectives

Describe the significance of WHO-listed Authorities in shaping the future of medical product regulation; Examine the concept of regulatory reliance as a key strategy to enhance access and efficiency in global regulatory practices; Discuss the critical role of regulatory excellence in safeguarding public health against the threats posed by substandard/falsified medical products.

Chair

Samvel Azatyan, MD, PhD

Speaker

Elevating Regulatory Reliance: The Strategic Impact of WHO-Listed Authorities in Transforming Global Regulatory Landscapes
Hiiti Sillo, MSc, RPh

Securing Supply Chains: A Global Imperative
Rutendo Kuwana, RPh

EMA Update
Emer Cooke, MBA, MSc

Industry Update
Janis Bernat, MSc

Moderator for Panel Discussion and Q&A
Marion Laumonier, MSc

Speakers

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland

Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →

Janis Bernat

Director, Scientific and Regulatory Affairs, IFPMA, Switzerland

Janis leads cross-functional activities in regulatory science and international health policy for IFPMA, while partnering with policy experts and stakeholders to strengthen the pharmaceutical regulatory environment. She is responsible for guiding the organization’s regulatory team... Read More →

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 →

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland

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

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland

Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →

Hiiti Sillo

Unit Head, Regulation and Safety, Department of Regulation and Prequalification, World Health Organization (WHO), Switzerland

Hiiti Sillo is the Unit Head, Regulation and Safety within the WHO department of Regulation and Prequalification. Until August 2021, he was the Team Lead, Regulatory Systems Strengthening (RSS), Regulation and Safety Unit. Before joining WHO in January 2018, he was the Director General... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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

8:00am PDT

#311: Australia, Canada, Singapore, Switzerland, and United Kingdom Consortium (Access): Re-Imagining Regulatory Collaboration

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-632-L04-P; CME 1.00; RN 1.00

Established in 2007, the Access Consortium brings together like-minded regulatory agencies to promote regulatory convergence and foster synergy to address scientific and regulatory issues. In this session, leaders from the Access Consortium will provide an update on achievements using work-sharing initiatives for timely medicines approvals for our populations, enabling industry to bring new, innovative products through Access pathways.

Learning Objectives

Discuss pathways and opportunities for industry to bring innovative products through Access; Describe new tools and methodologies to optimize regulatory collaboration under the Access Consortium to support access to medicines.

Chair

Pamela Aung-Thin

Speaker

Panelist
June Raine, MD, MSc, FRCP

Panelist
Anthony Lawler, MD, MBA

Panelist
Mimi May Ling Choong, DrMed, MD

Panelist
Jörg Schläpfer, PhD

Panelist
Eveline Trachsel

Speakers

Pamela Aung-Thin

Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, Canada

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

Mimi May Ling Choong

Chief Executive Officer, Health Sciences Authority (HSA), Singapore

Dr Choong was appointed as the Chief Executive Officer of the Health Sciences Authority (HSA) of Singapore on 1 July 2014. She oversees HSA’s wide-ranging public health responsibilities, comprising health products regulation, the national blood service, the national analytical and... Read More →

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia

Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →

June Raine

Chief Executive, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Dr June Raine DBE is CEO of the Medicines and Healthcare products Regulatory Agency. She trained in medicine in Oxford after completing a master’s degree by research in Pharmacology. Her interest in drug safety led to a career in medicines regulation which has spanned a number of... Read More →

Jörg Schläpfer

Head of Management Services and International Affairs, Swissmedic, Switzerland

Dr. Jörg Schläpfer, PhD is the Head of Management Services & International Affairs and Member of the Management Board of Swissmedic. He studied Veterinary Medicine at the University of Berne, completing his studies in 1991. After obtaining the title of Doctor of Veterinary Medicine... Read More →

Eveline Trachsel

Head of Medicinal Product Authorisation and Vigilance, Swissmedic, Switzerland

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Level Intermediate
Featured Topics Regulatory Collaboration, Regulator Perspectives
Level Intermediate
Feature Topics Regulatory Collaboration,Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-628-L04-P; CME 1.00; RN 1.00

Discussion of partnering with regulators to get novel digital health products through the approval processes. Learn insights from industry and regulators for creative, strategic, and flexible thinking on regulation of novel technologies.

Learning Objectives

Discuss the challenges of introducing novel digital technologies to FDA; Describe tactics to build better partnerships with regulators.

Chair

Rebecca Joy James, MBA, RAC

Speaker

Panelist
Anindita Saha

Panelist
James Wabby, MHS

Panelist
Adam Cargill, MS

Panelist
Wes Gerbig, PhD, MS

Speakers

Rebecca James

Director - Advisory, KPMG, LLC, United States

Rebecca is a Director in the Life Sciences consulting group at KPMG based out of Chicago, IL. She has over 14 years of experience in both consulting and industry roles with companies from pharmaceutical, medical device, and nutritional industries with an emphasis in Regulatory Affairs... Read More →

Adam Cargill

Director, QARACA, MediView XR, Inc., United States

Adam Cargill, MS RAC, is the Vice President of Quality, Regulatory, and Clinical for MediView XR. In his role he is accountable for the oversight of all regulatory, clinical, and quality functions. Responsibilities include overseeing the company’s global regulatory, clinical, and... Read More →

Wes Gerbig

Director, Global Regulatory Affairs, Drug Delivery and Digital Health, Eli Lilly and Company, United States

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States

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

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

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

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session

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

8:00am PDT

#312: Revolutionizing Regulatory CMC and Advanced Manufacturing with the Power of AI: Unleashing Innovation and Efficiency

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-633-L04-P; CME 1.00; RN 1.00

This forum session will explore the transformative potential of Artificial Intelligence (AI) in biotech RA CMC and advanced manufacturing. Discover how AI can optimize processes, improve efficiency, and ensure compliance of your data.

Learning Objectives

Define key concepts and principles of artificial intelligence (AI) in the context of biotech industry, regulatory CMC and advanced manufacturing; Identify the potential applications and benefits of AI including how it can automate deviation and change control processes or support strategic decision-making; Discuss the benefits, challenges and cons of AI i.e. data integrity and security.

Chair

Grzegorz (Greg) Podrygajlo, PhD

Speaker

Application of AI Tools to Support the Decision Process in Regulatory CMC
Grzegorz (Greg) Podrygajlo, PhD

Use of AI and ML in Pharmaceutical Manufacturing: Case Studies from the Shop Floor and Regulatory Landscape
Gert Thurau, DrSc, PhD

How to Use GenAI in a Smart Way for Now and for the Future
Hubert Niewiadomski, PhD

Speakers

Grzegorz (Greg) Podrygajlo

GRA CMC Director, Head of Global Manufacturing Support, CSL Behring, Switzerland

Grzegorz (Greg) Podrygajlo, PhD is Head of Global Manufacturing Support, Global Regulatory Affairs CMC for Biologics at CSL Behring. He obtained Master in Medical Biotechnology and PhD in Neuroscience. Greg leads Global Regulatory Strategy for optimal Change Control Process and Life... Read More →

Hubert Niewiadomski

Chief Executive Officer, Cledar, United States

Hubert Niewiadomski is the CEO of Cledar, a Machine Learning and Artificial Intelligence Development company partnering with private and public sectors. Hubert has been the key contributor to more than 100 publications and has been working on neural networks for more than 20 years... Read More →

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland

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

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Forum

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

8:00am PDT

#313: The Future of Women’s Health: Do We Really Want Innovation? Policy Ideas To Advance Innovation, Access, and Novel Approaches

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-634-L04-P; CME 1.00; RN 1.00

There is a critical need for innovation in women’s health, particularly maternal health. What will it take to improve care in this area? How can innovative regulatory, reimbursement and access policies encourage novel approaches to women’s health?

Learning Objectives

Identify areas of women’s health which face barriers preventing innovation; Describe disparities in women’s/maternal health and existing regulatory, payment and access policies intended to improve outcomes; Evaluate the types of policy changes needed to encourage innovation

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Panelist
Lynne Yao, MD

Panelist
Tara Croft, MBA

Panelist
Sandy Milligan, JD, MD

Speakers

Nancy Myers

CEO and Founder, Catalyst Healthcare Consulting, Inc, United States

Nancy Bradish Myers, JD, CEO & Founder, Catalyst Healthcare Consulting, is a sought-after leader with deep expertise in health law, regulation and policy. She has led a successful strategic regulatory policy consultancy for 19 years and has been active in the DC policy arena for three... Read More →

Tara Croft

Chief Executive Officer, Baymatob, Australia

Tara is a passionate advocate for womens health and technology. A MedTech expert with 20 years industry experience, Tara is the CEO of Baymatob, a female-founded, female-led, early-stage business aiming to improve and save the lives of mothers and their babies, by developing an AI-enabled... Read More →

Sandy Milligan

Board of Director Member, Gossamer Bio; Principal, Innovex Strategies, United States

Sandy Milligan is President of Aspira Women's Health, working to transform women’s gynecological health through the development and commercialization of innovative testing options. Previously, Sandy was the head of Research and Development at Organon, focused on improving the everyday... Read More →

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 →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12: Value-Access, Forum

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

9:00am PDT

Coffee Break

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

Wednesday June 19, 2024 9:00am - 10:00am PDT
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

9:00am PDT

DIA Global Annual Meeting Blood Drive

Component Type: Social Event

The drives will be held in Exhibit Hall B 1 on the following dates and times:
Monday, June 17 | 10:00am to 4:00pm; click here to schedule
Tuesday, June 18 | 9:00am to 3:00pm; click here to schedule
Wednesday, June 19 | 9:00am to 3:00pm; click here to schedule

Download Now

Wednesday June 19, 2024 9:00am - 3:00pm PDT
Exhibit Hall B 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

9:15am PDT

#314 IT: IQVIA Innovation Theater: Pre-Approval Access - Strategies for Providing Investigational Product to Patients Beyond Clinical Trials

Component Type: Session

This session on Pre-Approval Access (PAA) will address key considerations and challenges for provision of investigational products to patients outside of clinical trials, and before these therapies are approved by regulators. We will focus on key decisions and success factors for organizations to consider when developing their company’s philosophy on this type of access. We will also highlight pragmatic decisions that play into the development of efficient Pre-Approval Access programs.

Chair

IQVIA

Speaker

Speaker
Barbara Isquith Arone, MS

Speaker
Ana Tediosi

Speakers

IQVIA

United States

Barbara Isquith Arone

Vice President, Evidence Generation for Medical Affairs, IQVIA, United States

Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →

Ana Tediosi

Head of Expanded Access Strategy, WEP Clinical, United Kingdom

With over 10 years of experience in the pharmaceutical industry, Ana is a recognized expert in the field of Expanded Access Programs (EAP). Her expertise lies in oncology, hematology, Rare Diseases, and she has held various roles in the big Pharma (BMS, Roche, Menarini-Stemline... Read More →

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

9:15am PDT

#315 IT: ArisGlobal Innovation Theater: Unleashing the Power of Automation and Understanding the Promise of GenAI in Pharmacovigilance and Regulatory Affairs

Component Type: Session

In the rapidly evolving life sciences landscape, the integration of next-generation technologies is essential to innovation, improving efficiencies, and ensuring safety, compliance, and efficacy of drugs. In this keynote panel, hear from leaders at ArisGlobal and top pharam, as they discuss tangible automation use cases and their practical implications. Whether you are with a large organization aiming to scale automation and leverage GenAI or a smaller organization looking to begin leveraging automation within your workflows, you’ll find value in hearing the unique journeys our panelists and their organizations have taken - You’ll also learn about the benefits that they are seeing as a result.

