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
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11:00am EDT

#403: Clinical Operations in Transition: Leadership Perspectives on AI, the Workforce, and the Future of Trial Execution

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

108A

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-511-L04-P; CME 1.25; RN 1.25

Clinical Operations leaders today are navigating one of the most dynamic periods in recent history. From managing AI-driven transformation to rethinking global outsourcing models and rebuilding teams in a post-layoff landscape, the challenges facing clinical operations executives are unprecedented — and so are the opportunities. This session brings together senior leaders from large, mid-size, and emerging biopharma companies for an unscripted fireside conversation exploring how the role of Clinical Operations has evolved over the past decade and where it’s heading next. Panelists will share candid insights on leading change, balancing innovation with execution, and maintaining resilience in the face of shifting talent models and regulatory expectations.

Learning Objectives

Discuss current trends, pressures, and innovations shaping Clinical Operations directly from industry leaders; Recognize operational strategies using benchmark data through real-world examples of how organizations are adapting their models, technologies, and teams; Identify emerging roles, skill requirements, and leadership priorities within the evolving ClinOps landscape to guide personal career planning and organizational development.

Chair

Joseph Dustin

Speaker

Panelist
Jennifer Sheller, MPH

Panelist
Nikki Amaratunge, MA, PMP

Panelist
Rosalie Filing

Panelist
Emily Walker, MBA

Speakers

Joe Dustin

Founder and Principal, Dauntless eClinical Strategies, United States

Joe Dustin is a recognized leader in the clinical trials industry with over 20 years of experience driving digital innovation in Life Sciences. Throughout his career, Joe has spearheaded transformative initiatives across pharma and technology companies, notably at, Medidata Solutions... Read More →

Joseph Dustin

Founder and Principal, Dauntless eClinical Strategies, United States

Rosalie Filing

Vice President, Clinical Operations, Keenova Therapeutics, United States

Nikki Amaratunge, MA, PMP

Director Clinical Operations, Allergan, United States

Jennifer Sheller

Senior Vice President, Global Clinical Trial Operations, Merck & Co., Inc., United States

Jennifer Sheller is Senior Vice President and Head of Global Clinical Trial Operations at Merck, where she leads the global infrastructure responsible for the operational delivery of Merck’s clinical development portfolio. With more than 25 years of experience across pharma, biotech... Read More →

Emily Walker

Vice President, Study Management, Alnylam, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Project Management & Strategic Planning
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11:00am EDT

#405: AI Tools in Clinical Trials: Regulatory Considerations for Radiologic and Pathologic Assessment

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

109AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-514-L04-P; CME 1.25; RN 1.25

AI offers promise in standardizing radiology and pathology by reducing inter-human variability. This session examines opportunities, risks, regulatory oversight, and the role of reference datasets for tool validation.

Learning Objectives

Describe the current landscape and practical applications of AI-based diagnostic tools; Examine potential regulatory frameworks and strategies to ensure oversight and reliability of AI-based diagnostics; Identify key considerations in developing reference datasets to support validation of AI tools.

Chair

Hillary Andrews, PHD

Speaker

Industry Perspective
Alain Silk, PHD

Patient Advocate Perspective
Jason Binder, MA

Industry Perspective
Mike Montalto, PHD

Speakers

Jason Binder

Founder & CEO, Ember, United States

Jason Binder is the Founder and CEO of Ember, building the first continuous, real-world dataset of patient and caregiver decision-making in oncology. A former pharma data and clinical strategy leader with experience at AstraZeneca, Genentech, and Merck, he focuses on integrating AI... Read More →

Alain Silk

Senior Director, Regulatory Affairs, Tempus AI, Inc., United States

Alain Silk is a Senior Director of Regulatory Affairs at Tempus AI, a technology company applying analytic tools to provide data driven insights from clinical and molecular data. Dr. Silk has over a decade of experience as a medical device regulatory professional across diverse diagnostic... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum

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

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

#408: Combined Clinical Trials: A Focus on In Vitro Diagnostics

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

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-516-L04-P; CME 1.25; RN 1.25

In this session, we will address the challenges of conducting clinical research in Europe under IVDR and CTR, and explore stakeholder-proposed solutions. We will also discuss the evolving regulatory landscape for combined clinical trials.

Learning Objectives

Explain the key principles involved in biomarker-driven approvals; Describe the role of in vitro diagnostics; Identify the types of detailed information required in applications to meet regulatory expectations for biomarker-guided medicinal products.

Chair

Ana Trullas, PHARMD, MSC

Speaker

Building Bridges, Not Silos: Lilly's IVDR-Driven Transformation
Lauren Tobe, JD

tbd. In vitro biomarker tests for patient selection for efficacy
Martin Mengel

Companion Diagnostics and Medicinal Products: A notified Body perspective on Co-development under IVDR
Rolf Thermann, PHD

Combined studies in the EU- overview and considerations for industry
Joshua D Levin, MA

Speakers

Joshua Levin

Director, Global Regulatory Affairs, Precision Medicine and Digital Health, GSK, United States

Martin Mengel

Federal Institute for Drugs and Medical Devices, Germany

Rolf Thermann

Section Manager IVD, Companion Diagnostics lead, TÜV Rheinland, Germany

Rolf Thermann is currently Auditor and Technical Expert with a focus on Companion Diagnostics at TÜV Rheinland LGA Products GmbH. Before joining TÜV Rheinland in 2018 he worked in the Pharmaceutical Industry involved in Antiviral Drug Discovery and as a Head of Product Development... 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 →

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 →

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

05: PersonalizedMed-ComboProd-Diagnostics, Session

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

11:00am EDT

#410: Managing What Matters: Turning Project Decisions into Portfolio Impact in R&D and Medical

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

202AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-517-L04-P; CME 1.25; PDU 1.25 PMI 216647VJP8; RN 1.25

What if every investment were assessed for impact - before committing resources? As portfolio decisions in R&D and Medical Affairs are becoming increasingly complex, leadership teams often struggle to link individual projects to overall portfolio performance. This makes it difficult to clearly articulate portfolio potential, compare alternative portfolio configurations, or understand the portfolio-level impact of adding, re-prioritizing, or stopping initiatives. This interactive workshop explores whether and how an impact-driven portfolio approach, using the efficient frontier as a practical example, can help bridge this gap and support more effective management decision-making. Through hands-on exercises and facilitated discussion, participants will work with realistic portfolio scenarios to visualize portfolio performance and examine how individual initiatives contribute to overall portfolio value. Participants will test different portfolio scenarios, discuss trade-offs, and explore how project-level decisions shift portfolio-level performance. Rather than optimizing projects in isolation, the workshop focuses on using the efficient frontier to enable management-ready conversations that explicitly connect project choices to portfolio impact, risk, and strategic alignment. The workshop also examines the evolving role of project and portfolio managers as strategic impact managers, supporting leadership teams by creating portfolio transparency, enabling informed trade-offs, and driving value realization across R&D and Medical portfolios. The session is designed for Medical and R&D leaders seeking to strengthen strategic decision-making, improve transparency, and elevate portfolio management to impact stewardship.

Learning Objectives

Explain how the efficient frontier clarifies portfolio performance and supports leadership discussions portfolio-level impact and value; Analyze how individual initiatives change portfolio performance by using the efficient frontier to simulate adding, re-prioritizing, or stopping projects and assessing each decision by its portfolio-level effect; Discuss ways portfolio managers are evolving into strategic impact leaders.

Chair

Robin Boss, MS

Speaker

Panelist
Jill Orosz

Speakers

Robin Boss

VP, Business Transformation, Campana & Schott, United States

Robin Boss is Vice President of Business Transformation Consulting at Campana & Schott, where he leads a U.S. team working with Life Sciences organizations on large-scale pharma transformation programs. His focus is on portfolio and project management as a core lever to implement... Read More →

Jill Orosz

Vice President, TKI Franchise Head, Bayer, United States

Monday June 15, 2026 11:00am - 12:15pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Project Management & Strategic Planning
Tags Workshop

11:00am EDT

#411: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts

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

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-519-L04-P; CME 1.25; RN 1.25

The recent focus by the US government to increase US-based pharmaceutical manufacturing has created opportunities to revisit the regulations and guidelines that lead to the lengthy time that it takes to construct or expand a manufacturing facility.

Learning Objectives

Discuss critical path items that lead to extended construction and regulatory approval timelines; Describe how FDA's innovative regulatory concepts address these challenges; Identify the similarities and differences between bolstering domestic manufacturing by onshoring manufacturing to established facilities versus new or expanded US based facilities.

Chair

Joseph Kutza, PHD

Speaker

Modernizing Oversight: Enabling the Future of U.S.-Based Pharmaceutical Manufacturing
Lisa Wright, MS

Innovative Regulatory Approaches to Increasing US-based Pharmaceutical Manufacturing
Cecilia Tami, PHD

Building U.S. Biopharmaceutical Manufacturing Workforce Capacity: Challenges, Opportunities, and Innovations
John Balchunas, MSC

Speakers

John Balchunas

Workforce Director, National Institute for Innovation in Manufacturing Biopharma, United States

John Balchunas is the Workforce Director for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) where he is responsible for guiding strategy around workforce and talent development for a federally-funded public private partnership focused on transforming... Read More →

Joseph Kutza

Senior Director Regulatory Policy - CMC, Eli Lilly and Company, United States

Currently Senior Director Global Regulatory Policy and Strategy - CMC at Lilly. Focus on global regulatory policy and external engagement for all product types. Formerly in Regulatory Affairs CMC at AstraZeneca and a reviewer of monoclonal antibodies at the FDA. Ph.D. in Immunology... Read More →

Cecilia Tami

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

Cecilia Tami is currently the Head of US Technical Regulatory Policy at Genentech-Roche. In her role, she leads and executes US CMC regulatory policy strategies and advocacy plans and external outreach in technical, regulatory and legislative CMC related topics. Before joining Genentech-Roche... Read More →

Lisa Wright

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

Lisa Wright brings over a decade of experience in the pharmaceutical and biopharmaceutical industry. She has held multiple positions with a primary focus on regulatory affairs and policy. In her current role at Novo Nordisk, Lisa engages with the FDA on regulatory CMC and device issues... Read More →

Monday June 15, 2026 11:00am - 12:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session

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

#417: A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy

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

117

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-525-L04-P; CME 1.25; RN 1.25

This session will provide a practical, high-level walk-through of how Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Strategy work synergistically, centered on Critical to Quality (CtQ) factors, demonstrating how to build a unified quality strategy that aligns with regulatory expectations.

Learning Objectives

Recognize CtQ factors using integrated QbD and RBQM in a collaborative, cross-functional setting; Demonstrate the synergistic application of QbD and RBQM across the clinical trial lifecycle; Discuss regulatory expectations and industry best practices for a unified quality strategy; List practical strategies for implementing this approach within organizations.

