DIA 2025 Global Annual Meeting: Full Schedule

arrow_back View All Dates

8:30am EDT

#301: Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report

Wednesday June 18, 2025 8:30am - 9:30am EDT

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-609-L04-P; CME 1.00; RN 1.00

The session reports the CIOMS WG XII Benefit-Risk Balance for Medicinal Products that formulates key principles for lifecycle benefit-risk assessments to inform decision-making and further the development of medicines that patients need.

Learning Objectives

Discuss the Benefit-Risk Balance for Medicinal Products issued by CIOMS WG XII; Explain the conduct of high quality, balanced and comprehensive lifecycle benefit-risk assessments using the structured benefit-risk framework; Identify strategic guidance patient-centric benefit-risk assessment methodologies to improve transparency and understanding amongst key stakeholders.

Chair

Claudia Ana Ianos, MD

Speaker

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Claudia Ana Ianos, MD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Carmit Strauss, PharmD

Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Scott Evans, PhD, MS

Speakers

Scott Evans

Professor and Founding Chair, Department of Biostatistics and Bioinformatics, George Washington University Milken Institute of Public Health, United States

Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of The Biostatistics Center at George Washington University. He is the: Director of the SDMC for the Antibacterial Resistance Leadership Group (ARLG); PI of the Coordinating... Read More →

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer Inc, United States

Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 15 years of... Read More →

Carmit Strauss

Executive Director, Head of Risk Management and Organ Toxicity, Takeda, United States

Carmit Strauss PharmD, is an Executive Director at Takeda overseeing the Risk Management and Organ Toxicity centers of excellence. She has an extensive experience in risk management working in various leadership roles within Safety, Pharmacovigilance and Medical Affairs. Carmit participants... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#303: Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?

Wednesday June 18, 2025 8:30am - 9:30am EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-611-L04-P; CME 1.00; RN 1.00

Reporting of safety reports to FAERS using ICH E2B (R3) format. The presenters will discuss scenarios, system readiness, testing approach, challenges and lesson learned for a successful implementation and onboarding.

Learning Objectives

Recognize that FDA is live with E2B R3 standard and will require reporting of Investigational New Drug (IND) and postmarket safety reports to be submitted to FAERS; Describe how to prepare and be ready to submit electronically; Discuss reporting scenarios, system readiness, testing approach, challenges and lesson learned both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Industry Perspective: ICH E2B R3 Regional Implementations
Donald Williams

Beyond Borders: Navigating the Complexities of ICH E2B R3 Regional Implementations
Una Kessi

Speakers

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

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

Una Kessi

Product Management Director, Safety and Pharmacovigilance, Oracle Health & Life Sciences, United Kingdom

Una works as a Product Management Director, Safety and Pharmacovigilance, at Oracle Health and Life Sciences. Her main focus is on Regulator Strategy, Safety and PV Regulations, Thought Leadership and Roadmap, Competitive Intelligence updates and collateral for the field. She is also... Read More →

Donald Williams

Global Patient Safety and Pharmacovigilance, Regulatory Reporting, Boehringer Ingelheim Pharmaceuticals, Inc., United States

Donald Williams currently works in the Global Patient Safety & Pharmacovigilance department of Boehringer Ingelheim Pharmaceuticals, Inc. He is a member of the Regulatory Reporting Team, and his responsibilities include overseeing ICSR submission activities and monitoring global regulatory... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#304: Expanding Research Participation through Local Health Care Providers: Perceptions and Strategies to Reach Communities

Wednesday June 18, 2025 8:30am - 9:30am EDT

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-612-L04-P; CME 1.00; RN 1.00

This session will share healthcare professionals' (HCP) perceptions about participating in clinical research as non-investigators. We will address the challenges and opportunities for HCP participation, aligned to the FDA guidance on DCTs as well as Point of Care Trials.

Learning Objectives

Analyze healthcare professionals' (HCPs) perceptions, both positive and negative, about participating in clinical research; Evaluate which routine care trial assessments HCPs might conduct as part of trials and assess study fit; Identify key strategies to engage HCPs in trial participation without requiring them to become investigators

Chair

Jane Myles, MSc

Speaker

Industry Perspective
Shelly Barnes

Industry Perspective
Brittany Niland

Speakers

Shelly Barnes

Global Clinical Innovations Lead, UCB Biosciences, United States

Shelly Barnes is the UCB Global Innovations Lead based in Raleigh, NC, USA. She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Shelly is delivering solutions using novel technologies... Read More →

Meghana Chalasani

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

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She leads the CDER Center for Clinical Trial Innovation (C3TI) and co-leads the Advisory Committee workstream... Read More →

Jane Myles

Program Director, Decentralized Trials and Research Alliance, United States

Jane has worked in clinical drug development for almost 30 years, starting her career at the bench at Eli Lilly. Over the course of her career she led clinical trials, registrational filing teams, molecular asset decision teams, and eventually led a global function focussed on driving... Read More →

Brittany Niland

Senior Director-Clinical Trials Foundation Community Based Research, Eli Lilly and Company, United States

In May of 2016, I began my exciting career at Lilly. I fully embraced the project management role and swiftly advanced to become a subject matter expert in clinical development. As the technical leader, I mentored others and served as the point of contact for my trials, ensuring deliverables... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

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

8:30am EDT

#306: Tackling Fraud and Misconduct in Clinical Trials: Regulatory and Industry Perspectives

Wednesday June 18, 2025 8:30am - 9:30am EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-614-L04-P; CME 1.00; RN 1.00

Poor study management, misconduct, and data falsification threaten regulatory decisions on product safety and efficacy. This session will cover regulatory guidelines and case studies of clinical trial electronic systems, risk assessment strategies.

Learning Objectives

Describe regulatory expectations for electronic systems in clinical trials, including electronic health records (EHRs); Examine criteria for evaluating whether these systems are suitable for trials; Discuss methods for identifying and mitigating fraud and misconduct risks in these systems; Identify case studies of fraud and mismanagement to emphasize the need for thorough risk assessments.

Chair

Junko Sato, PhD

Speaker

How to Combat Fraud?
Kentaro Ichinose

FDA Perspective
Regina Zopf, MD, MPH

MHRA Perspective
Jason Wakelin-Smith

Speakers

Kentaro Ichinose

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

Kentaro Ichinose currently serves as a inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA).

Junko Sato

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

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

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Regina Zopf

Senior Medical Officer, CDER, FDA, United States

Dr. Regina Zopf is a Senior Medical Officer at the FDA with over 11 years of experience in drug evaluation and clinical research oversight. During her FDA tenure she has served in the Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) assessing the safety, efficacy... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#307: Regulators and Communication in a Changing World: The ICMRA Role

Wednesday June 18, 2025 8:30am - 9:30am EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-676-L04-P; CME 1.00; RN 1.00

ICMRA played a key role during the COVID-19 pandemic, ensuring sharing of vital information, providing common responses and aligning regulatory practices. A critical lesson learnt was that during a global crisis regulators need to become the main source of trusted information, both for each other and for the general public.

Learning Objectives

Evaluate ICMRA’s role in promoting global regulatory alignment and information sharing during the COVID-19 pandemic; Analyze strategies used by regulators to counter misinformation and disinformation during health emergencies.; Formulate evidence-based communication approaches to build public trust in regulatory authorities.

Chair

Tony Lawler, MD, MBA

Speaker

Panelist
Daniel Pereira

Regulators as Communicators in High-Income Settings
Emer Cooke, MBA, MSc

Findings from the 2025 Edelman Trust Barometer Special Report: Trust and Health
Camille DeSantis

Speakers

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 →

Camille DeSantis

Managing Director, US Lead Health Brand Development, Edelman, United States

Camille DeSantis is Managing Director and U.S. Lead of Health Brand Development at Edelman. She returned to Edelman after founding Guard Dog Brand Development and SIGNAVA. A pioneer in archetypal brand strategy and inventor of research methods, she builds successful health brands... Read More →

Tony Lawler

Deputy Secretary, Health Products Regulation Group, Australian Department of Health and Aged Care, Australia

Professor Lawler is the Deputy Secretary, Health Products Regulation Group with the Australian Department of Health and Aged Care. Prior to this he was the Chief Medical Officer and Deputy Secretary Clinical Quality, Regulation and Accreditation with the Tasmanian Department of H... Read More →

Daniel Pereira

ANVISA, Brazil

Wednesday June 18, 2025 8:30am - 9:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Session

8:30am EDT

#308: The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways

Wednesday June 18, 2025 8:30am - 9:30am EDT

147AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-615-L04-P; CME 1.00; RN 1.00

This presentation will explore the pivotal role of regulatory affairs consulting in the medical device/IVD industry, focusing on how consultants provide strategic value at every stage of product development and commercialization.

Learning Objectives

Analyze the strategic role of regulatory affairs consulting in the medical device/IVD industry and its impact on product development and commercialization; Evaluate how specialized regulatory consulting helps manufacturers navigate evolving regulatory requirements while fostering innovation and market competitiveness; Apply practical strategies for partnering with regulatory consultants to achieve regulatory compliance and commercial success.

Chair

Michael Ageboh, PhD, RAC

Speaker

Drug Delivery Device Combination Products - Exploring FDA Expectations from Clinical Investigation to Market Approval
Bryce Whited, PhD, MS

Speakers

Michael Ageboh

Senior Manager, MedTech Services, Pharmalex / Cencora, United States

Michael Ageboh is a regulatory affairs professional with extensive experience within the MedTech industry. He has been involved in the end-to-end process of getting new products to market and maintaining products post market launch. He has worked for small, medium and large companies... Read More →

Bryce Whited

Founder and Principal Consultant, WCI Medtech, United States

Bryce Whited, Ph.D. is the Founder and Principal Consultant at WCI MedTech, a consulting firm dedicated to providing medical device and pharma / biologics clients with expert regulatory affairs services for product development, market approval and post-market compliance. Bryce has... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#309: Building Upon Quality by Design and Risk-Based Monitoring Implementation Momentum

Wednesday June 18, 2025 8:30am - 9:30am EDT

150AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-616-L04-P; CME 1.00; RN 1.00

This forum will focus on practical Quality by design (QbD) and risk-based monitoring (RBM) clinical trial implementation strategies based on new case study examples of overcoming persistent adoption challenges, fostering organizational change management, and demonstrating value of implementation.

Learning Objectives

Apply practical QbD-RBM implementation strategies based on case study examples not previously publicly presented; Discuss new initiatives under development that will serve as additional future QbD tools; Identify persistent obstacles to broader QbD and RBM implementation, address their negative impacts, and provide applicable solutions to enable future adoption.

Chair

Gerrit Hamre, MA

Speaker

Existing Adoption Tools for All to Use
Morgan Hanger, MPA

Evidence of the QbD-RBM Continuum in Action
Marion Wolfs, MS

Agency Supporting Mechanisms for Clinical Trial Modernization
Alissa Mun, MS

New Case Study Examples for Others to Build Upon
Sameera Ibrahim

Speakers

Gerrit Hamre

Research Director, Duke-Margolis Institute For Health Policy (DMI), United States

Gerrit Hamre, MA, is a Research Director in Biomedical Regulatory Policy at the Duke Margolis Institute for Health Policy Institute. Gerrit has worked for nearly 20 years in the pharmaceutical industry with a focus on clinical research, regulatory, and commercial roles. Central to... Read More →

Morgan Hanger

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States

Morgan Hanger is the Executive Director of the Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the U.S. FDA. She brings extensive experience in convening diverse stakeholders to tackle complex challenges in evidence generation... Read More →

Sameera Ibrahim

Head of Risk Governance & Operations, R&D Quality, Bristol Myers Squibb, United Kingdom

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 →

Marion Wolfs

Associate Director Risk Management & Central Monitoring, Johnson & Johnson, Netherlands

Wednesday June 18, 2025 8:30am - 9:30am EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#310: Global Integration of the Middle East Region: Growing, Developing and Benchmarking to Global Standards

Wednesday June 18, 2025 8:30am - 9:30am EDT

145AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-617-L04-P; CME 1.00; RN 1.00

National Regulatory Authorities (NRAs) in the Middle East have been increasingly proactive in aligning their regulatory frameworks with international standards. They are actively participating in global standard-setting platforms such as the International Council for Harmonization (ICH), the International Pharmaceutical Regulators Programme (IPRP), the International Coalition of Medicines Regulatory Authorities (ICMRA), and the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In collaboration with the World Health Organization (WHO), these authorities are assessing their regulatory systems through WHO's global benchmarking initiative. This effort aims to achieve higher maturity levels. NRAs have been also committed to global harmonization efforts by obtaining membership in the ICH, as evidenced by countries like Egypt, Saudi Arabia, and Jordan. Notably, the Saudi Food and Drug Authority (SFDA) aspires to become a reference agency in the region, while reaching maturity level four (ML4) for medicines and vaccines regulation.