Chair

ArisGlobal, LLC

Speaker

Panelist
Hans van Leeuwen, PhD

Panelist
Claudia Schaffer, RN

Speakers

Art Brown

Marketing, ArisGlobal, United States

Hans van Leeuwen

Head of Regulatory Operations, Astellas Pharma Europe BV, Netherlands

ArisGlobal, LLC

United States

Claudia Schaffer

Sr. Director, Head Case and Vendor Management, EMD Serono, Germany

Claudia is an accomplished leader with over 17 years of experience in pharmacovigilance. Her journey started with handling ICSRs and quickly progressed to leadership roles where she gained expertise in diverse areas such as vendor management, business process management, system implementation... Read More →

Karthick Sukumaran

Technology Enablement Director, Roche, United States

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

9:15am PDT

#315.1 IT: HCL Innovation Theater

Component Type: Session

Chair

HCL Technologies

Speakers

HCL Technologies

United States

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

10:00am PDT

#317: Unlocking the Potential of Pharmacogenomics for Reducing the Burden of Adverse Drug Reactions

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-635-L04-P; CME 1.00; RN 1.00

This session will explore current progress in pharmacogenomics; the barriers and opportunities it represents for drug safety from the perspective of medicines regulators, industry, the scientific community, healthcare professionals, and patients.

Learning Objectives

Discuss the importance of pharmacogenomics for introducing better risk mitigation strategies; Appraise progress being made in this field internationally; Recognize opportunities for introduction of pharmacogenomic research in your organization.

Chair

Alison Cave, PhD

Speaker

From Post-Marketing Reports of Side Effects to Pharmacogenomic Research: Can we Reduce the Burden of ADRs?
Sarah Vaughan

Patient Perspective
Christine Von Raesfeld

Industry Perspective
Gregory Powell, PharmD, MBA

Academic Perspective
Kathleen M. Giacomini, PhD

Speakers

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

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

Kathleen Giacomini

Dean, School of Pharmacy, Professor and Principal Investigator, University of California San Francisco, United States

Kathleen M. Giacomini, Ph.D. Kathy Giacomini, a professor in the School of Pharmacy at the University of California, San Francisco, is a leader in the field of membrane transporters with a focus on genetic polymorphisms. She cloned, characterized and discovered the endogenous role... Read More →

Gregory Powell

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

Greg Powell is the Senior Director of Safety and Clinical Innovation at GlaxoSmithKline. He completed his PharmD at the University of Florida, his MBA at East Carolina University, and his BS in Pharmacy at the University of North Carolina. He has over twenty years of experience practicing... Read More →

Christine Von Raesfeld

Founder/SME, Patient Experience, The Light Collective, United States

Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. She is a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. As a patient, Christine has assisted in initiatives including... Read More →

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

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

10:00am PDT

#319: Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-637-L04-P; CME 1.00; RN 1.00

This session will discuss how the ISO IDMP standards have a pivotal role in enhancing global pharmacovigilance and improving visibility in the product supply chain. The collaborative efforts of the Global IDMP Working Group reflect the need to advance this critical endeavor.

Learning Objectives

Define IDMP standards and explain their benefits when globally implemented; Describe the role of the unique global IDMP identifiers in data exchange of medicinal product information; Discuss the impact of global IDMP identifiers on different use cases in the medicinal product life cycle, for example, pharmacovigilance and drug shortages, supply chain integrity.

Chair

Malin Kristina Fladvad, PhD, MSc

Speaker

Unlocking the Potential of IDMP: Global Use Cases
Ron Fitzmartin, PhD, MBA

Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
Hilmar Hamann, PhD

Speakers

Malin Fladvad

Portfolio Officer, Uppsala Monitoring Centre, Sweden

Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts... Read More →

Ron Fitzmartin

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

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

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

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

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 03: Data-Tech, Session

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

10:00am PDT

#324: Using Data Analytics for Good Pharmacovigilance Practices

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-642-L04-P; CME 1.00; RN 1.00

This session will consist of perspectives and case studies of how data-driven solutions are being leveraged to support the development of quality assurance strategies for pharmacovigilance activities and to generate quality evidence in relation to Good Pharmacovigilance Practice (GVP) compliance.

Learning Objectives

Investigate the use of data-driven solutions to develop quality assurance strategies for Good Pharmacovigilance Practice (GVP) activities and to generate quality evidence in relation to GVP compliance.

Chair

Kiernan Trevett, MSc

Speaker

Industry Update
Michelle Ruiz

Industry Update
John Okudjeto, MSc

MHRA Update
Sophie Radicke, MSc

Speakers

Kiernan Trevett

Principal Quality Lead, PDQ Quality Assurance Process GVP, Genentech, A Member of the Roche Group, United States

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP... Read More →

John Okudjeto

Manager, Pharmacovigilance QA, Janssen Research & Development LLC, United States

John Okudjeto is a quality assurance professional with over ten years of experience in pharma and medical device manufacturing, supply change management, and pharmacovigilance auditing. John completed a Bachelor of Science in Biology/Chemistry from Georgia State University in 2010... Read More →

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →

Michelle Ruiz

Principal Quality Data Analyst, Genentech, A Member of the Roche Group, United States

Michelle is a Principal Quality Data Analyst in Genentech's Product Development Quality organization. In her current role, Michelle focuses on identifying areas in the Pharmacovigilance domain where data analytics can transform business processes, as well as designing and delivering... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session | 08: RD Quality-Compliance, Session

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

10:00am PDT

#320: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-638-L04-P; CME 1.00; RN 1.00

Join us for a candid tour of three journeys toward integrating AI into key use cases. We share real-world metrics, best practices, and lessons learned as our teams evolve from traditional document development to effective digital solutions. This session focuses on practical ways in which medical writing organizations are using AI technologies to enable new ways of working, achieve business value, and get drugs to market faster.

Learning Objectives

Compare approaches to incorporating artificial intelligence (AI) in key use cases; Identify potential solutions to challenges within your organization; Appraise your organization’s plans for AI implementation.

Chair

Regina Lynn Preciado

Speaker

Evolution of Technology and Exploring Use of Generative AI in Medical Writing
Madhavi Gidh-Jain, PhD

Using GenAI to Write First Draft of Clinical Study Reports
John Henry April, III, MA

Evolve or Perish: Embracing Automation in Medical Writing
Waheed Jowiya, PhD

Speakers

Regina Lynn Preciado

Senior Director of Content Strategy Solutions, Content Rules, Inc., United States

Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →

John April

Senior Director, Adaptive Content Strategy, Global Scientific Communications, Eli Lilly and Company, United States

Twenty-five years of drug development experience focused on medical writing. Highlights include developing content reuse and generative AI strategies for Lilly, retooling Lilly's medical writing staff to structure its content, leading a medical writing start-up in India, designing... Read More →

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States

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

Waheed Jowiya

Digitalisation Strategy Lead, Novo Nordisk A/S, Denmark

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

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Session

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

10:00am PDT

#321: The ChatBot Will See You Now: Ethical Considerations in Incorporating AI into Informed Consent

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-639-L04-P; CME 1.00; RN 1.00

Generative AI is gaining traction in trial communications, with goals of expediency and efficiency. New technologies should incorporate patient views and ethical frameworks to keep human interactions that are desirable, necessary, and useful.

Learning Objectives

Describe the ethical framework that encompasses informed consent for clinical research; Evaluate goals for the use of artificial intelligence (AI) in clinical trials and how these goals interact with ethical goals for consent; Discuss how to incorporate patient and participant needs and perspective into AI-assisted clinical trial information and communication.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Patient Perspective Update
Deborah Collyar

Industry Update
Karla Childers, MS

Industry Update
Catina O'Leary, PhD

Speakers

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 →

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 →

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States

Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States

Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... Read More →

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session

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

10:00am PDT

#318: Defining an Inclusive Clinical Trials Approach in Europe

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

Learning Objectives

Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

Chair

Ambily Banerjee, PhD

Speaker

The EU Perspective and the Role of ACT EU
Ana Zanoletty Perez

Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
M. Khair ElZarrad, PhD, MPH

Industry Perspective of Community Engagement in Europe: A Case Study
Monique Adams, PhD, MS

CT Network One-Pager v2
Nicholas Brooke, MBA

Speakers

Ambily Banerjee

Senior Director/Head of Diversity in Clinical Trials, Johnson and Johnson Innovative Medicine, United Kingdom

After a decade as an academic scientist, following a Ph.D. in Molecular Biology, Ambily moved to GSK Regulatory Affairs, where she held increasingly senior roles in Global Regulatory Affairs and Internal Audit. She also led the race and ethnicity Employee Resource Group, EMBRACE... Read More →

Monique Adams

Executive Director, Global Head Diversity and Inclusion in Clinical Trials, Sanofi, United States

Monique Adams is the Executive Director, Global Head of Diversity and Inclusion in Clinical Trials, or DICT, at Sanofi where she drives the pharmaceutical company’s vision, strategy, and implementation of a holistic framework for DICT. Monique has a Ph.D. in Pharmacology from the... Read More →

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium

Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States

Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands

Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 02: ClinTrials -ClinOps, Forum

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

10:00am PDT

#323: Driving Capacity Building, Equity, and Geographic Expansion in Clinical Trials

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-641-L04-P; CME 1.00; PDU 1.00 PMI 2166PJJJ85; RN 1.00

90% of trials are performed in higher-income countries. In this session, the audience will learn directly from stakeholders about establishing infrastructure in low and/or middle income countries (LMICs) and how building capacity can improve quality of care and outcomes for patients.

Learning Objectives

Describe global research expertise and identifying gaps on a local level; Identify approaches to translate local research expertise to global research excellence; Recognize successful strategies for long-term sustainability and growth.

Chair

Muhammad Ali Hameed, CPA, MBA

Speaker

Facilitator
Twanna L Davis, MBA

Facilitator
Jeanine Condo Condo

Speakers

Jeanine Condo

Chief Executive Officer, CIIC-HIN, Rwanda

Twanna Davis

Global Head, Clinical Trial Services, Executive Advisor - Purpose Africa, Purpose Life Science, Canada

Twanna Davis is the Head of Clinical Trial Solutions at Purpose Life Sciences. In her role, Twanna oversees all functional services necessary to execute full-service global clinical trials. She has over 25 years of experience in clinical operations, directing multiple applicable services... Read More →

Muhammad Ali Hameed

Chief Operating Officer, Population Health Research Institute, Canada

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 07: ProjectManagement-StrategicPlanning, Session

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

10:00am PDT

#326: Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-644-L04-P; CME 1.00; RN 1.00

In this session, we will discuss international efforts to promote regulatory convergence and expand the use of reliance to bring these highly complex therapies to market earlier, particularly in less developed countries.

Learning Objectives

Describe how international harmonization, collaboration, and reliance principles can be effectively applied to the regulation of cell and gene therapies; Discuss the key considerations and regulatory challenges associated with bringing complex, innovative medicines such as cell and gene therapy products to less experienced, emerging markets.

Chair

Ginny Beakes-Read, BSN, JD

Speaker

FDA Update
Julia Tierney, JD

WHO Update
Samvel Azatyan, MD, PhD

PMDA Update
Yasuhiro Kishioka, PhD

Industry Update
Maria Antonieta Tony Roman, MPharm

EMA Update
Anabela Marcal, PharmD

Speakers

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland

Ginny Beakes-Read

Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States

Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →

Yasuhiro Kishioka

Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →

Maria Antonieta Roman

Head Regulatory Policy Emerging Markets LATAM, Novartis, Mexico

Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →

Julia Tierney

Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States

JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 09: Regulatory, Session

Format Session
Level Intermediate
Featured Topics Cell and Gene Therapy, Regulatory Reliance, Regulatory Collaboration
Level Intermediate
Feature Topics Cell and Gene Therapy,Regulatory Reliance,Regulatory Collaboration
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#322: Leveraging Testing Results Generated Within Treating Hospitals for Trials Across the Globe

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-640-L04-P; CME 1.00; RN 1.00

Precision medicine biomarker testing can be achieved in various formats, harnessing results generated in each patient's treating hospital or in centralized laboratories. We will examine resulting regulatory and technical challenges & opportunities.