Chair

Paula Walker, MA

Speaker

Panelist
Mandy Kaur Budwal-Jagait, MSC

Panelist
Paula Walker, MA

Panelist
Sumitra Sachidanandan

Panelist
Cheryl Grandinetti

Speakers

Mandy Budwal-Jagait

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

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

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States

Dr. Grandinetti is the Associate Director for Clinical Policy within the Office of Scientific Investigations’ Division of Clinical Compliance Evaluation and provides leadership and subject matter expertise on policy issues related to GCP, human subject protection, and clinical trial... Read More →

sumitra_sachidanandan

Regulatory Consultant - GCP Unit, Health Sciences Authority, Singapore

Sumitra is a Regulatory Consultant at the Health Sciences Authority (HSA) in Singapore, heading the GCP Compliance Inspection Unit, which oversees Good Clinical Practice (GCP) inspections and quality improvement for clinical trials. She is the Topic Lead representing HSA at the ICH... Read More →

Paula Walker

Global Head of Risk Based Quality Management, Roche, United Kingdom

Paula Walker is the Global Head of Risk-Based Quality Management (RBQM) at Roche and a member of the Quality Management Leadership team. As former Head of Compliance & Inspectorate at the MHRA, she brings over 13 years of regulatory experience to her mission of accelerating patient... Read More →

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

09: RD-Quality-Compliance, Forum | 02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance/Control & CMC
Feature Topics Cross-Functional Collaboration
Tags Forum

12:50pm EDT

#421 CH: From Siloed Data to AI Ready Insights: How HL7 FHIR Enables Health Authority Ready Interoperability

Monday June 15, 2026 12:50pm - 1:20pm EDT

Content Hub

Component Type: Workshop
Level: Intermediate

This session explores how to prepare data for AI and regulatory expectations through interoperable architectures with HL7 FHIR. Attendees will discuss how to make their own data reusable, trustworthy, and ready for tomorrow’s regulatory requirements.

Learning Objectives

• Show how the life sciences industry is using modern technology and HL7 FHIR to break down data silos. • Demonstrate how interoperable data becomes “AI ready” and “Health Authority ready.” • Engage participants in discussing practical steps for improving data quality, structure, and trust.

Speakers

Joan Cheung

Principal Consultant, Epista Life Science, United States

Joan Cheung is a Senior Consultant at Epista Life Science where she leverages new technologies for digital transformations in the life sciences. Since her Doctor of Pharmacy from St. John’s University, she gained technical project and product management skills in Regulatory Affairs... Read More →

Monday June 15, 2026 12:50pm - 1:20pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

12: Content-Hubs, Workshop

Audience Intermediate
Level Intermediate
format csv
Tags Workshop

1:00pm EDT

#422 RT: Roundtable Discussion: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts

Monday June 15, 2026 1:00pm - 2:00pm EDT

Zone B

Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Accelerating US Based Domestic Manufacturing by Leveraging Innovative Regulatory Concepts (Monday, June 15 | 1:00pm - 2:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Jude Nwokike, MPH, MSC, RPH, RAC

Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

1:00pm EDT

#423 RT: Roundtable Discussion: Enhancing Regulatory Collaboration through Cloud Technologies

Monday June 15, 2026 1:00pm - 2:00pm EDT

Zone A

Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Enhancing Regulatory Collaboration through Cloud Technologies (Monday, June 15 | 1:00pm - 2:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Khushboo Sharma, MBA

Monday June 15, 2026 1:00pm - 2:00pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

2:30pm EDT

#430: Responsible use of AI in Pharmacovigilance: Global Perspectives from CIOMS WG XIV

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

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-526-L04-P; CME 1.00; RN 1.00

The CIOMS Working Group XIV, presents consensus recommendations for the responsible use of AI in pharmacovigilance. Speakers will address principles of governance, transparency, robustness, fairness, and regulatory expectations using real examples.

Learning Objectives

Recognize common principles in the development and use of AI to support pharmacovigilance operations with a focus on processing of individual case safety reports; Describe a practical framework for critically appraising of AI models and systems, with focus on risk based approaches, human oversight, validity and robustness, transparency, data privacy, fairness and equity and governance.

Chair

Phil Tregunno

Speaker

Principles and recommendations from CIOMS WG XIV
Niklas Noren, PHD, MSC

Panelist
Beth Anne MacEntee Pileggi, BSN, MBA

Panelist
Walter Straus, DrMed, MD, MPH, FACP

Speakers

Niklas Noren

Chief Science Officer, Uppsala Monitoring Centre, Sweden

Niklas Norén is Chief Science Officer at the Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, and a member of its executive leadership team. He has published extensively on statistical pattern discovery in observational medical data, primarily... Read More →

Beth MacEntee Pileggi

Senior Director, Head of Safety Information Management and Automation, Johnson & Johnson, United States

Beth is a pharmaceutical executive with deep expertise in Pharmacovigilance (PV) at Johnson & Johnson (J&J). Beth has over 30 years of global pharmaceutical leadership experience developing and executing strategies, driving operational excellence, and ensuring compliance with worldwide... Read More →

Walter Straus

Vice President, Safety and PV, Moderna, United States

Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →

Phil Tregunno

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

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

Monday June 15, 2026 2:30pm - 3:30pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Tags Session

2:30pm EDT

#432: Industry Collaboration 2030: Head, Heart and Gut Perspectives

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

108B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-527-L04-P; CME 1.00; RN 1.00

No one can solve today’s R&D challenges alone. But are industry consortia fit for 2030? We examine the "head, heart, and gut" to re-imagine collaboration and explore what’s needed to accelerate co-creation and innovation.

Learning Objectives

Recognize the value of industry collaborations, analyze emerging trends and future innovation opportunities; Explain how to shift from patient-centric to patient-driven design thinking.

Chair

Sarah Tremethick

Speaker

Industry Collaboration 2030: Head Perspective
Adrian Hernandez, MD, MHS

Industry Collaboration 2030: Head, Heart and Gut Perspectives
Rebecca Vermeulen, RPH

Industry Collaboration 2030: Gut Perspective
Jeff Smith

Speakers

Adrian Hernandez

Professor of Medicine; Executive Director, Duke Clinical Research Institute , United States

Adrian Hernandez, MD, MHS, is Executive Director, Duke Clinical Research Institute, and Vice Dean of the Duke University School of Medicine. Dr. Hernandez has research interests in improving cardiovascular health and accelerating clinical evidence through outcomes research, clinical... Read More →

Jeff Smith

The Curator, Smith and Jones Innovation, United States

Sarah Tremethick

Global Program Lead - Product Development Industry Collaborations, Roche, United Kingdom

A change catalyzer that connects biopharmaceutical innovators to tackle problems and drive industry disruption. Part of Roche’s Industry Collaborations group, which believes that common challenges in drug development can be solved through industry consortia. Almost 30 years’ experience... Read More →

Rebecca Vermeulen

Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States

Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Global Alignment in Practice, Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Patient Engagement
Feature Topics Global Alignment in Practice,Patient-Centered Design and Experience
Tags Session

2:30pm EDT

#431: Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions

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

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-528-L04-P; CME 1.00; RN 1.00

Explore patient-focused decentralized trials and direct-to-patient shipments, highlighting their impact on recruitment, retention, and trial performance—and how sites adapt operations to deliver these solutions effectively.

Learning Objectives

Evaluate how DCT solutions and direct-to-patient shipments enhance patient access, recruitment, and retention; Identify best practices for sites to operationalize DCT workflows while ensuring quality and compliance.

Chair

Joan Chambers

Speaker

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Kevin Hudziak, MS

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Becky Suzanne Kottschade, MA, PMP

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Joan Chambers

Expanding Access and Engagement: Lessons from Decentralized Clinical Trial Solutions
Jane Myles

Speakers

Joan Chambers

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

With 30+ years in the health and life sciences industry, Joan has led senior initiatives across multiple organizations, specializing in team leadership, strategic planning, integrated marketing, communications, and educational programs for B2B and B2C audiences. She is a Senior Independent... Read More →

Kevin Hudziak

Senior Director - Patient Engagement, Clinical Trial Retention, Eli Lilly and Company, United States

Kevin is Senior Director of Clinical Trial Retention on the Patient Engagement team at Lilly. He has extensive experience gathering patient and site feedback, delivering innovation, and impacting DCT capability development and implementation at Lilly. Kevin has a passion for improving... Read More →

Becky Kottschade

Administrator, Clinical Research, Mayo Clinic, United States

Becky Kottschade is an experienced clinical research administrator. Driven by her commitment to developing innovative options for patients she takes pride in providing the best practices for implementing decentralized capabilities possible. As a research administrator her goals are... Read More →

Jane Myles

VP, Programs and Initiatives, Digital Trials and Research Alliance, United States

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

Monday June 15, 2026 2:30pm - 3:30pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 09: RD-Quality-Compliance, 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

2:30pm EDT

#433: ICH M11 in Action: Digital Protocols, AI, and Cloud for Patient-Centered Regulatory Science

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

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-529-L04-P; CME 1.00; RN 1.00

Explore how ICH M11, AI, and digital transformation are reshaping regulatory science to benefit patients. Learn from real-world pilots and global collaborations that accelerate trial design, streamline submissions, and foster patient-centered innovation.

Learning Objectives

Describe how ICH M11 and digital protocol standards enable seamless, patient-centric clinical trial design and regulatory submissions; Evaluate the impact of AI, cloud, and interoperable data platforms on accelerating regulatory review and improving patient access to innovation; Apply strategies for integrating patient experience data and digital tools to enhance trial inclusivity, data quality, and regulatory confidence.

Chair

Vada Perkins, MS

Speaker

Panelist
Mumtaz Sultani

Panelist
Jimita Parekh

Panelist
Robert DiCicco, PHARMD

Speakers

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States

Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. where for the last 3 years he has headed up a suite of programs that include Pragmatic Trials along with several digital and data driven transformational projects. He was the Chief Health Officer... Read More →

Jimita Parekh

Managing Director, Independent, United States

Vada Perkins

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

Mumtaz Sultani

European Medicines Agency, Netherlands

Monday June 15, 2026 2:30pm - 3:30pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

Audience Intermediate
Area Artificial Intelligence, Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Health Technology & AI
Feature Topics Artificial Intelligence,Global Alignment in Practice
Tags Session

2:30pm EDT

#434: Next-Generation Data Standards for Real-World Data and Real-World Evidence (FHIR, Dataset-JSON, and the Road Ahead)

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

111AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-530-L04-P; CME 1.00; RN 1.00

This forum will explore current and emerging data standards applicable to RWD when intended for regulatory purposes. Experts from FDA and industry will discuss how today’s standards set the stage for tomorrow’s regulatory landscape.

