DIA 2026 Global Annual Meeting: Full Schedule

8:00am EDT

#400: Hidden Potential: Turning Today’s Science into Tomorrow’s Cures

Monday June 15, 2026 8:00am - 10:00am EDT

Component Type: Session
Level: Intermediate

This opening plenary explores how patient driven science, AI enabled discovery, and regulatory innovation can uncover “hidden cures” in the medicines and data we already have. Through a keynote from David Fajgenbaum and a panel on AI in biopharma, the session asks how we can find, trust, and deliver tomorrow’s cures from today’s science.

Learning Objectives

Describe the latent potential of existing medicines and data, and how patient driven science can uncover new uses for known therapies; Explain how AI and advanced analytics can de risk drug discovery and trial design, surfacing overlooked opportunities and improving investment decisions; Identify system level levers: collaboration, regulation, and capital, that can help translate today’s science into tomorrow’s cures more quickly, safely, and equitably.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Lawrence Tallon

Panelist
David Pfeiffer

Panelist
Greg Sarafin

Panelist
Rahul Gupta, MD, MBA, MPH

Panelist
David Fajgenbaum

Panelist
Audrey Greenberg, CPA, MBA

Speakers

David Fajgenbaum

Co-Founder & President of Every Cure, Every Cure, United States

Audrey Greenberg

Mayo Clinic, Venture Partner and Chair, Mayo Ventures, United States

Rahul Gupta

President, GATC Health, United States

Dr. Gupta was appointed President of GATC Health, a tech-bio company advancing drug discovery and development, in February 2025. He previously served as Director of the White House Office of National Drug Control Policy (ONDCP) from 2021 to January 2025—the first physician to lead... Read More →

David Pfeiffer

SVP, Head of ARCAS, Bio-Tech, Acrisure Re, United States

Greg Sarafin

Chief Administrative Officer, Sovereign AI, United States

Greg Sarafin is the Chief Administrative Officer of Sovereign AI where he oversees corporate functions, capital, partnerships, and vendors. Sovereign AI is a vertically integrated, country-first AI infrastructure and platform designed to support governments, regulated industries... Read More →

Lawrence Tallon

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

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 →

Monday June 15, 2026 8:00am - 10:00am EDT
Ballroom AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 05: PersonalizedMed-ComboProd-Diagnostics, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 00: Plenary, Session

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Interest Area Health Technology & AI,Biotechnology & Investors
Feature Topics Digital Enablement and Modernization
Tags Session

11:00am EDT

#406: Enhancing Regulatory Collaboration through Cloud Technologies

Monday June 15, 2026 11:00am - 12:15pm EDT

111AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-513-L04-P; CME 1.25; RN 1.25

The session will explore lessons learned and challenges in scaling up cloud-powered regulatory collaborations. It will feature insights from technology providers, regulatory agencies, and industry representatives

Learning Objectives

Explain the value of regulatory collaboration and describe recent technological advancements that enable it; Identify key challenges and opportunities associated with integrating cloud technologies into regulatory processes; Examine perspectives from technology providers, regulators, and industry on the future of regulatory collaboration and outline ways to participate in these efforts.

Chair

Dominique Lagrave, PHARMD

Speaker

Panelist
Marko Eric

Panelist
Julie Lepin, MA

Panelist
Ana Carolina Moreira Marino Araujo

Panelist
Vada Perkins, MS

Speakers

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil

Ana Carolina Marino is Head of the International Affairs Office at ANVISA. Holds a permanent position at ANVISA as goverment employe, Health Regulatory Expert, since March 2007. Has experience in both technical and management roles: Advisor at the Fourth Directorate/ANVISA; Head for... Read More →

Marko Eric

Regulatory Assessor, Medicines and Medical Devices Agency of Serbia , Serbia

Marko Eric is a pharmacist. He joined the Medicines and Medical Devices Agency of Serbia (ALIMS) in 2009 at the National Pharmacovigilance Center, where he currently works as the coordinator of the development of the national pharmacovigilance system. In addition to standard PV assessments... Read More →

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States

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

Dominique Lagrave

Chief Regulatory Officer, Accumulus Technologies, United States

Julie Lepin

Senior Vice President & Chief Regulatory Officer, BeOne Medicines, United States

Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around... Read More →

Vada Perkins

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

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

Monday June 15, 2026 11:00am - 12:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Cross-Functional Collaboration, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Cross-Functional Collaboration,Digital Enablement and Modernization
Tags Forum

11:00am EDT

#415: Regulatory Cooperation Between the United States and Japan

Monday June 15, 2026 11:00am - 12:15pm EDT

115C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-522-L04-P; CME 1.25; RN 1.25

This session provides an update on the current regulatory affairs between FDA and PMDA. Both agencies will highlight significant regulatory collaboration in two areas, oncology and drug safety and discuss future regulatory activities in their region.

Learning Objectives

Describe the latest regulatory collaboration between the United States and Japan; Identify new key areas for further regulatory collaboration between FDA and PMDA.

Chair

Sema Hashemi, MS

Speaker

Panelist
Mark Abdoo

Panelist
Naoyuki Yasuda, MSC

Panelist
Gerald Dal Pan, MD, MHS

Panelist
Miki Ota, MPHARM

Panelist
Akihiro Ishiguro, PHD

Speakers

Mark Abdoo

Associate Commissioner for Global Policy and Strategy, FDA, United States

Sema Hashemi

Senior International Policy Advisor, FDA, United States

Ms. Sema Hashemi is a Senior International Policy Advisor in the Office of Global Policy and Strategy (OGPS) within FDA’s Office of the Commissioner. Her portfolio focuses on bilateral and regional engagements with Canada, East Asia, the Pacific, Middle East and North Africa. Sema... Read More →

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 →

Miki Ota

Director, Office of Informatic and Manegement for Safety, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Ms. Miki Ota joined the MHLW in December 2000, when she was assigned to the Pharmaceutical and Food Safety Bureau. She was mainly involved in Safety measure of Chemical Substance. Subsequently, she worked in several organizations including Ministry of the Environment, National Personnel... Read More →

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

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

Naoyuki Yasuda

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Mr. Naoyuki Yasuda graduated from Osaka University in 1991. He careered industrial policy, industrial chemicals assessment, medical devices revaluation, international cooperation on narcotics and psychotropics, blood/blood product safety and vaccine supply and overall pharmaceuticals... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Forum

11:00am EDT

#416.1: International Regulatory Cooperation with the African Medicines Agency

Monday June 15, 2026 11:00am - 12:15pm EDT

110A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-608-L04-P; CME 1.25; RN 1.25

A 60-minute session with AMA, FDA, and partners will review successes in collaboration, explore future opportunities to enhance oversight and access, and conclude with interactive Q&A on advancing harmonized regulatory systems in Africa.

Learning Objectives

Discuss the FDA priorities in regulatory alignment, supply chain resilience, and collaboration in Africa; Recognize how regulators work across regions to improve access, using approaches such as reliance, convergence, and joint inspections to reduce duplication, strengthen resilience, and advance public health.

Chair

Meisha Sampson, MS

Speaker

International Regulatory Cooperation with the African Medicines Agency
Emile Bienvenu

Panelist
Aissatou SOUGOU

International Regulatory Cooperation with the African Medicines Agency
Delese Mimi Darko, MBA, RAC

International Regulatory Cooperation with the African Medicines Agency
Ahmed Mohamed

International Regulatory Cooperation with the African Medicines Agency
Heran Gerba, PHD

Speakers

Emile Bienvenu

Director General, Rwanda Food and Drug Authority, Rwanda

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda

Dr. Mimi Darko graduated as a pharmacist with an MBA. Her career in food and health products regulation spans over 30 years. Prior to her appointment as AMA's first DG, she rose through the ranks of the FDA to become its first female CEO in 2017. She led FDA’s designation as a Regional... Read More →

Heran Gerba

Director General, Ethiopian Food and Drug Authority (EFDA), Ethiopia

Ahmed Mohamed

Chief Executive Officer, Pharmacy and Poisons Board, Kenya

Meisha Sampson

Director, FDA, United States

Meisha Sampson is the inaugural Director of the FDA African Medicines Agency Liaison Office within FDA’s Office of Global Policy and Strategy, based at the U.S. Embassy in Kigali, Rwanda, home to the African Medicines Agency. In this role, she advances a collaborative FDA–AMA... Read More →

Aissatou SOUGOU

Director General, Department of Pharmacy and Laboratories (DPL) , Senegal

Monday June 15, 2026 11:00am - 12:15pm EDT
110A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Global Alignment in Practice
Tags Forum

11:00am EDT

#416: Transforming Women’s Health Science: Closing the Innovation Gap and Accelerating Impact

Monday June 15, 2026 11:00am - 12:15pm EDT

204AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-524-L04-P; CME 1.25; RN 1.25

This session presents insights from the Women’s Health Innovation Radar, highlighting global evidence gaps and emerging research priorities. It explores strategic and policy implications to accelerate scientific and clinical progress in women’s health.

Learning Objectives

Identify key global evidence gaps and emerging areas of activity in women’s health R&D; Recognize how patterns in scientific evidence and clinical research can guide strategic and policy priorities in women’s health; Outline actionable levers, scientific, clinical, and policy-related, that can accelerate progress in women’s health innovation.

Chair

Martin Hodosi, MS

Speaker

-
Victoria DiBiaso, BSN, MPH, RN

-
Katherine Senter, MPH

-
Sanj Singh, MBA

Speakers

Victoria DiBiaso

Head of Patient Informed Development & Health Value Translation, Sanofi, France

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

Martin Hodosi

Partner, Healthcare and Life Sciences Practices, Kearney, United States

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

Katherine Senter

Assistant Director, Cancer Clinical Research Operations, Sidney Kimmel Cancer Center – Jefferson Health, United States

Katherine Senter, MPH, CCRP currently serves as Assistant Director for Cancer Clinical Research Operations at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Jefferson. Here she guides Clinical Research Managers, Investigators, and their teams to conduct and streamline high... Read More →

Sanj Singh

CEO, Temple Therapeutics, Netherlands

He is a biotech leader with 20+ years of driving innovation and growth. As co-founder and CEO of Temple Therapeutics, he has built a clinical-stage company at the forefront of women’s health—advancing a differentiated pipeline, securing strategic partnerships, expanding IP, and... Read More →

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States

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

Monday June 15, 2026 11:00am - 12:15pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

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

11:00am EDT

#413: Health Canada Town Hall

Monday June 15, 2026 11:00am - 12:15pm EDT

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-520-L04-P; CME 1.25; RN 1.25

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

Learning Objectives

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

Chair

Alysha Croker, PHD

Speaker

Panelist
Sophie Sommerer

Speakers

Alysha Croker

Director, Strategic and Horizontal Policy, Health Canada, Canada

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

Sophie Sommerer

Director General, Marketed Health Products Directorate, Health Canada, Canada

Sophie Sommerer is the Director General of Health Canada’s Marketed Health Products Directorate. She is responsible for post-market surveillance of a range of health products, including pharmaceutical and biologic drugs, natural health products and medical devices. From 2016 to... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Regulatory
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Session

11:00am EDT

#414: How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency

Monday June 15, 2026 11:00am - 12:15pm EDT

115AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-521-L04-P; CME 1.25; RN 1.25

As FDA–industry negotiators finalize future performance goals, Congress will shape the next user-fee statute. This session examines how budget politics, workforce shifts, and innovation priorities—from AI to MAHA—may reshape FDA’s mandate.

Learning Objectives

Describe the user-fee reauthorization timeline and how Congressional “adds” can modify negotiated performance goals; Examine how budget pressures and recent reductions in force may affect FDA capacity and review predictability; Assess how leadership priorities to accelerate innovation—including review vouchers, AI, and MAHA initiatives—could influence policy riders and oversight.

Chair

Jeffrey Francer, JD, MPA

Speaker

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Clare Paoletta

How the Upcoming FDA User Fee Legislation Could Advance Innovation and Reshape the Agency
Barrett Tenbarge, JD

Speakers

Jeffrey Francer

Vice President, Head of International Regulatory Affairs and Global Policy, Eli Lilly and Company, United States

Jeff Francer serves as Vice President, Head of International Regulatory Affairs and Global Regulatory Policy for Eli Lilly and Company. In this role, Jeff leads Lilly’s interactions with regulators and submissions in the Asia-Pacific, Europe, Middle East, and Africa regions. Jeff... Read More →

Clare Paoletta

Professional Staff Member, US House Committee on Energy and Commerce, United States

Barrett Tenbarge

Partner, Faegre Drinker, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 06: ProfDevelop-Program-PortfolioMgmt, Forum

Audience Intermediate
Area Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Project Management & Strategic Planning
Feature Topics Student and Early Career Pathway
Tags Forum

11:00am EDT

#412: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis

Monday June 15, 2026 11:00am - 12:15pm EDT

201AB

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-523-L04-P; CME 1.25; RN 1.25

This session aims to provide a comprehensive analysis of the FDA's practice of publicly posting CRLs. We will examine the past year's data, identify emerging trends, and assess the implications of this transparency initiative.