Learning Objectives

Discuss how evolving the Middle East region has been in the past decade in assessing/benchmarking their systems, attaining higher maturity levels & collaborating across key stakeholders; Identify the support for trainings to enable regulators & stakeholders to serve best patient’s needs; Recognize the key discussions from DIA MENA which took place in November 2024 & DIA Europe (Middle East townhall) in March 2025.

Chair

Amira Deia Younes

Speaker

Panelist
Maria Cristina Mota Pina, MBA

Panelist
Sara Torgal, MPharm

Panelist
Hamada Sherief

Panelist
Donia Albastaki

Speakers

Donia Albastaki

Acting Director, Pharmaceutical and Herbal Medicine Registration & Control Admin, Ministry of Health, State of Kuwait, Kuwait

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Hamada Sherief

Director of the General Administration of Registration of Pharmaceutical, EDA, Egypt

Hamada Sherief is the General Director for Human Pharmaceutical Drugs Registration at the EDA. He’s responsible for authorizing new registrations and re-registrations of human pharmaceutical drugs. His career began as a Quality Control Analyst at NODCAR & research after graduating... Read More →

Sara Torgal

Global Regulatory Policy Lead, DIA, Switzerland

Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA... Read More →

Amira Younes

Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates

Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Forum

8:30am EDT

#311: How to Reduce Post-Approval Changes Complexity Through Agile Regulatory Reliance

Wednesday June 18, 2025 8:30am - 9:30am EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-618-L04-P; CME 1.00; RN 1.00

This session will highlight the complexity of regulatory frameworks for PACs drawing from an IFPMA/Clarivate study and case studies. An expert panel from industry and regulatory agencies will discuss solutions and lessons learned on reliance implementation.

Learning Objectives

Explain the different regulatory frameworks for PACs compared to WHO and EMA; Identify lessions learned from reliance implementation for PACs to facilitate supply of medicinal products.

Chair

Max Wegner, PharmD, RPh

Speaker

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Marie Valentin, PharmD

Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management (PQKM) Capability
Theresa Mullin, PhD

Bringing Reliance into Action - Our Journey From Pilots to Practice
Susanne Ausborn, PhD

Why is Regulatory Reliance a Necessity and not a Choice? An Illustration Using Industry Survey Results
Andrew Deavin, PhD, MS

Speakers

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 →

Andrew Deavin

Senior Director, Regulatory Affairs, GSK, Belgium

Andrew Deavin has spent over 25 years in Regulatory Affairs, after having gained a M.Sc. and Ph.D. in Immunology and working in vaccine research. He has managed regulatory projects in development, registration and life-cycle primarily in vaccines but also in haematology/oncology... Read More →

Evdokia Korakianiti

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

Evdokia joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which includes Quality, GxP Compliance, Referrals and PhV. She is the EMA lead of the EU Network's strategic priority to facilitate the uptake of advanced manufacturing approaches. She... Read More →

Theresa Mullin

Associate Center Director - 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 →

Marie Valentin

Team Lead, Facilitated Product Introduction, WHO, Switzerland

At WHO, Marie works as the Team lead for the Facilitated Product Introduction Team supporting the Member States by implementing various approaches and mechanisms, including collaborative procedures, reliance approaches, and joint activities at the national, regional, and international... Read More →

Max Wegner

Head Regulatory Affairs, Bayer AG, Germany

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

Wednesday June 18, 2025 8:30am - 9:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

8:30am EDT

#312: Rare but Real: Navigating Rare Disease Product Development and Market Access Challenges

Wednesday June 18, 2025 8:30am - 9:30am EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-619-L04-P; CME 1.00; RN 1.00

Experts representing industry, non-profit, research, regulatory, and payor perspectives will explore key hurdles and solutions to rare disease treatment development, from recruitment and diagnosis to late-stage development and access after accelerated approval.

Learning Objectives

Identify hurdles and solutions to clinical trial recruitment, including early diagnosis and newborn screening; Identify approaches to patient stratification, disease understanding, and novel biomarkers, while de-risking late-stage development in competitive and high-failure landscapes; Examine challenges of market access and pricing after accelerated approval, and gain insights into addressing payer-specific concerns to ensure equitable access.

Chair

James Valentine, JD, MHS

Speaker

Panelist
Philip (P.J.) Brooks, PhD

Panelist
Anish Bhatnagar, MD

Panelist
Kim Quaintance-Lunn

Panelist
Matthew Klein, MD, MS

Panelist
Annie Kennedy

Panelist
Kerry Jo Lee, MD

Speakers

Anish Bhatnagar

Chief Executive Officer, Soleno Therapeutics Inc, United States

Dr. Bhatnagar, CEO of Soleno since its inception in 2017, brings over 20 years of medical expertise to the biopharmaceutical and medical device industries. His extensive background encompasses the development of biologics, drugs, drug-device combinations, and diagnostic/therapeutic... Read More →

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States

Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →

Annie Kennedy

Chief of Policy, Advocacy, and Patient Engagement, EveryLife Foundation for Rare Diseases, United States

Annie has served within the community for nearly three decades through her roles with Parent Project Muscular Dystrophy (PPMD) and the Muscular Dystrophy Association (MDA). In that time she helped lead legislative efforts around passage and implementation of the MD-CARE Act (2001... Read More →

Matthew Klein

CEO, PTC Theraputics, United States

Dr. Matthew Klein is CEO or PTC Therapeutics, a global biopharmaceutical company that discovers, develops and commercializes innovative therapies for rare disorders. Dr. Klein completed his undergraduate degree at the University of Pennsylvania graduating summa cum laude and Phi Beta... Read More →

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Accelerating Rare Disease Cures, FDA, United States

Dr. Kerry Jo Lee is a pediatric gastroenterologist/hepatologist and the Associate Director for Rare Diseases in the Office of New Drugs (OND), CDER. In this role she leads CDER’s Rare Diseases Team and the Accelerating Rare disease Cures (ARC) Program. Dr. Lee joined the FDA in... Read More →

Kim Quaintance-Lunn

Vice President, Head of Regulatory Science and Execution, Alexion, United States

Kim Quaintance-Lunn is Vice President, Head of Regulatory Science & Execution, for Alexion Pharmaceuticals; Strategic Advisor to the DIA Board of Directors; and Director at Large and Treasurer for the FDA Alumni Association. At Alexion, Kim is responsible for leading and implementing... Read More →

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States

James Valentine, JD, MHS is an attorney at Hyman, Phelps & McNamara where he assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. Mr. Valentine has been central... Read More →

Wednesday June 18, 2025 8:30am - 9:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

14: DIAmond, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#314: From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14

Wednesday June 18, 2025 10:30am - 11:30am EDT

145AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-620-L04-P; CME 1.00; RN 1.00

This forum will explore the implications of ICH M14, focusing on practical approaches to using its data sources. Participants will examine how ICH M14 impacts various stakeholders and how collaboration between these groups can be enhanced.

Learning Objectives

Discuss and demonstrate the operational implications of ICH M14; Illustrate simplified and more practical approaches for utilizing the data sources introduced in ICH M14; Differentiate how ICH M14 impacts multiple industry stakeholders, including big pharma, small pharma, CROs, and data network providers.

Chair

William Blumentals, PhD

Speaker

Panelist
Jie Li, PhD

Panelist
Susan A. Oliveria, DrSc, MPH

Panelist
Alice Hsu, MPH

Speakers

William Blumentals

Head of Pharmacoepidemiology, Specialty Care, Sanofi, United States

William has spent over 20 years supporting and leading epidemiology teams in biopharma, including roles in pharmacovigilance and medical affairs. Currently, he co-leads the real-world data access and availability workstream with TransCelerate and is the Head of Pharmacoepidemiology... Read More →

Alice Hsu

Director Integrated Signal Management, Amgen Inc., United States

Alice Hsu currently leads the Integrated Signal Management team within Global Patient Safety at Amgen. In this role, she is the business process owner for safety signal detection, signal management, and safety governance. She leads a team of signal management scientists, data scientists... Read More →

Jie Li

Associate Director for RWE, OSE, CDER, FDA, United States

Dr. Jie (Jenni) Li is Associate Director for RWE at the Office of Surveillance and Epidemiology (OSE), CDER FDA. She leads office activities relating to RWE, overseeing scientific input into guidance and policy development. An expert in RWE and pharmacoepidemiology, Dr. Li. led major... Read More →

Susan Oliveria

Vice President, Global Head of Epidemiology and Scientific Affairs Peri- and Pos, Thermo Fisher Scientific, United States

Dr. Oliveria's career as a pharmacoepidemiologist spans more than 25 years in academia, industry, and non-profit settings. She is trained as a pharmacoepidemiologist, having received her Doctor of Science from the Harvard School of Public Health. In her current role she leads the... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Forum

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

10:30am EDT

#315: Data and Methods for Signal Detection: Where are we Today and What is the Current State of the Art

Wednesday June 18, 2025 10:30am - 11:30am EDT

207A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-621-L04-P; CME 1.00; RN 1.00

Signal detection remains central to Pharmacovigilance activities. Better access and use of data, ever improving methods to maximise the utility of data, and better processes and governance to optimise signal detection activities are key focus areas as we continuously strive to do ever earlier and more effective safety signal detection. This session will discuss the current status of signal detection from all these aspects as well as how we anticipate the field evolving moving forwards.

Learning Objectives

Demonstrate and discuss how Generative AI can facilitate the future approach in augmenting PV systems in a trusted, compliant, and transparent manner; Summarize the opportunities and challenges with such an approach.

Chair

Andrew Bate, PhD, MA

Speaker

Industry Perspective
Mariette Boerstoel-Streefland, MD, MBA, MS

Speakers

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

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

Mariette Boerstoel Streefland

Senior Vice President, Patient Safety Officer, Bristol-Myers Squibb Company, United States

Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currently SVP, Worldwide Patient Safety Officer at BMS. Mariette joined pharma industry from clinical practice in 1989 and held various leadership positions in drug safety... 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 →

Wednesday June 18, 2025 10:30am - 11:30am EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Forum

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Forum

10:30am EDT

#317: Partnerships and Collaboration: How to Drive Clinical Trial Success in Africa

Wednesday June 18, 2025 10:30am - 11:30am EDT

209ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-623-L04-P; CME 1.00; RN 1.00

Partnerships are crucial to overcoming the challenges clinical trials face in Africa. We will present the current landscape, provide key pointers on navigating it, and share case studies demonstrating the key importance of involving Africa in trials.

Learning Objectives

Recognize the importance of including Africa in clinical trials; Identify challenges of conducting clinical trials in Africa; Apply knowledge to successfully conduct global clinical trials in Africa.