Learning Objectives

Demonstrate an understanding of different testing models (central vs decentralized); Identify their regulatory consequences for clinical study conduct and approval.

Chair

Mike Wierzba, PhD

Speaker

Panelist
Oliver Stoss, PhD

Panelist
Amanda Baker, PharmD, PhD

Panelist
Ilona Reischl, PhD, MPharm

Panelist
Adriana Racolta, PhD, RAC

Panelist
Philip Kelly, PhD

Speakers

Mike Wierzba

Director, GRA, Precision Medicine and Digital Health, GlaxoSmithKline, United States

Mike Wierzba is a Director within the Precision Medicine & Digital Health, Global Regulatory Affairs team at GSK where he is the diagnostic regulatory lead for multiple development programs and leads efforts related to IVDR. Mike is a participant in EFPIA Precision Medicine Working... Read More →

Amanda Baker

Clinical Development Lead (Director), Pathology Lab, Roche Tissue Diagnostics, United States

Dr. Baker was a faculty member at the University of Arizona for 13 years where her research focused on the characterization of biomarkers associated with stress signaling pathways activated in response to the tumor microenvironment. She also worked for 8 years as a Research Scientist... Read More →

Philip Kelly

IVDR Project Manager | Assessment and Surveillance, Health Products Regulatory Authority (HPRA), Ireland

Philip Kelly serves as the IVDR Project Manager for the HPRA. In this role Philip leads work items focused on ensuring compliance with regulatory requirements and facilitating the safe and effective use of IVDs. Recently as part of the COMBINE project Philip aided in the analysis... Read More →

Adriana Racolta

Director, Regulatory Affairs, Companion Diagnostics, Pfizer Inc, United States

Ilona Reischl

Biologics Quality Assessor, Austrian Medicines and Medical Devices Agency (AGES MEA), Austria

Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality... Read More →

Oliver Stoss

Senior Vice President of Operations, Discovery Life Sciences Biomarker Services GmbH, Germany

Dr. Stoss is leading the clinical trial operations at Discovery Life Sciences in his function as Senior Vice President Operations. Since 2004, he served in different leadership roles in both the USA and Europe and did oversee more than 600 phase I to phase III biomarker driven clinical... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: TranslationalDelivery Tech-PrecMedicine, Forum

Format Forum
Level Intermediate
Featured Topics Decentralized Clinical Trials (DCTs)
Level Intermediate
Feature Topics Decentralized Clinical Trials (DCTs)
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#328: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-646-L04-P; CME 1.00; RN 1.00

Advanced Therapies and combined advanced therapies emerging as innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Future technologies are most appealing to patients with ongoing medical conditions that require consistent treatment with daily injections or weekly procedures and unmet medical needs. Overall, the successful development of combination products will require great collaboration within the industry to overcome regulatory, clinical, and technical challenges. When developing an advanced therapy product, there are many things to be considered – relationships between tissue, biologic, and device development as well as early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation. With the dawn of a new millennium and the rapidly aging baby-boomer population, the pressure for companies to create safer and more effective treatments is growing. Advanced therapies are one of the solutions that have emerged to meet the more rigorous demands of patients. Drug-enhanced devices, including drug eluting stents and antimicrobial-coated catheters, have already proven themselves on the market. Pre-filled syringes and transdermal patches, which are novel drug delivery systems, have also been widely used treatments. However, advanced therapies and combined advanced therapies are innovative products and could provide solutions as well as cures for previously untreatable conditions, which can truly change the face of the industry. Speakers will be FDA and industry leaders and FDA illustrating hot topics and example case studies in a panel discussion for us to navigate the future regulatory framework for unmet medical needs and next generation of medical products.

Learning Objectives

Analyze latest regulatory expectations and challenges; Identify potential future innovation platforms; Acknowledge potential and future global convergence/harmonization initiatives for combination products; Describe the regulatory challenges and opportunities ahead.

Chair

James Wabby, MHS

Speaker

FDA Update
Andrea Gray, PhD

Panelist
Rob Schulz

Panelist
William Daunch, PhD

Panelist
Michael Lehmicke, MSc

Speakers

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

William Daunch

Chief Technology Officer, Focal Medical, Inc., United States

Professionally trained polymer scientist + analytical chemist. Began career as an industrial chemist/materials scientist in Belgium (ICI). Moved to Scotland and applied skills to helping early stage company (Aortech) develop the first fully synthetic heart valve (now commercialized... Read More →

Andrea Gray

Biomedical Engineer Advisor, CBER, FDA , United States

Andrea Gray is a Biomedical Engineer Advisor in the Regulatory Operations Branch of the Division of Regulatory Operations and Programs (DROP) in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER). She specializes in regulatory review of... Read More →

Michael Lehmicke

Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine, United States

Michael has over 20 years of R&D experience in biomaterials, medical devices and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple... Read More →

Rob Schulz

President and COO, Suttons Creek, Inc., United States

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: TranslationalDelivery Tech-PrecMedicine, Forum | 09: Regulatory, Forum | 14: DIAmond, Forum

Format Forum
Level Intermediate
Featured Topics Cell and Gene Therapy
Level Intermediate
Feature Topics Cell and Gene Therapy
Credit Type ACPE, CME, RN
Tags Forum

10:00am PDT

#325: A Paradigm Shift in Global Regulatory Reviews: Has the New Normal Arrived?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-643-L04-P; CME 1.00; RN 1.00

Global expert presentations and in-depth panel discussion on the regulatory agilities, regulatory reliance, platform approaches, and other regulatory innovations that are pivotal during public health emergencies and necessary for future pandemic preparedness.

Learning Objectives

Discuss regulatory agilities, reliance and platform approaches which significantly decreased review times internationally for COVID vaccines. Discuss additional CEPI case studies that highlight regulatory innovations to address future public health emergencies, and the inherent complexities of sustaining these innovations from a health authority perspective.

Chair

Helen Bayes Hartman, PhD

Speaker

Regulatory Reliance and Platform Approaches: Has the New Normal Arrived??
Donna Boyce, MS, RAC

Preparedness: Challenging the Traditional Regulatory Paradigms to Address Public Health Emergencies
Debra A Yeskey

FDA Update
David C. Kaslow, MD

Moderator
Khushboo Sharma, MBA

Speakers

Helen Hartman

Director, Global Regulatory Sciences, Pfizer Inc, United States

Helen has over 15 year of drug development experience as a global regulatory strategist and regulatory intelligence/policy professional across multiple therapeutic areas.

Donna Boyce

Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States

Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →

David Kaslow

Director, Vaccines Research and Review (OVRR), CBER, FDA, United States

David is director of the Office of Vaccines Research and Review, CBER, US FDA, where he oversees regulation of vaccines, allergenics, live biotherapeutics and bacteriophage. His 35+ years of experience in use-inspired research, product development, and product introduction include... Read More →

Khushboo Sharma

Chief Regulatory Innovation Officer, Accumulus Synergy, United States

Khushboo Sharma is the Chief Regulatory Innovation Officer for Accumulus. Sharma joined Accumulus Synergy in 2022 from BIO, where she focused on major regulatory policy initiatives to build the appropriate regulatory framework. Prior to BIO, Sharma spent 11 years in various roles... Read More →

Debra Yeskey

Head of Regulatory Policy and Intelligence, CEPI, United States

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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

10:00am PDT

#327: Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-645-L04-P; CME 1.00; RN 1.00

This session will include the regulator and industry perspective on the Green Deal initiative and chemical agenda and will have discussions on identified case study areas of expected heavy impact where panelists from industry, SMEs, and regulators will come together to share concerns and discuss opportunities and solutions on how to manage a more sustainable and environmentally future – for example through regulatory tools which enable innovation to address the challenges.

Learning Objectives

Identify insights into how manufacturers and regulators can collaborate to deliver a revolution without risks to the supply of medicines.

Chair

Ana Padua, MSc, RPh

Speaker

EMA Update
Veronika Jekerle, PhD, RPh

Sustainability and CMC (Chemistry, Manufacturing and Controls)
Benjamin Stevens, PhD, MPH

Industry Update
Anders Vinther, PhD, MSc

Speakers

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 →

Veronika Jekerle

Head of Pharmaceutical Quality, European Medicines Agency, Netherlands

Veronika Jekerle hold the position as Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division at European Medicines Agency. The office manages pharmaceutical quality aspects for all human medicines across the lifecycle from early development to post-authorisation... Read More →

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 →

Anders Vinther

Founder and Chief Executive Officer, QBA Leaders, United States

Anders Vinther, Ph.D, has established and grown companies, merged organizations, led Quality functions as Chief Quality Officer, chaired organizations and programs, and led culture change at large and small scale. Anders has more than 30 years work experience in the pharmaceutical... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10: RegCMC-Product Quality, Session

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

11:00am PDT

#329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle

Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle (Tuesday, June 18 | 1:15PM - 2:15 PM PDT). Space is limited.

Chair

Brooke Casselberry, MS, RAC

Speakers

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 03: Data-Tech, Session | 09: Regulatory, Session

Tags Session

11:00am PDT

#330.1 RT: Roundtable Discussion: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases

Component Type: Session

Join the Medical Writing Community for a follow up round table discussion tied to session: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases (Wednesday, June 19 | 10:00AM-11:00AM PDT). Space is limited.

Chair

Regina Lynn Preciado

Speakers

Regina Lynn Preciado

Senior Director of Content Strategy Solutions, Content Rules, Inc., United States

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 04: MedAffairs-SciComm, Session

Tags Session

11:00am PDT

#330 RT: Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation

Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation (Tuesday, June 18 | 3:15 PM - 4:15 PM PDT). Space is limited.

Chair

Chaitanya Koduri

Speakers

Chaitanya Koduri

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

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 10: RegCMC-Product Quality, Session | 09: Regulatory, Session

Tags Session

11:00am PDT

Luncheon Service

Component Type: Social Event

Wednesday June 19, 2024 11:00am - 1:00pm PDT
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

11:15am PDT

#331 CH: Emerging Standards for Novel Excipients

Component Type: Workshop
Level: Intermediate

Participants will delve into the challenges of applying novel excipients to pharmaceutical formulations and conducting safety assessment, while also gaining insights into the crucial regulatory requirements needed to ensure product compliance and safety.
Moreover, the rationale behind the development of emerging standards, their potential impact, and the ways in which they can contribute to elevating the standard of excellence with novel excipients will be presented. Attendees will also learn about emerging standard approaches that will help remove the current barriers to using novel excipients in new therapeutics/advanced formulations.

Learning Objectives

Explore challenges of using novel excipients in drug formulations; Gain insights into emerging standard approaches and possible pathways for novel excipients development.