Learning Objectives

Discuss FDA's process for issuing and publicly posting Complete Response Letters (CRLs); Analyze trends in CRLs over the past year, including common reasons for issuance; Evaluate the benefits and potential drawbacks of public CRL disclosure.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Eva Temkin, LLM

Panelist
Amanda Conti

Panelist
Eric Gascho

Speakers

Lina AlJuburi

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

A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... Read More →

Amanda Conti

Senior Research Analyst, Agencyiq By Politico, United States

Eric Gascho

Vice President, CRD Associates, United States

Eric is a Vice President at CRD Associates and the Executive Director of the Coalition for Health Funding, positions he has held since 2024. He has extensive experience in a variety of legislative and regulatory policy issue areas, including federal budget and appropriations, public... Read More →

Eva Temkin

Partner, Arnold & Porter, United States

A partner in Arnold & Porter's Life Sciences and Healthcare practice, Eva provides strategic counsel to clients regarding significant and complex issues associated with FDA-regulated pharma and biotech. Formerly the acting Director for Policy in FDA's Office of Therapeutic Biologics... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
Tags Forum

2:30pm EDT

#439.1: From Lag to Lead: Accelerating Global Innovative Medicines Through China’s NMPA

Monday June 15, 2026 2:30pm - 3:30pm EDT

203AB

Component Type: Session
Level: Advanced

China is reshaping global drug development and regulatory strategy. This session equips MNC regulatory leaders with decision framework, actionable strategies, pathway insights, and case studies to optimize China integration and global approvals.

Learning Objectives

Assess China’s evolving regulatory landscape to inform global portfolio strategy; Examine National Medical Products Administration (NMPA) regulatory pathways to optimize timelines and market entry; Apply decision frameworks and practical approaches to integrate China into global programs while balancing global alignment, local requirements, and execution risk.

Chair

Wenny Du, MBA, RAC

Speaker

Global Strategy and Challenges
Todd Paporello, PHARMD, MBA

China Strategy and Solution
Wei Zhang

Panel Discussion
Xiaoyuan Chen, MD

Industry Case Studies
Wenny Du, MBA, RAC

Speakers

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China

Researcher Chen Xiaoyuan graduated with a bachelor's degree in clinical medicine in 1996 and a master's degree in clinical pharmacology in 2002. In 2010, he received a doctorate in pharmacology from Shanghai Jiaotong University. In 2002, he joined the drug evaluation center of the... Read More →

Wenny Du

Sr. Director, Global Regulatory Lead, Amgen Inc., United States

Wenny Du, MS, MBA, RAC, serves as Senior Director and Global Regulatory Lead (GRL) for Oncology at Amgen Inc., where she leads global regulatory teams to shape and execute strategies that enable worldwide innovative medicine approvals. With over 25 years of biopharmaceutical industry... Read More →

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States

Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China

Monday June 15, 2026 2:30pm - 3:30pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Advanced
Level Advanced
format csv
Tags Session

2:30pm EDT

#439: Early Intervention in Slowly Progressing Chronic Diseases: Navigating Regulatory and Reimbursement Uncertainty

Monday June 15, 2026 2:30pm - 3:30pm EDT

115AB

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Application UAN: 0286-0000-26-536-L04-P; CME 1.00; RN 1.00

Global interest in early intervention for chronic diseases is driving regulatory innovation, but evidence and reimbursement barriers remain. This forum will highlight how global agencies and payers are adopting harmonized, patient-focused approaches.

Learning Objectives

Analyze global regulatory and reimbursement challenges associated with decision-making for early treatment of chronic diseases; Assess existing gaps and opportunities within US and EU regulatory and reimbursement frameworks to advance in this area.

Chair

Simon Bennett, MS

Speaker

Regulatory challenges facing the development of treatments for chronic neurological disorders
Steffen Thirstrup, MD, PHD

Panelist
Julian Beach, MBA

Patient Perspective
Mindy Cameron

Speakers

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Julian oversees the portfolio that is designed to ensure the quality and access of products to the UK market - this includes scientific advice, licensing assessment, marketing authorisations for all innovative and established medicines. A committed professional with over 15 years... Read More →

Simon Bennett

Director, EU Regulatory Policy, Biogen, United Kingdom

As Director of European Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities in key areas. Simon started at Biogen in 2003 in clinical development before moving into Regulatory Sciences... Read More →

Mindy Cameron

Patient Advocate, Advocacyworks, United States

Mindy Cameron's evolution as a rare disease patient expert started over 20 years ago when her second son was diagnosed with Duchenne muscular dystrophy. Through her work with non-profit, research, and industry organizations, Mindy has become a recognized voice for patients living... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Dr. Steffen Thirstrup, MD, PhD, has been Chief Medical Officer at the European Medicines Agency (EMA) since June 2022. A specialist in clinical pharmacology, he has held leadership roles at the Danish Medicines Agency, served as a CHMP member at EMA, and co-chaired the European Commission’s... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Advanced
Area Therapeutic Pathways, Global Alignment in Practice
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Value & Access,Regulatory
Feature Topics Therapeutic Pathways,Global Alignment in Practice
Tags Session

2:30pm EDT

#440: Harnessing International Regulatory Reliance and Collaboration to Accelerate Innovation and Patient Access to Medicines

Monday June 15, 2026 2:30pm - 3:30pm EDT

115C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-534-L04-P; CME 1.00; RN 1.00

Sponsors are increasingly leveraging regulatory collaboration and reliance approaches. In this Forum, international regulatory and industry experts will review ongoing pilot projects and discuss future opportunities.

Learning Objectives

Discuss Industry experience with reliance initiatives; Explain ICMRA and ICH efforts to facilitate a pharmaceutical quality knowledge management capability; Identify benefits and challenges for expanding global regulatory reliance and collaboration; Outline how cloud-based platforms and harmonized regional requirements can strengthen reliance.

Chair

Amanda Roache, MS

Speaker

Reflections on ICMRA Pilots and Opportunities for International Regulatory Collaboration
Sarah Pope Miksinski, PHD

Panelist
Evdokia Korakianiti, PHD, MSC

FDA Reflection on Experiences with International Regulatory Collaboration and Opportunities
Ashley Boam, MS

Industry Experiences with Regulatory Reliance and Collaboration Initiatives
Joann M Parker, MS, RPH

Speakers

Ashley Boam

Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA, United States

Ashley serves as Director of the Office of Policy for Pharmaceutical Quality in the Center for Drug Evaluation and Research at FDA. OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including... 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 →

Sarah Pope Miksinski

Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States

Sarah Pope Miksinski has been with Gilead since July 2023 and is currently an Executive Director in CMC Regulatory Affairs. She represents Gilead in various external capacities – including serving on PhRMA’s Global Quality and Manufacturing Committee, serving as chair of ISPE’s... Read More →

Joann Parker

Vice President of Regulatory CMC, Pfizer, United States

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Amanda Roache, MPP, is Deputy Vice President, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Global Alignment in Practice
Tags Forum

2:30pm EDT

#442: The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, MHRA, and PMDA

Monday June 15, 2026 2:30pm - 3:30pm EDT

204AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-535-L04-P; CME 1.00; RN 1.00

Senior leaders from FDA, EMA, MHRA and PMDA share insights on AI’s evolving role in regulatory review & decision-making. Attendees will explore current practices, key challenges, and future opportunities for AI in shaping global regulatory frameworks.

Learning Objectives

Discuss how AI is transforming regulatory review and decision-making at FDA, EMA, MHRA, and PMDA; Analyze key challenges and opportunities facing AI adoption in regulatory review and decision-making; Identify emerging trends and future directions for AI in shaping global regulatory practices.

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Joaquim Berenguer Jornet, MS

Panelist
Tomoharu Numanyu, RPH

Speakers

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

Joaquim Berenguer is currently the AI implementation lead and supports the digital strategy of the European Medicines Agency. He is also the chair of the European Agencies Network Working Group on AI. Mathematician as background, Joaquim had led different data scientist teams during... Read More →

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

Dr. Luan is currently the Executive Regulatory Science Director at AstraZeneca (AZ), where she oversees all regulatory aspects of obesity and diabetes drug development and supports the research, development, and commercialization efforts in these disease areas. She also leads the... Read More →

Tomoharu Numanyu

Senior Reviewer, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Tomoharu Numanyu is a Senior Scientific Officer in the Office of New Drug Review I at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. After obtaining his pharmacist license, he worked in the pharmaceutical industry for three years before joining PMDA in 2016. From 2016... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 03: Data-Tech-AI, Forum

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Regulatory
Feature Topics Artificial Intelligence
Tags Forum

2:30pm EDT

#438: A Conversation About Quality: A Global Regulators Discussion

Monday June 15, 2026 2:30pm - 3:30pm EDT

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-537-L04-P; CME 1.00; RN 1.00

This forum will present the perspectives of global regulatory agencies on encouraging a high standard for quality in pharmaceutical products. The panel will discuss their vision, key initiatives, challenges on how to improve drug quality worldwide.

Learning Objectives

Describe regulatory agencies’ shared priorities about drug quality in support of a secure, resilient, and high-quality pharmaceutical supply chain; Identify the role of oversight to ensure high-quality pharmaceutical manufacturing; Explain how regulators can work in partnership to reach a coherent, predictable, and efficient global regulatory environment for the benefit of global public health.

Monday June 15, 2026 2:30pm - 3:30pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 09: RD-Quality-Compliance, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Tags Forum

4:00pm EDT

#447: Enabling Faster Multi-Regional Study Start-Up Through Harmonization and Collaboration

Monday June 15, 2026 4:00pm - 5:00pm EDT

108B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-542-L04-P; CME 1.00; RN 1.00

This session reviews how ICH harmonization and new oncology MRCT guidelines from FDA, NMPA, and PMDA enable regulatory collaboration, speeding global trial start-up, drug development and patient access through shared data and adaptive approaches.

Learning Objectives

Analyze how regulatory harmonization and collaboration accelerate global study start-up; Differentiate key principles of ICH E17, E5, and regional oncology MRCT guidelines; Summarize strategies to navigate regional regulatory differences and enable global studies.

Chair

Angelika Joos, MPHARM

Speaker

ethical aspects of conducting MRCTs from a global perspective
Sarah A. White, MPH

Experience from global conduct of MRCTs
Aloka Chakravarty, PHD

Panelist
Paz Vellanki

PMDA perspective
Yoko Aoi, PHD

Speakers

Yoko Aoi

Coordination Director - Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yoko Aoi is a Coordination Director, Office of Review Management at the PMDA of Japan. After joining PMDA, Dr. Aoi has been involved in regulatory review/scientific advice for new drugs, including treatments for rheumatoid arthritis, asthma, and COPD (2011–2016); coordination... Read More →

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States

Aloka Chakravarty

VP, Clinical Data Insights and Advanced Analytics, Eli Lilly and Company, United States

Dr. Aloka Chakravarty is VP, Statistical Data Insights and Advanced Analytics at Eli Lilly. Prior to that, she was the Director, Office of Biostatistics(A) at FDA where her career spanned 31 years. She is recipient of FDA Award of Merit, the highest scientific award conferred by the... Read More →

Angelika Joos

Executive Director, Science & Regulatory Policy, MSD, Belgium

Angelika Joos is a trained pharmacist. She is responsible for Clinical Research Policy issues within MSD's Science & Regulatory Policy department. This role includes identifying policy priorities that align with MSD’s business priorities, leading cross-functional networks to define... Read More →

Paz Vellanki

Associate Director, OND, CDER, FDA, United States

Sarah White

Executive Director, MRCT Center, United States

Ms. White is the Executive Director at The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. In this capacity, she is responsible for developing and implementing the overall strategy and vision for the Center as well as oversee all management functions... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Regulatory
Feature Topics Global Alignment in Practice
Tags Forum

4:00pm EDT

#448: Accelerating Regulatory Readiness: A Vision for AI-Enabled Pandemic Preparedness

Monday June 15, 2026 4:00pm - 5:00pm EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-544-L04-P; CME 1.00; RN 1.00

Discover Coalition For Epidemic Preparedness Innovations (CEPI) Pandemic Preparedness Engine (PPE) regulatory node—a forward-looking digital platform using AI and cloud technology to accelerate vaccine approvals through structured data, automated workflows, and global collaborative review.

Learning Objectives

Discuss the conceptual framework of CEPI’s Pandemic Preparedness Engine (PPE) regulatory node and its role in accelerating emergency vaccine approvals; Recognize how AI-enabled workflows and cloud-based platforms can support concurrent, global regulatory review through PDDF and DSVI integration; Identify opportunities for regulatory collaboration and input to shape the future of digital dossier.

Chair

Ashley Jones-Mitchell, MPH

Speaker

Panelist
Melody Chessia

Panelist
Kevin Bugin, MS, RAC

Panelist
Teginder Singh, MPHARM

Speakers

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States

Dr. Kevin Bugin is the head of global regulatory policy and intelligence at Amgen. Prior to this role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER), where in addition, he led the creation... Read More →

Melody Chessia

Director of Product Management, Accumulus Technologies, United States

Melody Chessia

Director of Product Management, Accumulus Technologies, United States

Ashley Jones-Mitchell

Head of Global Regulatory Policy, Accumulus Synergy, United States

Ashley is Head of Global Regulatory Policy for Accumulus Synergy. With over 19 years of experience in the federal government and industry, Ashley advocates for policies that will advance digital transformation. Prior to her time at Accumulus Synergy, Ashley was with the U.S. Food... Read More →

Teginder Singh

Global Head Regulatory Quality Safety, Google, United States

Teginder Singh is a senior executive and pharmacist with over 25 years of leadership in health & life sciences. His early career focused on drug discovery, and he has since led complex transformation programs across R&D, Regulatory, Quality and Safety at Fortune50 companies like Google... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence, Global Alignment in Practice, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Artificial Intelligence,Global Alignment in Practice,Digital Enablement and Modernization
Tags Session

4:00pm EDT

#456: Middle East Town Hall: The Rising Global Innovation Hub - Aligning Regulations and Unlocking Fresh Opportunities

Monday June 15, 2026 4:00pm - 5:00pm EDT

112AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-549-L04-P; CME 1.00; RN 1.00

The Middle East is a fast-emerging innovation hub. Aligning with global standards, the region is opening new opportunities and incentives. Join us to discover Middle Eastern innovations and why companies should view it as a top investment destination.

Learning Objectives

Discuss how the Middle East has rapidly evolved over the past decade, benchmarking regulatory systems, achieving higher maturity levels, and accelerating cross-stakeholder collaboration.