Learning Objectives

Explain how current CDISC standards set the foundation for RWD/RWE submissions; Discuss evolving data standards, including Dataset-JSON and HL7 FHIR, focusing on how they may complement or extend CDISC; Identify actions sponsors can take now to prepare for evolving regulatory data standards.

Chair

James Browning, MPH

Speaker

Panelist
Chris Decker, MS

Panelist
Anne-Marie Meyer, MS

Speakers

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States

James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 16 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →

Chris Decker

President and CEO, CDISC, United States

Chris Decker is President and CEO of CDISC. Widely recognized in the industry, Chris has decades of experience leveraging technology and standards to optimize processes and help industry drive innovation forward. He has extensive experience in executive roles across software development... Read More →

Anne-Marie Meyer

Advisor, Lind AI, Switzerland

Dr. Meyer is Vice President of Healthcare Consulting at acc solutions and advisor to LindAI. As Adjunct Associate Professor at UNC Chapel Hill, she has bridged epidemiology and health informatics for 20+ years. At Lineberger Cancer Center, she built a secure data platform linking... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

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

2:30pm EDT

#435: AI Competency Framework for Medical Writers: Essential Skills to Enhance Medical Writing AI Expertise

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

105AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-531-L04-P; CME 1.00; RN 1.00

This session will describe essential AI-related skills for medical writers to leverage AI responsibly for greater efficiency while ensuring compliance and scientific integrity. The speakers will discuss how medical writers are becoming AI stewards.

Learning Objectives

Define the knowledge, skills, and behaviors medical writers need to responsibly and effectively integrate AI technologies in medical writing while meeting quality and compliance standards; Discuss how the medical writer’s role in scientific communications is changing with the use of generative AI.

Chair

Eileen Girten, MS

Speaker

Panelist
Mary Ost, PHD, MS

Panelist
Jeanette Towles, MA, RAC

Speakers

Eileen Girten

Medical Writing Therapeutic Area Lead, Pfizer, United States

Eileen M. Girten serves as the Medical Writing Therapeutic Area Lead at Pfizer and brings nearly 17 years of medical writing experience spanning publications and regulatory documentation. She holds a Bachelor of Arts in Chemistry from Rosemont College, a Master of Science in Psychology... Read More →

Mary Ost

Director, AI-assisted Operations, Regulatory Medical Writing, Johnson & Johnson , United States

Mary Ost, PhD, is Director of AI-assisted Operations for Regulatory Medical Writing at Johnson & Johnson Innovative Medicine, with 30 years of experience across the pharma and CRO spaces. As AI-assisted Operations Lead, Mary has defined strategy and led solution deployment for AI-driven... Read More →

Jeanette Towles

CEO, Synterex, United States

Jeanette Towles, MA, RAC is the Founder and CEO of Synterex, Inc., a clinical and regulatory consulting firm pioneering the digital transformation of regulatory science in life sciences and healthcare. Under her leadership, Synterex is developing a digital regulatory ecosystem—a... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

04: MedAffairs-SciComm, Session

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

2:30pm EDT

#436: Aligning Strategy with Execution: Leveraging Integrated Program Plans, Project, Program, and Portfolio Management, and AI to Advance Drug Development

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

202AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-532-L04-P; CME 1.00; PDU 1.00 PMI 21665YGZQV ; RN 1.00

This seminar shows how life sciences teams can align strategy with execution through integrated program plans, AI-enabled planning, and P3M practices to accelerate time to market, foster innovation, and drive organizational transformation.

Learning Objectives

Distinguish how to align strategy with execution by integrating program plans (IPPs) across R&D, Clinical, CMC, Regulatory, and Commercial Leverage AI-enabled planning and P3M practices to enhance visibility, decision-making, and risk management, accelerating time to market; Discuss ways to adapt leadership approaches to drive organizational transformation, innovation, and compliance in an evolving life sciences landscape.

Chair

Christine Mears, MBA, PMP

Speaker

Aligning Strategy with Execution: Leveraging Integrated Program, Project and Portfolio management with AI to advance drug development
Philip M Zack, DVM, PHD

Panelist
Erin Mulrooney, MSC, PMP

Speakers

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Executive Director, Portfolio Management, Generate BioMedicines, United States

Christine Mears

Founder, Lead Consultant, Premiere Consulting Services LLC, United States

Christine M. Mears is an enterprise program, portfolio, and operations executive with 25+ years of experience driving strategy execution and operational performance. Formerly at Eli Lilly in a COO-level capacity, she led global programs, launches, and transformations. As Founder of... Read More →

Erin Mulrooney

Director, Portfolio Analysis & Management, Daiichi Sankyo Co., Ltd., United States

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

Philip Zack

Executive Life Sciences Consultant Portfolio, Program and Alliance Management, Self-Employed, United States

Phil Zack has 25 years experience in the biopharmaceutical industry and research. He has held Portfolio, Program and Alliance Management leadership positions within NeXstar, Gilead, Amgen, Vertex, and Myovant Sciences. He has experience in all phases of drug development, in multiple... Read More →

Monday June 15, 2026 2:30pm - 3:30pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session | 07: RegCMC-Product Quality, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Project Management & Strategic Planning
Feature Topics Cross-Functional Collaboration
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

2:30pm EDT

#443: The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence

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

117

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-538-L04-P; CME 1.00; RN 1.00

This forum will present Health Authority (HA) expectations related to a robust Culture of Quality focused on Critical-to-Quality (CtQ) issue management. This session will provide specific examples of how leadership commitment and employee ownership enable a robust Quality Culture.

Learning Objectives

Explain Health Authority (HA) expectations of an effective Culture of Quality, specifically around Critical-to-Quality (CtQ) issue surveillance and management; Describe the vital link, and cultural best practices, between leadership commitment, employee ownership, and the ability to effectively manage CtQ issues.

Chair

Michael Torok, PHD

Speaker

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Sameera Ibrahim

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Leslie Sam

The Quality Blueprint: How Cross-Functional Leadership and Employee Ownership Drive Clinical Trial Excellence
Emily Gebbia, JD

Speakers

Emily Gebbia

Associate Director for Regulatory Development, OC, OSI, CDER, FDA, United States

Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise on good clinical practice, human subject protection, and... Read More →

Sameera Ibrahim

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

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

With 30 years of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

Michael Torok, Ph.D., serves as Vice President of Quality Assurance Programs at Roche/Genentech, focusing on de-risking the Development portfolio and accelerating patient access through risk-based quality practices. He leads a global team of Quality Professionals focused on proactive... Read More →

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

09: RD-Quality-Compliance, Forum

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

2:30pm EDT

#444: Driving Efficiency in Clinical Development with Master Protocols

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

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-539-L04-P; CME 1.00; RN 1.00

Master protocols are innovative designs for simultaneous evaluation of multiple drug or population under one protocol, enhancing efficiency. Despite their potential, these protocols pose complex scientific, operational, and regulatory challenges.

Learning Objectives

Explain the different master protocols (basket, umbrella, platform) in various therapeutic areas; Identify key statistical, operational, and governance challenges; Describe regulatory perspectives and recent guidance; Discuss practical case studies illustrating successes, pitfalls, and innovations.

Chair

Satrajit Roychoudhury, PHD

Speaker

Pooling shared controls in platform trials: operational and statistical considerations
Megan McCabe, PHD

The Art of Borrowing: Practical Strategies to Power Master Protocols
Haitao Chu, MD, PHD

Learnings Across Master Protocols – A Design Perspective
Purvi Prajapti, PHD, MS

Speakers

Haitao Chu

Senior Director, Pfizer, United States

Dr. Haitao Chu is a Senior Director at Pfizer’s Statistical Research and Data Science Center, a role he has held since 2022. He earned his PhD in Biostatistics from Emory University. Dr. Chu has held several academic appointments, including Assistant Professor of Epidemiology at... Read More →

Megan McCabe

Assistant Professor, Department of Biostatistics, The University of Alabama at Birmingham, United States

Megan McCabe is an Assistant Professor in the Department of Biostatistics at the University of Alabama at Birmingham (UAB), and the Assistant Director for Clinical Trials Development for the UAB DATA coordinating and Collaborative Research Unit (DATA CRU). She graduated with her PhD... Read More →

Purvi Prajapati

Sr. Advisor, Eli Lilly, United States

Purvi earned her PhD in Statistics from Baylor University prior to joining Lilly in 2020. Since joining she’s been a member of the Clinical Design Team where she collaborates with multiple study teams to design clinical trials across all phases of drug development across the immunology... Read More →

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States

Dr. Satrajit Roychoudhury is an Executive Director and the head of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical... Read More →

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

10: Stats-EvidenceGeneration-RWE, Session

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

4:00pm EDT

#445: Tailoring Risk Minimization Activities to Special Populations Locally: Patient Needs, Digitalization, Global Learning

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

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-540-L04-P; CME 1.00; RN 1.00

This session shares US, EU and global expertise and experiences on methods to tailor risk minimization interventions and digital implementation support to special patient populations (e.g. female, young and older patients) in local contexts.

Learning Objectives

Describe needs and methods for tailoring risk minimization interventions to special patient populations; Recognize challenges and opportunities of digital support to implementing risk minimization interventions with examples; Discuss experiences from around the globe with localization of risk minimization interventions and reliance.

Chair

Priya Bahri, PHD

Speaker

Panelist
Shelley Gandhi, MS

Localisation of risk minimisation interventions – Low- and middle-income countries and global reliance
Jean-Christophe Delumeau, MD, PHD

Tailoring risk minimisation interventions - Applying implementation science and user-testing
Meredith Yearsley Smith, MPA, FISPE

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, FISoP, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she oversees the developement of the EU Good Pharmacovigilance Practices (EU-GVP) and also instigates frameworks, research and... Read More →

Delese Mimi Darko

Director General, African Medicines Agency (AMA) , Rwanda

Jean-Christophe Delumeau

Senior Expert, Institute of Pharmacovigilance, Czech Republic

Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan... Read More →

Shelley Gandhi

Partner & PV trainer, Eliquent Life Sciences, United Kingdom

Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →

Gerald Dal Pan

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

Meredith Yearsley Smith

Fellow and faculty member, USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States

Meredith is a health services and implementation science researcher with + 20 yrs of experience in the pharmaceutical industry where she has held senior positions in drug safety, health economics and regulatory affairs. Currently, she is a Fellow of the Int. Society for Pharmacoepidemiology... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Rare Disease & Special Populations
Feature Topics Patient-Centered Design and Experience
Tags Session

4:00pm EDT

#446: DIA2026-001: Co-Creating the Patient-Centric Trial Live

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

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-541-L04-P; CME 1.00; RN 1.00

In this interactive forum, attendees will co-create “DIA2026-001” through live polling, exploring how early protocol decisions shapes: patient inclusion, recruitment feasibility, technology strategy, operational complexity. With perspectives from patient advocacy, recruitment and clinical technology experts, the session demonstrates how intentional study design and enabling technologies directly influence recruitment success and long-term retention, critical factors given that most trials struggle to meet enrolment targets.