Chair

Tong (Jenny) Liu, PhD

Speakers

Tong (Jenny) Liu

Principal Scientist, US Pharmacopeia, United States

Jenny holds a PhD in Chemistry from Boston University and has more than 20 years of experience in analytical method development and validation for pharmaceutical products. After postdoctoral research at Rutgers university (New Jersey) and work at AustarPharma and Catalent Pharma Solutions... Read More →

Wednesday June 19, 2024 11:15am - 11:45am PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 10: RegCMC-Product Quality, Workshop

Level Intermediate
Level Intermediate
Tags Workshop

11:15am PDT

#331.1 IT: Syneos Health Innovation Theater: From Formula One to Fortnite - Clinical Trials Fast-Track to Innovation

Component Type: Session

The world’s fastest time series database and analytics engine, and video game-style trainings are accelerating clinical trial efficiency, reducing costs, enhancing CRA performance, and speeding time to market in life-changing therapies. Learn how these technologies are being applied today to optimize site selection, predict enrollment rates, reduce environmental impact and identify trial risks earlier, and how future use cases will tackle patient selection and predicting drug efficacy.

Chair

Syneos Health

Speaker

Speaker
Bob Zambon, PhD

Speaker
Greg Christie

Speakers

Paula Bain

President of Clinical Delivery Services, Syneos Health, United States

Leading Clinical Delivery Services, Ms. Bain oversees Biometrics, Global Regulatory Affairs Solutions, Regulatory Intelligence and Medical Writing at Syneos Health. She has more than 35 years of clinical development experience, with a passion for science and creating integrated technology... Read More →

Greg Christie

Chief Product Officer, StudyKIK, a Syneos Health Company, United States

Greg Christie is a leader in human-centered product development and design, earning accolades for contributions to clinical research technology such as a SCOPE Award, a nomination for the Prix Galien UK 2023 Award for StudyKIK’s apps and a 2023 PM360 ELITE 100 Award in the Tech-Know... Read More →

Syneos Health

United States

Bob Zambon

Vice President, Technology Strategy and Strategic Partnerships, Syneos Health, United States

Dr. Zambon is VP, Technology Strategy & Strategic Partnerships at Syneos Health. He leads the development and operationalization of strategic solutions for clients to help address their key R&D and commercial needs by integrating data, technology, analytics, and various partnerships... Read More →

Wednesday June 19, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:15am PDT

#331.2 IT: OM1 Innovation Theater: Revolutionizing Prospective Studies and Registries with Automation and AI

Component Type: Session

Chair

OM1

Speaker

Speaker
Richard Gliklich, MD

Speakers

Richard Gliklich

Chief Executive Officer, OM1, United States

Dr. Richard Gliklich is the CEO of OM1, Inc., a real-world data, outcomes and technology company focused on using data and AI to accelerate medical research and personalize medicine, especially in chronic conditions. OM1 develops extensive data networks of participating practices... Read More →

OM1

United States

Wednesday June 19, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:15am PDT

#331.3 IT: N-Power Medicine Innovation Theater: A Unifying Platform to Unlock the Value of Cancer Patient Data for Both Clinical Trials and Routine Care

Component Type: Session

N-Power Medicine partners with oncology clinics to implement a purpose-built platform for accelerated and better-informed drug development. This first-of-its-kind integrated platform provides a single workflow across routine care and clinical trials. By enabling greater physician participation in research and thus deeper access to the full patient population, the platform helps sites achieve more predictable trial production and create unique SOC data that is fit-for-purpose for drug development

Chair

N-Power Medicine

Speaker

Speaker
Mark Lee

Speakers

Mark Lee

CEO, N-Power Medicine, United States

Dr. Lee was most recently Senior Vice President and Global Head for Personalized Healthcare, Product Development at Genentech/Roche. Prior to joining Genentech, Mark was a member of the founding leadership team and Head of Clinical Development and Medical Affairs at GRAIL, where his... Read More →

N-Power Medicine

United States

Wednesday June 19, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

11:45am PDT

#332 CH: Informing Clinical Trials with Patient Feedback Through Simulations: An Innovative Methodology

Component Type: Workshop
Level: Intermediate

Clinical trial simulations are a valuable and insightful methodology in understanding the patient experience during a clinical trial. Discussion will focus on strategies in operationalizing clinical trial simulations to inform clinical trial design.

Learning Objectives

Discuss how to derive and operationalize insights from patients and caregivers from clinical trial simulations; Explain strategies on how insights can impact clinical trial design and operation.

Chair

Wesley D Peters, MS

Speakers

Wesley Peters

Research Specialist II, Patient Experience, Evidera/Thermo Fisher Scientific, United States

Wes Peters is a public health professional with over 7 years of experience in the Life Science industry. Wes received his Master of Science in Public Health (MSPH) from the Johns Hopkins Bloomberg School of Public Health with a focus in Health Education and Health Communication. Currently... Read More →

Wednesday June 19, 2024 11:45am - 12:15pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 05: Patient-Focused Drug Dev, Workshop

Level Intermediate
Level Intermediate
Tags Workshop

11:55am PDT

#332.2 IT: Wipro Innovation Theater

Component Type: Session

Chair

Wipro

Speakers

Wipro

United States

Wednesday June 19, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

12:30pm PDT

#333 CH: Real-World Evidence (RWE) for Regulatory and Health Technology Assessment (HTA) Decision Making – Where are we?

Component Type: Workshop
Level: Intermediate

While the use of Real-World Data (RWD) in the post-marketing surveillance setting has increased in recent years, RWD use for decision-making in the pre-licensing is currently the focus of all stakeholders through various initiatives, including at the global level.

Learning Objectives

Discuss the value and importance of various multi-stakeholder collaborations to agree what and how real-world data (RWD) can be collected in order to generate real-world evidence (RWE) to support and optimise drug development; Understand the initiatives and recommendations on the use of RWE to inform decisions by healthcare systems (HTA/payers and regulators).

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Facilitator
David Sidney Ross, MBA, MSc, PMP, RAC

Speakers

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 →

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States

David Ross has led enterprise projects at AstraZeneca and Abbott Labs. He implemented enterprise solutions at AZ for cross-functional CSR Initiative, led the PQ/CMC pilot for AZ, developed roles for Early Clinical Authoring and leads Clinical Study Start up improvements in alignment... Read More →

Wednesday June 19, 2024 12:30pm - 1:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 12: Value-Access, Workshop

Level Intermediate
Level Intermediate
Tags Workshop

1:15pm PDT

#344: Leveraging Point of Care Technologies for Near Real Time, Interactive Safety Surveillance: Opportunities and Challenges

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-647-L04-P; CME 1.00; RN 1.00

Forum will summarize a study that demonstrated the ability of healthcare provides (HCPs) and pharmacovigilance (PV) staff to have near real-time adverse event communications. Panelists will discuss opportunities and challenges for extending this new, potentially transformative capability.

Learning Objectives

Discuss how digital technologies can facilitate the near real time, interactive exchange of adverse drug information between healthcare providers (HCPs) and pharmacovigilance (PV) experts in a trusted, compliant, and transparent manner; Identify the opportunities and challenges with such an approach.

Chair

Gregory Powell, PharmD, MBA

Speaker

MHRA Update
Phil Tregunno

Patient Update
Dave deBronkart

Physician/EHR update
Auren Weinberg, MD, MBA

Speakers

Gregory Powell

Senior Director, Safety and Clinical Innovation, GlaxoSmithKline, United States

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 →

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 →

Auren Weinberg

Chief Medical Officer, Veradigm, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

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

1:15pm PDT

#348: Challenges and Solutions to Building the Right Patient-Centered Evidence to Support Fit-For-Purpose Sensor-Based Outcomes

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-651-L04-P; CME 1.00; RN 1.00

Challenge areas for developing patient-centered sensor-based outcomes (SBOs) will be identified, along with solutions and key considerations using real-world examples of SBO development.

Learning Objectives

Describe key challenges to leveraging the patient-focused drug development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product development and decision making; Identify potential solutions to inform development of fit-for-purpose, patient-centered SBOs.

Chair

Katelyn R Keyloun, PharmD, MS

Speaker

Sensor-Based Outcome Measure Development: Challenge Areas for Concept Elicitation and Interpretation of Endpoints
Bill Byrom, PhD

FDA Update
Michelle Campbell, PhD

EMA Update
Steffen Thirstrup, MD, PhD

Speakers

Katelyn Keyloun

Director, R&D Digital and Data Strategy, AbbVie, United States

Kate has spent the last 10 years in the HEOR space, supporting evidence generation and the intersection of Patient Centered Outcomes Research and Digital Health. She started her career researching a cure for malaria, which fostered her strong desire to study medicine and gain a 360... Read More →

Bill Byrom

Vice President, Product Intelligence and Positioning; Principal, eCOA Science, Signant Health , United Kingdom

Bill is an eCOA scientist and VP of product intelligence and positioning at Signant Health. He has worked in the Pharmaceutical industry for over 30 years and is the author of over 70 publications and two industry textbooks on ePRO. His recent scientific work includes the use of wearable... Read More →

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 →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

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

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Workshop | 03: Data-Tech, Workshop

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

1:15pm PDT

#345: Regulatory Considerations in Trial Design for Cell and Gene Therapies

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-648-L04-P; CME 1.00; RN 1.00

Cell and gene therapies have enormous potential to address unmet medical need. The application of validated clinical trials design tools along with biomarkers to assess safety and endpoints can help address regulatory uncertainty.

Learning Objectives

Discuss regulatory considerations for cell and gene therapies including the use of data modeling in clinical trial design and the application of biomarkers both for safety assessment and measures of outcome; Discuss how to plan for meeting regulatory requirements and be able to incorporate these plans into your company’s drug development plans.

Chair

Kanwaljit Singh, MD, MBA, MPH

Speaker

Regulatory Considerations for Development of Pediatric Cell and Gene Therapies: FDA Update
Najat Bouchkouj, MD

Regulatory Consideration for Pediatric Cell and Gene Therapies - Industry Perspective
Paulla Dennis

Path from Bench-to-Bedside for a Cell and Gene Therapy Drug Product
Stephanie Cherqui, PhD

Speakers

Najat Bouchkouj

Associate Director for Pediatrics (Acting), Office of Clinical Evaluation, FDA, United States

Dr. Najat Bouchkouj is the Acting Associate Director for Pediatrics in the Office of Clinical Evaluation, OTP, CBER, FDA. Dr. Bouchkouj joined the FDA in 2016. She earned her medical degree from Damascus University, Syria and completed a residency in Pediatrics at the State University... Read More →

Stephanie Cherqui

Director, UC San Diego Gene Therapy Initiative, University of California San Diego, United States

Stephanie Cherqui is Professor in the Department of Pediatrics, Division of Genetics at the University of California San Diego. She is also the Director of the UC San Diego Gene Therapy Initiative. Her laboratory primarily centers on two research areas: the development of hematopoietic... Read More →

Paulla Dennis

Senior Director, Rare Diseases, Advanced Therapies, and Pediatrics, Fortrea, United States

• Paulla Dennis, Senior Director, is a leading member of the Rare Disease, Advanced Therapies, and Paediatric Team (RAPT) with over 20 years in the clinical research industry. Paulla has expertise in global phase I through IV pediatric and rare disease operational strategy and planning... Read More →

Kanwaljit Singh

Executive Director, International Neonatal Consortium, Critical Path Institute, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: TranslationalDelivery Tech-PrecMedicine, Session | 09: Regulatory, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Intermediate
Featured Topics Cell and Gene Therapy
Level Intermediate
Feature Topics Cell and Gene Therapy
Credit Type ACPE, CME, RN
Tags Session

1:15pm PDT

#346: A Clinical Research Workforce in Crisis: Imperatives for a Sustainable Staffing Model

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-649-L04-P; CME 1.00; RN 1.00

The clinical research workforce crisis threatens to undermine the entire drug development ecosystem. This session will discuss the glaring disconnect between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. It will feature a variety of industry leaders who will frame the issue and share lessons, solutions, and workforce development models that can be emulated globally to help build the next generation of clinical researchers--diverse and research ready.