Chair

Amira Deia Younes

Speakers

Amira Younes

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

Amira is Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years’ experience in regulatory science and policy. A recognized thought leader in regulatory reliance, work sharing, and harmonization, she builds cross-sector networks to strengthen... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Biotechnology & Investors
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Forum

4:00pm EDT

#454: Accelerating Pediatric Innovation: Leveraging Extrapolation and Global Policy to Transform Drug Development for Children

Monday June 15, 2026 4:00pm - 5:00pm EDT

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-550-L04-P; CME 1.00; RN 1.00

This session will explore innovative regulatory approaches, including the ICH E11A guideline, to accelerate access to effective treatments for children with chronic conditions such as pediatric multiple sclerosis.

Learning Objectives

Identify innovative regulatory strategies for pediatric drug development, including the ICH E11A guideline; Evaluate the impact of extrapolation and trial design on accelerating access to treatments for children with chronic conditions; Recognize ways to engage in collaborative discussion to propose actionable solutions for reducing approval lag times for children.

Chair

Christina Bucci-Rechtweg, MD

Speaker

Panelist
Laura Jawidzik, MD

Panelist
Lauren Krupp, MD

Panelist
Lynne Yao, MD

Speakers

Christina Bucci-Rechtweg

Global Head, Maternal Health and Pediatric Regulatory Policy, Novartis , United States

Christina is Global Head of Pediatric & Maternal Health Policy at Novartis. She graduated from the U Rochester Sch of Medicine & Dentistry and trained in Peds/Pediatric Critical Care Medicine at SUNY Buffalo. She has 20+ yrs of experience in Clinical Development and Regulatory Policy... Read More →

Laura Jawidzik

Division Director, Division of Neurology 2 (DN2), OND, CDER, FDA, United States

Dr. Jawidzik is a board-certified neurologist and the director of the Division of Neurology 2 (DN2) at FDA. She joined the Agency in 2015 in DN2 as a clinical reviewer on the migraine/TBI/stroke team. In 2020, she moved from DN2 to DN1 and has served in various positions in DN1 including... Read More →

Lauren Krupp

Director, Multiple Sclerosis Comprehensive Care Center, NYU Langone Health, United States

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States

Monday June 15, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Global Alignment in Practice
Tags Forum

4:00pm EDT

#455: Japan Town Hall

Monday June 15, 2026 4:00pm - 5:00pm EDT

115AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-551-L04-P; CME 1.00; RN 1.00

This session explores the benefits of drug development and approval in Japan, highlighting market size, development predictability, and regulatory support, with insights from administrative bodies and the international pharmaceutical industry.

Learning Objectives

Recognize misconceptions about Japan's drug development environment and learn the latest updates; Discuss the benefits of drug development in Japan from regulatory and industry perspectives.

Chair

Daisuke Koga, MS, MSC

Speaker

Panelist
Seiko Usami, PHD

Panelist
Yoshiaki Uyama, PHD, MS, RPH

Speakers

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Mr. Daisuke Koga is the Director of the Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the Ministry on drugs, medical devices, food... Read More →

Seiko Usami

Pharmaceuticals and Medical Devices Agency, Japan

Yoshiaki Uyama

Associate Executive Director, Regulatory Science Center, 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 →

Monday June 15, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Clinical Development & Operations
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Session

4:00pm EDT

#457: Understanding the Misconceptions and Myths around Surrogate Endpoints

Monday June 15, 2026 4:00pm - 5:00pm EDT

204AB

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-548-L04-P; CME 1.00; RN 1.00

Explore the science and debate surrounding the FDA’s use of surrogate endpoints in drug approvals, with a focus on their role in addressing unmet medical needs. This session will bring together diverse perspectives to clarify misconceptions.

Learning Objectives

Describe an evidence-based overview of the development and utilization of surrogate endpoints in FDA approvals; Examine the increasing reliance on surrogates, particularly case studies in fields like rare diseases and oncology, where overall survival data may be years away; Discuss ways to incorporate the patient and provider perspective to understand what constitutes “meaningful” endpoints.

Chair

Bridget Doherty, MPH, MS

Speaker

Panelist
Kara Berasi, PHARMD, MS

Panelist
Jenny Myers Ahlstrom

Panelist
Alexis Reisin Miller, JD

Speakers

Jenny Ahlstrom

Founder & CEO/Multiple Myeloma Patient, HealthTree, United States

Kara Berasi

CEO, Haystack Project, United States

Kara Berasi started working in patient advocacy after her son was diagnosed with a rare disease. She has a personal passion to change the landscape of care as it relates to those living with rare diseases. She is the CEO of Haystack Project, an umbrella organization representing over... Read More →

Bridget Doherty

Director, Access and Policy Research, Johnson & Johnson, United States

Bridget Doherty, MPH, MS, is a strategic policy, research, and communications professional with extensive experience in pharmaceuticals, medical devices, and healthcare publishing. Currently serving as the Director of Access and Policy Research at Johnson & Johnson Innovative Medicine... Read More →

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States

Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the... Read More →

Alexis Miller

Head, Global Regulatory Policy, MSD, United States

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping shape and respond with agility to an evolving global regulatory landscape. Her work centers on advancing regulatory science, implementing practical policy frameworks, expanding use of data beyond traditional... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

Audience Basic
Area Evidence Innovation
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
Feature Topics Evidence Innovation
Tags Forum

8:00am EDT

#500: Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies

Tuesday June 16, 2026 8:00am - 9:00am EDT

114

Component Type: Session
Level: Intermediate

This plenary session will bring together first-hand perspectives from academic and pharmaceutical experts involved in the development of the GLP1 therapies that first achieved regulatory approval for the treatment of obesity. Speakers will reflect on the scientific and clinical journey that enabled these breakthroughs, while examining how innovation in this space continues to evolve. The session will also address the persistent access gap facing patients worldwide and explore how global companies are working closely with regulators to expand access in a sustainable and equitable manner. Key health policy implications will be discussed, setting the stage for subsequent sessions within the new Chronic Disease and Obesity Pathway.

Learning Objectives

Analyze the key scientific and clinical milestones that led to the first regulatory approvals of GLP-1 therapies for obesity using expert perspectives; Assess how innovation in GLP-1 therapies is evolving and consider its impact on future obesity and chronic disease treatment; Examine global access gaps to obesity therapies and identify policy and regulatory strategies to expand equitable and sustainable patient access.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Robert M. Califf, MD

Panelist
Brad Jordan, PHD

Panelist
W. Scott Butsch, MD, MSC

Speakers

W. Scott Butsch

International Medical Vice President - Obesity, Novo Nordisk A/S, Denmark

Robert Califf

Instructor, Medicine, Duke University School of Medicine, United States

Dr. Robert Califf is an Adjunct Professor of Medicine at Duke University and a practicing cardiologist. He served as FDA Commissioner (2016–2017) and Deputy Commissioner for Medical Products and Tobacco. At Duke, he was Vice Chancellor for Clinical and Translational Research and... Read More →

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.

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

00: Plenary, Session | 02: ClinicalTrialOps-Innovation, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Therapeutic Pathways
Level Intermediate
format csv
Interest Area Clinical Development & Operations
Feature Topics Therapeutic Pathways
Tags Session

10:15am EDT

#505: Agility Unlocked: How Mixed FSP/FSO Models Enhance Efficiency and Facilitate the Transition from FSO to FSP Outsourcing

Tuesday June 16, 2026 10:15am - 11:30am EDT

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-558-L04-P; CME 1.25; RN 1.25

Learn how mixed FSP (functional service provider)/FSO (full-service outsourcing) models deliver additional agility to help clinical trial sponsors manage complexity, enhance efficiency, and facilitate the transition from FSO to FSP outsourcing.

Learning Objectives

Identify opportunities where mixed FSP (functional service provider)/FSO (full-service outsourcing) models create additional agility in clinical trial operations; Discuss how mixed FSP/FSO models facilitate the transition from FSO to FSP outsourcing; Assess flexible options to deliver drug development on time and on budget in complex, global trials.

Speaker

Moderator
Andrew Studna

Panelist
Samantha Hadfield

Panelist
Nick Scott

Speakers

Samantha Hadfield

Vice President, Operational Delivery, PPD FSP solutions, Thermo Fisher Scientific, United Kingdom

Nick Scott

Head, Strategic Resourcing and Performance Optimization, Biogen, United States

Andrew Studna

Senior Editor, Applied Clinical Trials, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 01: ClinSafety-PV-RM, Forum | 08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Tags Forum

10:15am EDT

#513: Advancing Chronic Disease Development: Insights from FDA, EMA, PMDA, and MHRA

Tuesday June 16, 2026 10:15am - 11:30am EDT

201AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-565-L04-P; CME 1.25; RN 1.25

Chronic Disease Town Hall spotlights emerging programs and global initiatives for chronic disease drug development, outlines the current landscape, explores opportunities and challenges, and assesses strategies to boost efficiency and accelerate therapeutic innovation.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of chronic disease drug development; Describe emerging programs and global initiatives designed to facilitate development of chronic disease drugs; Assess various considerations and strategies to enhance the efficiency of chronic disease drug development.

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Alison Cave

Panelist
Maria Vassileva, PHD

Panelist
Ayaka Kubota, RPH

Speakers

Alison Cave

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

Dr Alison Cave is Chief Safety Officer at the Medicines and Healthcare products Regulatory Agency (MHRA), with responsibility for the safety of medicines and medical devices in the UK. She holds a BSc (Hons) and PhD from the University of London and has extensive academic and regulatory... Read More →

Ayaka Kubota

Office of Safty II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

She is a reviewer at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is involved in the scientific review of pharmaceuticals, primarily focusing on cardiovascular drugs and treatments for Alzheimer’s disease, with an emphasis on clinical evaluation and regulatory... Read More →

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway, Therapeutic Pathways
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Rare Disease & Special Populations,Regulatory
Feature Topics Global Alignment in Practice,Student and Early Career Pathway,Therapeutic Pathways
Tags Session

10:15am EDT

#509: Integrating Artificial Intelligence and Real-World Evidence: FDA's Framework for Advancing Medical Product Development

Tuesday June 16, 2026 10:15am - 11:30am EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-559-L04-P; CME 1.25; RN 1.25

This session will provide FDA perspective on opportunities for AI and RWE to enhance drug and biologic development and improve patient outcomes. FDA presenters will discuss key RWE and AI program updates, including new Agency level initiatives.

Learning Objectives

Describe FDA's current AI and RWE regulatory frameworks and key guidance documents and how these align with FDA’s mission; Identify the promise and the limitations of AI in the context of drug and biologics development and identify opportunities for integrating AI and RWE approaches; Apply FDA recommendations for use of AI/RWE in regulatory submissions.

Chair

Marie Bradley, MPH

Speaker

Panelist
Hussein Ezzeldin, PHD

Speakers

Marie Bradley

Senior Advisor, Real-World Evidence , Office of Medical Policy, CDER, FDA, United States

Dr. Marie Bradley is a Senior Advisor for RWE in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER). Her responsibilities related to real-world evidence (RWE) include serving as lead for the Advancing Real-World Evidence Program, the Real-World Evidence Subcommittee... Read More →

Hussein Ezzeldin

Associate Director for Advanced Technologies, OBPV, OMP, CBER, FDA, United States

Dr. Ezzeldin is the Associate Director for Advanced Technologies in the Office of Biostatistics and Pharmacovigilance (OBPV), in the Center for Biologics Evaluation and Research (CBER). Dr. Ezzeldin supported multiple programs in previous roles, for example, leading the digital health... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Evidence Innovation, Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Regulatory
Feature Topics Evidence Innovation,Artificial Intelligence
Tags Session

10:15am EDT

#511: AI Risk Scores and Regulatory Forks: Diagnose Your Software’s Regulatory Fate

Tuesday June 16, 2026 10:15am - 11:30am EDT

203AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-561-L04-P; CME 1.25; RN 1.25

Explore how FDA’s Clinical Decision Support (CDS) guidance impacts software classification in drug development. Learn to apply a decision tree through real-world case studies and a hands-on workshop to determine whether a tool is a regulated medical device or exempt CDS.

Learning Objectives

Apply FDA’s CDS guidance criteria to determine whether AI software tool (used to identify patients or risk factors) qualifies as a regulated medical device or exempt CDS; Analyze real-world digital health scenarios using a structured decision tree to support regulatory classification; Evaluate the impact of software classification on drug development strategy, trial design, and regulatory planning

Chair

Michael Mayrosh, PHARMD

Speaker

AI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory Fate
Jeppe G. Manuel, MLIS

AI Risk Scores and Regulatory Forks: Diagnose Your Software's Regulatory Fate
Lesley Maloney, PHARMD

Speakers

Lesley Maloney

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

Lesley R. Maloney, Pharm.D., is Regulatory Policy Leader at Genentech, a member of the Roche Group. She is responsible for shaping the external regulatory environment in the US and globally on topics including patient-focused drug development, digital health technologies, and artificial... Read More →

Jeppe G. Manuel

Data Science External Affairs & Intelligence Director, Novo Nordisk A/S, Denmark

Jeppe joined Novo Nordisk in 2015 and prior to his current role worked as a specialist in Clinical Reporting and Disclosure. He has 15+ years of experience from the pharmaceutical industry, primarily from Regulatory and Clinical working with Enterprise Content Management, Digitalisation... Read More →

Michael Mayrosh

Associate Director Global Regulatory Policy and Strategy, Eli Lilly and Company, United States

Mike Mayrosh is an Associate Director, Global Regulatory Policy and Strategy for Eli Lilly and Company. Mike leads Lilly's policy work on E-labeling, Artificial Intelligence, Digital Health Technologies, and Clinical Trial Modernization. Mike earned his PharmD from the University... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Workshop | 02: ClinicalTrialOps-Innovation, Workshop | 08: RegPolicy-Strategy-GlobalCollaboration, Workshop

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI
Feature Topics Artificial Intelligence
Tags Workshop

10:15am EDT

#516: Modernizing Nonclinical Safety Assessment: FDA and EMA Roadmaps to Reduce Animal Testing

Tuesday June 16, 2026 10:15am - 11:30am EDT

115C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-563-L04-P; CME 1.25; RN 1.25

This session explores the FDA and EMA’s evolving strategies to modernize nonclinical regulatory frameworks. We will examine both agency initiatives to reduce animal testing where scientifically appropriate and their roadmaps for increasing the regulatory acceptance of New Approach Methodologies (NAMs). We will discuss efforts to drive international harmonization on alternative nonclinical strategies via ICH. Participants will also gain insights into how the industry is currently integrating NAMs into submissions and broader strategies for animal testing reduction.