Chair

Kwaku Marfo, PharmD, MBA, MPH

Speaker

Harnessing Partnerships and Collaboration to Sustain the Ecosystem
Chimwemwe Chamdimba

Clinical Trial Conduct In Africa: Current Regulatory Systems and Regulations
Yvonne Adu-Boahen

Unlocking Clinical Research to Drive Access to Innovation
Beno Nyam Yakubu, DVM

Speakers

Yvonne Adu-Boahen

Head of Clinical Trials Department, Food and Drugs Authority, Ghana

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa

Chimwemwe Chamdimba heads the African Medicines Regulatory Harmonization Initiative at AUDA-NEPAD. She manages the AMRH Programme, supports AMA operationalization, and drives policy reforms connecting regulatory strengthening to local medical product manufacturing. A health policy... Read More →

Kwaku Marfo

Africa Market Development Specialist, IQVIA, Ghana

Kwaku Marfo currently holds a role of Market Development Specialist for sub-Sahara Africa with IQVIA. Kwaku is a dynamic Life Sciences leader with 18 years of experience in Pharma and Global Health across US, Europe and Africa markets in diverse therapeutic areas such as Hematology... Read More →

Beno Yakubu

Head of Clinical Trial Department, National Agency for Food and Drug Administration, Nigeria

Dr Yakubu background training is Veterinary Medicine, have undergone related trainings on vaccines, epidemiology, Bioethics, and other regulatory activities for over 20 years. has attended many WHO trainings on Vaccines regulatory activities. Dr Yakubu has been involved in the review... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives
Tags Session

10:30am EDT

#318: Patient Referral: Is It Hope or Hype?

Wednesday June 18, 2025 10:30am - 11:30am EDT

201

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-624-L04-P; CME 1.00; RN 1.00

This highlights the challenges of using real-world data (RWD) for patient referral in clinical trials, focusing on issues like data variability, lack of investigator training, and insufficient incentives. It proposes strategic solutions to overcome these barriers.

Learning Objectives

Identify innovative strategies for patient recruitment using RWD referrals that challenge existing practices; Propose new methods for integrating naïve sites into the clinical trial process to expand participation; Evaluate the potential impact of broader patient inclusion on clinical trial outcomes.

Chair

Kim Ribeiro, MS

Speaker

Panelist
Joan Chambers

Panelist
Barbara Isquith Arone, MS

Panelist
Karen Correa, PhD

Panelist
Irfan A. Khan, MD

Speakers

Barbara Isquith Arone

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

Barbara has worked within late phase research for 25+ years, 20+ 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 →

Joan Chambers

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

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

Karen Correa

Vice President, Clinical Development Operations, Boehringer Ingelheim, United States

Dr. Karen Correa is the Vice President, Head of Global Development Operations at Boehringer Ingelheim; where she is responsible for the advancement of the portfolio and execution of global clinical trials in the US. Her 30 years of clinical research experience cover a large range... Read More →

Irfan Khan

Founder and Chief Executive Officer, Circuit Clinical, United States

Dr. Khan is a cardiologist and the founder & CEO of Circuit Clinical, one of the fastest growing Integrated Research Organizations in the US. His work is focused on democratizing access to clinical trials.

Kim Ribeiro

Director Patient Experience & Engagement, Boehringer Ingelheim, United States

Kim Ribeiro, MLS (ASCP) CM, MS, has over 10 years of clinical trial patient experience with her most recent position being at AbbVie. She has a strong focus on strategy development for patient engagement, recruitment and retention planning as well as digital outreach and raising clinical... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Forum

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Forum

10:30am EDT

#320: Delivering Business Value by Utilizing AI and Structured Content Authoring Tools in Regulatory Medical Writing

Wednesday June 18, 2025 10:30am - 11:30am EDT

151A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-626-L04-P; CME 1.00; RN 1.00

Artificial Intelligence (AI) and Structured Content Authoring (SCA) tools are here. The challenge of seamlessly integrating these technologies into compliant and efficient workflows is reshaping the regulatory document development process. This session will delve into the balance and interdependence of four pillars (technology, process, people, and organization) to drive the business value of these tools. The interplay of these elements stokes an environment of thriving innovation, leading to enhanced efficiency, quality, and value proposition for the underlying business. AI/SCA have been thoroughly discussed in the regulatory writing process. Now there is focus on evolving technologies, the challenge lies in integrating these advancements into our workflows and processes, or implementing change management processes to allow for their use. Utilizing these tools coupled with organizational and process driven acceleration levers will condense the time to document approval and decrease the number of resources need to produce these documents. Moreover, the concerted and collaborative efforts across various functions, ranging from clinical sciences to biostatistics programming to review and approval pathways, ensures a thorough and compliant documentation process. It is time to focus and clearly define, emphasize, and promote the importance of the human element in the utilization of these tools, the people and the processes, at the heart of transformative authoring. Attendees will gain insights into the strategic integration of the four pillars in medical writing, drawing real-world use cases of these technologies in industry. These strategies, while transformative, do not necessitate a radical shift when applied independently. Instead, their true power lies in their harmonious application, which collectively refines traditional authoring paradigms.

Learning Objectives

Analyze the business value of AI and Structured Content Authoring tools in Regulatory Medical Writing to enhance efficiency and compliance; Evaluate process modifications in document development resulting from technology innovations to optimize workflow; Develop strategies to implement change management and organizational shifts that support technology-driven solutions.

Chair

David Meats, II

Speaker

Industry Perspective
James Best, MBA

Speakers
Louise Lind Skov, PhD

Speakers

James Best

Digital Transformation Lead (Medical Writing), GSK, United Kingdom

Focused on human centered digital transformation - leading strategy, design, end execution. Developer of the pragmatic trust model, a framework informed by psychology and change management models, for trusting and accepting AI within sociotechnical systems.

David Meats

Director, Regulatory Services & Medical Affairs Management, Certara, United States

Mr. Meats is a medical writing director with a diverse therapeutic area background that includes diabetes, oncology, immune-oncology, women’s health, musculoskeletal, and cardiac, with minor experience in other areas. He has extensive experience in all types of medical writing and... Read More →

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark

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

Wednesday June 18, 2025 10:30am - 11:30am EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

04: MedAffairs-SciComm, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

10:30am EDT

#321: Why Patient/Site Collaboration is a Must Have to Ensure Accessibility of Digital Health Technologies and Development of Patient Relevant Clinical Endpoints

Wednesday June 18, 2025 10:30am - 11:30am EDT

202A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-627-L04-P; CME 1.00; RN 1.00

Multiple stakeholders, including patients, will demonstrate how patient/site collaboration enhances the simultaneous digital health technologies (DHT)/patient journey to produce potential improvements/efficiencies in patient experience, data capture/quality, equitable access, and site/participant burden.

Learning Objectives

Describe the value of patient involvement to improve site engagement and user experience in application of DHTs in clinical research; Discuss key issues with accessibility of patient-reported outcome measurements; Identify how to incorporate patient-defined measurements into potential clinical endpoint development to better align with patient experience.

Chair

Stacy Hurt, MBA, MHA

Speaker

Patient Involvement to Improve Use of eCOA in Clinical Trials
Stacy Hurt, MBA, MHA

Lets Make Sure Accessibility is Considered in ePRO Best Practices: Are We Risking Our Data?
Florence Mowlem, PhD, MSc

Patient-Defined Flare Measurement Development in Conditions with Known Flares
Nell Meosky Luo

Speaker
Alicia Staley, MBA, MS

Speaker
Brian Hunter, MA

Speakers

Brian Hunter

VP / Chief Operating Officer, CNS Healthcare / Sitecentric, United States

In 20 years with CNS Healthcare, I’ve worked as a CRC, Site Administrator, Director of Marketing, Clinical Development Liaison and Director of Contracts & Trial Management. Through these roles, I’ve had the opportunity to interact with patients, physicians and study teams, and... Read More →

Nell Meosky Luo

Chief Executive Officer, Folia Health, United States

Nell Meosky Luo is the Found & CEO of Folia Health, a patient-driven health informatics company where since 2017, she has led a team to develop novel methods for enabling the collection, analysis, and use of home-reported outcomes of patients and caregivers for precision care and... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities and equal access to better treatments... Read More →

Florence Mowlem

Chief Scientific Officer, Umotif, United Kingdom

Flo is an expert eCOA scientist who has spent her career advising and guiding organizations on the electronic capture of COAs and the use of DHTs in clinical trials. She has a deep knowledge of clinical research, study design, and leveraging technology to support it, having worked... Read More →

Alicia Staley

Chief Patient Officer, Medidata, a Dassault Systèmes Company, United States

Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
202A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Forum

Level Intermediate
Keyword Digital Technology
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Digital Technology
Tags Forum

10:30am EDT

#323: Why Does Drug Loss Occur? Challenges to be Addressed for Patients, and Japan's Contribution to Globalized Drug Development

Wednesday June 18, 2025 10:30am - 11:30am EDT

151B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-629-L04-P; CME 1.00; RN 1.00

This forum will address need for a global development strategy aimed at enhancing patient access to new drugs and maximizing business opportunities in Japan. The panelists will consist of members from pharma industry associations, agency and academia

Learning Objectives

Discuss maximizing value of innovative products for the global market including Japan; Apply learnings to clinical development strategy to expand target patients and market effectively; Describe need to enhance access to innovative drugs for children and patients with rare diseases; Discuss influencing regulators, industry, and trial sites to improve the local environment and reduce burdens in global simultaneous development.

Chair

Toshiharu Sano, RPh

Speaker

Initiatives of Medical Institutions - Introduction to High-Quality Trials Using Networks
Kenichi Nakamura, MD, PhD, MBA

Changes in Japan's Pharmaceutical Regulations and Clinical Environment
Akihiro Ishiguro, PhD

What is Drug Lag and Loss: Challenges for Globalization in Japan
Nobutaka Kobayashi, MPharm

Speakers

Akihiro Ishiguro

Head of PMDA, Washington D.C. Office, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Akihiro Ishiguro, PhD is the Head of Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office. His work at PMDA began in 2004 when PMDA was established, allowing him to experience the contribution of post marketing drug safety, new drug review, review management... Read More →

Nobutaka Kobayashi

Deputy Director, Mitsubishi Tanabe Pharma Corporation, Japan

Kobayashi was engaged in medicinal chemistry as a research scientist in the pharmaceutical company for 13 years. After that, he was engaged in medical policy, drug price application, and management planning for 13 years.

Kenichi Nakamura

Chief, Department of International Clinical Development, National Cancer Center Hospital, Japan

Dr. Nakamura is Chief of International Clinical Development at the National Cancer Center Hospital. After earning his MD from Kyoto University in 1999 and completing surgical training, he joined NCC to manage JCOG, Japan’s largest cancer clinical trial group. Since 2015, he has... Read More →

Toshiharu Sano

Associate Vice President, MSD, Japan

Toshiharu Sano has over 30 years of experience in pharmaceutical industry and has broad experiences in Clinical Research, R&D planning and Business Operations for Clinical Development in Japan. He also worked as several initiative’s leads and change manager through his career in... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Forum

Level Intermediate
Keyword Rare Disease, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Global Perspectives
Tags Forum

10:30am EDT

#325: Practical Implementation of MRCTs Based on ICH E17 Guidelines

Wednesday June 18, 2025 10:30am - 11:30am EDT

144ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-631-L04-P; CME 1.00; RN 1.00

Hear directly from the regulators and industry about the challenges and opportunities in applying the ICH E17 guidelines. Some cases based on ICH E17 guidelines will be presented in the panel. Panelists will be asked to make comments for each case regarding points to consider in planning a study or evaluating results.

Learning Objectives

Explain how ICH E17 guidelines are being implemented in the conduct of multiregional clinical trials; Evaluate the limitations, gaps, and opportunities for applying the guideline globally.