Learning Objectives

Discuss the extent of the clinical research workforce crisis, including a diminishing pool of experienced clinical research professionals a ‘war for talent’ that is driving high and unsustainable turnover; Identify factors contributing to this crisis; Describe promising steps that can help with future workforce development.

Chair

Susan Landis

Speaker

Industry Update
Jimmy Bechtel, MBA

Industry Update
Meghan McKenzie, MA

Academic Update
Jonathan Watanabe, PharmD, PhD

Speakers

Susan Landis

Executive Director, Association of Clinical Research Professionals (ACRP), United States

Susan Landis serves as the Executive Director for the Association of Clinical Research Professionals. Prior to joining the Association, Susan led Strategic Engagement & Marketing Communications for the Duke Clinical Research Institute (DCRI). While at Duke, Susan established and led... Read More →

Jimmy Bechtel

Vice President, Site Engagement, Society for Clinical Research Sites (SCRS), United States

Jimmy brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum as a data specialist, patient recruiter and operations manager. On the pharma side where he worked... Read More →

Meghan McKenzie

Patient Inclusion and Head, Equity, Chief Diversity Office, Genentech, A Member of the Roche Group, United States

Meghan McKenzie works in Patient Inclusion and Health Equity in Genentech’s Chief Diversity Office (CDO). She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity. Genentech’s... Read More →

Jonathan Watanabe

Associate Dean, Pharmacy Assessment and Quality | Prof, Clinical Pharmacy, University of California Irvine, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjectManagement-StrategicPlanning, Session | 13: ProfDevelopment, Session | 02: ClinTrials -ClinOps, Session

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

1:15pm PDT

#351: Revolutionizing Quality Management: Harnessing the Power of AI for Enhanced Decision Making and Continuous Improvement

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-654-L04-P; CME 1.00; RN 1.00

This session explores four use cases of AI's potential to revolutionize quality management (QM) decision making and enhance organizational processes. Discover how AI is being implemented within QM and AI's role in identifying trends and driving improvement initiatives.

Learning Objectives

Describe the role of AI for quality management (QM) decision making, with a focus on advanced data analysis and pattern recognition, quality risk management, inspection readiness and drive continuous improvement initiatives; Identify practical use cases of AI in enterprise QMS, metadata extraction, risk assessment, and knowledge management systems, showcasing the benefits of AI integration.

Chair

Oliver Fink, MS

Speaker

AI Embedded Capabilities in an Enterprise Quality Management System
Michael Pelosi, MA, MBA, MSc

Augmenting Quality Assurance Activities with AI
Oeystein Kjoersvik, MS, MSc

AI Use Cases in Regulatory Monitoring
Haleh Valian, PhD

Speakers

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany

Oeystein Kjoersvik

Technology Auditor and Quality Projects Lead, Merck Sharp & Dohme LLC, Czech Republic

Oeystein Kjoersvik is currently a Technology Auditor and Quality Projects lead at Merck, one of his focuses is AI within QA. Oeystein also served as a Machine Learning SME for TransCelerate's Intelligent Automation team. Prior to his current role, he held the role of Product Owner... Read More →

Michael Pelosi

Director, Quality Analytics, Astellas, United States

Mike is the Astellas lead for strategy, implementation and integration of analytics and digital transformation capabilities and services across the Quality Assurance function.

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States

Haleh is the Biogen's Head of R&D Decision, Quality Analytics and innovations. She has more than 21 years of expertise utilizing advanced analytics to solve challenging business problems relating to process optimization in a variety of industries, including pharma, healthcare, and... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

08: RD Quality-Compliance, Session

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

1:15pm PDT

#352: Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA)

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-655-L04-P; CME 1.00; RN 1.00

This will be an interactive panel discussion with experts sharing examples how AI/ML can be used to create solutions for better regulatory decision-making and predicting regulatory success. Risks and benefits of using this approach will be discussed.

Panelists will include world-renowned experts on drug development, drug regulations, decision science and data analytics.

Learning Objectives

Evaluate how AI/ML can be used to help with regulatory decision making; Analyze scenarios using case studies by world’s leading expert on drug development, cloud computing, and predicting regulatory success; Compare risks and benefits for using this evolving technology.

Chair

Romi Singh, PhD

Speaker

Panelist
Kilian Weiss

Panelist
Subha Madhavan, PhD, FACMI

Panelist
Lily Li, JD

Speakers

Romi Singh

Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States

Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →

Lily Li

Founder and President, Metaverse Law, United States

Lily Li is the founder and president of Metaverse Law, a firm that focuses exclusively on privacy, AI, and cybersecurity law. She advises mid-sized, public, and multinational clients on a broad range of AI and data protection matters, such as the CCPA, GDPR, NIST AI Framework, Biden... Read More →

Subha Madhavan

Vice President and Head of AI/ML, Global Biometrics and Data Management, Pfizer Inc, United States

Subha Madhavan heads up AI/ML, Quantitative and Digital Sciences within Global Product Development at Pfizer. Prior to joining Pfizer, she was Head of Data Science and AI within Oncology R&D Strategy at AstraZeneca Pharmaceuticals. She has initiated and successfully directed several... Read More →

Kilian Weiss

General Manager, Veeva Link, Veeva, Germany

As general manager of Veeva Link, Kilian is responsible for the strategic direction, growth, and customer success of Veeva’s global Link Platform. He is also responsible for Veeva’s European Data business and commercial strategy. Before joining Veeva, Kilian founded Mederi, a... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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

1:15pm PDT

#353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-656-L04-P; CME 1.00; RN 1.00

Model Informed Drug Development (MIDD) can enhance the efficiency of drug development and regulatory decision-making. The ICH M15 guideline aims to enable the further integration and consistent use of MIDD. This session will cover the draft guideline in greater detail.

Learning Objectives

Discuss the draft guideline and what may be new to drug developers and the regulatory community, including the concept of a risk-based assessment, the value of multidisciplinary team alignment on MIDD strategy, and early alignment with regulators; Identify current approaches, best practices, and future opportunities to enhance development and decision-making.

Chair

Erin Greene, JD

Speaker

Industry Perspective
Malidi Ahamadi

Regulatory Perspective
Hao Zhu, PhD

Industry Perspective
Mark C. Peterson, PhD

Speakers

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.

Malidi Ahamadi

US Head, Modeling and Simulation, Sanofi, United States

Mark Peterson

Senior Director, Modeling and Simulation, Vertex Pharmaceuticals, United States

Dr. Mark C. Peterson works at Vertex Pharmaceuticals as a Senior Director in Clinical & Quantitative Pharmacology. Prior to that, he was at Pfizer (9 years), Biogen (2 years) and Amgen (8 years). Dr. Peterson received a Bachelor of Sciences in Pharmacy (1992) and a Doctorate in Pharmaceutical... Read More →

Hao Zhu

Division Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

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

1:15pm PDT

#354: ICMRA Post-Pandemic: Regulators Looking into the Future

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-657-L04-P; CME 1.00; RN 1.00

ICMRA regulators will share their views on the opportunities and challenges brought by some of the main innovative concepts and technologies they are facing, including artificial intelligence, evolving clinical trials, and real-world evidence in the authorization of advanced therapy medical products (ATMPs).

Learning Objectives

Identify how regulators are working on maximizing the opportunities offered by artificial intelligence while minimizing the risks; Discuss new concepts for enhanced clinical trials (e.g.: platform CTs, decentralized CTs); Describe opportunities and challenges brought by the use of real-world evidence data for authorization of advanced therapy medical products.

Chair

Emer Cooke, MBA, MSc

Speaker

Panelist
Anthony Lawler, MD, MBA

Panelist
Antonio Barra Torres, MD

Panelist
Lorraine Nolan, PhD

Panelist
Daisuke Koga, MSc, RPh

Panelist
Robert M. Califf, MD

Speakers

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia

Antonio Barra Torres

President Director, ANVISA, Brazil

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

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority , Ireland

Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →

Daisuke Koga

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan

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

Robert Califf

Commissioner, FDA, United States

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session

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

1:15pm PDT

#349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-652-L04-P; CME 1.00; RN 1.00

This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.

Learning Objectives

Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.

Chair

Yao-Yao Zhu, MD, PhD

Speaker

Panelist
Katherine A. High, MD

Panelist
Vaishali Popat, MD, MPH

Clinical Considerations for Oncology Cell and Gene Therapy Trials
Ke Liu, MD, PhD

Speakers

Yao-Yao Zhu

Regulatory Affairs Director, AstraZeneca, United States

Yao-Yao Zhu, MD, PhD, has over 15 years of regulatory experience. She is currently a Regulatory Affairs Director for cardiovascular, renal, and metabolic diseases at AstraZeneca (AZ). Prior to AZ, she was a head of Global Regulatory Affairs at Biosion for antibody products in oncology... Read More →

Katherine High

Co-Founder and Former President, Sparks Therapeutics; Visiting Professor, Rockefeller University, United States

Dr. Katherine High is the former President at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High... Read More →

Ke Liu

Chief Development Officer, Marengo Therapeutics, United States

As Chief Development Officer of Marengo Therapeutics, Ke Liu joins Marengo with over 20 years of experience in the field of oncology, immuno-oncology, and cell and gene therapy, most recently serving as Senior Vice President and led the key regulatory activities at Sana Biotechnology... Read More →

Vaishali Popat

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States

Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum | 04: MedAffairs-SciComm, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Cell and Gene Therapy
Level Intermediate
Feature Topics Regulator Perspectives,Cell and Gene Therapy
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#347: Artificial Intelligence in the Drug Development Lifecycle: Opportunities and Challenges in Regulatory Operations

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-650-L04-P; CME 1.00; RN 1.00

This panel will discuss opportunities and challenges of leveraging artificial intelligence (AI) in the drug development lifecycle, especially in regulatory operations. The panel will include representation from regulatory, and industry.

Learning Objectives

Identify the impact of artificial intelligence (AI) in the drug development lifecycle from health authorities' and, industry's perspectives; Recognize opportunities for the regulators and industry to leverage rapid advancement of AI to the drug development lifecycle; Discuss challenges to implement changes from policy, technology, standard, data security in regulatory operations.

Chair

Ethan Chen, MBA, MS, PMP

Speaker

The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Hilmar Hamann, PhD

Panelist
Tala Fakhouri, PhD, MPH

Panelist
Nicole Mahoney, PhD

Speakers

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →

Tala Fakhouri

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

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States

Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum | 03: Data-Tech, Forum

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

1:15pm PDT

#350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-653-L04-P; CME 1.00; RN 1.00

Discussion of ICH work to harmonize recommendations for inclusion of patient’s perspective in drug development. Patient group representatives will also highlight key considerations for clinical research and development of international standards.

Learning Objectives

Discuss ICH’s portfolio for inclusion of patient’s perspective in drug development and outline specific case examples; Describe the patient perspective in clinical research and identify key considerations that may be relevant for the international community in developing standards; Evaluate linkages between ICH’s mission and key interests of patient, health care professional, and life science communities.