Learning Objectives

Describe FDA's objectives under their roadmap to reducing animal testing in preclinical safety studies; Recognize EMA's ongoing activities to promote the integration of NAMs and reduce NHP studies; Discuss international harmonization via ICH; Discuss industry's experience to date with submitting NAMs in regulatory applications and overall reduction of animal testing strategies.

Chair

Imein Bousnina, PHARMD, MSC

Speaker

FDA Presentation on Modernizing Nonclinical Safety Assessment
Haleh Saber, PHD

Modernizing Nonclinical Safety Assessment via ICH
Amanda Roache, MS

EMA Presentation on Modernizing Nonclinical Safety Assessment
Orla Moriarty, PHD

Speakers

Imein Bousnina

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

Imein Bousnina, Pharm.D, is a Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Over her decade at Roche-Genentech, she has served as a subject matter expert and led the implementation of regulatory policy strategies on topics such as FDA and EMA's regulation... Read More →

Orla Moriarty

Scientific Officer, European Medicines Agency, Netherlands

Orla Moriarty is a scientific officer in the Translational Sciences Office at EMA where she is responsible for providing scientific support to the Agency’s 3Rs and Non-clinical Working Parties. She joined EMA in 2023 as a Seconded National Expert from the Irish Health Products Regulatory... Read More →

Amanda Roache

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States

Haleh Saber

Deputy Director, DHOT/ OHOP/ CDER, FDA, United States

Dr. Saber is the Deputy Director in the Division of Hematology Oncology Toxicology (DHOT). In this role, she provides leadership for day-to-day activities, leads and coordinates scientific research, and participates in guidance development. Dr. Saber has extensive industry and regulatory... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Preclinical & Early Phase Research,Regulatory
Tags Forum

10:15am EDT

#517: Navigating the New FDA: Insights from Former FDA Chief of Staffs

Tuesday June 16, 2026 10:15am - 11:30am EDT

204AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-638-L04-P; CME 1.00; RN 1.00

The session will feature former FDA Chief of Staffs discussing their contributions to regulatory policies, patient engagement, and innovative technologies, offering insights into the evolving regulatory landscape and helping stakeholders navigate FDA

Learning Objectives

Identify key initiatives and challenges described by former FDA Chief of Staffs; Explain how the regulatory landscape is evolving and how these changes may influence future drug approval processes; Discuss FDA organizational dynamics and strategic decision-making factors that shape public health outcomes, helping stakeholders to navigate the new FDA more effectively.

Chair

Elizabeth Lange, MPH, MS

Speaker

Panelist
Susan Winckler, JD

Panelist
Elizabeth Jungman, JD, MPH

Panelist
Kalah Auchincloss, JD, MPH

Panelist
Lauren Silvis, JD

Panelist
Julie Tierney

Speakers

Kalah Auchincloss

Canal Row Advisors, United States

Kalah is a consultant to pharma, biotech and medical device companies providing strategic regulatory advice. Prior to her consulting and legal roles, Kalah spent six years at the FDA, including as Deputy Chief of Staff to Commissioner Robert Califf, and in senior positions in CDER’s... Read More →

Elizabeth Jungman

Partner, Global Regulatory, Hogan Lovells US LLP, United States

Elizabeth Jungman is a Partner at the global law firm Hogan Lovells where she advises life sciences companies on high-stakes regulatory strategy and engagement with the FDA. Prior to joining Hogan, Elizabeth was FDA’s Chief of Staff, where she oversaw the day-to-day management of... Read More →

Elizabeth Lange

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

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

Elizabeth Rosenkrands-Lange

VP & Head, RQC, Science, Policy & Intelligence (SPI), Novo Nordisk Inc., United States

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

Lauren Silvis

Senior Vice President, External Affairs, Tempus, United States

Lauren Silvis serves as Senior Vice President of External Affairs at Tempus, overseeing regulatory, public policy, government affairs and strategic communications. She has held a number of senior career public health roles, serving as a Senior Advisor at the Department of Health and... Read More →

Julie Tierney

Principal, Leavitt Partners, United States

Susan Winckler

Chief Executive Officer, Reagan-Udall Foundation For the FDA, United States

Prior to accepting her post as CEO for the FDA’s Foundation in May of 2020, she served as President of Leavitt Partners Solutions. She advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Forum

10:15am EDT

#519.1: European Integration in Times of Geopolitical Crisis: Supporting Ukraine’s EU Accession and Building Resilient Public Institutions

Tuesday June 16, 2026 10:15am - 11:30am EDT

105AB

Component Type: Session
Level: Intermediate

This session will explore how Ukraine’s EU accession process is driving the transformation of its healthcare and pharmaceutical regulatory system during one of the most challenging geopolitical periods in modern European history. Speakers from the Ukrainian government, Poland, the European Medicines Agency, and the European Commission will discuss how resilient public institutions, regulatory convergence, and international cooperation contribute to European security, democratic stability, and health system resilience. The discussion will highlight the strategic importance of supporting Ukraine’s institutional integration into the European Union and the broader future of European cooperation in health governance.

Learning Objectives

Analyze the role of regulatory reform and resilient public institutions in supporting Ukraine’s EU accession process during geopolitical crisis; Compare the contributions of EU Member States, the EMA, and the European Commission in advancing Ukraine’s integration into the European regulatory framework; Assess how international regulatory cooperation and alignment with the EU acquis communautaire can strengthen health security, governance, and institutional resilience in candidate countries.

Chair

Magdalena Pajewska

Speaker

Panelist
Maryna Slobodnichenko

Panelist
Grzegorz T Cessak

Speakers

Grzegorz Cessak

President, URPLWMIPB, Poland

Magdalena Pajewska

Head of the International Relations Unit, Office For Registration of Medicinal Products, Medical Devices and Biocides, Poland

Maryna Slobodnichenko

Deputy Minister, Ministry of Health of Ukraine, Ukraine

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Tuesday June 16, 2026 10:15am - 11:30am EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

10:15am EDT

#514: Innovation Gridlock: When Misaligned Policies Threaten Progress for Patients

Tuesday June 16, 2026 10:15am - 11:30am EDT

115AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-564-L04-P; CME 1.25; RN 1.25

Examines how fragmented policies, trade barriers, pricing pressures, and other restrictions create innovation gridlock—blocking or stalling R&D, delaying clinical trials, disrupting supply, and threatening patient access to critical therapies.

Learning Objectives

Identify key policy and regulatory misalignments contributing to innovation gridlock in biopharma; Assess the global impact of these barriers on patient access to transformative therapies. and prioritize action based on criticality; Examine opportunities and actionable policy levers to realign systems and accelerate innovation for patients.

Chair

Alexis Reisin Miller, JD

Speaker

PMDA perspective
Daisuke Koga, MS, MSC

Industry perspective
Michelle Rohrer, PHD

Speakers

Daisuke Koga

Director, Office of International Strategy and Planning, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Alexis Miller

Head, Global Regulatory Policy, MSD, United States

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech, A Member of the Roche Group, United States

Michelle Rohrer, PhD is Global Head of Product Development Regulatory at Genentech Roche. Michelle has worked at the company for 31 years, starting as a post-doctoral fellow. Michelle's awards include SF Business Times “The Most Influential Women in Bay Area Business” and PharmaVOICE... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 03: Data-Tech-AI, Forum

Audience Intermediate
Area Digital Enablement and Modernization, Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Digital Enablement and Modernization,Artificial Intelligence
Tags Forum

1:45pm EDT

#537: EMA Town Hall

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

204AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-670-L04-P; CME 1.25; RN 1.25

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

Steffen Thirstrup, MD, PHD

Speaker

Panelist
Sabine Haubenreisser, PHD, MSC

Panelist
Ana Trullas, PHARMD, MSC

Panelist
Denise Umuhire, MBA, MSC

Panelist
Joaquim Berenguer Jornet, MS

Speakers

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Ana Trullas

Senior scientific specialist, European Medicines Agency, Netherlands

Ana is a Senior Scientific Specialist who works as a Product Lead in the Oncology and Haematology Office at EMA. Responsible for clinical and regulatory science input for a portfolio of products from pre-submission of initial marketing authorisation through post-authorisation. Further... Read More →

Denise Umuhire

Pharmacoepidemiologist and Real-World Evidence Specialist, European Medicines Agency, Netherlands

I am a pharmacoepidemiologist & RWE specialist within the Data Analytics and Method Taskforce at the Europea Medicine Agency (EMA). I am part of the RWE workstream that provides support on RWE related matters to different evaluation committees, delivering rapid analyses of RWD to... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Session

1:45pm EDT

#538: Innovations in Drug Review: A Global Perspective

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-579-L04-P; CME 1.25; RN 1.25

This roundtable will discuss innovations in drug review, including real-time review, AI-enabled dossier analysis, cloud data exchange, mid-cycle communications, and cross-disciplinary review, and how modern tools create a dynamic review environment.

Learning Objectives

Examine drug review practices, and highlight key PDUFA VIII enhancements; Describe the evolving role of technology (AI, cloud) in drug evaluation; Explain drug review practices globally.

Chair

Cartier Esham, PHD, MSC

Speaker

Panelist
Max Wegner, PHARMD, RPH

Panelist
Donna Boyce, MS, RAC

Panelist
Brittany Avin McKelvey, PHD

Speakers

Donna Boyce

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

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

Cartier Esham

Chief Scientific Officer, Biotechnology Innovation Organization (BIO), United States

Cartier Esham serves as Executive Vice President for Emerging Companies at the Biotechnology Innovation Organization (BIO). In this role, Dr. Esham manages and directs BIO’s policy development, advocacy, research and educational initiatives for BIO’s emerging companies, which... Read More →

Rhonda Hearns-Stewart

Senior Physician, FDA, United States

Rhonda Hearns-Stewart, MD, is a Senior Physician. She joined the FDA as a Medical Officer in the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER) in 2013. As a senior clinical reviewer in the Division of Bone, Reproductive, and Urologic Products... Read More →

Brittany McKelvey

Senior Director, Regulatory Policy, LUNGevity Foundation, United States

Brittany McKelvey is the Senior Director of Regulatory Policy at the LUNGevity Foundation. In her role, she leads the organization in advancing lung cancer policy, clinical trial reform, and regulatory initiatives. Brittany directs the Transforming Clinical Trials Initiative, fostering... Read More →

Max Wegner

Senior Vice President,Head Regulatory Affairs, Bayer, Germany

A global leader in regulatory science, Max Wegner is Senior Vice President and Head of Regulatory Affairs at Bayer, overseeing all regulatory activities for the Pharmaceuticals division. He began his career in pharmacy at the University of Bonn, continued his pharmacology PhD at Bayer... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

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

1:45pm EDT

#540: Regulators Approach to Address Drug Shortages

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

115C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-578-L04-P; CME 1.25; RN 1.25

Drug shortages are difficult to measure across healthcare systems and complex pharmaceutical supply chains. At this session, the FDA and their international regulatory counterparts will address the key aspects of drug shortages in their region and how real-world data are used to inform on shortages and their impact on patients.

Learning Objectives

Discuss recent regulatory updates related to drug shortages in the United States; Recognize how real-world data can be used to inform the identification, mitigation, and resolution of shortages; Describe how recent international collaboration efforts are helping to combat drug shortages.

Chair

Sema Hashemi, MS

Speaker

Panelist
Emily T. Thakur, RPH

Panelist
Grace Chai, PHARMD

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Grace Chai

Associate Director for Special Initiatives, OSE, CDER, FDA, United States

Sema Hashemi

Senior International Policy Advisor, FDA, United States

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Emily Thakur

Team Leader, Drug Shortage Staff, Office of the Center Director, CDER, FDA, United States

CDR Emily Thakur has been working with the Drug Shortage Program since February 2011. She joined the FDA in 1999, working in the Office of Generic Drugs. She then joined the Office of Regulatory Policy in 2005. She received her Bachelor of Science degree from Rutgers College of Pharmacy... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Global Alignment in Practice
Tags Forum

1:45pm EDT

#541: Taiwan Town Hall: Strategies to Promote Medicine Supply Resilience

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-669-L04-P; CME 1.25; RN 1.25

This Taiwan Town Hall showcases Taiwan’s evolving approach to medicine supply resilience. It brings together regulators, industry, and health systems from Taiwan, the EU, Japan, and the US to explore coordinated global pathways for critical medicines.

Learning Objectives

Explain Taiwan’s transition from medicine shortage management to supply resilience governance; Compare regulator, industry, and health system perspectives from Taiwan, EU, Japan, and US on critical medicines and international cooperation; Identify practical pathways for Taiwan to engage with global partners to strengthen coordinated frameworks for resilient medicine supply.