Chair

Yoshiaki Uyama, PhD, MS, RPh

Speaker

Panelist
Armin Koch, DrSc

Panelist
Adriane Alves de Oliveira, MSc

Panelist
Hideki Hiraoka, PhD

Panelist
William Wang, PhD

Speakers

Hideki Hiraoka

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

Armin Koch

Head, Institute of Biometry, Hannover Medical School, Germany

Dr. Armin Koch, Ph.D., received his diploma in Mathematics and then worked in the Biostatistics Department at the German Cancer Research Center in Heidelberg. From there he moved to the Biostatistics Department at Heidelberg University where he wrote his PhD-thesis (1994). He has... Read More →

Adriane Alves de Oliveira

Health Regulation Expert, ANVISA, Brazil

Health Regulation Expert with 11 years of experience monitoring non-clinical and clinical development of drugs and biological products, with a focus on monoclonal antibodies and vaccines. She is also Good Clinical Practice(GCP) inspector and participated as a representative of Anvisa... Read More →

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 →

William Wang

President, Merck & Co, Inc, United States

Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and a deputy topics-leader... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
144ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#326: Clinical Trial Innovation at Scale: Opportunities to Increase Adoption and Acceptance

Wednesday June 18, 2025 10:30am - 11:30am EDT

147AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-632-L04-P; CME 1.00; RN 1.00

This forum will address the implementation of innovative clinical trial designs. Specific examples will be discussed and regulatory efforts to foster innovation will be examined to identify opportunities to increase stakeholder understanding.

Learning Objectives

Identify precedents and opportunities to adopt innovative trial designs in severe, chronic diseases; Describe and assess regulatory efforts to foster clinical trial innovation; Identify mechanisms to enhance public awareness regarding implementation of clinical trial innovation in drug development.

Chair

Samantha Roberts, PhD

Speaker

Industry Reflection
Rasika Kalamegham, PhD

Industry Reflection
Victoria A. Dohnal, RAC

FDA Update
Meghana Chalasani, MHA

Speakers

Meghana Chalasani

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

Victoria Dohnal

Director, Global Regulatory Policy and Intelligence, Johnson & Johnson, United States

Victoria Dohnal is currently Director, Regulatory Policy, North America at Johnson and Johnson (J&J) where she is responsible for driving US regulatory policy work related to rare diseases, patient focused drug development, cell and gene therapies, precision medicine, and PDUFA VII... Read More →

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States

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

Samantha Roberts

Senior Director, Regulatory Intelligence, AstraZeneca, United States

Samantha Roberts leads Respiratory & Immunology Regulatory Intelligence and Portfolio Policy at AstraZeneca. Previously she was in Genentech’s US Regulatory Policy team where she focused on topics including patient-focused drug development, innovative trials, diversity and inclusion... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Keyword Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Clinical Trial Design
Tags Forum

10:30am EDT

#322: Navigating the Challenges of Drug Delivery Using a Novel Device

Wednesday June 18, 2025 10:30am - 11:30am EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-628-L04-P; CME 1.00; RN 1.00

Explore the evolving regulatory landscape of combination products for the delivery of cell and gene therapies. This session will provide essential insights into the current regulatory frameworks for drug delivery systems.

Learning Objectives

Explain the regulatory challenges that may exist for novel combination products; Identify regulatory strategies for resolving challenges.

Chair

John Lockwood

Speaker

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Yoshiko Stowell, PhD, MS, PMP, RAC

Regulatory Considerations for the Next Generation of Drug Delivery Devices
Sarah Fairfield, MBA, RAC

Speakers

Sarah Fairfield

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

Sarah Fairfield is a dedicated and passionate regulatory professional with extensive expertise in medical devices and combination products. Currently, she serves as the Associate Director of Regulatory Affairs at AbbVie, Inc., where she supports global product development. She also... Read More →

John Lockwood

Sr. Director, Cencora Pharmalex, United States

John Lockwood, RAC, is the Senior Director of Medical Devices/IVDs for the Americas at Cencora PharmaLex, where he is responsible for managing and expanding Medical Device Services related to quality and regulatory. John has more than 25 years of experience in quality, regulatory... Read More →

Yoshiko Stowell

Vice President Regulatory Affairs, Kenai Therapeutics, United States

Yoshiko Stowell, PhD is VP Regulatory Affairs at Kenai Therapeutics. She has over 20 years of diverse experience in Regulatory Affairs (Clinical and CMC), R&D, and Project Management. She has experience in all states of development from proof of concepts to global Phase III Clinical... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session | 06: PersonalizedMed-ComboProd-Diagnostics, Session

Level Intermediate
Keyword Cell and Gene Therapy
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Cell and Gene Therapy
Tags Session

10:30am EDT

#327: Quality Oversight: Enhancing Approaches Across Organizations to Ensure Stable Product Supply and Timely Approval

Wednesday June 18, 2025 10:30am - 11:30am EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-633-L04-P; CME 1.00; RN 1.00

Perceived and real lapses in Manufacturing Quality have resulted in CRLs, impacting approvals and threatening supply. This session will discuss issues and opportunities to enhance oversight and communication by sponsors/applicants and approaches to improve collaborative problem solving across organizations.

Learning Objectives

Discuss the current state of quality across organizations and trends for delays in regulatory approvals due to cGMP and submission issues; Explain the approaches for enhancing oversight, including quality systems for early detection and correction, application of the Quality Management Maturity model, and expectations between organizations for improved communication and collaborative problem solving.

Chair

Holly Kleinschrodt

Speaker

Speaker
Rosemary Orciari

Speaker
Patrick Saunders

Speakers

Holly Kleinschrodt

Head, Device & Operations Quality, Astellas, United States

Holly Kleinschrodt has over 20 years of experience in the medical device and pharmaceutical industry. Her experiences have included Quality Assurance, Manufacturing, and R&D. She has contributed to technologies such as implantable heart valves and rings, consumable infusion sets and... Read More →

Rosemary Orciari

Senior Director, Reg Intel, Policy and QMS Lead, Pfizer, United States

Rosemary Orciari is the Senior Director of Regulatory Intelligence and Quality Standards at Pfizer, Inc. In this role, she is responsible for enabling quality and compliance excellence to support breakthroughs that change patients' lives. Together with her team, Rosemary actively... Read More →

Patrick Saunders

Senior Director-Quality, Lilly del Caribe, Eli Lilly & Co., United States

Patrick A. Saunders currently serves as the Sr Director - Quality at Lilly del Caribe in Carolina, Puerto Rico. Patrick is a seasoned professional with nearly two decades of experience in the pharmaceutical industry. His expertise spans across both parental and oral solid dosage drug... Read More →

Wednesday June 18, 2025 10:30am - 11:30am EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

10:30am EDT

#328: Artificial Intelligence in the Medicines Lifecycle: Delivering Globally for Public and Animal Health

Wednesday June 18, 2025 10:30am - 11:30am EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-634-L04-P; CME 1.00; RN 1.00

Aftificial Intelligence (AI) is being adopted across the medicine lifecycle to increase insights into data and improve efficiency of processes, for the benefit of public and animal health. This session will address key elements to enable the safe and responsible use of AI.

Learning Objectives

Identify AI opportunities across the medicine lifecycle; Examine the legal ecosystem of AI across jurisdictions and identify opportunities for convergence; Discuss how regulators worldwide are developing guidance to support AI innovation in the medicine lifecycle; State other strategic AI initiatives, including approaches to leveraging AI with healthcare data.

Chair

Luis Pinheiro, PharmD, MSc

Speaker

Panelist
Timothe Menard, PharmD, MSc

Panelist
Tala Fakhouri, PhD, MPH

Speakers

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland

Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

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

Wednesday June 18, 2025 10:30am - 11:30am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session

Level Intermediate
Keyword Artificial Intelligence (AI), Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Student Programming,Global Perspectives
Tags Session

11:40am EDT

#330 CH: Pharmacoequity: The Route to Representative Clinical Trials in the Current Political Environment

Wednesday June 18, 2025 11:40am - 12:10pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

In the current political environment where anything related to diversity is at risk, ensuring clinical trials represent the real world is a scientific imperative, not a DEI initiative. The concept of pharmacoequity not only aims to balance the needs

Learning Objectives

Understand the concept of pharmacoequity; Explain how to apply pharmacoequity to ensure representative clinical trial.

Chair

Dyan Bryson

Wednesday June 18, 2025 11:40am - 12:10pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Level Intermediate
format csv
Tags Workshop

12:20pm EDT

#334 CH: Addressing Key Challenges in Global Biosimilar Development and Regulation

Wednesday June 18, 2025 12:20pm - 12:50pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

Explore National Regulatory Authorities’ expectations for quality data packages for biosimilars in the context of rapidly evolving regulatory science, including advanced analytical tools and the opportunity to reduce clinical data requirements.

Learning Objectives

Examine challenges identified by National Regulatory Authorities regarding review of quality data packages for biological products; Identify trends in regulatory expectations for analytical vs. clinical data and use of advanced analytical tools in biosimilar development; Understand opportunities and challenges in the use of public standards to meet regulatory expectations for biosimilars.

Chair

Allison Radwick, PhD, RPh

Speakers

Allison Radwick

Senior Regulatory and Policy Communications Manager, U.S. Pharmacopeia, United States

Allison is accomplished in combining communications, regulatory affairs, policy and science with demonstrated success driving public engagement initiatives, implementing integrated outreach plans and liaising across executive and functional levels. Skills include building awareness... Read More →

Wednesday June 18, 2025 12:20pm - 12:50pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Workshop | 15: Content-Hubs, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

1:00pm EDT

#335 CH: Can Drug Repurposing Benefit Drug Development In Children and In Paediatric Rare Diseases?

Wednesday June 18, 2025 1:00pm - 1:30pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

Using case examples, the session will be an interactive discussion to share learnings and the impact of the use of drug repurposing from different end users such as industry and academia with input from regulators, patients and HTA representatives.

Learning Objectives

Understand drug repurposing and share lessons learnt so far based on case examples; Identify what could be opportunities using repurposing for rare diseases; Explain what has been done as part of the pilot on repurposing initiated by EMA at the end of 2021.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Can Drug Repurposing benefit drug development in Children & in Paediatric Rare Diseases?
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 (Senior Director, Regulatory Data and Submissions, AZ) has undergraduate degrees in Chemical Engineering, and Biochemistry with an MBA and Engineering Management graduate degrees. He led global complex Business Transformation projects in the Pharmaceutical and Biologics... Read More →

Wednesday June 18, 2025 1:00pm - 1:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

15: Content-Hubs, Workshop

Level Intermediate
Level Intermediate
format csv
Tags Workshop

1:45pm EDT

#337: AI, Virtual Control Groups, and Organoids: How New Technologies are Being Developed to Align With Ethical Principles in Animal Research

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-637-L04-P; CME 1.00; RN 1.00

This session will review the 3Rs (replacement, refinement, reduction) of animal use in non-clinical drug development research, and how new technologies including AI, Victorian Clinical Genetics Services (VCGs) and organoids are introducing innovative ways to meet these ethical principles.

Learning Objectives

Discuss the “3Rs” (replacement, refinement, reduction) of ethical animal use in non-clinical drug development research; Recognize how new technologies including AI, VCGs and organoids are being explored to follow these ethical principles as part of the overall drug development program.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

How New Technologies are Being Developed to Align With Ethical Principles in Animal Research
Julie Frearson, PhD

Panelist
Szczepan Baran

Speakers

Szczepan Baran

Tech4Pets, Chief Barks and Purrs Officer, United States

Julie Frearson

Senior Vice President, Chief Scientific Officer, Charles River Laboratories, United States

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 →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Keyword Artificial Intelligence (AI), Bioethics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Bioethics
Tags Session

1:45pm EDT

#338: Clinical Development of Orphan and Pediatric Drugs, Along with Regenerative Medicine Products in Japan

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-638-L04-P; CME 1.00; RN 1.00

Japan's regulatory authorities have enacted various measures to strengthen drug R&D and accelerate clinical development, particularly for regenerative medicine, pediatric, and orphan drugs, offering great prospects for biopharma/ biotech companies.