Chair

Amanda Marie Roache, MS

Speaker

Moderator
Theresa Mullin, PhD

ICH E22 Patient Preference Studies
Brett Hauber, PhD, MA

ICH Patient Engagement
Francesco Pignatti, MD

Patient Perspective on Engagement to Inform Drug Development
Nicholas Brooke, MBA

Speakers

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium

Brett Hauber

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

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States

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

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 →

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States

Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 05: Patient-Focused Drug Dev, Session

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

1:15pm PDT

#355: Unlocking the Puzzle of Borrowing Adult Data for Designing Innovative Hybrid Pediatric Trials

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-658-L04-P; CME 1.00; RN 1.00

Recruiting pediatric patients is a challenge and one of the solutions is to carefully design the study in an hybrid way to borrow adult data for pediatric study using innovative statistical techniques. The workshop discusses the recruitment challenges involved and then attendees will play a role of providing their thoughts on pediatric recruitment challenges. The workshop explains how well a study can be designed in an innovative way with appropriately utilizing the statistical techniques with case study to overcome recruitment challenges.

Learning Objectives

Discuss how to borrow historical adult data for pediatric study where recruiting pediatric patients is a huge challenging task.

Chair

Rajesh Kumar Gajendran, SR, MSc

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Workshop

Format Workshop
Level Intermediate
Featured Topics Special Populations
Level Intermediate
Feature Topics Special Populations
Credit Type ACPE, CME, RN
Tags Workshop

2:15pm PDT

#356 RT: Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent

Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Karla Childers, MS

Speakers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 05: Patient-Focused Drug Dev, Session

Featured Topics Ethics
Feature Topics Ethics
Tags Session

2:15pm PDT

#357 RT: Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience

Component Type: Session

Join the Digital Acceleration Community for a follow up round table discussion tied to session: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Cesar Vinces

Speakers

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States

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

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

16: Community Rounds, Session | 09: Regulatory, Session | 03: Data-Tech, Session

Tags Session

2:15pm PDT

Refreshment Break

Component Type: Social Event

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

17: Networking Opportunities, Social Event

Tags Social Event

2:30pm PDT

#358 CH: RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room?

Component Type: Workshop
Level: Intermediate

Critical-to-Quality (CtQ) factors are key to determining which protocol-related processes and variables matter. These should be defined cross-functionally during risk assessment and built into all functional plans to have a common focus and approach.

Learning Objectives

Define Critical-to-Quality (CtQ) variables; Streamline CtQ to all functional plans for common approach; Understand the benefits from reduced SDR/SDV by focusing on CtQ as variables that matter.

Chair

Terry Katz, MS

Speakers

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States

Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Wednesday June 19, 2024 2:30pm - 3:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

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

Level Intermediate
Level Intermediate
Tags Workshop

2:30pm PDT

#358.1 IT: DIA Innovation Theater: The 2024 DIA Science Priorities - Inspired by the Original Olympic Games Motto "Faster, Higher, Stronger"

Component Type: Session

Discussion of the new DIA Science Priorities and our approach for establishing new avenues for collaborative research and regulatory harmonization through information sharing and multi-stakeholder consensus building, with patients in the center of our agenda.

Chair

Maria Vassileva, PhD

Speaker

Speaker
Chockalingam Palaniappan, PhD

Speakers

Chockalingam Palaniappan

Life Sciences Innovation Executive, United States

Member of the DIA Board of Directors and also serves as the Co-chair for the DIA Science Policy Advisory Committee. He is an accomplished global life sciences innovation executive with more than 20 years of leadership experience across three multinational corporations, GE Healthcare... Read More →

Maria Vassileva

Global Head of Science and Scientific Strategy, DIA, United States

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →

Wednesday June 19, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

19: InnovationTheaters, Session

Tags Session

3:15pm PDT

#359: A Safety Surveillance Plan for Serious Anticipated Events

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-659-L04-P; CME 1.00; RN 1.00

A number of questions remain about Safety Surveillance Plans (SSPs). The proposed panel discussion will include persons from multiple sponsors who have experience with developing processes to address the FDA’s recommendations in the 2021 guidance.

Learning Objectives

Discuss when a safety surveillance plan (SSP) is warranted; Describe specifics on implementation of the trigger method; Evaluate a product in different patient populations and ensure study integrity; Identify clarity on roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting.

Chair

Greg Ball, PhD

Speaker

Panelist
Susan Talbot

Panelist
Ranjeeta Sinvhal, MD

Panelist
Susan Kindig, JD, MD

Speakers

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 →

Susan Kindig

Prior Executive Director, Medical and Drug Safety, United States

Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience... Read More →

Ranjeeta Sinvhal

Executive Medical Director, Medical Safety, AbbVie, United States

Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Instructor in Loyola PV Certificate Course. Co-chair of Cardiovascular Internal Safety... Read More →

Susan Talbot

Director Biostatistics, Amgen, United States

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Forum

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

3:15pm PDT

#362: Streamlining Processes and Data Exchange Across R&D Functions to Improve Performance and Facilitate Automation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-662-L04-P; CME 1.00; RN 1.00

In this interactive forum, panelists share how they are working across R&D to improve processes and data flows, govern their data, move toward more data-driven processes, and facilitate the use of artificial intelligence (AI) and advanced technologies.

Learning Objectives

Identify how sponsor companies are optimizing their business processes and getting more value from their data across R&D; Discuss approaches for process optimization, data governance and standardization; Describe ways to move towards data-driven business processes and how to enable greater automation and business efficiency across product development.

Chair

Cary Smithson, MBA

Speaker

Panelist
Linda Chong, MBA

Panelist
Rayna Venook, PhD

Speakers

Cary Smithson

Senior Director, Business Transformation & Systems Management, Cencora Pharmalex, United States

Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory... Read More →

Linda Chong

Director, Regulatory Information Management, Daiichi Sankyo, United States

Linda Chong has overall 20 years of experience within the Pharmaceutical industry specifically Regulatory Information Management, Global Submission Management, and Data Governance including organization change management. She is currently the Director of Regulatory Information Management... Read More →

Rayna Venook

Team Lead, Pharma Development Regulatory, Genentech, A Member of the Roche Group, United States

Rayna Venook is a Team Lead within the Regulatory Information Management organization at Roche. In this capacity, she focuses on facilitating the development and delivery of solutions to enhance data interoperability to enable integrated solutions across Roche. She has 17 years of... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

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

3:15pm PDT

#360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-660-L04-P; CME 1.00; RN 1.00

Unlocking AI's potential to facilitate diversity in clinical trials demands inclusive images capturing skin manifestations of internal diseases across races and ethnicities. Join our panel to learn more about inclusive innovation in AI solutions.

Learning Objectives

Discuss the importance of photographs and images in AI algorithms to identify internal diseases impacting patients of color and how that supports clinical trial enrollment; Identify the questions to ask of AI solution providers to ensure imagery is inclusive; Describe what’s being done to improve imagery in AI learning to drive clinical trial diversity.

Chair

Pamela Simpkins, MBA

Speaker

Patient Update
Tricha Shivas, MS

Industry Update
Lionel Phillips, MBA

Industry Update
Brian H Johnson

Speakers

Pamela Simpkins

Managing Partner, Mezzopointe. LLC, United States

Biopharma R&D executive with 26+ years in the industry and nearly a decade as an institutional investor. Expert in R&D Finance with a proven track record in accelerating development of key pipeline assets to achieve regulatory approval and market authorization. Built, led and sold... Read More →

Brian Johnson

Vice President, R&D Technology, Takeda, United States

Lionel Phillips

President, Inside Edge Consulting, United States

Tricha Shivas

Chief of Staff and Strategy, Foundation For Sarcoidosis Research, United States

Tricha Shivas joined the Foundation for Sarcoidosis Research (FSR) in December of 2020. As the Chief of Staff and Strategy, she works with various stakeholders including individuals living with sarcoidosis. Through her career she has built strong stakeholder relations, created comprehensive... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Session | 11: Statistics-Data Science, Session | 02: ClinTrials -ClinOps, Session

Format Session
Level Basic
Featured Topics Artificial Intelligence (AI), Decentralized Clinical Trials (DCTs)
Level Basic
Feature Topics Artificial Intelligence (AI),Decentralized Clinical Trials (DCTs)
Credit Type ACPE, CME, RN
Tags Session

3:15pm PDT

#366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-666-L04-P; CME 1.00; RN 1.00

This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.

Learning Objectives

Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.

Chair

Allison Martin, MS
Victoria DiBiaso, BSN, MPH, RN

Speaker

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
Michelle Campbell, PhD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
Francesco Pignatti, MD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: Industry Update
Jill Yersak

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
Hollie Schmidt, MS

Speakers

Allison Martin

Director, Regulatory Science and Policy, North America, Sanofi, United States

As a Director on Sanofi’s Regulatory Science and Policy North America team, Allison is responsible for advancing regulatory science and strategically engaging in regulatory policy efforts. In this role, Ms. Martin collaborates with internal and external stakeholders to identify... Read More →

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, Sanofi, France

Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Hollie Schmidt

Vice President of Scientific Operations, Accelerated Cure Project, United States

Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →

Jill Yersak

Head, US ALS Patient Advocacy and Engagement, Amylyx Pharmaceuticals, United States

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 09: Regulatory, Session

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

3:15pm PDT

#364: Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-664-L04-P; CME 1.00; PDU 1.00 PMI 216658O27Z; RN 1.00

In this session, we will provide an overview of lifecycle management for an asset from patent filing to loss of exclusivity. Critical success factors require early planning, rigorous prioritization, organizational alignment, cross-functional buy-in and collaboration, and retention of enterprise memory over the long lifecycle of an asset. Program managers will gain insight into their unique role as champions of process and people, ensuring therapies reach patients faster. Proven strategies from case study examples will outline key decision points at each stage of product development, identify tools for strengthening cross-functional team planning, ensure quality oversight, and enhance successful delivery of the product lifecycle strategy.

Learning Objectives

Identify the concept of pharmaceutical lifecycle management and its role in bringing lifesaving therapies to patients efficiently; Discuss the challenges of pharmaceutical lifecycle management, such as siloed department planning and lack of resources; Describe the role of project management in ensuring continuity of lifecycle management and the execution of the product strategy.

Chair

Susan Carino, MBA, MS, PMP, RAC

Speaker

Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey: Industry Update
Aditi Khurana, MBA, PMP, RAC

Speakers

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

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

07: ProjectManagement-StrategicPlanning, Session

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

3:15pm PDT

#365: Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-665-L04-P; CME 1.00; RN 1.00

Adequate enrollment of underrepresented groups continues to be a challenge in a complex, global regulatory and research ecosystem. Review and assess evolving expectations and processes in the US, Canada, and other regulatory systems, what has been implemented, what adjustments have been made, what has worked, and what hurdles or differences remain.

Learning Objectives

Describe the background and underlying requirements to FDA’s and other health authorities’ diversity and inclusion policies and guidance; Discuss how different stakeholders have implemented and reacted to implementation of new and evolving policies; Identify areas where views or expectations diverge; Discuss and describe what has worked, what has not; Identify how this area might change in future.

Chair

Alexis Miller, JD

Speaker

FDA Update
Karen Hicks, DrMed

Health Canada Update
Alysha Croker, PhD

UK Update
Naho Yamazaki, PhD

Patient Update
Loriana Hernandez-Aldama

Speakers

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →

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 →

Loriana Hernandez-Aldama

Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup For Life, United States

Loriana is a 2x cancer survivor, international motivational speaker, award-winning journalist, podcast host, and author of "Becoming the Story: The Power of Prehab." Bold, transparent, and honest, Loriana has emerged as a game-changer in healthcare, advocating globally for transformative... Read More →

Karen Hicks

Deputy Director, Office of Medical Policy, CDER, FDA, United States

Dr. Hicks is the Deputy Director of the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). She oversees regulation and policy development for CDER and participates in cross-cutting agency initiatives... Read More →

Naho Yamazaki

Deputy Director, Policy and Partnerships, Health Research Authority, United Kingdom

Naho is Deputy Director, Policy and Partnerships at the Health Research Authority (HRA), where she is leading on a range of policy and engagement initiatives for the HRA to make it easy to do research that people can trust. This includes pushing for change to increase diversity and... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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

3:15pm PDT

#367: EMA Town Hall

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-667-L04-P; CME 1.00; RN 1.00

The European Forum will explain our various platforms and ways to engage to support innovation, illustrated on an example of an Advanced Therapy Medicinal Product (ATMP).