Chair

Chih-Kang Chiang, MD

Speaker

From Shortage Management to Resilience Governance: Taiwan’s Evolving Policy Approach
Chih-Kang Chiang, MD

From Regulation to Resilience: Taiwan’s Strategy in Controlled Drug Manufacturing and Future Directions
Meng-Hsiu Wu

From Shortage to Resilience: Building Medication Supply Preparedness in Health Systems
Matthew Eberts, PHARMD, MBA, MHA

Lessons from Japan: Rebuilding Domestic Antibiotics Production for Enhanced Supply Resilience
Masaya Tamae

Speakers

Chih-Kang Chiang

Director General, Taiwan Food and Drug Administration, Taiwan

Dr. Chiang has been the Director General of Taiwan Food and Drug Administration (TFDA) since February 27, 2025. He oversees the regulation of food, drugs, medical devices, and cosmetics. Prior to the DG of TFDA, Dr. Chiang was a highly accomplished professional serving as the Director... Read More →

Matt Eberts

Senior Director System Pharmacy Business and Outcomes, University of Maryland Medical System, United States

Matt is the Senior Director of System Pharmacy Business and Outcomes for the University of Maryland Medical System (UMMS). In his role he is responsible for the medication supply chain, centralized distribution, and business functions for the 12 hospital health care system.

Masaya Tamae

Deputy General Manager, Corporate Strategy Division, Meiji Seika Pharma., Co., Ltd, Japan

Meng-Hsiu Wu

Senior Technical Specialist, Taiwan Food and Drug Administration, Taiwan

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Session

1:45pm EDT

#539: Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication

Tuesday June 16, 2026 1:45pm - 3:00pm EDT

115AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-577-L04-P; CME 1.25; RN 1.25

Explore how patient-focused principles can transform product labeling into a strategic asset. Learn how to integrate patient perspectives early, align with regulatory trends, & leverage labeling to support decision-making and differentiate products.

Learning Objectives

Identify opportunities to incorporate patient experience data into product labeling that aligns with FDA/EMA guidance; Examine case studies of successful patient-centered labeling that supports decision-making; Outline approaches to develop labeling strategies that bridge regulatory requirements with patient value.

Chair

Julie Guery, PHD

Speaker

Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication
Kelly Treonze, MS

Labeling as a Strategic Asset: Advancing Patient Voice and Creating Value Through Meaningful Product Communication
Jason Harris

Panelist
Kaisa Immonen, MA

Speakers

Robyn Bent

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

Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). . Ms. Bent also serves as an FDA representative to the Management Committee of the International... Read More →

Julie Guery

Global Regulatory Affairs Labeling Head, Sanofi, United States

Julie Guery is the Global Regulatory Affairs Labeling Head at Sanofi, leading a team of 50+ professionals focused on Labeling Strategy, Innovation, and Operations. She supports a broad portfolio across Inflammatory & Immunology, Rare Diseases, Oncology, Vaccines, and General Medicine... Read More →

Jason Harris

Vice President, Government Relations and Advocacy, National Psoriasis Foundation, United States

Kaisa Immonen

Patient and Consumer Liaison, European Medicines Agency, Netherlands

Kaisa Immonen joined the Stakeholders and Public engagement team of the European Medicines Agency (EMA) in 2023. She supports interactions with patients, consumers and their organisations. Kaisa holds a Master’s degree in Health Policy, Management and Innovation (Maastricht University... Read More →

Kelly Treonze

Head, Global Labeling, Merck & Co., Inc., United States

Kelly M. Treonze, MS, Head, Global Labeling, Merck & Co., Inc. Kelly leads Global Labeling at Merck which is part of Global Regulatory Affairs and Clinical Safety. In this role, Kelly leads a team of 80+ labeling professionals who support the labeling strategy and development for... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 04: MedAffairs-SciComm, Forum

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Patient Engagement
Feature Topics Patient-Centered Design and Experience
Tags Forum

4:15pm EDT

#550: Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-586-L04-P; CME 1.00; RN 1.00

This session examines evolving US and EU regulatory approaches to AI in drug development and explores how policy expectations are translated into real world GxP implementation. Attendees will gain insight into regulatory convergence, operational challenges, and good practices for compliant AI adoption.

Learning Objectives

Compare and contrast US and EU regulatory frameworks governing AI use across the drug development lifecycle; Assess how regulatory expectations and emerging convergence efforts translate into practical implementation challenges; Identify good practices for operationalizing AI within GxP quality systems while maintaining compliance and innovation.

Chair

Junyang Wang, MSC

Speaker

Panelist
Martin Benedikt Heitmann, MS

Panelist
Luis Pinheiro, PHARMD, MSC

Panelist
Joaquim Berenguer Jornet, MS

Speakers

Martin Heitmann

Volunteer – ISPE GAMP Guide Artificial Intelligence Co-Lead, Secretary of the GA, International Society for Pharmaceutical Engineering (ISPE), Germany

Martin Heitmann is a trained business mathematician and serves as consultant and advisor to organizations in the Life Sciences. He holds a decade of experience focusing on technology, innovation, and transformation. He drives progress and inspires excellence in life sciences, while... Read More →

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

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 at the European Medicines Agency. He is a rapporteur for the AI workstream of the NDSG Data and AI Workplan, with a special focus on Guidance Development. He coordinates the Health Data... Read More →

Junyang Wang

Global Regulatory and Scientific Policy, EMD Serono, United States

Junyang Wang, MSc has over 15 years of public health experience and over a decade of combined regulatory policy and stakeholder engagement experiences across drugs, devices, and digital. He currently serves as Director for US Global Regulatory and Scientific Policy (GRASP) at EMD... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

4:15pm EDT

#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

105AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-587-L04-P; CME 1.00; RN 1.00

This session explores how lean authoring streamlines clinical regulatory documents, debunks myths about reviewer preferences, and offers practical strategies and case studies to improve authoring and better serve both teams and regulators.

Learning Objectives

Identify common misconceptions around regulatory reviewer preferences and practices in reviewing CSRs and Module 2 documents; Explain how to prepare well-informed and effective arguments to persuade cross-functional authoring teams to create leaner, more concise, user-focused, and automation-ready documents; Recognize how and when to implement successful change management practices at your own organization

Chair

Lauren Geary, PHD

Speaker

Panelist
Inger Oedum Nielsen, PHD, MS

Speakers

Lauren Geary

Senior Director, GSC, Regulatory Writing and Submission Capabilities, Eli Lilly and Company, United States

As the Sr. Director of Regulatory Capabilities and Submissions at Eli Lilly, I am responsible for ensuring functional proficiency in regulatory medical writing. Leveraging my medical training at the USC Keck School of Medicine, and regulatory training and experience in clinical trial... Read More →

Inger Nielsen

Associate Director, Novo Nordisk A/S, Denmark

Inger Ødum Nielsen is Associate Director in Content Innovation and Management, Clinical Reporting at Novo Nordisk, where she leads a team focused on driving digital transformation in clinical reporting. She has a strong track record of operationalising digital tools into the line... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

04: MedAffairs-SciComm, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Medical Affairs & Scientific Communication,Regulatory
Tags Session

4:15pm EDT

#553: Latest in Combination Product Industry Trends: Development and Submission Strategies for Success

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

203AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-588-L04-P; CME 1.00; RN 1.00

Explore the latest combination product trends, sustainability in design, recent FDA/global guidelines, post-approval device changes, and emerging submission practices to help navigate the evolving regulatory landscape and achieve development success.

Learning Objectives

Discuss recent FDA and global guidelines (ICH Q1, ICH Q6, ICH M4Q) that inform effective control strategies & stability programs; Recognize how to manage post-approval changes for device constituents and focusing on best practices; State recent IND and submission trends (e.g., Human Factors, design verification, stability) and successful health authority interactions to accelerate therapies to patients.

Chair

Rumi Raquel Young, MS

Speaker

Panelist
Alan Stevens, MS

Panelist
James Bertram, PHD, MS, RAC

Panelist
Chelsea O'Connell, MS, RAC

Panelist
Katie Duncan, PHD

Speakers

James Bertram

Director, Office of Combination Products, OC, FDA, United States

James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective... Read More →

Katie Duncan

Director, CMC Policy and Advocacy, GSK, United States

Katie Duncan is a Director of CMC Policy and Advocacy with Global Regulatory Affairs/CMC Excellence. Prior to joining GSK, Katie was a senior pharmaceutical quality assessor with the Office of Pharmaceutical Quality at the US Food and Drug Administration. She previously worked in... Read More →

Chelsea O'Connell

Director, Global Regulatory Policy & Intelligence, Amgen, United States

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

Alan Stevens

Global Head, Complex Devices and Drug Delivery Systems, Abbvie, United States

Alan joined AbbVie as Global Head of Complex Devices and Drug Delivery Systems for RA Devices in October 2023. Prior to joining AbbVie, Alan worked at FDA/CDRH for 20 years as an expert in drug delivery devices and combination products. While at FDA, he led guidance development for... Read More →

Rumi Young

Director, Regulatory Policy, Novo Nordisk A/S, United States

Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Global Alignment in Practice
Tags Session

4:15pm EDT

#554: Reverse Pitches: How Pharma Actually Buys

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

103A

Component Type: Session
Level: Advanced

Founders pitch to pharma expecting a straightforward evaluation, but pharma doesn't buy the way VCs do. Led by Whale Tank judges and biopharma thought leaders, this session flips the script—showing how pharma actually evaluates, negotiates, and commits to partnerships with innovative companies.

Learning Objectives

Identify the hidden criteria and decision-makers that determine whether a pharma deal moves forward; Understand MSAs, compliance requirements, and relationship dynamics that shape biopharma partnerships; Recognize common deal-stoppers and structure early conversations to align with how pharma actually evaluates and buys.

Chair

Ligia Kilinski Kilinski Cevasco

Speaker

Panelist
Mindy Gruba

Speakers

Ligia Kilinski Cevasco

BioPharma Consultant, Ligia Kilinski-Cevasco, Inc., United States

Mindy Gruba

Associate Director, Clinical Trial Digital Health, Moderna, United States

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 18: Lift-Series, Session

Audience Advanced
Area Biotech-ClinTech-Pathway
Level Advanced
format csv
Interest Area Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway
Tags Session

4:15pm EDT

#556: Access Consortium Town Hall

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

201AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-594-L04-P; CME 1.00; RN 1.00

The session will showcase the new Access Consortium’s GROWTH Manifesto and the resulting opportunities. It will also provide an update one year after publishing the Access Strategic plan, highlighting our achievements in speeding up approvals through work-sharing initiatives.

Learning Objectives

Describe and justify the strategic developments and priorities of the Access Consortium; Reflect and evaluate previous challenges on communication and engagement, to discuss improvements to further strengthen international collaboration; Demonstrate on-going regulatory developments and innovation, which adhere to and support international harmonization aligned with global standards.

Chair

Lawrence Tallon

Speaker

Panelist
Raymond S.B. Chua, MD, MBA, MPH, FRCP

Panelist
Anthony Lawler, MD, MBA

Panelist
Vincenza Trivigno

Panelist
Pamela Aung-Thin

Speakers

Pamela Aung-Thin

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

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

Raymond Chua

Deputy Director of Medical Services, Health Regulation Group, Ministry of Health, Singapore

Adj A/Prof (Dr) Raymond Chua is a Registered Medical Practitioner and Public Health Specialist. He is currently the Deputy Director of Medical Services, Health Regulation Group to oversee the regulations of healthcare services and premises in Singapore, so as to safeguard public health... Read More →

Anthony Lawler

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

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

Lawrence Tallon

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

Vincenza Trivigno

Executive Director of Swissmedic, SwisMedic, Switzerland

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Session

4:15pm EDT

#557: Advancing Global Regulatory Harmonization for Cell and Gene Therapies: Enhancing Access and Innovation

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

115AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-591-L04-P; CME 1.00; RN 1.00

This session will explore scientific and regulatory considerations unique to cell and gene therapies (CGTs), emphasizing the urgent need for harmonization among health authorities globally. Participants will discuss regulatory challenges and examine opportunities for regulatory collaboration, including harmonization efforts led by the ICH Cell and Gene Therapy Discussion Group. The session will also cover recent efforts by regulatory authorities to streamline expectations for CGT manufacturing, showcasing best practices and flexible regulatory strategies that support faster development. Attendees will gain an understanding of current collaborative efforts and policy innovations shaping the future of CGTs worldwide.

Learning Objectives

Analyze global regulatory considerations and opportunities posed by current frameworks for cell and gene therapy products to drive innovation and increase patient access to medicines; Discuss work under international organizations, such as ICH, to align regulatory expectations and harmonize technical requirements; Evaluate recent regulatory approaches and best practices designed to streamline CGT manufacturing, and recognize policy initiatives shaping the advancement of CGTs.