Learning Objectives

Discuss PMDA's efforts to address Japan's drug lag and promote an accelerated clinical development environment; Describe the trial landscape and analyze the challenges in developing Regenerative Medicine, Orphan, and Pediatric drugs in Japan; Develop strategies for Japan to engage in multi-regional trials, considering the unique aspects of conducting clinical studies in the country.

Chair

Edward C. Ian, MBA

Speaker

Industry Perspective
Sumati Nambiar, DrMed, MPH

Panelist
Teppei KIUCHI, MD, PhD, MPH

Speakers

Edward Ian

Head of Integrated Innovation Service Center, Mediscience Planning Inc., Japan

Edward Ian began his career as a lab. scientist and expanded his work into clinical development. His extensive experience with multinational companies in APAC and the US has made him a seasoned executive with expertise across a wide range of areas within the clinical research and... Read More →

Teppei KIUCHI

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

Teppei Kiuchi, M.D., MPH, PhD, is an associate executive director in the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In this role, Kiuchi is in charge of the review of regenerative medical products, Bio-CMC, vaccine and blood products. In his career Kiuchi has been... Read More →

Sumati Nambiar

Senior Director, Johnson and Johnson, United States

Dr. Nambiar is board certified in pediatrics and pediatric infectious diseases. She is a Fellow of the American Academy of Pediatrics and has over 20 years of experience in drug development and regulatory science. Currently, she is a Senior Director in the Child Health Innovation... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

Level Intermediate
Keyword Cell and Gene Therapy, Pediatrics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Cell and Gene Therapy,Pediatrics
Tags Session

1:45pm EDT

#340: Post-Marketing Safety Management in Asia Using Real-World Data: Changes and Regulatory Harmonization with the US and Europe

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

201

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-640-L04-P; CME 1.00; RN 1.00

As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.

Learning Objectives

Discuss how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.

Chair

Judy Shin, PhD

Speaker

Evolving Post-Marketing Safety Management in Korea: Opportunities and Challenges in Integrating RMP
Min-Jung Lim, MPharm, RPh

Case study using Real-World Data on Post-Marketing Safety in Korea
Bonggi Kim, PhD

An Overview of RWD Utilization for Drug Safety Assessment in PMDA
Shinya Watanabe

Global Perspectives on Post-Marketing Safety: Leveraging RWD for Regulatory Alignment and Enhanced Safety Surveilance
Jeff Lange, PhD

Speakers

Bonggi Kim

Director, Korea Institute of Drug Safety and Risk Management, Korea, Republic of

Jeff Lange

Director of Observational Research in Asia, Amgen, Hong Kong

Jeff is an epidemiologist within Amgen’s Center for Observational Research, based in Hong Kong. During his ten years at Amgen, he has been enhancing the use of pharmacoepidemiology to inform drug development and to support regulatory decision-making. He received his PhD from the... Read More →

Min-Jung Lim

CEO & Senior Pharmacovigilance Consultant, MediSafe, Pharmacovigilance Services, Korea, Republic of

Min-Jung Lim is the CEO and Senior Pharmacovigilance Consultant at MediSafe, with over 25 years of experience in clinical research and pharmacovigilance. She previously led drug safety functions as Head of Pharmacovigilance & Post Marketing Studies at GSK Korea. She also serves as... Read More →

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of

Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →

Shinya Watanabe

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

Mr. Shinya Watanabe is an epidemiologist at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. He conducts pharmacoepidemiological studies using medical information databases, such as the National Database of Health Insurance Claims and Specific Health Checkups of Japan... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Keyword Global Perspectives, Regulatory Convergence and Harmonization, Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Perspectives,Regulatory Convergence and Harmonization,Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

1:45pm EDT

#341: Techquity in Digital Trials: Tech, Data, and Operationalizing Equity in Clinical Research

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-641-L04-P; CME 1.00; RN 1.00

Industry leaders explore how biopharma is leveraging data foundations and technological advancements, including AI/ML, to improve access and representation in clinical trials, moving from DEI planning to tangible progress in clinical research.

Learning Objectives

Identify key areas where tech and analytics facilitate health equity advancement, focusing on achievable, tech-enabled outcomes; Illustrate concrete use cases where tech and data can support equitable clinical research, such as community outreach, recruitment, and measurement against diversity action plans; Discuss non-technical success factors needed to wholly support data-driven tech

Chair

Katrina Rice, MS

Speaker

From Data to Action: Driving Inclusive Clinical Trials
Del Smith, PhD, MS

Placing Patients First in the Era of Advanced Tech and AI
Patrick Gee, SR, PhD, MS

Responsible AI and Diversity in Clinical Trials
Nicole Ward, MBA, MS, PMP

Speakers

Patrick Gee

Chief Executive Hope Dealer & Founder, iAdvocate, United States

As a Healthcare Consultant and Professional Global Patient Activist, Patrick has received numerous accolades, such as the American Society of Nephrology President’s Medal and Celeste Castillo Lee Lectureship in 2022, and the National Kidney Foundation’s Celeste Castillo Lee Patient... Read More →

Katrina Rice

Chief Delivery Officer, Biometrics Services, eClinical Solutions, United States

Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 25 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →

Del Smith

Co-Founder and Chief Executive Officer, Acclinate Inc., United States

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

Nicole Ward

Senior Product Manager, Business Insights & Technology, Bristol Myers Squibb, United States

Nicole G. Ward is a customer-centric servant leader with 15+ years of project / program management expertise and solid track record of translating complex business requirements into simple technology solutions spanning across multiple industries (Healthcare, IT, Consumer, Pharmaceutical... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session | 02: ClinTrials-Ops, Session

Level Intermediate
Keyword Artificial Intelligence (AI), Digital Technology, Advanced Analytics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Digital Technology ,Advanced Analytics
Tags Session

1:45pm EDT

#343: Portfolio Management in Pharma: Strategies and Insights from Large, Medium, and Small Pharma Organizations

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

151B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-643-L04-P; CME 1.00; PDU 1.00 PMI 2166DQV2DD; RN 1.00

This panel discussion explores the diverse strategies employed by organizations in managing their portfolio across the value chain. Experts will discuss how systems, tools, benchmarks and visualizations are utilized to enhance decision-making.

Learning Objectives

Describe the different Portfolio Management approaches used across the pharmaceutical value chain in organizations of varying size; Outline success factors for effective Portfolio Management within your own organization.

Chair

Erin Mulrooney, MSc, PMP

Speaker

Biotech Perspective
Christine Mears, MA

Rare Disease Industry Perspective
Katie Bloom

Large Pharma Industry Perspective
Rosa Tarng, MA

Speakers

Katie Bloom

Executive Director, Co-Head of PMO, Program Management Office, Ultragenyx, United States

Katie Bloom, Executive Director of Program and Portfolio Management with over 25 years of industry experience. Currently, she co-leads the Program Management Office at Ultragenyx. Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment... Read More →

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Erin Mulrooney

Director, Portfolio Management, Daiichi Sankyo, Inc, United States

Erin Mulrooney is a Director of Portfolio Management in the Global Project Management and Leadership group at Daiichi Sankyo. There she is responsible for portfolio prioritization and reporting to enable data-driven decision making. Before joining Daiichi Sankyo in August 2024, Erin... Read More →

Rosa Tarng

Translational Program Management, Takeda, United States

Rosa Tarng is a program management professional with ~20 years of industry experience. Rosa is currently the Head of Oncology Translational Program Management at Takeda where she has also held roles in Cell Therapy Program Operations and Oncology Research Program Management. Prior... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

07: ProjectManagement-StrategicPlanning, Forum

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Tags Forum

1:45pm EDT

#344: Pharmacovigilance Inspections: How Do Inspectors Decide Where and When to go?

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-644-L04-P; CME 1.00; RN 1.00

This session will outline the risk assessment approaches undertaken by four global regulators, the US FDA, UK MHRA and EMA to identify suitable candidates for inspection and explain the differences in inspection cycles. The session will focus on the risk assessment methodologies undertaken by each regulator, highlighting information sources, risk assessment processes and decision-making factors which help determine define the appropriate type of inspection and frequencies. The session will provide information into the types of inspection which may be undertaken for pharmacovigilance and why a company may be subject to one of these inspection types as well as explain why the same company may be subject to more frequent inspections. The session will include information on new and existing initiatives between regulators to collaborate on inspection risk assessments to share information, improve process, and reduce the inspection burden on industry. Companies can use the information from this session to gain tips to help identify and assess high-risk areas of their own pharmacovigilance systems for quality processes such as auditing.

Learning Objectives

Define the methods and risk assessment considerations used by regulatory authorities to decide which entities are subject to pharmacovigilance inspections, including frequency, timelines and inspection type; Recognize the different approaches used among regulators to define risk and apply appropriate assessments and efforts to harmonize processes in future.

Chair

Sophie Radicke, MSc

Speaker

EMA Perspective
Peter Twomey, MA, MPharm

US FDA Perspective
Sheilyn Huang, PharmD

Speakers

Sheilyn Huang

Consumer Safety Officer, Pharmacovigilance Compliance Team, FDA, United States

Sheilyn Huang is a licensed pharmacist who currently serves as a Consumer Safety Officer on the Pharmacovigilance Compliance Team in FDA's Center for Drug Evaluation and Research. Over the past 16 years at FDA, she has had the opportunity to work in areas such as drug information... 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 →

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

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

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Keyword Regulator Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives
Tags Session

1:45pm EDT

#345: Africa's Evolving Regulatory Landscape

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

145AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-645-L04-P; CME 1.00; RN 1.00

Dialogue between key stakeholders on AMA operationalization, proposals on improved collaboration, regulatory harmonization and convergence, reliance pathways and other strategies for an efficient and sustainable regulatory system in the continent.

Learning Objectives

Evaluate progress made on AMA operationalization including achievements so far with the support of partners; Discuss key insights and lessons from the Continental Pilot; Identify the way forward for successful implementation of revised AU Model Law; Discuss cultivating a sustainable regulatory ecosystem in Africa employing good regulatory practices and agilities as well as prioritizing capacity building.

Chair

Janis Bernat, MSc

Speaker

Panelist
Bunmi Femi-Oyekan

Panelist
David Mukanga, PhD, MPH

Panelist
Grace Matimba, MS

Panelist
Chimwemwe Chamdimba

Speakers

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 →

Chimwemwe Chamdimba

African Medicines Regulation Harmonization Programme Head, African Union Development Agency-NEPAD, South Africa

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 →

Bunmi Femi-Oyekan

Senior Director Accord & Access Regulatory Lead, Pfizer Specialities Ltd, Nigeria

Bunmi Femi-Oyekan is a pharmacist with over 32 years of experience in the pharmaceutical industry, primarily in regulatory, sales, and safety, currently serving as the Regulatory Lead, Accord and Access for Pfizer. She is responsible for development and execution of regulatory strategies... Read More →

Grace Matimba

Chief Regulatory Officer, Medicines Control Authority of Zimbabwe, Zimbabwe

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulatory Collaboration, Regulator Perspectives, Regulatory Reliance, Regulatory Convergence and Harmonization, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration ,Regulator Perspectives,Regulatory Reliance,Regulatory Convergence and Harmonization,Global Perspectives
Tags Session

1:45pm EDT

#347: EMA Town Hall

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

146BC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-647-L04-P; CME 1.00; RN 1.00

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

Learning Objectives

Describe EMAs regulatory initiatives and strategic priorities; Identify opportunities for engagement with the regulators.