Learning Objectives

Describe the assessment procedure and the role of CHMP and rappoteur; Describe platforms to support developers; Discuss a successful submission of an ATMP.

Chair

Steffen Thirstrup, MD, PhD

Speaker

Panelist
Sabine Haubenreisser, PhD, MSc

Panelist
Anabela Marcal, PharmD

Panelist
Evdokia Korakianiti, PhD, MSc

Speakers

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 →

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 →

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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

3:15pm PDT

#363: Implementing Changes To Drug-Device Combination Products Globally

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-663-L04-P; CME 1.00; RN 1.00

Industry and regulators will collaborate to discuss current challenges and future opportunities to streamline post approval changes to combination products.

Learning Objectives

Describe current regulatory frameworks for lifecycle management changes to combination products; Compare differences in expectations for submissions of post-approval changes globally; Discuss the utilization of harmonized guideline, ICH Q12, for management of post approval changes to combination products globally.

Chair

Chelsea O'Connell, MS, RAC

Speaker

FDA CBER Perspective on Postmarket Changes to CBER-Led Combination Products
Andrea Gray, PhD

Industry Perspective on the Latest ICH Q12 Training Module 8
Andrew Chang, PhD

Industry Perspective on Postmarket Changes to Combination Products: Global
Amy Wise, MBA

PMDA Update: Postmarket Changes to Combination Products in Japan
Keisuke Tanaka, PhD

Industry Perspective on Postmarket Changes to Combination Products: US
Lori-Anne Boville

Speakers

Chelsea O'Connell

Director, Global Regulatory and R&D Policy, Amgen, United States

Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →

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 →

Amy Wise

Associate Director, RA Device and Combination Products, AbbVie, United States

Amy Wise is an Associate Director Regulatory Affairs Device and Combination Products at AbbVie. Amy has been in the pharmaceutical industry for 25 years with 15 years in regulatory affairs, 5 years in quality and 5 years in pharmaceutical sciences. She has successfully provided the... Read More →

Andrea Gray

Biomedical Engineer Advisor, CBER, FDA , United States

Keisuke Tanaka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Tanaka is Reviewer of the Office of Cellular and Tissue-based Products, PMDA. He received his Ph, D. from Osaka University in Bioorganic chemistry with emphasis in nucleic acid therapy. Since joining PMDA in 2021, he has worked in the Office of Cellular and Tissue-based Products... Read More →

Lori-Anne Boville

Group Director, Pharma Technical Regulatory, Device and Combination Products, Genentech, A Member of the Roche Group, United States

She is a Regulatory Affairs Expert in Biologics products, Medical Devices & Combination Products at Genentech. Lori has over 20 years of Biopharmaceutical product development, analytical testing, commercial quality, regulatory affairs and medical device experience. She has successfully... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session

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

3:15pm PDT

#368: Harnessing the Power of Artificial Intelligence (AI) in Clinical Research From Knowledge Graphs to Generative AI

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-668-L04-P; CME 1.00; RN 1.00

This session discusses usage of a variety of artificial intelligence (AI) solutions (knowledge-based expert systems, generative AI, machine learning) across the clinical research lifecycle from drug discovery to patient recruitment, data quality management, and submission. We will go over specific problems that lend themselves to AI and how we go about building scalable solutions with emphasis on explainability, reliability, and validity.

Learning Objectives

Discuss the use of generative artificial intelligence (AI) and machine learning in clinical research and measures taken to insure validity and reliability; Describe the role of knowledge graph (KG) in building AI systems.

Chair

Katy Ghantous, PhD, MS

Speaker

Industry Update
John Overington

Industry Update
Joe Mullen, PhD, MS

Academic Update
Ramona Lynn Walls, PhD

Speakers

Katy Ghantous

Senior Director, Data Science, Medidata Solutions, United States

Joe Mullen

Head of Data Science and Professional Services, SciBite, United Kingdom

Leading SciBite's data science and professional services team, Joe is dedicated to helping customers unlock the full potential of their data using SciBite's semantic stack. Joe spearheads R&D initiatives within the team, pushing the boundaries of what is possible. Joe's expertise... Read More →

John Overington

Chief Data Officer, Exscientia, United Kingdom

John Overington is Chief Data Officer at Exscientia & has over 35 years experience of drug discovery & design, data science & machine learning; encompassing innovation and leadership positions in pharma, academia & biotech sectors. After a degree in Chemistry, a PhD in protein structure... Read More →

Ramona Walls

Executive Director of Data Science, Data Collaboration Center, Critical Path Institute, United States

Ramona Walls, Ph.D. is Executive Director of Data Science at the non-profit Critical Path Institute (C-Path). She oversees multiple efforts including C-Path’s Data and Analytics Platform, development of a rare disease knowledge graph, and expansion and modernization of C-Path’s... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Session

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

3:15pm PDT

#361: Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-661-L04-P; CME 1.00; RN 1.00

Recruitment is a significant building block of clinical trials and also one of the greatest challenges, often having a direct influence on trial success or failure. In-efficiencies associated with patient recruitment may lead to prolonged trial durations, increased costs, and delays in bringing effective treatments to market. This session will explore methods for predicting the effect of different recruitment patterns on trial progression, outcomes and likelihood of the trial to meet its goals and present newly available technologies and trial design measures for successfully advancing recruitment.

Learning Objectives

Describe the considerations of recruitment rate optimization in clinical trials and adaptive trials in particular; Discuss the available technologies and methodologies for optimizing recruitment via dedicated software, patient advocacies, databases and registries and the evaluation of trade-offs between trial duration and sample size requirements within a variety of adaptive trial designs as compared with standard fixed designs.

Chair

Raviv Pryluk, PhD

Speaker

Time is Life: Leveraging Innovation in Clinical Trials for Rapid Recruitment
Tanya Russell, PhD, MS, RPh

Potential for Leveraging AI/ML in Pre-Trial Recruitment Modelling
Jenny Higley, MS

Demystifying Site Engagement: Leveraging an Omnichannel Approach with Data-Driven Clinical Analytics
Sanghita Bhattacharya, PhD

Optimizing Clinical Trial Site Selection: Balancing Recruitment Efficiency and Population Diversity
Raviv Pryluk, PhD

Speakers

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 →

Sanghita Bhattacharya

Associate Director Data Science , Feasibility and Analytics, Clinical Operations, Johnson & Johnson Innovative Medicine, United States

Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as... Read More →

Jenny Higley

Director, Head of Feasibility CoE, Biogen, United States

Jenny has 20 years of clinical research experience and is currently the Director of the Feasibility Center of Excellence at Biogen, where she has worked for the past four years. Jenny’s career also includes CRO and ARO experience from IQVIA, Syneos Health, and the Duke Clinical... Read More →

Tanya Russell

Vice President, Integration Lead, Pfizer Inc, United States

Tanya Russell recently moved into a new role as Vice President, CD&O Integration Lead supporting the R&D integration of Seagen and Pfizer into one Pfizer Oncology department. For the last 3+ years, Tanya was Pfizer’s Oncology and Rare Disease Clinical Operations Head with accountability... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Session | 03: Data-Tech, Session | 02: ClinTrials -ClinOps, Session

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

3:15pm PDT

#369: Improving Communication Across Differences in Drug Development Teams

Component Type: Workshop
Level: Intermediate

The interactive workshop will provide an opportunity for participants to discuss common barriers that hinder effective communication in cross-cultural, diverse teams. Discussion will draw from the management, psychology, and drug development literature to help contextualize communication and feedback giving.

Learning Objectives

Identify and discuss common interactions and patterns that can hinder effective communication in diverse and cross-cultural teams in drug development; Describe common pitfalls and fallacies related to feedback and learn how to avoid them; Identify evidence-based solutions on how to reduce barriers to communication.

Chair

Jennifer Kim, PhD

Speaker

Empirical Perspective: What the Research on Team Communication in Drug Development Reveals
Emily Botto

Learning and Development Perspective: Best Practices for Training and Implementation
Tamei Elliott, MS

Case Perspective: Learnings from the Field
Christine Mayer-Nicolai, PharmD

Speakers

Jennifer Kim

Research Assistant Professor, Tufts Center for the Study of Drug Development, United States

I'm a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining how diversity, equity and inclusion dynamics impact individual, group, and organizational outcomes... Read More →

Emily Botto

Research Analyst, Tufts Center for the Study of Drug Development, United States

Emily Botto joined the Tufts Center for the Study of Drug Development (Tufts CSDD) as a Research Analyst in October 2020 after graduating from Brandeis University. Her work focuses on studies relating to clinical research execution strategies and practices as well as clinical trial... Read More →

Tamei Elliott

Associate Director, Scientific Programs, DIA, United States

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →

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 →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Format Workshop
Level Intermediate
Level Intermediate
Tags Workshop

4:30pm PDT

#370: Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-669-L04-P; CME 1.00; RN 1.00

Artificial intelligence solutions may support and enhance human decision-making and information processing throughout pharmacovigilance. This session aims to outline best practices and potential pitfalls in their use.

Learning Objectives

Recognize key challenges in assessing artificial intelligence solutions and interpreting evaluations of their performance; Describe some best practices for critical appraisal of artificial intelligence solutions; Identify the need for consideration of human computer interactions.

Chair

Jim Barrett, PhD, MSc

Speaker

MHRA Update
Phil Tregunno

FDA Update
Monica Munoz, PharmD, PhD

Industry Update
Andrew Bate, PhD, MA

Speakers

Jim Barrett

Senior Data Scientist, Uppsala Monitoring Centre (UMC), Sweden

Jim is a senior data scientist at Uppsala Monitoring Centre (UMC), where he has worked for the past 4 years. In that time, Jim has worked on several projects including advanced signal detection methods, tools to facilitate analysis of large case series and NLP methods for mining structured... Read More →

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 →

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States

CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

01: ClinSafety-PV, Session

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

4:30pm PDT

#374: Updated Status of Multiregional Clinical Trials Based on ICH E17 Guideline: 5 Years After the Implementation

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-673-L04-P; CME 1.00; RN 1.00

The forum will consist of regulators and industry experts who were the authors of the ICH E17 guidelines. As regulators and sponsors, they will provide first-hand narrative on their experiences in implementing the ICH E17 guidelines.

Learning Objectives

Discuss the status of adoption of ICH E17 guidelines on conduct of multiregional clinical trials (MRCT) by the regulators and industry. • Identify reasons behind slow uptake of the ICH E17 guidelines. • Discuss points for increasing usage of E17 for conduct of MRCT and simultaneous global development.