Learning Objectives

Discuss how to co-create a model protocol while examining how patient and site input influence design decisions and technology choices; Evaluate how early protocol and technology decisions impact recruitment strategy, inclusivity, and operational feasibility; Identify practical approaches to leveraging digital and hybrid delivery models to support patient-centric trial execution.

Chair

Farrell Healion, MSC

Speaker

Panelist
Alexandra Charge

Panelist
Ross Jackson

Speakers

Alexandra Charge

CEO, ISPEP, United Kingdom

A global life sciences executive, specialising in strategic transformation, innovation, and patient-centric approaches in healthcare, medicines development and clinical trial optimisation. As the CEO of the International Society for Patient Engagement Professionals, Alex is an active... Read More →

Farrell Healion

Founder & Managing Director, Optitrial, United Kingdom

Farrell Healion is the Founder and Principal Consultant of OptiTrial, where he partners with sponsors and study teams to deliver smarter, faster, and more connected clinical trials. With over 13 years of experience across sponsor and clinical technology roles, including at AstraZeneca... Read More →

Ross Jackson

Patient Recruitment Specialist, Ross Jackson Consulting, United Kingdom

A patient recruitment consultant who's worked on nearly 200 successful projects. Author of two Amazon best-selling books on patient recruitment, Ross provides advice and oversight to organizations that wish to improve the effectiveness of their patient recruitment activities - sponsors... Read More →

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

02: ClinicalTrialOps-Innovation, Forum

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Project Management & Strategic Planning
Feature Topics Patient-Centered Design and Experience
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

#449: Study Participants Want to Know When AI is Processing Their Medical Data: Perceptions of AI and Operational Implications

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

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-543-L04-P; CME 1.00; RN 1.00

This session shares insights from a global survey of 12,000+ respondents, highlighting patient comfort levels and receptivity to AI processing their medical information as part of a clinical trial.

Learning Objectives

Discuss patient comfort levels and receptivity to AI processing medical information as part of a clinical trial; Describe strategies to address patient preferences and comfort levels with AI analyzing medical data.

Chair

Annick De Bruin, MBA

Speaker

Panelist
T.J. Sharpe, PMP

Panelist
Shanelle Gabriel, MED

Speakers

Annick De Bruin

Chief Research and Insights Officer, Research Services, Center for Information & Study on Clinical Research Participation (CISCRP), United States

Annick de Bruin is the Chief Research and Insights Officer of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including... Read More →

Shanelle Gabriel

Patient Advocate, N/A, United States

Shanelle Gabriel

Patient Advocate/Speaker/Poet, Building Constellations, LLC, United States

Shanelle Gabriel is an internationally touring poet, speaker, communications consultant, and lupus patient advocate. She has performed globally gracing stages from Carnegie Hall to the Vatican. As a creative strategist, she has crafted poetry on various themes for events and for campaigns... Read More →

Ellyn Getz

Director, R&D Patient Engagement, CSL Behring, United States

Ellyn Getz, MPH is the Director of R&D Patient Partnerships at global biotech CSL, where she gathers input into clinical development and operations from patients, care partners, health care professionals, and researchers, and she develops strategies to support patient engagement and... Read More →

T.J. Sharpe

Patient Engagement Expert, Sharpe Patient Insights, United States

T.J. Sharpe is a keynote speaker, writer, and patient engagement leader who partners with life sciences companies and healthcare organizations to integrate meaningful patient perspectives into clinical research and healthcare innovation. He develops and leads patient engagement programs... Read More →

Monday June 15, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 02: ClinicalTrialOps-Innovation, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Clinical Development & Operations
Feature Topics Patient-Centered Design and Experience
Tags Session

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

#450: Medical Writing Ted Experience

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

105AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-545-L04-P; CME 1.00; RN 1.00

Medical writing myths persist, including the assumption that “anyone can write” and “an AI can write this in 10 minutes”—even as the stakes for clarity, accuracy, and scientific integrity continue to rise. In this TED-talk–style session, three presenters will explore why medical writing expertise matters, how writers can evolve into influential cross-functional leaders, and the value and limitations of AI currently in use. Attendees will leave with practical insights to elevate the role of medical writers and adopt emerging tools responsibly to improve quality, efficiency, and credibility in drug development communication.

Learning Objectives

Examine the specialized value professional medical writers bring, including how writing expertise reduces risk, improves efficiency, and strengthens scientific credibility—beyond what generalist writing can achieve; Identify the skills and mindsets needed for “future-ready” medical writers; Describe practical ways to grow from document execution roles into strategic leadership and cross-functional influence; Assess current AI uses in medical writing, distinguishing opportunities from hype.

Chair

Monica Chiaramonte, PHD

Speaker

Panelist
Anna Whitling, PHARMD

Everyone Thinks They Can Write: Why Medical Writers Make the Difference
Monica Chiaramonte, PHD

Amid the Ballyhoo Over AI, What Are We Losing?
Steve Sibley, MS

Speakers

Monica Chiaramonte

Director, Clinical Regulatory Writing, AstraZeneca, United States

Monica Chiaramonte is a Director of Clinical Regulatory Writing at AstraZeneca, with over 35 years in the scientific field and 19 years in Medical Writing across CRO and pharmaceutical settings. She brings deep expertise in authoring and leading high quality regulatory submissions... Read More →

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

Anna Whitling

Senior Manager of Medical Writing, Alcon Laboratories, Inc, United States

Monday June 15, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

04: MedAffairs-SciComm, Forum | 03: Data-Tech-AI, Forum

Audience Intermediate
Area Artificial Intelligence, Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Medical Affairs & Scientific Communication
Feature Topics Artificial Intelligence,Student and Early Career Pathway
Tags Forum

4:00pm EDT

#453: Navigating CMC Challenges for Innovative Cell and Gene Therapy Products: From Starting Materials to Comparability

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

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-576-L04-P; CME 1.00; RN 1.00

Explore regulatory and manufacturing challenges in cell and gene therapy, including starting material variability, potency testing, comparability, specification, and stability strategies. Gain insights into FDA expectations, ICH initiatives, and collaborative approaches to harmonize definitions and accelerate development while ensuring quality and regulatory clarity across individualized therapies.

Learning Objectives

Identify key regulatory and manufacturing challenges in CGT development, including starting material variability, comparability, stability, setting specifications, and post-approval changes; Discuss FDA and global expectations, harmonization needs, and strategies for individualized therapies to ensure quality and compliance across development phases.

Chair

Lesbeth Caridad Rodriguez, MS

Speaker

Defining and Controlling Raw and Starting Materials for CGT Manufacturing
Kevin Carrick, PHD

Comparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing Process
Andrew Chang, PHD

Setting specifications for ATMPs: insights from the ICHQ6 revision
Cecilia Tami, PHD

Stability Considerations for Cell and Gene Products
Akanksha Kaushal, MS

Speakers

Kevin Carrick

Senior Director, Science and Standards, Biologics, United States Pharmacopeia, United States

Dr. Kevin Carrick is a Senior Director of Science & Standards in USP’s Global Biologics Department. Dr. Carrick and his team work with the five USP Expert Committees and multiple Expert Panels in the area of biologics to develop standards that support biopharmaceutical quality assessment... Read More →

Andrew Chang

Sr. Quality and Regulatory Compliance Director, Novo Nordisk A/S, United States

Dr. Andrew Chang is a multifaceted quality and CMC leader with 30 years well-rounded medical product regulatory and industry experiences. He is a member of the board of directors for Parenteral Drug Association (PDA). Andrew has served as a member of the planning committee for DIA... 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 →

Cecilia Tami

Head US CMC Regulatory Policy, Genentech, United States

Cecilia Tami

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

Monday June 15, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session

Audience Intermediate
Area Global Alignment in Practice, Therapeutic Pathways
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Feature Topics Global Alignment in Practice,Therapeutic Pathways
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

#458: Regulatory and Industry Perspectives: Understanding the Significance and Impact of GCP Inspection Observations

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

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-552-L04-P; CME 1.00; RN 1.00

Explore global GCP inspection outcomes featuring FDA’s 7-year data and international trends, highlighting compliance patterns, regulatory harmonization, and industry strategies for sustaining quality in complex global trials

Learning Objectives

Examine GCP inspection classification and outcomes across regulatory agencies, highlighting similarities and differences in enforcement; Identify common deficiency patterns and regulatory expectations across regions, emphasizing protocol adherence, recordkeeping, and data integrity; Recognize the impact of inspection observations on regulatory decisions; Discuss industry best practices.

Chair

Jenn Sellers, MD

Speaker

Overview of MHRA's GCP Inspections
Rachel Mead

Speakers

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Rachel joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a GCP Inspector in July 2019. She conducts a wide range of routine and triggered GCP inspections across both commercial and non commercial organisations, including Phase 1 units registered under the MHRA... Read More →

Jenn Sellers

Chief, GCP Assessment Branch, FDA, United States

Dr. Sellers serves as Chief of the Good Clinical Practice (GCP) Assessment Branch in the Office of Scientific Investigations at the U.S. FDA, where she leads the evaluation of GCP compliance and provides regulatory recommendations in support of marketing applications. She is a board-certified... Read More →

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

09: RD-Quality-Compliance, Session | 02: ClinicalTrialOps-Innovation, Session

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

4:00pm EDT

#459: Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding

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

107AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-554-L04-P; CME 1.00; RN 1.00

This session highlights methodological challenges in External Control Arms (ECAs) using Real-World Data (RWD). Speakers will address time-related biases, endpoint alignment challenges between RWD and trial standards, and methodological strategies to address unmeasured confounding.

Learning Objectives

Discuss exposure and time-related issues in ECA construction, including defining time-zero and avoiding immortal time bias; Describe endpoint alignment challenges between RWD and trial standards, and outline methods to address measurement error and bias. Evaluate approaches for handling missing data and unmeasured confounding, and explain new insights on defining index dates in EC studies.