Chair

Ralf Herold, DrMed, MD

Speaker

Panelist
Anabela Marcal, PharmD

Panelist
Corinne de Vries, PhD, MA, MSc

Panelist
Luis Pinheiro, PharmD, MSc

Speakers

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands

Ralf Herold MD PhD is the head of EMA’s Regulatory Science and Academia Workstream, part of the Regulatory Science & Innovation Taskforce, coordinating research and engagement with researchers and developers from the academic sector and not-for-profit organisations. Previously... 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 →

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Session

Level Intermediate
Keyword Regulator Perspectives, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Student Programming,Global Perspectives
Tags Session

1:45pm EDT

#342: Evolving Regulatory Considerations for Medical Affairs Communications

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

151A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-642-L04-P; CME 1.00; RN 1.00

This session will cover FDA developments relevant to Medical Affairs activities, including guidance and enforcement on sharing "scientific information about unapproved uses" (SIUU), responding to medical misinformation, and presenting efficacy data.

Learning Objectives

Identify recent FDA policy developments that are relevant to common Medical Affairs activities; Discuss and assess potential legal/regulatory risk of current and new Medical Affairs activities in light of these developments.

Chair

Torrey Cope, JD

Speaker

Evolving Regulatory Considerations for Medical Affairs Communications
Bill Cook

Evolving Regulatory Considerations for Medical Affairs Communications
Lisa Hubbard, RPh, RAC

Speakers

Bill Cook

Senior Global Medical Affairs Leader, AstraZeneca, United States

Torrey Cope

Partner, Sidley Austin LLP, United States

Torrey Cope advises and represents clients in a full range of regulatory, enforcement, litigation, and transactional matters involving FDA issues. He has been recognized as a “Life Sciences Star” in the FDA: Pharmaceutical category by LMG Life Sciences since 2016 and has been... Read More →

Lisa Hubbard

Principal Consultant, Regulatory Advertising and Promotion, Opus Regulatory, Inc., United States

Lisa Hubbard is a Principal Consultant in Advertising and Promotion at Opus Regulatory, Inc. Her prior roles included Director, Advertising and Promotional Compliance at Alexion/Astra Zeneca and Senior Regulatory and Medical Consultant at One Source Regulatory. Lisa spent 15 years... Read More →

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum | 04: MedAffairs-SciComm, Forum

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

1:45pm EDT

#339: Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation

Wednesday June 18, 2025 1:45pm - 2:45pm EDT

209ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-639-L04-P; CME 1.00; RN 1.00

ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.

Learning Objectives

Explain the drivers, purpose, and plan for a global regulator-industry collaboration platform for PQKM; Describe the platform operating framework including governance and operation implications for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.

Chair

David C. Isom

Speaker

Industry Perspective
David Sidney Ross, MBA, MSc, PMP, RAC

EMA Perspective
Hilmar Hamann, PhD

Health Canada Perspective
Marcin Boruk, MBA, MSc

Speakers

Marcin Boruk

acting Director, Business Facilitation and Modernization Directorate, Health Can, Health Canada, Canada

Marcin Boruk has been with Health Canada since 2005 and has worked in the areas review, legislation and business transformation. Currently he is an acting Director in the Business Facilitation and Modernization Directorate, Health Canada supporting the branch in projects related to... Read More →

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands

Dr Hilmar Hamann is currently the Head of Information Management at the European Medicines Agency (EMA) where he focuses on improving technological capabilities within the EU Regulatory Medicines Agencies Network to support efficient, all-digital, and data-driven operations. Previously... Read More →

David Isom

Senior Director, Global Regulatory Policy and Intelligence, Global Product Devel, Pfizer Inc, United States

David Isom is Senior Director, Global Regulatory Policy and Intelligence at Pfizer. He leads policy and advocacy for digital modernization of the regulatory ecosystem. Before joining GRPI (2016), David led Pfizer information management, digital, and data services for clinical and... Read More →

David Ross

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

Wednesday June 18, 2025 1:45pm - 2:45pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session | 03: Data-Tech, Session

Level Intermediate
Keyword Regulatory Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulatory Collaboration
Tags Session

3:00pm EDT

#355 CH: Business Agility in the Age of AI - Why Zooming in Matters Just as Much as Zooming Out

Wednesday June 18, 2025 3:00pm - 3:30pm EDT

L Street Bridge

Component Type: Workshop
Level: Intermediate

Digital transformation at the C-suite level promises significant ROI but must be done purposefully. Attendees will explore strategic considerations in implementing AI with thought-provoking Q&A, cutting through the noise of the widespread AI buzz.

Learning Objectives

Evaluate perceived versus actual ROI for generative AI, balanced with lessons learned in past decades from traditional AI and automation; Define how to upskill internal teams to use AI effectively and responsibly while achieving business goals; Apply current understanding to brainstorm digital transformation avenues for teams and businesses beyond what is being done currently with AI.

Chair

Jason Casavant, JD

Speakers

Jason Casavant

Executive Director, Medical Writing, Synterex, Inc., United States

Jason Casavant is a 25-year veteran in the industry and is the current head of medical and regulatory writing at Synterex, Inc. Over his career, he has held various positions in medical and regulatory writing, QA/QC, operations, training, and site monitoring.

Wednesday June 18, 2025 3:00pm - 3:30pm EDT
L Street Bridge Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Level Intermediate
format csv
Tags Workshop

4:00pm EDT

#356: Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

207A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-652-L04-P; CME 1.00; RN 1.00

This session aims to explore the application of AI to drug labeling to enhance pharmacovigilance, reduce medication errors, and improve patient safety. Presenters will discuss the complexities and share real examples from both end-user and technology perspectives.

Learning Objectives

Discuss opportunities to apply artificial intelligence (AI) to drug labeling to enhance labeling review, surveillance activities, and medication error reduction; Identify the complexities and barriers to applying AI techniques to modernize labeling-related activities.

Chair

Daniele Sartori, MPharm

Speaker

Regulatory Perspective
Brett Howard, JD, PhD

From Text to Intelligence: Architecting AI Systems for Drug Labeling and Pharmacovigilance
Fatima Sabar, MSc

AI in Drug Labelling: Toward Harmonized, Globally Aligned Product Information
Daniele Sartori, MPharm

Computerized Labeling Assessment Using AI
Suranjan De, MBA, MS

Speakers

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States

Brett Howard

Senior Director, US Regulatory Policy, USP, United States

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

Fatima Sabar

CEO and Founder, Bluenote AI, United States

Fatima Sabar is the CEO & Founder of Bluenote. Bluenote’s AI Agents Platform for Life Sciences is driving 50-75% efficiency gains for scientists and engineers at the world’s leading biopharma, medical devices and diagnostics companies. The platform focuses on regulatory workflows... Read More →

Daniele Sartori

Senior Pharmacovigilance Scientist, Uppsala Monitoring Centre, Sweden

Daniele is a senior pharmacovigilance scientist at Uppsala Monitoring Centre and a candidate for a DPhil in Evidence-Based Health Care at the University of Oxford. He has over 10 years of experience in pharmacovigilance, focusing on signal detection, regulatory decision-making, and... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

01: ClinSafety-PV, Session

Level Intermediate
Keyword Artificial Intelligence (AI)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI)
Tags Session

4:00pm EDT

#357: Examining Bias in Lung Cancer Study Protocols: Lessons Learned from Multi-Stakeholders

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

151B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-653-L04-P; CME 1.00; RN 1.00

This session will be based on a recent effort that examined lung cancer studies to determine how and whether exclusion criteria could hinder the participation of racial minority patients. The panel will feature experts from sponsors, research sites, and academia to discuss challenges and areas of opportunities for re-thinking how to make lung cancer protocols more inclusive, and will include perspectives from the clinical operations, regulatory, research sites, and academia.

Learning Objectives

Identify areas within a study protocol that can adversely exclude marginalized patient populations; Identify organizational challenges that may hinder redesign efforts, and the implications these challenges can have on the clinical operations and regulatory front; Discuss approaches, strategies, and lessons-learned to help simplify protocol design.

Chair

Jennifer Kim, PhD

Speaker

Sponsor Perspective: Implications of Protocol Complexity on Regulatory Oncology
Ritesh Jain, PhD

Perspectives from the Clinical Research Sites: Challenges Enrolling Racial Minority Participants
Umit Tapan, MD

Sponsor Perspective: Overcoming Re-Design Efforts of Study Protocols
Kim Ribeiro, MS

Application of Large Language Models (LLM) to Examine Lung Cancer Protocol Exclusion Criteria
Abigail Dirks, MS

Speakers

Abigail Dirks

Data Scientist, Tufts Center for the Study of Drug Development, United States

Abigail Dirks is a Data Scientist at the Tufts Center for the Study of Drug Development (Tufts CSDD) where she specializes in analyzing large datasets pertaining to all aspects of industry-funded drug development performance including protocol design complexity, investigative site... Read More →

Ritesh Jain

Senior Director, EMD Serono, United States

Ritesh Jain is Senior Director and Portfolio Lead in Global Regulatory Affairs Oncology at EMD Serono, Inc. In his role he is accountable for driving global regulatory strategy for several projects in the oncology and immuno-oncology portfolio. Prior to joining EMD Serono, he has... Read More →

Jennifer Kim

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

I'm a Research Associate Professor and Organizational Psychologist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining strategies and interventions that can positively impact individual... Read More →

Kim Ribeiro

Director Patient Experience & Engagement, Boehringer Ingelheim, United States

Umit Tapan

Assitant Professor of Medicine, Boston University, United States

Dr. Umit Tapan is an Assistant Professor of Medicine at Chobanian and Avedisian School of Medicine and practicing Thoracic Oncologist at Boston Medical Center. His clinical interests are Non-small cell lung cancer, Small cell lung cancer, Mesothelioma, Immunotherapy, Targeted therapy/Precision... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

02: ClinTrials-Ops, Session

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

4:00pm EDT

#358: Privacy-Preserving Data Access and Collaboration for RWE Generation Across Locations: Advances, Opportunities, and Challenges

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

207B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-654-L04-P; CME 1.00; RN 1.00

Data privacy has been a long-standing challenge for RWD sharing and evidence generation across geography. This session will discuss privacy-preserving approaches that enable data access, sharing and collaboration in industry, academia and regulatory

Learning Objectives

Identify privacy-preserving approaches for accessing and sharing real-world data (RWD); Discuss use cases leveraging various applications (e.g., federated learning networks, synthetic data) in industry, academia and regulatory for RWE generation; Examine policy and regulatory perspectives, methodological challenges and identify future development needs.

Chair

Echo Wang, DrPH, MPH

Speaker

Global Privacy and Regulatory Considerations for Synthetic Data
Rachele Hendricks-Sturrup, DrSc, MA, MSc

Real-World Applications of Distributed Data Analytic Solutions in Real-World Data Networks
Darren Toh, DrSc, FISPE

Privacy-Preserving Solutions for RWD Access and Collaboration: A Life Science Industry Perspective on Challenges & Opportunities
Mehmet Burcu, PhD, MS, FISPE

Speakers

Patrice Verpillat

Head of Real World Evidence, European Medicines Agency

He is a medical doctor, specialist in epidemiology. He has worked during 20 years in the pharmaceutical industry where he had positions in several international companies, always dealing with real world data (RWD) and non-interventional studies (NIS) in order to bring RWE into research... Read More →

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Institute For Health Policy, United States

Dr. Rachele Hendricks-Sturrup is the Research Director of Real-World Evidence (RWE) at the Duke-Margolis Institute for Health Policy in Washington, DC, strategically leading and managing the Institute's RWE Collaborative and RWE policy research portfolio and education. As an engagement... Read More →

Darren Toh

Professor, Harvard Medical School and Harvard Pilgrim Health Care Institute, United States

Darren Toh, ScD is DPM Endowed Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. He is a pharmacoepidemiologist with an interest in the comparative safety and effectiveness research of medical products. His research... Read More →

Echo Wang

Director, Outcome Research, Merck & Co., Inc, United States

Echo Wang is currently a Director, Outcome Research in Merck & Co., Inc. and based in Massachusetts, United States. In her current role, she manages strategic partnerships and drives emerging capabilities that support real-world evidence (RWE) generation. She has led several studies... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
207B Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Session

Level Intermediate
Keyword Real-World Data (RWD) / Real-World Evidence (RWE)
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Real-World Data (RWD) / Real-World Evidence (RWE)
Tags Session

4:00pm EDT

#359: Cutting Through the Hype: How are AI and Emerging Technologies Accelerating Progress Now?