Chair

Akanksha Kaushal, MS

Speaker

EMA’s role in Transforming CGT Innovation and Access
Patrick Celis, PHD

Industry Perspective on Driving Regulatory Alignment: Analyzing Regulatory Challenges and Identifying Needs and Opportunities for Convergence
D. Allen Callaway, II, MBA, MS

ICH Harmonization Efforts- The Cell and Gene Therapy Discussion Group
Lesbeth Caridad Rodriguez, MS

FDA Initiatives to Streamline CGT Manufacturing to Accelerate Development
Andrew Byrnes, PHD

Speakers

Andrew Byrnes

Director, Division of Gene Therapy 1, CBER, FDA, United States

Andrew P. Byrnes, PhD, is the Director of the Division of Gene Therapy 1 at FDA’s Center for Biologics Evaluation and Research. The Division of Gene Therapy 1 reviews manufacturing of gene therapy vectors, microbial vectors, cancer vaccines, oncolytic viruses, in vivo genome editing... Read More →

D. Allen Callaway

Associate Director - Global Regulatory Affairs CMC, Johnson and Johnson, United States

Patrick Celis

Scientific Administrator, European Medicines Agency, Netherlands

Patrick Celis joined the European Medicines Agency (EMA) in 1997. He holds a degree in Pharmacy and a PhD in Pharmaceutical Sciences. P Celis is Lead Scientific officer in EMA’s ATMP Office and since December 2008, he is responsible for the Scientific Secretariat of the Committee... Read More →

Akanksha Kaushal

Director, Science and Regulatory Advocacy, PhRMA, United States

Akanksha Kaushal, MS, is Director, Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). She supports PhRMA’s work under the International Council for Harmonisation (ICH) as well as other global quality and manufacturing initiatives... Read More →

Lesbeth Rodriguez

Director, Regulatory Affairs Policy and Science, Bayer, United States

Lesbeth Rodriguez is director of Regulatory Affairs, Policy and Science at Bayer. She leads Bayer’s global regulatory policy strategies for Cell & Gene Therapy. Ms. Rodriguez represented PhRMA in ICH working groups—including the Q13 Implementation Working Group and the Cell and... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Global Alignment in Practice
Tags Session

4:15pm EDT

#560: Novel Endpoints, Biomarkers, and Digital Tools: Strategies for Regulatory Acceptance and Scientific Alignment

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

119AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-590-L04-P; CME 1.00; RN 1.00

Novel endpoints, biomarkers, and digital tools offer transformative potential but face regulatory acceptance challenges. Explore current landscape, successful case studies, and strategies for enhanced regulatory engagement through collaboration.

Learning Objectives

Discuss the current FDA regulatory framework for novel endpoints, biomarkers, and digital tools; Identify key challenges and gaps in regulatory acceptance and validation; Examine strategies for enhancing regulatory engagement and scientific alignment; Apply lessons from case studies and partnerships to future development programs.

Chair

Pujita Vaidya, MPH

Speaker

Industry Perspective
M. Khair ElZarrad, PHD, MPH

Duke Margolis Perspective
Valerie J. Parker, MSC

Industry Perspective
Lauren Tobe, JD

Speakers

M. Khair ElZarrad

Vice President, Regulatory Policy, BridgeBio, United States

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

Valerie Parker

Assistant Research Director, Duke-Margolis Institute For Health Policy, United States

Valerie J. Parker is an Assistant Research Director at the Duke-Margolis Institute for Health Policy. Valerie manages one of the institute’s cooperative agreements with the US FDA as well as oversees a core workstream of the institute’s Real-World Evidence Collaborative, where... Read More →

Lauren Tobe

Sr. Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Lauren Tobe serves as the Senior Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing gene therapies, diagnostics and digital health technologies. Her role involves collaborating with industry leaders, regulators and other important stakeholders to... Read More →

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States

Pujita Vaidya has 13+ 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 →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Digital Enablement and Modernization
Tags Forum

4:15pm EDT

#559: China Town Hall

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

202AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-592-L04-P; CME 1.00; RN 1.00

In this session, speakers from NMPA, Center for Drug Evaluation (CDE) and Center for Food and Drug Inspection (CFDI) will present and discuss the latest information on regulatory policy, drug review and approval, and international collaboration.

Learning Objectives

Recognize the latest information on the National Medical Products Administration (NMPA) activities in drug regulation, supporting innovation and international collaboration; Describe the recent update on the progress in drug review, inspection and approvals in China; Discuss the issues on drug regulation with NMPA officials.

Chair

Ling Su, PHD

Speaker

Panelist
Wei Zhang

Panelist
Qinghua Wang, MD

Introduction
Hui Shi

Update on Drug Regulation in China
Huijuan Zhou

Evolution of clinical trial landscape enabling early clinical development
Xiaoyuan Chen, MD

Speakers

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China

Hui Shi

Director, Development Research Division, China Center for Food and Drug International Exchange, China

Ling Su

Research Fellow, Yeehong Business School, China

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

Qinghua Wang

Founder and CEO, Innogen Pharmaceuticals, China

Professor Qinghua Wang has dedicated over 30 years to translational research in metabolic diseases. He began his medical training in Shanghai, followed by graduate studies in Biochemistry in Antwerp. By 2000, he became an Assistant Professor at the University of Toronto’s Department... Read More →

Wei Zhang

SVP, Head of Medicine, Greater China, Boehringer Ingelheim, China

Huijuan Zhou

Exchange Division, China Center for Food and Drug International Exchange, China

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Global Alignment in Practice
Feature Topics Student and Early Career Pathway
Tags Session

4:15pm EDT

#558: Advancing Pediatric Drug Development in Asia through Real-World Evidence and Regulatory Innovation

Tuesday June 16, 2026 4:15pm - 5:15pm EDT

115C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-593-L04-P; CME 1.00; RN 1.00

This session will showcase how Real-World Evidence (RWE) supports pediatric drug development in Asian countries, share US and EU perspectives, and highlight innovations in regulatory strategies, policies, and methodologies to enhance regulatory-grade pediatric RWE.

Learning Objectives

Demonstrate emerging trends in the use of RWE in regulatory decision-making in Asia, with real examples of leveraging RWE to accelerate pediatric drug development, highlighting innovative approaches and successful outcomes; Discuss challenges and strategies for high-quality pediatric RWE and explore regulatory frameworks for RWE evaluation through innovative cross-organizational collaborations.

Chair

Yongjing Zhang, PHD

Speaker

Panelist
Reiko Nakashima

Panelist
Shaoqing Ni, PHD

Panelist
Ju-Young Shin, PHD

Speakers

Reiko Nakashima

Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Ms. Reiko Nakashima is a Deputy Review Director in the Office of New Drug III at the Pharmaceuticals and Medical Devices Agency (PMDA), where she is responsible for the review of new drugs for central nervous system (CNS) disorders.

Shaoqing Ni

Attending Pharmacist , Director, Children's Hospital Zhejiang University School of Medicine, China

30+ years in pediatric pharmacy & clinical research. PhD, Chief Pharmacist, Doctoral Supervisor. Director of Clinical Trial Office, Children's Hospital, Zhejiang University; Head of Secretariat, China Pediatric Clinical Trial Network; Course Director, Zhejiang University graduate... Read More →

Ju-Young Shin

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

Dr. Ju-Young Shin is current chair professor of department of biohealth regulatory science at school of pharmacy, SungKyunKwan University (SKKU). She also serves as an associate editor of SCIE journal including ‘Pharmacoepidemiolgoy and Drug Safety’, and ‘Epidemiology and Health... Read More →

Yongjing Zhang

Senior Director, Global Epidemiology, Johnson & Johnson, China

Dr. Zhang has been working on Real-World research in the pharmaceutical and medical device industry for over 18 years. He is dedicated to promoting global universal standards for electronic health databases in the Asia-Pacific region, practicing emerging theories and methods in epidemiological... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
115C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards
Feature Topics Evidence Innovation
Tags Session

8:00am EDT

#600: From Breakthrough to Life: Engineered T-Cells, Patients, and the Future of Biotech

Wednesday June 17, 2026 8:00am - 9:00am EDT

114

Component Type: Session
Level: Intermediate

Following a keynote presentation by Bruce Levine on the future of genetically engineered T-cells for human therapeutics, sit down with Bruce and Brad Watts for a fireside chat. Through scientific, policy, and patient lenses, the session will examine what it takes to translate high-risk science into sustainable therapies, and what that implies for regulators, payers, sponsors, and technology partners.

Learning Objectives

Describe how advances in engineered T-cells, including CAR-T, are reshaping expectations for cancer treatment and the broader pipeline; Identify scientific, regulatory, and system conditions needed to translate high-risk engineered innovations into equitable, scalable patient benefit; Discuss how real patient and family experiences inform future strategies for regulators, payers, sponsors, researchers, and technology partners developing next-generation cell therapies.

Chair

Katie Truong

Speaker

Panelist
Bradley Watts

Plenary Presenter
Bruce Levine

Speakers

Bruce Levine

Barabara and Edward Netter Professor in Cancer Gene Therapy, Perelman School of Medicine at the University of Pennsylvania, United States

Katie Truong

SVP & Managing Director, DIA Americas and Global Head of Business Operations, DIA, United States

Katie Truong is the Senior Vice President & Managing Director of DIA Americas and the Global Head of Business Operations. In her role, Katie focuses on driving growth, optimizing operations, and enhancing business performance. With experience spanning various industries, including... Read More →

Bradley Watts

Patient/Industry Advocate and Vice President, Business Development Executive, Emily Whitehead Foundation and Conner Strong & Buckelew, United States

Brad Watts is a cancer survivor and CAR-T therapy recipient, Brad is an active advocate with The Emily Whitehead Foundation and Blood Cancer United, and is a member of Act for Hope, which is working to expand patient access by collaborating across the healthcare ecosystem. Drawing... Read More →

Wednesday June 17, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 00: Plenary, Session | 18: Lift-Series, Session

Audience Intermediate
Area Biotech-ClinTech-Pathway, Therapeutic Pathways, Student and Early Career Pathway
Level Intermediate
format csv
Interest Area Clinical Development & Operations,Rare Disease & Special Populations
Feature Topics Biotech-ClinTech-Pathway,Therapeutic Pathways,Student and Early Career Pathway
Tags Session

10:15am EDT

#607: Preparing for the Future: From EU Legislative Reform to Digital Transformation and AI-Driven Efficiencies

Wednesday June 17, 2026 10:15am - 11:30am EDT

115AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-600-L04-P; CME 1.25; RN 1.25

This session will explore how regulators are preparing to implement the New EU Pharmaceutical Legislation turning the digital by default ambition into practice, combining legislative reforms with digital and AI strategies.

Learning Objectives

Describe the digital by default ambition of the New EU Pharmaceutical Legislation; Explain how digitalization and AI enable more agile, transparent, and patient-centered processes, that drive efficiency, productivity and innovation in regulatory science and operations; Discuss practical implementation challenges related to trust, quality, data interoperability, and organizational readiness.

Chair

Joaquim Berenguer Jornet, MS

Speaker

Panelist
Derick Mitchell

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Gabriel Westman, MD, PHD, MSC

Speakers

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

Jeppe G. Manuel

Data Science External Affairs & Intelligence Director, Novo Nordisk A/S, Denmark

Derick Mitchell

Executive Director PFMD, The Synergist/Pfmd, Ireland

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden

GW is an infectious disease specialist and associate professor (MD, PhD), member of EMA/HMA Network Data Steering Group and EMA CHMP Methodology Working Party. He also has an MSc in Engineering with experience in bioinformatics, AI and big data applications within medicine and pharmaceutics... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

10:15am EDT

#608: Can You Complete Your Submission in 10 Weeks?

Wednesday June 17, 2026 10:15am - 11:30am EDT

202AB

Component Type: Workshop
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-605-L04-P; CME 1.25; PDU 1.25 PMI 2166B0UIY1 ; RN 1.25

Drug development teams are being expected to deliver marketing applications in record time, despite increased complexity. This workshop is designed to give participants first-hand experience in such a submission.

Learning Objectives

Recognize key factors that must be identified proactively to ensure creation of a submission timeline that is both expedited and feasible; Diagnose the critical path and rate-limiting components in the plan, and learn ways of mitigating the risks of those components; Demonstrate the ability to adjust to changes and embrace scenario-planning when faced with uncertainty.

Chair

Steve Sibley, MS

Speaker

Can You Complete Your Submission in 10 weeks!
Sharon Wolfe-Schwartz, MS

Speakers

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Certara, United States

With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Veristat LLC, United States

Sharon Wolfe-Schwartz

Executive Director, Regulatory Medical Writing, Harmony Biosciences Management, Inc., United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop | 08: RegPolicy-Strategy-GlobalCollaboration, Workshop | 04: MedAffairs-SciComm, Workshop

Audience Advanced
Area Artificial Intelligence
Level Advanced
format csv
Credit Type ACPE, CME, PMI, RN
Feature Topics Artificial Intelligence
Tags Workshop

10:15am EDT

#614: Indonesia Town Hall 2026

Wednesday June 17, 2026 10:15am - 11:30am EDT

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-656-L04-P; CME 1.25; RN 1.25

Indonesia is advancing coordinated reforms across governance, regulation, and site readiness to achieve a four-months clinical trial start-up. This session highlights regulatory alignment, WHO recognition, ethics harmonization, and CRU transformation positioning Indonesia as a credible global research partner.

Learning Objectives

Describe Indonesia’s coordinated regulatory and governance reforms to accelerate clinical trial start-up; Explain the impact of WHO-Listed Authority recognition and ethics harmonization on global collaboration; Identify operational improvements at CRU level supporting trial readiness and execution.