Chair

Ju-Young Shin, PHD

Speaker

Choosing an Index Date for Untreated Patients in External Comparator Studies
Ju Hwan Kim, PHARMD, PHD

Quantifying and mitigating measurement bias in real-world endpoints when constructing external control arms
Benjamin Ackerman, PHD

Choosing an Index Date for Untreated Patients in External Comparator Studies
Gerd Rippin, PHD

Speakers

Benjamin Ackerman

Principal Scientist, Biostatistics, Johnson & Johnson, United States

Ben Ackerman is a Principal Scientist at Johnson & Johnson Innovative Medicine, where he provides support across therapeutic areas to design and analyze randomized trials, namely those that combine trial data with real-world data. He has expertise in causal inference methods to address... Read More →

Benjamin Ackerman

Director, Real-world Biostatistics, GSK, United States

Ben Ackerman is a Director of Real-world Biostatistics at GSK, where he designs and analyzes real-world evidence studies in oncology. He has expertise in causal inference methods to address various biases in both randomized trials and non-experimental studies. Previously, he led a... Read More →

Ju Hwan Kim

Research Professor, Sungkyunkwan University, Korea, Republic of

Ju Hwan (Joe) Kim, PharmD, PhD, is a Research Professor at the School of Pharmacy, Sungkyunkwan University, South Korea. His work spans pharmacoepidemiology, clinical pharmacy, regulatory science, and real-world data/evidence. He leads international collaborative studies leveraging... Read More →

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany

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

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 →

Monday June 15, 2026 4:00pm - 5:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Evidence Innovation
Tags Session

4:00pm EDT

#460: Is There an Urgent Need for Global Alignment on External Controls in Clinical Trials?

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

203AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-553-L04-P; CME 1.00; RN 1.00

This session will focus on use of external controls, including historical cohorts and real-world data, in clinical trials across drug development, focusing on the gaps and need for alignment between regulators from different regions

Learning Objectives

Explain the current guidance and reflection papers on the use of external controls from leading regulatory agencies (FDA, PMDA, MHRA) and discuss recent progress within the EU on this topic; Analyze the key similarities and differences in regulatory recommendations for study design, and describe the rationale for greater alignments across agencies.

Chair

Gracy G Crane, MS

Speaker

Panelist
Motiur Rahman, PHD, MPHARM, MS

Panelist
Denise Umuhire, MBA, MSC

Panelist
Tricia Luhn, PHD, MPH

Speakers

Gracy Crane

Policy Lead, Roche, United Kingdom

Gracy holds a Ph.D. in Molecular Oncology from King’s College Hospital, an M.Sc. in Biomedical Research from King’s College. She did her postdoctoral training at Oxford (UK) and at MIT (USA). Gracy brings broad experience in clinical research, medical affairs and health outcomes... Read More →

Tricia Luhn

RWD Oncology, Genentech, United States

Tricia Luhn

RWD Oncology, Genentech, A Member of the Roche Group, United States

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Dr. Motiur Rahman is a Senior Epidemiologist and Policy Advisor in Real-World Evidence (RWE) Analytics within the Office of Medical Policy at CDER, FDA. He leads the consult service for reviewing RWD study submissions, leads international regulatory collaborations including ICH initiatives... 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 →

Monday June 15, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

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

#504: From Conventional to Intelligent: Redefining Pharmacovigilance with AI and Global Collaboration

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

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-555-L04-P; CME 1.25; RN 1.25

This session traces the evolution of PV innovation: from algorithms tailored to vulnerable groups, to FDA pilots applying AI at scale, to regulatory guidance ensuring readiness and global harmonization for next-generation safety systems.

Learning Objectives

Identify algorithmic innovations that address signal detection challenges in vulnerable populations; Examine how AI is being piloted to extend these methods into large-scale pv workflows with transparency and oversight; Describe regulatory approaches that translate methodological and technological advances into practice through validation and international harmonization.

Chair

Ju-Young Shin, PHD

Speaker

Recent advances in PV innovation: implementing/deploying for practical impact
Raymond Kassekert, MBA

A method for systematically retrieving pregnancy-related reports
Daniele Sartori, MSC

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Raymond Kassekert

Executive Director, PV Systems Management, GSK, United States

Ray is Executive Director and Head, PV Systems at GlaxoSmithKline. In this role, Ray is responsible for the global technology platforms supporting Pharmacovigilance and Drug Safety. In addition, Ray is a member of the ICH E2B(R3) Implementation Working Group and a member of the MedDRA... Read More →

Gerald Dal Pan

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

Daniele Sartori

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

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

Ju-Young Shin

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

Tuesday June 16, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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

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

10:15am EDT

#506: From Barriers to Bridges: Unlocking Research Potential in Primary Care

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

108B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-556-L04-P; CME 1.25; RN 1.25

Too few sponsors and sites have access to primary care organizations (PCOs). PCOs deliver first-contact, comprehensive, and continuous care to over 100 million people. This session will bring forth easy to use and action oriented PCO tactics.

Learning Objectives

Distinguish between types of primary care organizations (PCOs) & their objectives to increase study participation; Discuss common PCO research barriers to improve collaboration outcomes short and long-term; Outline actionable tactics for study implementation and strategic initiatives.

Chair

Pete Fronte, MBA

Speaker

Panelist
Alpa Patel

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Ruma Bhagat, MPH

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Osa Eisele, MD, MPH

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Rakesh Patel, MD, MBA, FAAFP

From Barriers to Bridges: Unlocking Research Potential in Primary Care
Maggie McGuire Kuhl

Speakers

Ruma Bhagat

Process Excellence Leader, Genentech, A Member of the Roche Group, United States

Osa Eisele

Executive Director, Amgen, United States

Osa Eisele, MD, MPH, is a physician-scientist and global health leader with over 20 years of experience in drug safety, clinical research, and population health. As Head of Representation in Clinical Research (RISE) at Amgen, she advances proportional representation in clinical trials... Read More →

Pete Fronte

Founder and Chief Executive Officer, Altura, United States

Pete Fronte, MBA is President/CEO of Altura. During the past 30 years Mr. Fronte has been a leader in developing technology and services to expand clinical study participation for patients and building quality-based research centers within primary care organizations and community... Read More →

Maggie McGuire Kuhl

Vice President, Patient Engagement, The Michael J. Fox Foundation For Parkinson's Research, United States

Rakesh Patel

CEO, Neighborhood Healthcare (FQHC), United States

Dr. Rakesh Patel is the Chief Executive Officer (CEO) for Neighborhood Healthcare, Neighborhood Healthcare PACE, and Neighborhood Healthcare Institute of Health. Neighborhood Healthcare is a 501(c)3 nonprofit Federally Qualified Health Center (FQHC) with 30 Health Centers serving... Read More →

Alpa Patel

Senior Vice President, Population Science, American Cancer Society, United States

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

02: ClinicalTrialOps-Innovation, Forum

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

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

#515: Leveraging Federated AI and Open Data to Transform Oncology Research and Development

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

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-566-L04-P; CME 1.25; RN 1.25

This session covers the importance of data sharing and the new tools that might enable that pooling and integration in order to facilitate progress in personalized medicine and ensure faster access to treatments for the oncology patients who need them the most.

Learning Objectives

Discuss the present landscape, opportunities, and challenges of oncology data pooling efforts and the advancements offered by AI that can allow faster integration; Describe emerging programs and global initiatives designed to facilitate faster oncology drug development; Assess various considerations and strategies that are meaningful to both physicians and patients.

Chair

Alberto Grignolo, PHD

Speaker

Panelist
Beth Meagher, MA

Panelist
Sean Khozin, MD, MPH

Panelist
Stacy Hurt, MBA, MHA

Leveraging Federated AI and Open Data to Transform Oncology Research and Development
Maria Vassileva, PHD

Panelist
Joseph Kannarkat, MD

Speakers

Alberto Grignolo

Editor-in-Chief, DIA Global Forum, United States

Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion... Read More →

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States

Joseph is a physician with a deep interest in drug regulatory policy and has previously published articles in venues like The New England Journal of Medicine, The Journal of the American Medical Association, and The Brookings Institution. His research interests include studying the... Read More →

Sean Khozin

CEO, Roundtable on Cancer (CEORT) and Project Data Sphere (PDS), United States

Dr. Khozin is the Chief Executive Officer of CancerLinQ, LLC, and Executive Vice President of ASCO. He has more than a decade of leadership experience in health technology, regulation, clinical research, and data science, including the application of artificial intelligence and machine... Read More →

Beth Meagher

Principal, Deloitte Consulting, United States

Beth Meagher is a Deloitte Consulting LLP principal and leader of the Federal Monitor Deloitte Strategy practice. She started and leads Deloitte's Translational Medicine, which bring strategy, informatics, clinical, and research capabilities together on collaborative teams. Beth focuses... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

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

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session

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

10:15am EDT

#510: The Trials and Virtues of Founder Led Selling: Rapid Discovery and Validation of Product-Market Fit for ClinTech

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

103A

Component Type: Session
Level: Intermediate

Many clinical research technology founders rush to build and fundraise before understanding how sponsors and sites make buying decisions. This session explores how to perform streamlined customer discovery to build a winning go to market strategy.

Learning Objectives

Design and execute a streamlined customer discovery process to validate unmet needs, buying triggers, and budget ownership before finalizing a go-to-market strategy; Translate insights into a sales learning roadmap that tests positioning, pricing, compliance, and objections to reduce commercial risk before raising capital; Align GTM and fundraising with validated demand to present a credible revenue story.

Chair

Dan Sndyer

Speaker

Panelist
Peter Schaeffer, MBA, PMP

Panelist
Laura Hilty

Panelist
Jeff B Lee, MBA

Speakers

Laura Hilty

Principal, HealthX Ventures, United States

Jeff Lee

Board Director, Medstar Health Research Institute, United States

Jeff Lee is a seasoned entrepreneur, angel investor, and venture partner with a strong background in business development and entrepreneurship. He successfully founded/exited mProve Health and held leadership roles in several other startups with successful exits. Jeff also serves... Read More →

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States

Pete Schaeffer has worked in the Pharmaceutical industry for approximately 20 years in both the Pre-Clinical and Clinical areas. During this time, he has worked in roles to improve performance and decision making, led continuous improvement programs and collaborated with teams to... Read More →

Dan Sndyer

The Playbook, United States

Dan Sndyer

The Playbook, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session | 18: Lift-Series, Session

Audience Intermediate
Area Biotech-ClinTech-Pathway, Digital Enablement and Modernization, Cross-Functional Collaboration
Level Intermediate
format csv
Interest Area Data Management & Data Standards,Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway,Digital Enablement and Modernization,Cross-Functional Collaboration
Tags Session

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

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 →

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

#508: How Standardized Protocol Data Plus AI Power Patient Centric Studies

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

111AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-560-L04-P; CME 1.25; RN 1.25

Clinical trial start-up is often delayed by manual processes, fragmented systems, and inconsistent data. This workshop will explore how biopharmaceutical companies are using AI and interoperable data standards to enable patient centric study designs.

Learning Objectives

Explain how AI and USDM (the CDISC digital protocol data standard) work together to streamline study design and protocol development; Discuss ways to achieve patient-centric design and reduced patient burdens using AI in conjunction with clinical standards; Examine how data standards enable interoperability and multi-stakeholder collaboration including with sites and patients.