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

209ABC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-655-L04-P; CME 1.00; RN 1.00

We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?

Learning Objectives

Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.

Chair

Jessica Federer, MPH

Speaker

Panelist
Leo Barella

Panelist
Diogo Rao

Speakers

Leo Barella

Chief Technology Officer, Takeda, United States

Jessica Federer

Board Member, Angelini Ventures, United States

Ms.Federer is an independent board member for public and private companies, and is a globally recognized leader in digital transformation and health technologies. Previously, she was the Chief Digital Officer for one of the world’s largest life sciences companies, leading the enterprise-wide... Read More →

Diogo Rao

Chief Information Officer, Eli Lilly, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
209ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

03: Data-Tech, Forum

Level Intermediate
Keyword Artificial Intelligence (AI), Student Programming, Advanced Analytics
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Student Programming,Advanced Analytics
Tags Forum

4:00pm EDT

#360: Maximizing the Voice of the Patient in Healthcare Decision-Making: Integrating Patient Experience Data into Regulatory, Value Assessment, and Payer Decision-Making

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

204ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-656-L04-P; CME 1.00; RN 1.00

Patient experience data (PED) is sought by regulators, payers, and value/health technology assessment (V/HTA) bodies globally and used in different ways. Actively including PED in scientific, regulatory, and V/HTA processes has been a recent feature of regulatory and HTA reform, notably FDA guidance on patient-focused drug development (PFDD) and the EU Joint Clinical Assessment framework. Evolving perspectives on V/HTA have brought attention to the role of PED and there is a need to more systematically integrate PED into payer decision-making. Yet, the PED needs and perspectives of different stakeholders must be better understood for PED to have meaningful impact on product development, evaluation, and related decision-making. Many questions remain. Where do patients believe they have the most impact? What is industry experience gathering and leveraging PED globally? Do government agencies believe their efforts to include patient perspectives are being impactful on evidence they finally review? How can the impact of PED on V/HTA increase and be optimized globally? We will explore options to increase the impact of PED on development, V/HTA, and access decisions through optimal coordination and information sharing, and highlight options and good practices for integrating PED into regulatory, V/HTA, and payer decisions. We will discuss learnings across various opportunities for leveraging PED through policies and processes that affect patient access. Perspectives on PED from patient-group, EMA, payer, and industry panelists will showcase differences and similarities in stakeholder views and evidence needs to inform PFDD, V/HTA, and payer decisions, ultimately impacting patient access. Panelists’ experiences provide a lens on how current processes are working in concert or opposition, and opportunities for meaningful multi-stakeholder collaborations maximize PED impact on access decisions.

Learning Objectives

Discuss patient-group, payer, regulator, and industry perspectives on PED, in general, and regarding how to optimize PED use in decision-making in their respective roles; List the benefits and challenges to integrating PED in regulatory, V/HTA, and payer decision-making, from various stakeholder perspectives; Describe two examples of good practices and recommendations for integrating PED into regulatory, V/HTA, and payer decisions.

Chair

Eleanor M. Perfetto, PhD, MS

Speaker

Panelist
Maria Mavris, PhD

Panelist
Maxwell Isaacoff

Panelist
Magdalena Harrington, PhD

Panelist
Anna Hyde, MA

Speakers

Magdalena Harrington

Senior Director, Patient-Centered Outcomes Assessment (PCOA) Team Lead, Pfizer, United States

Magdalena Harrington is a subject matter expert in clinical outcomes assessment (COA) research with over 15 years of experience in delivering health outcomes strategies that demonstrate clinical and economic value of new medicines. She has extensive training in qualitative and quantitative... Read More →

Anna Hyde

Vice President of Advocacy & Access, Arthritis Foundation, United States

Anna Hyde is VP of Advocacy and Access at the Arthritis Foundation, overseeing federal/state legislative programs and grassroots engagement. She works to elevate arthritis as a public health priority, expand access to affordable care, and involve patients in policymaking. Since joining... Read More →

Maxwell Isaacoff

Director, Federal & External Affairs, Elevance Health, Inc, United States

Maria Mavris

Patient Relations, European Medicines Agency, Netherlands

Maria Mavris joined EMA in 2014 as a Patient Liaison in the Public and Stakeholder Engagement department. Her work focuses on engaging patients all along the regulatory lifecycle and supporting them in their involvement as members of EMA’s scientific committees, as representatives... Read More →

Eleanor Perfetto

Independent Consultant, Consultant, United States

Dr. Perfetto is a caregiver and recognized advocate for people with head-trauma-related dementias. She is a current member and past secretary and governance-committee chair for the Brain Injury Association of America’s Board of Directors and past chair of the Concession Legacy Foundation... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
204ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Session

Level Intermediate
Keyword Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience
Tags Session

4:00pm EDT

#362: Collaborating for Equity: Reaching Communities Through Partnerships with Federally Qualified Health Centers and Community Health Workers

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

201

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-658-L04-P; CME 1.00; RN 1.00

Federally Qualified Health Centers and Community Health Workers play a critical role in reaching underserved populations, often serving as the first point of contact for healthcare in their communities. By partnering with these trusted entities, we can better connect with communities, bridging the gap between clinical research and underrepresented groups to ensure that clinical trials are more inclusive and reflective of the populations they aim to serve. This session will highlight the power of grassroots partnerships in expanding access to clinical research and showcase effective models that can be replicated in other regions.

Learning Objectives

Identify key components of the partnership between Reaching Communities, FQHCs, and CHWs; List ways to leverage the strengths of Federally Qualified Health Centers and Community Health Workers to effectively raise awareness and promote participation in clinical trials among underrepresented populations; Discuss how to foster greater inclusivity and accessibility for historically underserved populations in clinical research.

Chair

Perla Nunes

Speaker

NCCHCA and the FQHCs
Korrey Monroe, MPH

MedNorth Health Center and CHWs
Sharon Renee Brown-Singleton, LPN, MS

Durham Technical Community College and Clinical Research
Sharleen Traynor, PhD, MPH

Speakers

Sharon Brown-Singleton

Chief Strategy Officer, MedNorth Health Center, United States

Sharon Brown-Singleton is currently the Chief Strategy Officer at MedNorth Health Center. She led the implementation of the Community Health Worker program, having experience in writing, developing, and implementing various CHW programs centered around maternal and child health, substance... Read More →

Korrey Monroe

Program Manager, North Carolina Community Health Center Association, United States

Korrey Monroe is the Research Program Manager at the North Carolina Community Health Center Association (NCCHCA). In this role, he collaborates with the department director, Dr. Becca Hayes, to facilitate innovative research to raise awareness and provide resources for underserved... Read More →

Perla Nunes

Patient Advocate, Community Outreach and Clinical Research DEI Thought Leader, United States

Ms. Nunes' research career began at Hoffmann-LaRoche, where she worked in drug discovery. In NC she worked in at at the Cannon Research Center of Atrium Health focusing on preclinical and clinical research areas related to oncology and immunology. She worked at Duke University's CTSI... Read More →

Sharleen Traynor

Instructor, Durham Tech, United States

Sharleen Traynor is an epidemiologist and educator with 20 years of public health experience in government and academic settings. In her current role as Director of the Clinical Trials Research Associate program at Durham Technical Community College, Dr. Traynor now focuses on clinical... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
201 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

05: Patient-Impact-Product-Dev, Forum

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

4:00pm EDT

#363: Critical to Quality Assessment Reports from Inception to Operationalization: How to Engage Internal Stakeholders

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

152AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-659-L04-P; CME 1.00; RN 1.00

There is an opportunity to inspire and engage internal stakeholders on the value proposition of the Critical to Quality Assessment Report (CAR). Sponsors will weigh in on the challenges and opportunities related to the value of the CAR for their internal stakeholders.

Learning Objectives

Recognize the internal value proposition of the Critical to Quality Assessment Report and its application throughout the QMS and beyond; Discuss ways to apply different tactics to persuade and engage internal stakeholders on the value and application of the Critical to Quality Assessment Report.

Chair

Kiernan Trevett, MSc

Speaker

A Sponsor's Perspective on Engaging Internal Stakeholders on the Critical to Quality Assessment Methodology and its Application Throughout the QMS
Jennifer Emerson, PhD, MPH, RN, PMP

A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Mandy Kaur Budwal-Jagait, MSc

A Regulator's Perspective on the Value Proposition of the Critical to Quality Assessment Report
Cheryl Grandinetti, PharmD

Speakers

Mandy Budwal-Jagait

Head of GCP, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Mandy Budwal-Jagait is the Head of GCP and Lead Senior GCP inspector with the MHRA. She joined the Agency in April 2014 as a GCP Inspector and became GPvP Operations Manager in 2020, responsible for the Pharmacovigilance Inspection programme. In 2022, Mandy became the Head of GCP... 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 →

Kiernan Trevett

Quality Policy Lead, Genentech, A Member of the Roche Group, United States

Kiernan Trevett is the Quality Policy Chapter Lead in Roche’s R&D Quality function and is responsible for strategic leadership on the shaping of clinical and safety quality policy. Previously, she worked as a GVP Inspector at the UK MHRA for 1O years, with her most recent role being... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
152AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

08: RD-Quality-Compliance, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

4:00pm EDT

#365: International Regulatory Engagement for Advancing Regulatory Science Approaches to Enable New Products to Address Patient Needs

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

150AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-661-L04-P; CME 1.00; RN 1.00

Regulators will showcase how working together to advance regulatory science is key for new approaches. Participants will discuss how to efficiently translate drug development tools into practice, how industry and not-for-profits can drive innovation.

Learning Objectives

List the usefulness of engaging in advancing regulatory science tools and subsequent translation into research practice, product development and evaluation; Discuss global regulatory convergence and activities towards new regulatory science approaches to enable new products.

Chair

Ralf Herold, DrMed, MD

Speaker

How Industry Is Shaping Public-private Partnerships To Facilitate New Development Pathways For Products
Ginny Beakes-Read, BSN, JD

The ITCC-P4 Consortium: A Pediatric Oncology Case Study In Innovative Multistakeholder Collaboration To Address R&D Challenges
Louis Stancato, PhD

Accelerating Translation of Regulatory Science Research – EFPIA’s perspective
Solange Corriol-Rohou, DrMed, MD, PhD

Speakers

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 →

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France

Ralf Herold

Head of Regulatory Science and Academia Workstream, European Medicines Agency, Netherlands

Louis Stancato

VP Enabling Technologies, Indiana Biosciences Research Institute, United States

Dr. Stancato is a cancer biologist at the Indiana Biosciences Research Institute, pursuing his passion to bring life-saving therapies to children with cancer. Upon his retirement from Eli Lilly and Company, Dr. Stancato had 26 years of comprehensive drug discovery experience, and... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
150AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Regulator Perspectives, Regulatory Convergence and Harmonization, Student Programming, Global Perspectives
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Regulatory Convergence and Harmonization,Student Programming,Global Perspectives
Tags Forum

4:00pm EDT

#366: FDA Rare Disease Town Hall

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

146BC

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-662-L04-P; CME 1.00; RN 1.00

This annual town hall provides a forum for senior FDA officials to reflect on key trends and discuss opportunities in rare disease drug development and review. Officials answer moderated and audience burning questions facing the work that they do.

Learning Objectives

Describe new FDA programs and initiatives intended to help facilitate development of drugs for rare diseases; Evaluate opportunities for sponsors and patient stakeholders to engage with regulators; Identify current trends in challenges and opportunities facing orphan drug development.