Chair

Endang Wahjuningtyas Hoyaranda

Speaker

Panelist
Budi Gunadi Sadikin

Panelist
Taruna Ikrar, MD

INA-CRC: Harmonizing Indonesia's Clinical Research and Our Recent Achievements
Indri Rooslamiati Supriadi

Panelist
Nina Dwi Putri

Speakers

Endang Hoyaranda

President, Indonesian Association For the Study of Medicinals (IASMED), Indonesia

Endang is currently the President of the Indonesian Association for the Study of Medicinals, aside from holding her responsibilities as President of Prodia Utama which is the holding company of Prodia Group, a Group of 8 healthcare companies including the largest health laboratory... Read More →

Taruna Ikrar

Chairperson, Indonesia Food and Drug Authority, Indonesia

Prof. dr. Taruna Ikrar, M.D., M.Biomed, Ph.D. Since August 2024, Prof. Ikrar brings exceptional expertise in pharmacology, cardiovascular science, and neuroscience to DIA's Annual Meeting. His remarkable journey spans education at Hasanuddin University, University of Indonesia, and... Read More →

Nina Dwi Putri

Head of Sub-Unit Clinical Research Implementation, Clinical Research Unit Cipto Mangunkusumo Hospital, Indonesia

Budi Gunadi Sadikin

Minister, Ministry of Health, Indonesia

Mr. Sadikin was the Vice Minister I of State-owned Enterprises and tasked to establish market leading and globally competitive state-owned enterprises. From July 2020 until December, 22nd 2020, he lead the National Economic Recovery and Transformation Task Force amidst the COVID-19... Read More →

Indri Supriadi

Head of BB Binomika (Parent Organization of INA-CRC), Indonesia Ministry of Health (MOH), Indonesia

Indri Rooslamiati Supriadi is Director of Indonesia’s National Center for Biomedical and Health Genomics and the Indonesia Clinical Research Center (INA-CRC) under the Ministry of Health. She leads national efforts in precision medicine and clinical research, streamlining regulations... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Session

10:15am EDT

#615: Navigating the FDA Commissioner's National Priority Voucher Program: Implementation Insights and Strategic Impact

Wednesday June 17, 2026 10:15am - 11:30am EDT

204AB

Component Type: Forum
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-26-607-L04-P; CME 1.25; RN 1.25

The FDA Commissioner's National Priority Voucher (CNPV) program represents a novel regulatory mechanism designed to accelerate the development and review of drugs addressing critical public health priorities. This session provides a comprehensive analysis

Learning Objectives

Discuss the fundamental framework and eligibility criteria of the CNPV program; Analyze real implementation challenges and successful strategies; Evaluate the program's impact on expediting critical drug development and public health priorities.

Chair

Lina AlJuburi, PHARMD, MSC

Speaker

Panelist
Emel Mashaki Ceyhan

Panelist
Lawrence Eugene Liberti, RAC

Panelist
Kellie Taylor

Speakers

Lina AlJuburi

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

Emel Mashaki Ceyhan

SVP & Head, Regulatory, Quality & Clinical Reporting (RQC), R&D, Novo Nordisk, Turkey

Elizabeth Lange

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

Lawrence Liberti

Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States

Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. From 2009 to 2021 he served as the Executive Director of CIRS. He is the Director of the DK Kim International (USC DRQS) and has been actively involved in promulgating... Read More →

Mallika Mundkur

Deputy Chief Medical Officer, OC, FDA, United States

Kellie Taylor

VP, CMC Regulatory Affairs, Regeneron Pharmaceuticals, United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
204AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Forum

10:15am EDT

#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice

Wednesday June 17, 2026 10:15am - 11:30am EDT

102AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-610-L04-P; CME 1.25; RN 1.25

Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous, operationally feasible, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs can: Align with ICH E6(R3) expectations; Apply selective safety data collection under ICH E19; Incorporate decentralized elements consistent with FDA guidance; Advance FDA’s STEP demonstration objectives Participants will engage in a structured design exercise debating a pragmatic clinical trial in the obesity setting—contrasting a traditional “overbuilt” protocol with a streamlined, embedded alternative. Through moderated discussion, we will identify critical-to-quality factors, risk mitigation strategies, and the regulatory conversations necessary to support global implementation.

Learning Objectives

Apply Quality by Design principles under ICH E6(R3) to pragmatic RCTs in high-impact therapeutic areas; Evaluate where selective safety data collection (ICH E19) may or may not be appropriate in long-term obesity trials; Identify operational and safety risks unique to embedding obesity trials in routine practice—and propose mitigation strategies; Debate the tradeoffs between traditional and streamlined trial designs.

Chair

Kevin Bugin, MS, RAC

Speaker

Panelist
Mary Thanh Hai, MD

Panelist
Henry Wei, MD

Panelist
Zhanna Jumadilova, MD, MBA

Speakers

Kevin Bugin

Head of Global Regulatory Policy and Intelligence, Amgen, United States

Alison Cave

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

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States

Zhanna Jumadilova

Clinical Lead, Pfizer, United States

Dr. Jumadilova is a physician scientist, pharmaceutical executive with extensive industry experience in Clinical Development, Medical Affairs, and HEOR. In her roles as a senior leader, she has led numerous development programs. Her diverse experience in both large pharmaceutical... Read More →

Henry Wei

Executive Director, Data, Technology & Innovation, Regeneron Pharmaceuticals, United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Workshop | 02: ClinicalTrialOps-Innovation, Workshop

Audience Intermediate
Area Global Alignment in Practice, Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Global Alignment in Practice,Evidence Innovation
Tags Workshop

10:15am EDT

#613: FDA Rare Disease Town Hall

Wednesday June 17, 2026 10:15am - 11:30am EDT

201AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-609-L04-P; CME 1.25; RN 1.25

Senior FDA leaders will discuss evolving regulatory trends in rare disease development, including accelerated approval, innovative trial designs, patient engagement, and real-world evidence, followed by open Q&A with attendees.

Learning Objectives

Identify current FDA regulatory trends and scientific approaches shaping rare disease drug development; Apply FDA expectations around accelerated approval, surrogate endpoints, and innovative trial designs; Integrate patient voice and real-world evidence into development strategies to support benefit-risk assessment.

Chair

James Valentine, JD, MHS

Speakers

Vijay Kumar

Acting Director OTP/CBER, FDA, United States

James Valentine

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

James Valentine advises medical product companies and patient advocacy organizations on regulatory strategy for the development and approval of drugs and biologics, with a focus on rare diseases. He has helped secure FDA approvals, and often works in areas without well-defined regulatory... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Therapeutic Pathways, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Feature Topics Therapeutic Pathways,Student and Early Career Pathway
Tags Session

1:45pm EDT

#633: Advancing Biosimilar Development: The EU Tailored Clinical Approach and Global Harmonization Efforts

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-672-L04-P; CME 1.00; RN 1.00

EU’s Reflection Paper introduces a tailored clinical approach for biosimilars, driving an optimised and efficient development programme by reducing unnecessary studies, as regulators and industry discuss opportunities for patient access and global harmonization.

Learning Objectives

Describe the scientific basis and regulatory rationale behind the EU’s tailored clinical approach for biosimilar development; Discuss how enhanced analytical similarity assessments can support leaner clinical development programs; Explain circumstances under which comparative clinical efficacy studies may be reduced or waived.

Chair

Peter Richardson

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Speakers

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands

Dr. Richardson, a pharmacist with a Ph.D. in pharmaceutics from Queen's University Belfast, has extensive experience in formulation R&D with companies like Bristol-Myers Squibb, SmithKline Beecham, Pfizer, and Serono, focusing on drug delivery systems. He worked as a pharmaceutical... Read More →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

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

1:45pm EDT

#635: MHRA Town Hall

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

119AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-626-L04-P; CME 1.00; RN 1.00

In this session, senior leaders from Medicines & Healthcare products Regulatory Agency (MHRA) will provide an update on new regulatory and strategic priorities for the agency. The session will provide the opportunity for the audience to submit questions.

Learning Objectives

Describe MHRA’s regulatory initiatives and strategic priorities; Identify opportunities for engagement with MHRA regulators.

Chair

Lawrence Tallon

Speaker

Panelist
Alison Cave

Panelist
Julian Beach, MBA

Speakers

Julian Beach

Interim Executive Director, Healthcare Quality and Access, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Alison Cave

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

Lawrence Tallon

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

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

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

1:45pm EDT

#636: The Next Frontier: Autoimmune Cell and Gene Therapy, Regulation, and Patient Access

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-625-L04-P; CME 1.00; RN 1.00

This panel will explore how patient advocacy can shape regulatory strategy, trial design, and access planning for autoimmune cell and gene therapies as they move toward future approvals.

Learning Objectives

Identify how patient advocacy can shape regulatory strategy and access for future autoimmune CGTs; Describe approaches to incorporating patient priorities such as quality of life and treatment burden into trial design; Discuss strategies to ensure equitable and sustainable patient access.

Chair

Samantha Roberts, PHD

Speaker

Perspectives from the Myositis Community
Paula Eichenbrenner, MBA

Patient Perspective
Joy Buie, BSN, PHD, MS, RN

Patient advocacy perspective
Brian Kennedy

FDA perspective
Vijay Kumar

Speakers

Joy Buie

Vice President of Research, Lupus Foundation of America, United States

Dr. Joy Buie is a nurse-scientist and leader advancing patient-centered innovation in autoimmune disease, particularly lupus. She leads strategic research initiatives that integrate real-world and patient experience data into clinical development, regulatory decision-making, and therapeutic... Read More →

Paula Eichenbrenner

Executive Director, The Myositis Association, United States

Brian Kennedy

Executive Director, Global Alliance for Patient Access, United States

Vijay Kumar

Acting Director OTP/CBER, FDA, United States

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 17, 2026 1:45pm - 2:45pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Area Therapeutic Pathways
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Therapeutic Pathways
Tags Forum

1:45pm EDT

#634: Access Unlocked: Collaborative Strategies for Navigating Regulatory and Payor Landscapes

Wednesday June 17, 2026 1:45pm - 2:45pm EDT

115AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-623-L04-P; CME 1.00; RN 1.00

Aligning regulatory and payor expectations is critical in the evolving healthcare landscape. Regulatory Affairs, Medical Affairs, and Market Access functions are collaborating within this complex ecosystem to ensure sustained patient access to medicines.

Learning Objectives

Examine the dynamic collaboration between Regulatory Affairs, Medical Affairs, and Market Access to effectively address current regulatory and payor requirements; Describe advancements in drug development that ensure clinical trials align with regulatory frameworks and coverage decisions.

Chair

Alison Maloney, MBA, MS

Speaker

An Academic Perspective
Sean D. Sullivan, PHD

A Medical Perspective
Emma Lee

A Regulatory Perspective
Todd Paporello, PHARMD, MBA

Speakers

Emma Lee

Executive Director and Head, US Medical Affairs Patient Access and Quality, Gilead Sciences, United States

Alison Maloney

Head of Regulatory Affairs North America, Bayer , United States

Alison Maloney is currently Head of Regulatory Affairs North America for Bayer Pharmaceuticals. Prior to this role, she was the Head of Regulatory Affairs for Bayer Radiology and Consumer Health North America. Alison has also held Canadian positions as the Head of Regulatory Affairs... Read More →

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States

Sean Sullivan

Prof. of Pharmacy, Public Hlth, University of Washington, United States

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session | 04: MedAffairs-SciComm, Session

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Value & Access
Feature Topics Cross-Functional Collaboration
Tags Session

4:00pm EDT

#652: Anvisa Townhall - From Backlogs to Breakthroughs: Building a Smarter Regulatory Future

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

107AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-666-L04-P; CME 1.00; RN 1.00

This town hall will present Anvisa’s strategy to reduce backlogs, modernize regulatory processes, and integrate innovation and AI into decision-making. The session will explore how Brazil is building a more agile, risk-based, and globally connected regulatory system.

Learning Objectives

Describe Brazilian Health Regulatory Agency (Anvisa)’s strategy to reduce regulatory backlogs and modernize processes; Discuss how innovation, digital tools, and AI are being integrated into regulatory decision-making; Identify how Brazil is advancing a more agile, risk-based, and globally connected regulatory system.

Chair

Diogo Penha Soares

Speaker

Panelist
Ana Carolina Moreira Marino Araujo

Panelist
Maira Ribeiro de Souza, DRSC, PHARMD

Panelist
Adriane Alves de Oliveira, MSC

Panelist
Daniel R. Coradi de Freitas, DRSC

Speakers

Ana Carolina Moreira Marino Araujo

Head, International Affairs Office, ANVISA, Brazil

Daniel R. Coradi de Freitas

GENERAL MANAGER, ANVISA, Brazil

Biologist, MSc in Genetics and Molecular Biology, PhD in Epidemiology, with continuous work in health surveillance since 2000 in technical and senior management roles. Former FETP (2004–2006), joined Anvisa in 2005, working in blood, tissues, cells and organs, cell therapy, health... Read More →

Adriane Alves de Oliveira

Deputy Head, Clinical Trials Office, ANVISA, Brazil

Health Regulation Expert with over 12 years of experience in the regulatory evaluation and oversight of non-clinical and clinical development of drugs and biological products. She is currently the Deputy Head of the Clinical Trials Office at Anvisa and a Good Clinical Practice (GCP... Read More →

Diogo Penha Soares

Deputy Director, ANVISA, Brazil

Maira Ribeiro de Souza

Expert, Division of Safety and Efficacy Assessment, ANVISA, Brazil

Industrial pharmacist with a degree from the Federal University of Ouro Preto, Master of Pharmaceutical Sciences from the Federal University of Ouro Preto (2012), and Ph.D. in Pharmaceutical Sciences from the Federal University of Rio Grande do Sul (2022). Currently, works as a Specialist... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Session

4:00pm EDT

#655: Navigating the New US and EU Rare Disease Regulatory Framework and Global Harmonization Efforts

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

201AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-640-L04-P; CME 1.00; RN 1.00

This session will assess the evolving global rare disease regulatory landscape and examine global harmonization efforts. Panelists will include leaders from FDA, EMA, NORD, Global Genes and they will discuss how get medicines to patients faster.

Learning Objectives

Describe the evolving US and EU regulatory policy landscape; Examine how to advance global harmonization efforts for rare disease drug development; Discuss the opportunities and challenges on how to get rare disease medicines to patients faster.

Chair

Emel Mashaki Ceyhan

Speaker

Panelist
Corinne de Vries, PHD, MA, MSC

Panelist
Steffen Thirstrup, MD, PHD

Speakers

Emel Mashaki Ceyhan

SVP & Head, Regulatory, Quality & Clinical Reporting (RQC), R&D, Novo Nordisk, Turkey

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Corinne de Vries

EMA liaison official to the US FDA, 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. At EMA, she has headed the offices of Risk Management, Science and Innovation... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
201AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Rare Disease & Special Populations,Regulatory
Tags Forum

4:00pm EDT

#656: Singapore Town Hall

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-668-L04-P; CME 1.00; RN 1.00

The Singapore Town Hall will show case how Singapore's world-class regulatory environment creates compelling business value, showcasing innovative pathways, digital transformation initiatives, and strategic advantages that make Health Sciences Authority (HSA) registration essential for Asia-Pacific success.