Chair

William Illis, MPH

Speaker

Panelist
Nicholas Brooke, MBA

Panelist
Prasanna Rao

Panelist
Vivian Dewoskin, MBA

Panelist
Sahishnu Patel, PHD

Speakers

Nicholas Brooke

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

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

Vivian Dewoskin

Chief Commercial Officer, Faro Health Inc., United States

Vivian is the Chief Commercial Officer at Faro, where she leads sales, marketing, and commercial strategy. She works closely with Faro’s customers to understand their needs and goals, and translate them into Faro’s product development roadmap. Prior to Faro, Vivian held multiple... Read More →

William Illis

Executive Director, Technology and Scientific Computing, Novartis , United States

Bill is Executive Director, Technology and Scientific Computing in the Advanced Quantitative Sciences line function at Novartis. He responsible for developing and implementing the analytics technology strategy focused on end-to-end clinical data flows, systems and processes. For the... Read More →

Sahishnu Patel

Associate Director, AI and Automation R&D, Synterex, United States

Sahishnu Patel, PhD, is Associate Director of AI and Automation R&D at Synterex, where he leads the design, validation, and responsible deployment of AI-enabled medical and regulatory solutions. His work focuses on building high-impact generative and agentic systems, advancing scalable... Read More →

Prasanna Rao

Chief Products and Innovation Officer, Saama, United States

Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Senior Director, Global Head of AI/ML, Clinical Data Sciences, Pfizer R&D. With over 30 years of experience in information technology and analytics, including more than a decade in... Read More →

Tuesday June 16, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Workshop

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

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

#512: Enhanced Analytical Procedure Development: Principles, Prior Knowledge, and Change Management

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

202AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-562-L04-P; CME 1.25; RN 1.25

This workshop will focus on the principles of enhanced analytical procedure development, and use of prior knowledge in creating robust methods. It will include industry case studies, a regulator’s perspective, and a debate-style panel. Part 2 of this workshop is Future of Enhanced Product Development: Enabled through new ICH guidelines scheduled for Wednesday, June 17 at 10:15AM ET.

Learning Objectives

Describe ICH Q14 and the principles of analytical procedure development and lifecycle management; Apply enhanced approaches to analytical procedure development through the use of prior knowledge; Discuss health authority expectations for submission of information regarding enhanced analytical procedure development and lifecycle management.

Chair

Bryan Castle, PHD

Speaker

Exploring the Principles of Enhanced Analytical Procedure Development Emphasizing the Role of Prior Knowledge in Designing Robust Methods
Nina S. Cauchon, PHD

Panelist
Julie Armitstead

Panelist
Gary McGeorge

Speakers

Julie Armitstead

Principal Scientist, Pfizer, United States

Bryan Castle

Associate Vice President, Synthetic Molecule Design & Development, Eli Lilly and Company, United States

Dr. Castle is a technical leader in Eli Lilly & Company's Synthetic Molecule Design and Development organization. He has been part of the Lilly team for over 25 years and has held many different roles in drug substance and drug product analytical development. He currently is engaged... Read More →

Nina Cauchon

Director Regulatory Affairs CMC, Amgen, United States

Nina S. Cauchon, PhD, leads external engagement and advocacy for RA-CMC at Amgen Inc. She has experience leading both early phase & commercial programs, including small molecules and biologics. Her areas of interest are regulatory harmonization including collaboration, regulatory... Read More →

Gary McGeorge

Director for PAT, Bristol Myers Squibb, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Workshop

Audience Intermediate
Area Global Alignment in Practice
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Feature Topics Global Alignment in Practice
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

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 →

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

10:15am EDT

#518: Next Generation Clinical Trial Quality Assurance Using Advanced Analytics

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

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-567-L04-P; CME 1.25; RN 1.25

See how different pharmaceutical companies use advanced analytics to augment traditional quality assurance methods, hear the Regulators’ perspective on use of innovative quality assurance methods.

Learning Objectives

Identify the different methods that are available to assure the quality of clinical trials that go beyond traditional on-site auditing; Discuss how different companies have applied analytics methods and their impact on clinical trial quality assurance.

Chair

Jennifer Emerson, MPH, RN, PMP

Speaker

Regulators Perspective Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
Rachel Mead

SCORE - Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
Jamie Bridges, MPH

Critical to Quality Assessment Report - Next Generation Clinical Trial Quality Assurance Using Advanced Analytics
Kiernan Trevett, MSC

Panelist
Kavita C. Dada, PHARMD, RAC

Speakers

Jamie Bridges

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

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

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States

Captain Kavita Dada, Pharm.D., RAC (US), is Associate Director for Regulatory Operations in the Office of Scientific Investigations, Office of Compliance, at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She provides strategic leadership... Read More →

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

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

Rachel Mead

Senior GCP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Kiernan Trevett

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

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

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

09: RD-Quality-Compliance, Session

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

10:15am EDT

#519: Patient Registries: Basket Trial or Basket Case?

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

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-568-L04-P; CME 1.25; RN 1.25

Akin to basket trials which study a single treatment for multiple conditions, patient registries enroll people with similar conditions, look for safe and effective treatments and disease management strategies, and are used to guide decision-making by clinicians, regulators and payers. Yet the very nature of real-world evidence requires that patient registries be nimble and opportunistic -- desirable attributes to maintain relevance, but ones that inevitably raise questions about data quality and completeness, transparency, provenance and Fitness for Use. Recent guidance documents from regulators and professional societies hint that real-world data from patient registries may be viewed more favorably than other, less traceable and auditable sources of real-world data. This session will illustrate key attributes of high quality, trustworthy patient registries, the criticisms and barriers they generally face and what they do to bolster trust.

Learning Objectives

Explain the value of RWE on population groups that may not be fully representative of all cases, and who may have some missing data; Explain expectations for quality, transparency and provenance; Describe key values of patient registries and common approaches to bolster trustworthiness.

Chair

Nancy Dreyer, MPH, FISPE

Speaker

How registries are changing with technology and AI, and what that means for quality
Richard Gliklich, MD

Gauging registry quality according to its intended use
Mike D'Ambrosio

Life in the trenches of a patient registry: navigating the reality of RWD
Angela Dobes, MPH

Speakers

Mike D'Ambrosio

Parexel, United States

22 Years Industry experience at top 5 CRO’s including in RWE/RWD general manager roles, leading RWE/RWD and medical affairs cross functional teams. Currently leads Parexel's Real World Research (RWD/RWE) business franchise - Helping customers build innovative RWD/RWE solutions to... Read More →

Angela Dobes

SVP, IBD Plexus, Crohn's & Colitis Foundation, United States

Angela Dobes is the senior vice president of IBD Plexus, a real-world data platform and biorepository that redefines how researchers study inflammatory bowel disease to advance precision-medicine strategies and cut years off the R&D timeline. She strives to elevate the important role... Read More →

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer brings her experience as Chief Scientific Officer at IQVIA Real World Solutions and SVP roles at IQVIA, Quintiles, Outcome Sciences Inc and UnitedHealth Group to independent consultancy. Her work focuses on advancing the use of real-world evidence for safety, effectiveness... Read More →

Richard Gliklich

Founder & Director, OM1, United States

Dr. Richard Gliklich is the Founder of OM1, Inc., a data, outcomes and technology company focused on using data and AI to accelerate medical research and improve clinical decision making. OM1 accelerates and lowers the cost of prospective and retrospective studies and registries for... Read More →

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

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

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

11:40am EDT

#521 CH: Achieving Representative Enrollment in Phase 3 Lupus Clinical Trials: A Case Study

Tuesday June 16, 2026 11:40am - 12:10pm EDT

Content Hub

Component Type: Workshop
Level: Intermediate

This session covers the importance of representative enrollment in Phase 3 Lupus trials, Biogen’s approach to setting and achieving these goals, and how patient-focused strategies improve clinical trial integrity and outcomes.

Learning Objectives

1. Understand the key challenges in representative enrollment in Phase 3 Lupus clinical trials. 2. Learn how Biogen approached setting enrollment goals that reflect the epidemiology of the disease and specific strategies developed and initiatives executed to achieve these goals. 3. Understand the importance of representative enrollment on trial outcomes and patient care and how this is achievable

Tuesday June 16, 2026 11:40am - 12:10pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

12: Content-Hubs, Workshop

Audience Intermediate
Level Intermediate
format csv
Tags Workshop

12:30pm EDT

#526 RT: Roundtable Discussion: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis

Tuesday June 16, 2026 12:30pm - 1:30pm EDT

Zone A

Component Type: Session
Level: Intermediate

Join the Statistics & Data Science Community for a follow up round table discussion tied to session: FDA Public Posting of Complete Response Letters: A Year in Review, Trends, and Impact Analysis (Tuesday, June 16 | 12:30pm - 1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Matthew Vankoski

Tuesday June 16, 2026 12:30pm - 1:30pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

1:45pm EDT

#532: Applied Innovation for Patients: Implementing AI, Cloud, and Data in Regulatory Science

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

109AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-572-L04-P; CME 1.25; RN 1.25

This session explores strategies to implement AI, cloud, and different data sources across the drug lifecycle and in regulatory activities to deliver patient benefits. Experts will discuss pilots, policies, and partnerships that can enable faster access to safe and effective medicines.

Learning Objectives

Explain how AI, cloud, and data can be utilized in regulatory processes to accelerate patient access to therapies; Assess implementation strategies that balance innovation with patient safety and trust; Identify collaborative models that embed patient-centric principles into digital regulatory ecosystems.

Chair

Rebecca Nebel, PHD

Speaker

Panelist
Kimberly Ann Beer, MA

Panelist
Andrew Robertson, JD, PHD

Panelist
Jonathan Walsh, PHD

Speakers

Kimberly Beer

Senior Vice President, Policy & External Affairs, National Health Council, United States

Kimberly Beer is Senior Vice President of Policy and External Affairs at the National Health Council, where she leads policy and advocacy to improve access to affordable, high-quality care for people with chronic conditions and disabilities. She previously served as Senior Director... Read More →

Rebecca Nebel

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

Rebecca Nebel, PhD, is a Deputy Vice President of Science and Regulatory Advocacy at PhRMA. In this role, she leads advocacy efforts to advance regulatory policy on key issues including digital health, artificial intelligence, regulatory information technology, real-world evidence... Read More →

Rebecca Nebel

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

Rebecca Nebel

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

Andrew Robertson

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States

Andrew Robertson, PhD, JD, is Vice President and Head of Global Regulatory Policy & Innovation at Takeda. He leads Takeda’s global regulatory science and policy agenda, shaping engagement with FDA, EMA, PMDA, WHO, and other authorities, and guiding strategy on initiatives such as... Read More →

Jonathan Walsh

Chief Scientific Officer, Unlearn.AI, United States

Jon Walsh is the co-founder and Chief Scientific Officer of Unlearn.AI and a physicist by training. At Unlearn, Jon leads the integration of digital twins into drug development, with a particular focus on regulatory pathways and the intersection of statistics and machine learning... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Data Management & Data Standards,Health Technology & AI
Feature Topics Digital Enablement and Modernization
Tags Session

1:45pm EDT

#535: Unlock AI's Full Potential: The Power of FAIR Data

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

119AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-574-L04-P; CME 1.25; RN 1.25

AI underperforms when data isn’t machine-actionable. This talk shows how FAIR + open standards turn fragmented R&D data into fuel for LLMs and analytics—via a mini-rubric, case studies, and a 90-day roadmap to lift AI-readiness.