Chair

James Valentine, JD, MHS

Speaker

Perspectives on Rare Immunology & Inflammation Product Development
Nikolay Nikolov, MD

Perspectives on Rare Neuroscience Product Development
Teresa Buracchio, MD

Speakers

Teresa Buracchio

Director, Office of Neuroscience, OND, CDER, FDA, United States

Teresa Buracchio, MD, is Director of the Office of Neuroscience in the Center for Drug Evaluation and Research, Food and Drug Administration (FDA). She oversees the review of new drug programs for neurologic and psychiatric diseases. Dr. Buracchio joined FDA in 2013. Dr. Buracchio... Read More →

Nikolay Nikolov

Director, Office of Immunology and Inflammation, OND, CDER, FDA, United States

Dr. Nikolay P. Nikolov is a board-certified Internist and Rheumatologist and is currently the Director of the Office of Immunology and Inflammation, CDER. During rheumatology fellowship at NIAMS, NIH, he studied cellular and molecular mechanisms of autoimmunity. Then, at the Sjögren's... Read More →

James Valentine

Director, Hyman, Phelps & McNamara, PC, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Keyword Rare Disease, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Rare Disease,Student Programming
Tags Forum

4:00pm EDT

#367: Beyond Weight Loss: Pioneering the Future of Obesity Drug Development

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

147AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-663-L04-P; CME 1.00; RN 1.00

This forum on obesity drug development helps the audience understand the present landscape, participate in discussions on the prevention and treatment of comorbidities, and assess various strategies in enhancing clinical trial efficiency.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of obesity drug development; Identify the prevention and treatment of comorbidities associated with obesity; Assess various considerations and strategies in enhancing the efficiency of obesity drug development.

Chair

Jingyu (Julia) Luan, PhD

Speaker

Panelist
Joseph Nadglowski, JR

Panelist
Maria Vassileva, PhD

Panelist
John Sharretts

Panelist
Brad Jordan, PhD

Speakers

Brad Jordan

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Brad Jordan is the Associate Vice President of Regulatory Policy and Strategy at Eli Lilly, where he is responsible for the regulatory policy strategy for Lilly’s cardiometabolic and immunology therapeutic areas.

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she... Read More →

Joseph Nadglowski

President/Chief Executive Officer, Obesity Action Coalition, United States

Joe Nadglowski is President & CEO of the Obesity Action Coalition (OAC) – a nonprofit organization formed in 2005 dedicated to elevating and empowering individuals affected by obesity through education, advocacy and support. A frequent speaker and author, Mr. Nadglowski is especially... Read More →

John Sharretts

Director at Division of Diabetes, Lipid Disorders, and Obesity, FDA, United States

Maria Vassileva

Chief Science and Regulatory Officer, 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 18, 2025 4:00pm - 5:00pm EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

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

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Forum

4:00pm EDT

#368: Perspectives on the Adoption of Advanced Manufacturing Technologies

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

143ABC

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-664-L04-P; CME 1.00; RN 1.00

Share regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Listen to Industry cases studies showing implementation journeys and interactions with Regulators globally. Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss remaining challenges and priority areas for Industry and Regulators to work collaboratively to promote the adoption of advanced manufacturing technologies.

Learning Objectives

Discuss regulatory efforts to support advanced manufacturing, including global regulatory developments from EMA and FDA; Describe avenues available to industry and academia to support development of advanced manufacturing technologies; Discuss priority areas for regulatory consideration to promote the adoption of advanced manufacturing technologies.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

Implementation Journey for AI use in Manufacturing (without hallucinating)
Gert Thurau, DrSc, PhD

Implementation Journey of a Digital Twin
Benjamin Stevens, PhD, MPH

mRNA-Based Vaccines: From First Approvals Towards a Platform Technology
Brian Doyle

Speakers

Brian Doyle

Senior Director, Technical Development, Moderna, United States

Brian Doyle has over 15 years of experience in technical and CMC development for vaccines and therapeutics. Since joining Moderna in 2019, Brian has led organizations focused on late-stage and commercial process development and CMC technical writing, with a particular interest at... Read More →

Evdokia Korakianiti

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

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States

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

Gert Thurau

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

Dr. Gert Thurau is the Head of Manufacturing Technology and Innovation Advocacy in the CMC Reg PTR Policy team at Hoffmann- La Roche in Basel, Switzerland. His responsibility includes the regulatory advocacy for the adoption of advanced technologies in GMP manufacturing – covering... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

10: RegCMC-Product Quality, Session

Level Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Tags Session

4:00pm EDT

#370: Modernizing Evidence in Oncology: Real World Data and Artificial Intelligence in Clinical Drug Development

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

145AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-666-L04-P; CME 1.00; RN 1.00

Regulatory, industry, and academic organizations discuss modern approaches to clinical drug development by describing novel methods and use cases integrating real-world data and AI to generate real-world evidence, with focus on oncology and rare diseases.

Learning Objectives

Discuss global regulatory guidance and frameworks supporting innovative designs using real-world data as well as approaches to inclusion of artificial intelligence (AI); Describe innovative approaches and methods through examples of applied AI use in drug development; Discuss areas of research interest and promote community collaboration.

Chair

Donna Rivera, PharmD, MSc, FISPE

Speaker

Applying Artificial Intelligence in Drug Development
Sid Jain, MBA

Use of Artificial Intelligence Approaches for Rare Diseases
Christina Mack, PhD, MPH

Speakers

Sid Jain

Senior Vice President, Clinical Development and Data Science, Recursion, United States

Sid Jain is a healthcare innovator reimagining drug discovery and clinical development through data, technology, and biology. As SVP of Clinical Development & Data Science at Recursion, he leads teams integrating AI, real-world data, and clinical expertise to modernize therapy development... Read More →

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States

Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →

Donna Rivera

Associate Director for Pharmacoepidemiology, Oncology Center of Excellence, FDA, United States

Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD... Read More →

Kelly Robinson

Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada

Kelly Robinson is the Director General of the Pharmaceutical Drugs Directorate at Health Canada. In this role she leads a multidisciplinary team responsible for the authorization of innovative and generic pharmaceuticals, clinical trial evaluation, and the Special Access Program... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Forum

Level Intermediate
Keyword Artificial Intelligence (AI), Clinical Trial Design
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence (AI),Clinical Trial Design
Tags Forum

4:00pm EDT

#364: Beyond Clinical-Outcome Assessments: Best Practices for Submitting Other Types of Patient Experience Data to Regulators

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

151A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-660-L04-P; CME 1.00; RN 1.00

This session will provide an opportunity for key stakeholders, including regulators, product developers and patients to discuss best practices around patient experience data, including planning, collecting, and submitting such data to regulators.

Learning Objectives

Discuss current expectations for regulator/sponsor interactions related to patient experience data that will be used in regulatory submissions; Recognize common pitfalls for submission of patient experience data in regulatory applications, and how to avoid them.

Chair

Robyn Bent, BSN, MS, RN

Speaker

Panelist
Pujita Vaidya, MPH

Panelist
Brett Hauber, PhD, MA

Speakers

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States

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

Brett Hauber

Patient Preference Evidence Integration Lead, Pfizer Inc, United States

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States

Pujita Vaidya has 12+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Forum | 09: Regulatory, Forum

Level Intermediate
Keyword Patient Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Patient Experience
Tags Forum

4:00pm EDT

#371: Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations

Wednesday June 18, 2025 4:00pm - 5:00pm EDT

206

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-667-L04-P; CME 1.00; RN 1.00

The session aims to enhance the participant's ability to recognize the global business environment, focusing on critical factors influencing business strategy. We will illustrate adopting business and regulatory strategies to evolving landscapes.

Learning Objectives

Identify key factors and trends influencing the biotechnology and pharmaceutical industries; Evaluate the impact of these trends on business and regulatory strategies; Propose strategic adaptations to address evolving industry and regulatory challenges.

Chair

Lawrence Fine, PhD, MBA

Speaker

Beyond Borders: Impact of Economic Shifts on Regulatory Strategies in Obesity Care
Tetyana Fine, MS

Global Strategy Considerations for Biosimilar Approvals
Rosalyn Janine Bailey, MPharm, MS

Artificial Intelligence in Drug Development
Darshini Trivedi, PhD

Speakers

Rosalyn Bailey

Executive Director NA & LATAM Head – Global Regulatory Affairs Solultions, Syneos Health, United States

Rosalyn Bailey, MS, is an experienced Regulatory Affairs leader with over 20 years in the drug development industry. As Executive Director of Global Regulatory Affairs Solutions at Syneos Health, she oversees regulatory teams across the Americas, guiding products through the regulatory... Read More →

Lawrence Fine

Business Consultant, Lawrence Fine, LLC, United States

Extensive experience working with companies of various sizes, including Fortune 500 companies. Deep expertise in Technology, Healthcare, Hospitality and Biotechnology industries across different functions including but not limited to marketing, information technology, and personnel... Read More →

Tetyana Fine

Director, Global Regulatory Affairs, Astrazeneca, United States

Fifteen (15) years of diverse biotechnology and pharmaceutical industry experience, including leadership, regulatory strategy development and execution, chemistry manufacturing and controls (CMC), and program and project management. Effectively direct multinational, cross-functional... Read More →

Darshini Trivedi

Global Regulatory Affairs and Product Strategy, Amgen, Inc, United States

Wednesday June 18, 2025 4:00pm - 5:00pm EDT
206 Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

12: ProfDevelopment, Session

Level Intermediate
Keyword Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Student Programming
Tags Session

Filter By Date

Jun 9 - 19, 2025

June 2025
Sun Mon Tue Wed Thu Fri Sat

1 2 3 4 5 6 7

8 9 10 11 12 13 14

15 16 17 18 19 20 21

22 23 24 25 26 27 28

29 30
Filter By Venue

Washington, D.C., USA

All

143ABC
144ABC
145AB
146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
Filter By Type

00: Plenary

All
Forum

01: ClinSafety-PV

All
Forum

Session

02: ClinTrials-Ops

All
Forum

Session

Tutorial

Workshop

03: Data-Tech

All
Forum

Session

Tutorial

Workshop

04: MedAffairs-SciComm

All
Forum

Session

05: Patient-Impact-Product-Dev

All
Forum

Session

06: PersonalizedMed-ComboProd-Diagnostics

All
Forum

Session

Tutorial

07: ProjectManagement-StrategicPlanning

All
Forum

Session

Tutorial

Workshop

08: RD-Quality-Compliance

All
Forum

Session

Tutorial

09: Regulatory

All
Forum

Session

Tutorial

Workshop

10: RegCMC-Product Quality

All
Forum

Session

Tutorial

Workshop

11: Statistics-Data Science

All
Forum

Session

Tutorial

12: ProfDevelopment

All
Forum

Session

Tutorial

Workshop

13: Spotlight

All
Forum

Session

14: DIAmond

All
Forum

Session

15: Content-Hubs

All
Workshop

16: Community-Rounds

All
Session

Workshop

17: Posters

All
Session

18: InnovationTheaters

All
Session

19: Networking Opportunities

All
Session

Social Event

20: Short-Courses

All
Tutorial
Level

Advanced

Basic

Intermediate
Keyword

Advanced Analytics

Artificial Intelligence (AI)

Bioethics

Biomarkers

Cell and Gene Therapy

Clinical Trial Design

Diagnostics

Digital Technology

Global Perspectives

Non-CE

Patient Experience

Payers

Pediatrics

Rare Disease

Real-World Data (RWD) / Real-World Evidence (RWE)

Regulator Perspectives

Regulatory Collaboration

Regulatory Convergence and Harmonization

Regulatory Reliance

Student Programming
Timezone

June 2025
Sun	Mon	Tue	Wed	Thu	Fri	Sat
1	2	3	4	5	6	7
8	9	10	11	12	13	14
15	16	17	18	19	20	21
22	23	24	25	26	27	28
29	30