Chair

Yoshiaki Uyama, PhD, RPh

Speaker

PMDA Perspective
Yoko Aoi, PhD

Pharmaceutical Industry Perspective
Romi Singh, PhD

FDA Update
Douglas Pratt

Taiwan Perspective
I-Chun Lai, MD, MS

China Perspective
Yangfeng Wu, MD, PhD

Speakers

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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

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 →

I-Chun Lai

Director, Consultation Division, Center for Drug Evaluation, Taiwan

Dr. I-Chun Lai graduated with her medical degree from Taipei Medical University in Taiwan in 2001 and worked as a physician until 2007, when she joined the Center for Drug Evaluation (CDE) in Taiwan. In 2013, she received her Master of Science from the Institute of Health Policy and... Read More →

Douglas Pratt

Supervisory Medical Officer, OVRR, CBER, FDA , United States

Romi Singh

Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States

Yangfeng Wu

Executive Director, Peking University Clinical Research Institute, China

Professor Wu is the Executive Director of Peking University Clinical Research Institute. He has been principal investigators of tens of research projects sponsored by national and international founding agencies including China Ministry of Science and Technology, China Natural Science... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum | 09: Regulatory, Forum

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

4:30pm PDT

#372: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence: An Industry and Regulatory Agency Experience

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-671-L04-P; CME 1.00; RN 1.00

This forum will discuss regulatory activities and technology to enable global convergence and reliance for post-approval changes (PAC). Diverse panelists will share examples of efficient collaboration and information exchange to reduce the PAC process cycle times.

Learning Objectives

Recognize the importance of global collaboration to support sovereign decision making; Discuss how building in reliance practices into cloud-based solutions could accelerate the post-approve changes (PAC) process globally; Explain how cloud solutions support transparency, trust, regulatory convergence, and information exchange, and collaboration to increase patient access to therapies.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Samvel Azatyan, MD, PhD

Panelist
David Mukanga, PhD, MPH

Panelist
Susanne Ausborn, PhD

Panelist
Cynthia Ban

Speakers

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States

Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →

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 →

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland

Cynthia Ban

Global Head, Regulatory Affairs CMC, Vaccines, Sanofi, Canada

Cynthia Ban is the Global Head Regulatory CMC & Devices for Vaccines at Sanofi. Senior Global Leader in the pharmaceutical industry specializing in Regulatory Affairs. Worked for small biotech and large multinational companies. Led and developed teams across multiple geographies and... Read More →

David Mukanga

Deputy Director, Africa Regulatory Systems, Bill & Melinda Gates Foundation, United States

Dr. David Mukanga is Deputy Director Africa Regulatory Systems at the Bill & Melinda Gates Foundation, where he leads the foundation’s Africa regulatory systems optimization portfolio, and the linkage between regulatory systems and health care services. In this role, David supports... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

03: Data-Tech, Forum

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

4:30pm PDT

#373: Patient-Centric Approaches in Summaries and Data Return

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-672-L04-P; CME 1.00; RN 1.00

Join us for a multi-stakeholder discussion to learn more about the practical tools and considerations available to help sponsors get started or improve their participant communications including lay protocol synopses, lay summaries, and participant data return.

Learning Objectives

Recognize the problems in explaining benefit and risk to patients and lay audiences; Define meaningful communication of information to research participants; Identify how evolving collaborations, proactive planning, interoperability, digital health advancements, and secure data management enable participant data return options that do not compromise data integrity, confidentiality, or submission timelines.

Chair

Jean Sposaro, MHS, LLM

Speaker

Individual Participant Data Return: Feasible, Personal, and Actionable Options to Support Informed Decision-Making
Jean Sposaro, MHS, LLM

Patient Perspective
T.J. Sharpe, PMP

Speakers

Jean Sposaro

Director, Global Drug Development Operations, Industry Collaborations, Bristol-Myers Squibb Company, United States

Healthcare Provider, Researcher, Patient Advocate, Bioethics, Pharmaceutical Law & Policy Professional advancing science through impactful collaboration with stakeholders across the R&D ecosystem to "co-create a healthier future". Optimizing global collaborations as enablers of innovation... Read More →

T.J. Sharpe

Patient Engagement Expert, Consultant, United States

T.J. Sharpe is a speaker, writer, and patient expert consultant working with top pharmaceutical companies and clinical research stakeholders seeking sustained, ingrained, consistent patient engagement. A Stage IV melanoma survivor given two years to live, his continuation from survivorship... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session

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

4:30pm PDT

#371: Using Influencers to Recruit Hard-to-Engage Populations

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-670-L04-P; CME 1.00; RN 1.00

Influencers are community connectors that can be leveraged to expand patient recruitment, particularly for hard-to-engage populations. We will discuss how influencers can engage patient audiences for clinical trial participation.

Learning Objectives

Discuss the power of influencer marketing to improve clinical trial participation, including among diverse populations; Describe how to build an effective influencer campaign — matching the right influencer to your objectives; Develop effective digital assets; Identify how to maximize exposure among a captivated audience.

Chair

Sarah McKeown-Cannon

Speaker

Industry Update
Lara Lane

Speakers

Lara Lane

Director, Clinical Operations, Ironwood Pharmaceuticals, United States

As Director of Clinical Operations at Ironwood, Lara is responsible for developing and executing clinical operations program strategies, ensuring the delivery of high-quality results. With 20+ years of expertise in the industry, her work experience has spanned across clinical sites... Read More →

Sarah McKeown-Cannon

Vice President, Growth, Publicis Health, United States

Sarah McKeown-Cannon (she/her/hers) provides innovative patient recruitment and engagement solutions that enrich study experiences and deliver measurable results. She is driven by her commitment to making a difference in people's lives, by understanding all the dimensions that make... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Session | 02: ClinTrials -ClinOps, Session

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

4:30pm PDT

#375.1: Middle East Emerging Opportunities

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-694-L04-P; CME 1.00; RN 1.00

In this forum, regulatory authorities from the Middle East region will share updates, success stories, lessons learned and plans for the future.

Learning Objectives

Identify the regulatory authorities' representatives from the Middle East region; Discuss new developments and opportunities in the region.

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

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

4:30pm PDT

#375: Sustainability of Rare Disease Drug Development

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-674-L04-P; CME 1.00; RN 1.00

Panelists will reflect on the past forty years of the orphan drug act including advancements and impediments. The panel will discuss what is needed in the future to continue to advance rare disease drug development to treat as many patients as possible.

Learning Objectives

Discuss the outcomes, challenges, and opportunities in the next forty years of the Orphan Drug Act; Identify policy advancements that need to be made to continue innovative rare disease drug development.

Chair

Darcy Frear, PhD

Speaker

Panelist
Katherine Donigan, PhD

Panelist
Patroula Smpokou, MD

Panelist
Karin Hoelzer, DVM, PhD

Panelist
Julia Tierney, JD

Speakers

Darcy Frear

Associate Director, Bridgebio, United States

Dr. Darcy Frear is currently the associate director for Regulatory Policy and Intelligence at BridgeBio. Prior to joining BridgeBio in 2022, Darcy began her regulatory career at Genentech supporting program management in oncology and US regulatory policy. Subsequently, she joined... Read More →

Katherine Donigan

Senior Director, Science and Regulatory Policy, Sarepta, United States

Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory Policy at Sarepta Therapeutics. Prior to joining Sarepta, Dr. Donigan was a Senior Director of Science and Regulatory at Biotechnology Innovation Organization (BIO) and spent 7 years in regulatory policy... Read More →

Karin Hoelzer

Senior Director, Policy and Regulatory Affairs, NORD, United States

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

Patroula Smpokou

Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER, FDA, United States

Patroula Smpokou, MD, is a board-certified pediatric clinical geneticist working in the Division of Rare Diseases and Medical Genetics at CDER. Her work involves the clinical review and regulation of products intended for rare genetic diseases. Prior to joining FDA, she was a practicing... Read More →

Julia Tierney

Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Rare Disease
Level Intermediate
Feature Topics Rare Disease
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-675-L04-P; CME 1.00; RN 1.00

This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.

Learning Objectives

Identify the key current challenges in quality control for cell and gene therapy development; Explain global regulators’ perspectives on quality control, including raw material selection, control, and qualification; Discuss best practices, including standards and reference materials, to support the development and manufacture of cell and gene therapies.

Chair

Fouad Atouf, PhD

Speaker

Qualification and Selection of Raw Materials During Early Stage of Development
Mo Heidaran, PhD

Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
Haritha Vallabhaneni, PhD

Cell and Gene Therapy Products: Global Regulatory Perspective
Michael Day, PhD

Speakers

Fouad Atouf

Senior Vice President, Global Biologics, United States Pharmacopeia (USP), United States

Dr. Atouf has over 20 years’ experience in research, product development, characterization and quality assessment of biologics including cell and gene therapies (CGT). At USP, he heads the Biologics program and oversees standards development, stakeholder engagement and external... Read More →

Michael Day

Senior Director, Regulatory Science, VCLS, United States

As a Senior Director, Regulatory Science and Head of Cell and Gene Therapies at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced... Read More →

Mo Heidaran

Chief Regulatory Scientist, Cellx Inc., Consulting, United States

Dr. Mo Heidaran is currently Chief Regulatory Scientist at Cellx Inc. He previously worked as Head of Translational and Regulatory Strategy at GCTx (GC Therapeutics). He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the... Read More →

Haritha Vallabhaneni

Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER, FDA, United States

Dr. Vallabhaneni is a CMC Reviewer in the Division of Cell Therapy 1, CBER, FDA. She is involved in CMC review of regulatory applications involving cellular therapy products. She has extensive research experience in stem cells previously working on multiple research projects investigating... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Session | 06: TranslationalDelivery Tech-PrecMedicine, Session | 10: RegCMC-Product Quality, Session

Format Session
Level Intermediate
Featured Topics Cell and Gene Therapy
Level Intermediate
Feature Topics Cell and Gene Therapy
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-676-L04-P; CME 1.00; RN 1.00

This session will include a case study in a short-term depression trial with repeated measurements of continuous outcomes and two types of intercurrent events, and evaluate the four developed data-generating models. Can we jointly generate outcomes and intercurrent events that are associated for a generic phase 3 trial in simulation studies? What data-generating models can be used to achieve this?

Learning Objectives

Describe phase 3 randomized controlled trial data (clinical outcomes and intercurrent events) and model the association between efficacy outcomes and intercurrent events; Discuss how this research is needed to enable analytical or simulation studies that can investigate estimands and strategies on datasets generated under the same data-generating models; Identify how to implement the E9(R1) estimand framework.

Chair

Marian Mitroiu, PhD

Speaker

EMA Update
Francesco Pignatti, MD

FDA Update
Cesar Daniel Torres, PhD, MS

MEB Update
Laura Rodwell, PhD

Speakers

Marian Mitroiu

Associate Director Biostatistics, Biogen, Switzerland

Marian is from Romania. In 2015-2016 he did a traineeship at EMA in London at the Biostatistics and Methodology Office. In 2017, he started his doctoral studies at Julius Center, UMC Utrecht and Utrecht University. He worked in parallel at CBG-MEB, being part of the Methodology Working... Read More →

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands

Laura Rodwell

Statistical Assessor, Dutch Medicines Evaluation Board, Netherlands

Laura has been working in research and biostatistics in one way or another for the past 20 years. After starting her career in crime research she became more interested in medical research and clinical trials. She completed her Master of Biostatistics in 2010 and a PhD in Biostatistics... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Session

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

4:30pm PDT

#378: From X to Z: Unleashing the Power of Multigenerational Collaboration in Life Sciences – The Basics for All

Component Type: Workshop
Level: Basic

Unlock the secrets of workplace success! Learn to harness the strengths of each generation and build a cohesive and successful team. Don't miss out on the opportunity to learn valuable insights and strategies for managing a diverse workforce.

Learning Objectives

Explore the unique characteristics and differences among different generations in the workplace; Discuss practical ideas on how to effectively manage and create a harmonious and productive work environment; Describe how to dispel the myths and stereotype of each generation.

Chair

Tywnia Brewton

Speaker

Facilitator
Leslie Sam

Speakers

Tywnia Brewton

Executive Director, Human Resources, Astellas , United States

Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

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

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

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