Learning Objectives

Apply a mini-FAIR rubric to one dataset/document to diagnose AI-readiness and summarize 2–3 priority gaps; Recognize and select the appropriate standards—such as PIDs, metadata, controlled vocabularies, that best enable a target AI use case (e.g., RAG, model reuse); Recognize the key components of a 90-day plan—including roles, metrics, checkpoints—designed to elevate FAIR maturity and improve AI outcomes.

Chair

Anuj Uppal, MS

Speaker

AI Readiness Organizational Barriers
Kathleen Rand, PHARMD

AI Readiness: A Statistical View
Kaveen Hiniduma

The FAIR Principles: 10 Years Later
Ted Slater, MA, MS

Speakers

Kaveen Hiniduma

Graduate Research Associate, Ohio State University, United States

Kathleen Rand

Principal Scientist, Procter & Gamble, United States

Ted Slater

Global Head, Knowledge Engineering & Data Advisory, EPAM Systems, United States

My work focuses on FAIR Data and the application of semantic technologies and artificial intelligence to scientific problems in pharmaceutical R&D and related fields. I am a molecular biologist and a computer scientist.

Anuj Uppal

Vice President, Life Sciences Transformation, Campana & Schott, United States

Anuj Uppal is a data scientist and AI product leader at Campana & Schott who builds intelligent platforms that transform how life sciences organizations assess data readiness. His creation, DATA Compass, challenges the industry assumption that "clean data" equals "AI-ready data"—a... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
119AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session

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

1:45pm EDT

#534: The Best Pitch Advice I Ever Got: How to Nail Main Stage Talks, Pitch Decks, and Any Talk of a Lifetime

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

103A

Component Type: Workshop
Level: Intermediate

In this interactive workshop, coach Jeff Smith shares essential building blocks – Prep as Empathy, the Impact Wave, Visuals on Purpose, and Dynamic Delivery – used to shape “talks of a lifetime,” from founding pitch decks to keynote and TED stages.

Learning Objectives

Use preparation as an empathy tool to align with enterprise/pharma stakeholders; Structure pitches using the “Impact Wave” to guide audiences from problem recognition to urgency to action; Design clear visuals that increase trust and decision velocity; Elevate delivery using the “Dynamism Checklist” to project confidence and persuasive presence.

Chair

Jeff Smith

Speakers

Jeff Smith

The Curator, Smith and Jones Innovation, United States

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Workshop | 06: ProfDevelop-Program-PortfolioMgmt, Workshop | 18: Lift-Series, Workshop

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

1:45pm EDT

#536: Project Management as a Catalyst for Enterprise Transformation

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

202AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-575-L04-P; CME 1.25; PDU 1.25 PMI 21662N25CW; RN 1.25

Project Management as a Catalyst for Enterprise Transformation explores how Project Management (PM) drives strategic alignment, organizational evolution, and long-term sustainment across the enterprise. This session will examine how PM-led governance and decision-making frameworks bring clarity to chaos and accelerate transformation, while positioning PM as a strategic engine regardless of company size. Participants will engage in a hands-on exercise that applies these concepts to realistic scenarios, enabling them to identify capability gaps and define scalable PM practices that support both the evolution and the sustained success of their organizations.

Learning Objectives

Explain how PM-led governance and decision-making frameworks act as catalysts for strategic alignment and enterprise-wide transformation; Describe how to position Project Management as a strategic driver of organizational transformation across companies of all sizes; Identify PM capability gaps and define scalable practices that accelerate transformation.

Chair

Elizabeth Somers, MS

Speaker

Project Management as a Catalyst for Enterprise Transformation
Joann O'Connor

Project Management as a Catalyst for Enterprise Transformation
Jayanthi Reddy, MBA, MS

Speakers

Joann O'Connor

Executive Director, Head of Pipeline Project Management for BD and Alliances, GSK, United States

Joann O’Connor is a pharmaceutical R&D leader with 20 years of drug development experience spanning research, development, and commercialization. She is Executive Director, Head of Pipeline Project Management for Business Development and Partnerships at GSK, where she leads a specialized... Read More →

Jayanthi Reddy

Eikon Therapeutics, Head of Project and Portfolio Management, United States

Jay has over 20 years of pharmaceutical industry experience and over 14 years of project Management experience. She is currently the cardiovascular franchise leader within the Project Management group at Merck.

Elizabeth Somers

Associate Vice President, Global Project and Alliance Management, Merck & Co., Inc., United States

Liz is an Associate Vice President in Global Project and Alliance Management at Merck leading a large team that is focused on end to end drug development Project Management in the therapeutic areas of Imm, Neuro, CV, ID/Vaccines and Ophthalmology. She has direct experience managing... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Project Management & Strategic Planning
Tags Workshop

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

Denise Umuhire

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

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

1:45pm EDT

#542: Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?

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

117

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-580-L04-P; CME 1.25; RN 1.25

This forum will present: 1) HA expectations related to cross-functional QbD, 2) Specific examples will highlight the change need for traditional clinical trial functions to meet QbD requirements.

Learning Objectives

Explain Health Authority (HA) expectations for cross-functional Quality by Design (QbD); Describe the current state of traditional clinical trial functions and the needed change in those functions to meet HA expectations for QbD.

Chair

Michael Torok, PHD

Speaker

Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Jennifer Emerson, MPH, RN, PMP

Quality by Design Revolution: Is There Still a Place for Traditional Clinical Trial Functions?
Mandy Kaur Budwal-Jagait, MSC

Speakers

Mandy Budwal-Jagait

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

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

Cheryl Grandinetti

Associate Director for Clinical Policy, CDER/OC/OSI/DCCE, FDA, United States

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States

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

09: RD-Quality-Compliance, Forum

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

3:15pm EDT

#544 RT: Roundtable Discussion: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust

Tuesday June 16, 2026 3:15pm - 4:00pm EDT

Zone B

Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Is Your AI Ready to Scale? Build the Governance Backbone for Reliable Innovation and Trust (Tuesday, June 16 | 3:00pm - 4:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Atika Kumar, MBA, MS

Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

3:15pm EDT

#545 RT: Roundtable Discussion: Regulators Approach to Address Drug Shortages

Tuesday June 16, 2026 3:15pm - 4:00pm EDT

Zone A

Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Regulators Approach to Address Drug Shortages (Tuesday, June 16 | 3:15pm - 4:00pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Allison Radwick

Tuesday June 16, 2026 3:15pm - 4:00pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

4:15pm EDT

#549: Reimagining Site Source: Optimizing Clinical Trial Execution for Sponsors, Sites, and Patients

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

108B

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-583-L04-P; CME 1.00; RN 1.00

This session is intended to show how modern site source and integrated site solutions connect data, people, and processes to create a more efficient, future-ready clinical trial ecosystem.

Learning Objectives

Discuss the evolving role of site source in optimizing trial execution and ensuring data quality, compliance, and efficiency across stakeholders; Identify best practices for implementing digital site solutions including eSource and integrated site technologies that balance standardization with site autonomy; Recognize how site-centered innovations connect data, people, and processes.

Chair

Jonathan Andrus, MS

Speaker

Technology Perspective
Samir Jain

Site Perspective
Aneesh Vaze

CRO and Site Network Perspective
Melissa Gottschlich, MSC

Speakers

Jonathan Andrus

CEO, CRIO, United States

With 30 years of experience, Jonathan specializes in developing eClinical services that integrate data and technology to optimize study execution. At CRIO, he oversees customer success, sales, marketing, finance, compliance, and people programs. An active thought leader, Jonathan... Read More →

Melissa Gottschlich

Senior Director Site Network, Accellacare, United States

Melissa “Missy” Gottschlich is Senior Director, Site Network at ICON, where she leads global strategy and centralized operations for Accellacare, ICON’s proprietary clinical site network. She oversees cross-functional teams spanning technology, finance, quality, project management... Read More →

Samir Jain

Head of EHR and Interoperability Solutions, Medidata, a Dassault Systèmes Company, United States

Samir Jain is the Head of EHR and Interoperability Solutions at Medidata, driving the company's healthcare interoperability strategy. With over 20 years in health tech, he previously built EHRs and led interoperability at Allscripts, developed large-scale Health Information Exchanges... Read More →

Aneesh Vaze

Managing Director, Clinical Research of Philadelphia, United States

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum

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

#551: Operationalizing Large Language Models in Drug Development

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

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-585-L04-P; CME 1.00; RN 1.00

Generative AI and large language models (LLMs) are reshaping drug development and Real-World Evidence (RWE). This session explores real-world applications, debunks common myths, and outlines what’s needed for safe, scalable, and compliant use across the drug development lifecycle.

Learning Objectives

Distinguish between the current capabilities and limitations of generative AI and large language models (LLMs) in drug development; Identify practical and regulatory challenges in adopting GenAI across evidence generation workflows; Discuss future opportunities for integrating GenAI into the various areas of the drug development pipeline; Identify/mitigate bias in regulated workflows

Chair

Wesley Anderson, PHD

Speaker

GenAI for literature-based evidence synthesis: From systematic literature review to digitization of trial publications
Emily Nieves

Panelist
Danielle Boyce, MPH

Speakers

Wesley Anderson

Scientist, Quantitative Medicine, Critical Path Institute, United States

Wes Anderson, Ph.D. is a Quantitative Medicine Scientist at the Critical Path Institute, where he develops data-driven solutions to support drug development using machine learning, artificial intelligence, natural language processing, and informatics. He has also contributed to the... Read More →

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States

Danielle Boyce

Principal Investigator and Data Consultant, ALS Therapy Development Institute, United States

Dr. Danielle Boyce is Principal Investigator of Real World Evidence at the ALS Therapy Development Institute and a faculty member at Johns Hopkins University, with affiliations at the University of Calgary, University of Chicago, and Emory University. A mother of a child with rare... Read More →

Emily Nieves

CEO/ Co-Founder, Delineate, United States

Emily Nieves is the co-founder and CEO of Delineate, a seed-stage startup partnering with pharmaceutical companies to accelerate Model-Informed Drug Development workflows through advanced AI techniques. Prior to founding Delineate, Emily pursued graduate studies in Biological Engineering... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

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

#563: Oncology Pathways Under Pressure: From CAR-T Access Today to Longevity-Driven Care Tomorrow

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

107AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-655-L04-P; CME 1.00; RN 1.00

By placing CAR-T within a broader trajectory—from breakthrough therapies today to longevity-driven oncology tomorrow—this session challenges stakeholders to rethink how access, value, and sustainability must evolve to keep pace with scientific progress.