Learning Objectives

Evaluate HSA's innovative regulatory frameworks and fast-track pathways that accelerate time-to-market for pharmaceutical products, clinical trials to adoption; Identify strategic advantages of Singapore registration for companies seeking Asia-Pacific market expansion and regional manufacturing hubs; Discuss how to apply HSA's regulatory processes and collaborative approaches to optimize product development and approval strategies.

Chair

Raymond S.B. Chua, MD, MBA, MPH, FRCP

Speaker

Panelist
Wan Yee Goh

Speakers

Raymond Chua

Deputy Director of Medical Services, Health Regulation Group, Ministry of Health, Singapore

Wan Yee Goh

Senior Vice President and Head, Healthcare, Singapore Economic Development Board, Singapore

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Session

4:00pm EDT

#653: Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII Across the Product Lifecycle

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

115AB

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Application UAN: 0286-0000-26-637-L04-P; CME 1.00; RN 1.00

Benefit-risk planning is recommended by both FDA and CIOMS XII but it is complex to implement. In this forum, a panel will discuss the importance of strategically conducting continuous benefit-risk planning for development programs.

Learning Objectives

Demonstrate the need for a continuous approach to benefit-risk planning; Recognize the risks of failing to conduct benefit-risk planning; Identify ways to introduce benefit-risk planning into drug development

Chair

Claudia Ana Ianos, MD

Speaker

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Robyn Bent, BSN, MS, RN

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Diana Morgenstern, MD, FACP

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Megan Aragon, MBA

Benefit-Risk Planning: Implementing Benefit-Risk Guidelines from FDA and CIOMS XII across the Product Lifecycle
Bennett Levitan, MD

Speakers

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States

Megan Aragon is the Technology Services Administrator at East Texas Lighthouse for the Blind, where she leads Assistive Technology (AT) strategy and training initiatives. A native AT user, she brings lived experience with vision loss to systems-level program design and service delivery... Read More →

Robyn Bent

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

Ana-Claudia Ianos

Senior Director, Safety Risk Management Lead, Pfizer, 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 →

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States

Bennett Levitan, MD-PhD is Executive Director Benefit-Risk (B-R)/Epidemiology at Johnson & Johnson. He introduced state of the art patient-focused B-R to J&J and his team has led numerous clinical teams in B-R assessments and patient preference studies. He co-led development of the... Read More →

Diana Morgenstern

Head, Real World Evidence and Outcomes Research, Viatris, United States

Diana Morgenstern, MD, FACP is a general internist whose varied career includes depth and breadth in clinical practice, medical education, and strategic approaches to pharmaceutical industry medical affairs, including real world evidence generation to address care gaps. Dr. Morgenstern... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
115AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 01: ClinSafety-PV-RM, Forum

Audience Basic
Level Basic
format csv
Credit Type ACPE, CME, RN
Tags Forum

4:00pm EDT

#654: India Town Hall: India’s Evolving Regulatory Landscape - Policy Reforms and Digital Systems Accelerating Innovation

Wednesday June 17, 2026 4:00pm - 5:00pm EDT

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-639-L04-P; CME 1.00; RN 1.00

India’s recent regulatory, policy, and digital reforms are accelerating innovation, quality, and global collaboration. This town hall will highlight key updates shaping clinical research, medtech growth, and patient safety, and India’s rising global role.

Learning Objectives

Identify key regulatory, policy, and digital reforms transforming India’s healthcare and innovation ecosystem; Evaluate how updates in clinical trial rules, medical device policy, GMP standards, and data privacy impact global development; Identify opportunities for global collaboration and regulatory convergence enabled by India’s evolving frameworks.

Chair

Vivek Ahuja, MD

Speaker

Panelist
Marc Franklin

Panelist
Shahin Fesharaki

Panelist
Rajeev Singh Raghuvanshi

Speakers

Shahin Fesharaki

Chief Scientific Officer, Lupin, United States

Marc Franklin

CEO - North America, Cipla, United States

Vivek Ahuja, MD

Program Chair, Executive Vice President, Pharmacovigilance, EVERSANA, India

Dr. Vivek Ahuja is a physician-turned pharmaceutical leader with 25 years of experience across pharmacovigilance, clinical research, public health, and technology. In 2005 he pioneered pharmacovigilance in India by establishing the first global PV unit at Ranbaxy. He is Executive... Read More →

Rajeev Singh Raghuvanshi

Drug Controller General, Central Drugs Standard Control Organization, India

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
116 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum | 02: ClinicalTrialOps-Innovation, Forum | 07: RegCMC-Product Quality, Forum

Audience Intermediate
Area Global Alignment in Practice, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Clinical Development & Operations
Feature Topics Global Alignment in Practice,Student and Early Career Pathway
Tags Forum

8:00am EDT

#702: Cross-Functional Agentic End-to-End Dossier Preparation: Where are we Today and Progress Towards Realizing the Vision

Thursday June 18, 2026 8:00am - 9:00am EDT

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-644-L04-P; CME 1.00; RN 1.00

As pharma companies set increasingly bold ambitions for productivity, technology is more crucial than ever. This session presents a vision for how productivity can be boosted end-to-end with Agentic AI, with humans working alongside agents.

Learning Objectives

Describe recent trends in regulatory submission preparation acceleration, including role of technology; Discuss a vision for how Agentic AI can underpin each step of submission dossier preparation.

Chair

Anton Mihic, MSC

Speaker

Agentic AI for statistical programming and rapid biostatistical analysis
Ralf Raschke

Panel discussion: Learnings from AI-enabled clinical and regulatory decision making
Jennings Xu

Panel discussion: Learnings from AI-enabled regulatory submissions
Cassie Gregson

Panel discussion: Learnings from AI-enabled end-to-end dossier generation
Andrea Doyle

Speakers

Andrea Doyle

Global Regulatory Affairs NA Head, Sanofi, United States

Andrea Doyle is Global Regulatory Affairs Head of Region North America (NA) and Global Advertising and Promotion at Sanofi. She provides oversight and regulatory expertise to optimize development programs and leads Global Advertising and promotion to deliver dynamic solutions to support... Read More →

Cassie Gregson

VP Head of AI Enterprise Process & Innovation Center, AstraZeneca, United States

Anton Mihic

Partner, McKinsey & Company, United States

Anton is a management consultant serving clients in McKinsey’s Life Science R&D practice across global PharmaCos, innovative Biotechs, CROs and Private Equity portfolio companies. Anton leads McKinsey’s global Regulatory Affairs, Safety and R&D Quality service line, and focuses... Read More →

Ralf Raschke

Senior Expert, McKinsey & Company, United States

Jennings Xu

Senior Director, Data Science & Digital Health, Johnson & Johnson Innovative Medicine, United States

Jennings Xu is Senior Director of Data Science at Johnson & Johnson, where he leads R&D Generative AI strategy, partners with Global Regulatory Affairs on end-to-end AI-enabled acceleration, and heads Asia-Pacific R&D Data Science. He oversees multidisciplinary teams across discovery... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 04: MedAffairs-SciComm, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Medical Affairs & Scientific Communication
Feature Topics Artificial Intelligence
Tags Session

8:00am EDT

#707: EMA - FDA Question Time

Thursday June 18, 2026 8:00am - 9:00am EDT

114

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-667-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Corinne de Vries, PHD, MA, MSC

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Orla Moriarty, PHD

Panelist
Joaquim Berenguer Jornet, MS

Speakers

Joaquim Berenguer Jornet

AI Implementation lead, Digital Business Transformation Task Force, European Medicines Agency, Netherlands

Orla Moriarty

Scientific Officer, European Medicines Agency, Netherlands

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Corinne de Vries

EMA liaison official to the US FDA, European Medicines Agency, Netherlands

Thursday June 18, 2026 8:00am - 9:00am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Session

8:00am EDT

#708: Patient Preference Studies in Clinical Trial Design and Submissions: Enhancing Patient-Centricity with Insights from ICH E22

Thursday June 18, 2026 8:00am - 9:00am EDT

102AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-624-L04-P; CME 1.00; RN 1.00

This workshop explores integrating patient preference studies into clinical trial design and drug application submissions, highlighting operational strategies, stakeholder collaboration, and how these align with the upcoming ICH E22 guideline.

Learning Objectives

Recognize key aspects of patient preference studies (PPS) design using a practical, interactive preference elicitation example; Describe how to incorporate PPS into clinical trial design and regulatory decisions using insights from ICH E22; Identify key operational strategies and challenges in designing PPS.

Chair

Bennett Levitan, MD

Speaker

Patient Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Megan Aragon, MBA

Regulatory Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Robyn Bent, BSN, MS, RN

Industry Perspective: Patient Preference Studies in Clinical Trials and ICH E22
Leila Lackey, MHS, PHD

Speakers

Megan Aragon

Technology Services Administrator, East Texas Lighthouse for the Blind, United States

Robyn Bent

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

Leila Lackey

Director, Patient Preference Evidence Generation, Pfizer, United States

Dr. Lackey has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering. Currently, Dr. Lackey is a Director of Patient Preference Evidence Generation at Pfizer. In this role, she oversees patient... Read More →

Bennett Levitan

Executive Director, Benefit-Risk Assessment / Epidemiology, Johnson & Johnson, United States

Thursday June 18, 2026 8:00am - 9:00am EDT
102AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Workshop

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory,Patient Engagement
Feature Topics Patient-Centered Design and Experience
Tags Workshop

9:30am EDT

#712: FDA Town Hall

Thursday June 18, 2026 9:30am - 10:30am EDT

114

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-652-L04-P; CME 1.00; RN 1.00

In this session, senior leaders from the U.S. Food and Drug Administration (FDA) will provide an update on key priorities, including the Commissioner's National Priority Voucher Program, artificial intelligence in drug and biological product development, and the Agency's digital transformation efforts. The session will provide the opportunity for the audience to ask questions.

Learning Objectives

Discuss FDA’s key initiatives and strategic priorities; Identify opportunities for engagement with FDA regulators.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
R. Angelo De Claro, MD

Panelist
Katherine Szarama

Panelist
Jeremy Walsh

Panelist
Mallika Mundkur, MD, MPH

Speakers

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 is part of the FDA team for Prescription Drug... Read More →

R. Angelo De Claro

Deputy Director (Acting), Oncology Center of Excellence, FDA, United States

Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →

Mallika Mundkur

Deputy Chief Medical Officer, OC, FDA, United States

Katherine Szarama

Deputy Director, CBER, FDA, United States

Jeremy Walsh

Chief AI Officer, OC, FDA, United States

Thursday June 18, 2026 9:30am - 10:30am EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

08: RegPolicy-Strategy-GlobalCollaboration, Forum

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Regulatory
Tags Forum

11:00am EDT

#713: No More Incremental Change: The Radical Future of Healthcare

Thursday June 18, 2026 11:00am - 12:30pm EDT

114

Component Type: Session
Level: Intermediate

This closing session brings together pioneering voices at the intersection of AI, advanced computing, and biopharma to explore how a new intelligence layer is rewiring the entire life sciences value chain—from discovery to delivery. The discussion will examine how foundational AI, cloud-scale infrastructure, and digital platforms are reshaping R&D, clinical development, manufacturing, and patient engagement. The conversation will highlight not only breakthrough opportunities—smarter target discovery, more adaptive trials, real-world evidence at scale, and hyper-personalized care—but also the governance, ethics, workforce, and partnership models needed to harness these technologies responsibly in a highly regulated environment.

Learning Objectives

Describe key ways AI and other advanced digital technologies are reshaping the life sciences value chain; Discuss concrete examples of how leading pharma and tech companies are using digital platforms, cloud infrastructure, and AI to accelerate R&D and improve patient outcomes; Evaluate key risks and governance challenges associated with deploying powerful AI and data technologies in regulated life sciences settings, including bias, transparency, and accountability.

Chair

Eli Weinberg, PHD, MS

Speaker

Panelist
Susan Furth, MD, PHD

Panelist
Carlos Garner, PHD, MSC

Panelist
Dhruv Jayanth

Panelist
Shweta Maniar

Speakers

Susan Furth

Executive Vice President and Chief Scientific Officer, Children's Hospital of Philadelphia, United States

Carlos Garner

Senior Vice-President Global Regulatory Affairs and Head, Lilly Regenerative Med, Eli Lilly and Company, United States

Dr. Garner is executive leader for Global Regulatory Affairs for Eli Lilly and Company. The organization is responsible for the regulatory leadership, strategic and operational support for human drugs, medical devices, and global manufacturing for Eli Lilly and Company. Additionally... Read More →

Dhruv Jayanth

Business Lead, Life Sciences, OpenAI, United States

Shweta Maniar

Global Director, Strategic Industries - Life Sciences, Google, United States

Shweta leads Healthcare & Life Sciences Strategic Industries at Google Cloud, where she bridges the gap between cutting-edge technology and patient outcomes. A PharmaVoice 100 trailblazer, she is a seasoned innovator known for turning complex data ecosystems into collaborative engines... Read More →

Eli Weinberg

Partner, Bain & Co., United States

Eli Weinberg is a leader in Bain's Life Sciences and Private Equity practices. He is an advisor and thought partner to life science innovators in biopharma, diagnostics, and medtech, as well as investors active in those areas. He is keenly interested in commercialization, value creation... Read More →

Thursday June 18, 2026 11:00am - 12:30pm EDT
114 The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 08: RegPolicy-Strategy-GlobalCollaboration, Session | 00: Plenary, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

DIA 2026 Global Annual Meeting

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8:00am EDT

11:00am EDT

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2:30pm EDT

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8:00am EDT

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1:45pm EDT