Learning Objectives

Assess how CAR-T experience has revealed gaps in health technology assessment and reimbursement in the US and Europe; Examine how durable benefit, earlier intervention, and longer oncology horizons challenge current value, outcomes, and sustainability models; Apply multi-stakeholder and patient insights to inform evolving reimbursement and access approaches for potentially curative therapies.

Chair

Bradley Watts

Speaker

Panelist
Tom Whitehead

Panelist
Ronald DePinho, MD

Panelist
Laura Okpala, MPH

Speakers

Ronald DePinho

Professor, Cancer Biology, The University of Texas MD Anderson Cancer Center, United States

Laura Okpala

Executive Director, Head of US Reimbursement Policy, Gilead Sciences, United States

At Gilead Sciences, Laura leads the US reimbursement policy team focused on driving access to innovative medicines across Gilead’s oncology and virology portfolio, including reimbursement strategies for Kite Pharma, a leader in the development of novel CAR T therapies. Laura joined... 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 →

Tom Whitehead

Co-Founder and President, Emily Whitehead Foundation, United States

Tom Whitehead President & Co-founder, Emily Whitehead Foundation Tom Whitehead is a keynote speaker, author, and journeyman lineman for an energy company. He is also the proud father of Emily and the co-founder of the Emily Whitehead Foundation, which is dedicated to raising awareness... Read More →

Tuesday June 16, 2026 4:15pm - 5:15pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session

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

#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

Lesbeth Rodriguez

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

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

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

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 →

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

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

4:15pm EDT

#561: Unlocking Transformative Value: AI and Advanced Analytics in Good Clinical Practice and Good Pharmacovigilance Practice Quality Assurance

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

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-595-L04-P; CME 1.00; RN 1.00

In this session, we explore the transformative value of integrating AI and advanced analytics into Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) quality assurance, transforming Quality Assurance (QA) from a reactive oversight function to a value-generating enabler for the business and patients.

Learning Objectives

Recognize the value unlocked by the incorporating AI and advanced analytics in GCP/GVP quality assurance; Describe the short and long term transformative benefits; Discuss how to develop strategies for demonstrating the value created by embedding AI and advanced analytics into quality assurance audits.

Chair

Roshan D'Souza

Speaker

Value realisation in augmenting Quality Assurance with advanced analytics & AI?
Frederik Collin, MS

Lessons learned in implementing advanced analytics & AI in Quality Assurance
Jeremy Jones, MS

The Why behind the Value proposition
Roshan D'Souza

Data & Digital: Assessing Measurable Value in QA
Michael Pelosi, MA, MBA

Speakers

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany

Frederik is a Data Scientist working at Boehringer Ingelheim developing advanced analytics solutions leveraging data in the GCP space. He has co-developed several statistical open-source tools and published scientific articles on quality statistics.

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom

Roshan is currently the head of Quality Excellence Digital at Roche's Product Development Quality organisation. The utilisation of data analytics and digital technologies to unlock meaningful business outcomes has been a common thread since he started his career at Roche. An engineer... Read More →

Jeremy Jones

Director, R&D Quality Operations & Excellence, BeOne Medicines, United States

Jeremy Jones is Director of R&D Quality Operations & Excellence at BeOne Medicines, where he leads R&D Quality Operations & Excellence across global research, clinical development, and pharmacovigilance activities. With over 12 years of leadership experience, he specializes in cross-GxP... Read More →

Michael Pelosi

Lead, Quality Assurance, Analytics, Astellas, United States

Mike is the Astellas lead in Quality Governance for data analytics and digital leadership and provides support to all Astellas functions for Management Review and electronic Quality Management Systems related activities.

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

09: RD-Quality-Compliance, Session | 01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Artificial Intelligence
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Health Technology & AI
Feature Topics Artificial Intelligence
Tags Session

4:15pm EDT

#562: Leveraging Real-World Evidence and External Controls in Clinical Trials of Rare Outcomes/Diseases: Statistical Innovation and Novel Applications

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

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-596-L04-P; CME 1.00; RN 1.00

Learn how the Real-World Evidence (RWE) can be utilized in studies of rare outcomes and diseases. Speakers from industry, academia, and regulators share insights on external controls, causal inference, and evidence synthesis to inform regulatory submissions.

Learning Objectives

Identify when to use hybrid design and or external controls for rare outcomes and diseases using RWE sources; Design RWE-based studies and address confounding, missing data, and intercurrent events; Evaluate robustness of study results with sensitivity analyses.

Chair

Huan Wang, PHD

Speaker

Assessing the Validity of External Versus Randomized Controls in Pancreatic Cancer and Other Diseases
Ruthie Davi, PHD, MS

Real World Evidence for Post-Marketing Drug Safety Outcomes: FDA’s Sentinel System
Jennifer Lyons, PHD, MPH

Single Arm, External-Controlled Studies – Pitfalls and Pathways
Van Tran, PHD

Speakers

Ruthie Davi

Senior Vice President, Medidata, a Dassault Systèmes Company, United States

Ruthie Davi is Senior Vice President, Statistics and Regulatory Science Innovation at Medidata, and has a background in pharmaceutical clinical trials with more than 20 years working at the FDA, most recently as a Deputy Division Director in the Office of Biostatistics in CDER. At... Read More →

Jennifer Lyons

Research Scientist, Harvard Pilgrim Health Care Institute, United States

Jennifer Lyons is a Research Scientist in the Therapeutics and Infectious Disease Epidemiology group at the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. She works on the FDA-sponsored Sentinel Initiative for drug safety surveillance... Read More →

Van Tran

Mathematical Statistician, OTS, CDER, FDA, United States

Van Tran, PhD, is a Senior Mathematical Statistician at the U.S. Food and Drug Administration, where she provides statistical review of clinical trials and real-world evidence to support regulatory decisions on drug safety and efficacy. Her interests include evaluation of rare and... Read More →

Huan Wang

Mathematical Statistician, CDER, FDA, United States

Dr. Huan Wang joined the FDA in 2021, where he focuses on statistical reviews for drug approval applications in non-malignant hematologic diseases. Prior to this role, he earned his Ph.D. in Biostatistics from the George Washington University, where he conducted research on developing... Read More →

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

10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Area Evidence Innovation
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Biostatistics
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

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

#603: From Guidance to Practice: Regulatory and Stakeholder Views on Evaluating Risk Minimization Measures

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

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-597-L04-P; CME 1.25; RN 1.25

Risk Minimization Measures (RMMs) target multiple healthcare stakeholders, and effectiveness varies by context. This session highlights guidance on their mixed-method evaluations, empirical examples, methodological advances, and insights from SmPC content analysis.

Learning Objectives

Discuss the US and EU regulatory rationale and expectations for RMM evaluations; Explain empirical examples where mixed-method evaluations altered interpretation of effectiveness compared with quantitative results alone; Discuss emerging methodological advances and data sources for meaningful patient safety outcomes.

Chair

Daniele Sartori, MSC

Speaker

Panelist
Gita Toyserkani, PHARMD, MBA

Panelist
Elaine Lippmann, JD

Panelist
Helga Gardarsdottir, FISPE

Panelist
Priya Bahri, PHD

Speakers

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Helga Gardarsdottir

Professor RWD for decision making on medicines, Utrecht University, Netherlands

Helga Gardarsdottir is professor in use of RWD for decision making on medicines at Utrecht University (NL). Since January 2025, she has also been serving as a Seconded National Expert in the Data Analytics and Methods Taskforce (RWE Workstream) at the European Medicines Agency. Her... Read More →

Elaine Lippmann

Principal, Leavitt Partners, United States

Elaine Lippmann, J.D., is a Principal at Leavitt Partners based on Washington, D.C., bringing more than 15 years of leadership experience at the U.S. Food and Drug Administration (FDA) and deep expertise in pharmaceutical regulatory policy to her client work. Elaine most recently... Read More →

Daniele Sartori

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

Gita Toyserkani

Regulatory Strategy Lead, Perspective Pharmacovigilance, United States

Dr. Gita Toyserkani, PharmD, MBA, is Regulatory Strategy Lead at Perspective Pharmacovigilance, where she advises life sciences companies on regulatory strategy across drug safety, risk management, and benefit–risk assessment. She brings more than 20 years of experience at the U.S... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session | 10: Stats-EvidenceGeneration-RWE, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Biostatistics
Tags Session

10:15am EDT

#605: Bridging the AI Divide: Regulatory Trends, Industry Innovation, and the Future of AI in Pharma & Biotech

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

109AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-602-L04-P; CME 1.25; RN 1.25

Artificial Intelligence is redefining pharma and biotech. This session contrasts AI-native and traditional models, examines FDA, EMA, and EU AI frameworks, and delivers strategies to ensure credible, compliant AI use in regulatory decision-making.

Learning Objectives

Differentiate between AI-native and traditional pharma/biotech models in drug development; Assess regulatory expectations for AI from FDA, EMA, and the EU AI Act; Apply strategies to establish AI model credibility for regulatory decision-making.

Chair

Mark Rutter

Speaker

Panelist
Graziella Collu, DRSC, MS, MSC

Panelist
Hussein Ezzeldin, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE

Panelist
Megha Sinha

Speakers

Graziella Collu

Vice President, Global Regulatory, AstraZeneca, Netherlands

Hussein Ezzeldin

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

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States

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

Mark Rutter

Vice President, Regulatory Affairs, Formation Bio, United States

Mark Rutter is Vice President, Regulatory Affairs at Formation Bio, where he leads regulatory strategy across the development portfolio with a focus on innovative approaches to evidence generation. He brings extensive experience from leadership roles at Biogen, AbbVie, and Celgene... Read More →

Megha Sinha

CEO, Kamet Consulting Group, United States

Wednesday June 17, 2026 10:15am - 11:30am EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum

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

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

#606: Enhancing Clinical Trial Oversight: Using Statistical Outlier Detection with Generative AI for Protocol Deviation Analysis

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

107AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-601-L04-P; CME 1.25; RN 1.25

In this session, we demonstrate an integrated approach that uses bootstrap-based statistical outlier detection and generative AI to identify and characterize clinical investigator sites that underreport or overreport protocol deviations.

Learning Objectives

Describe the core principles of Gen AI and explain their relevance to clinical operations; Identify practical considerations for implementing AI for clinical trial oversight; Illustrate how combing a statistical bootstrap-based method with Gen AI can identify clinical investigator sites that significantly underreport or overreport clinical protocol deviations.

Chair

Ioannis Spyroglou, PHD

Speaker

Panelist
Roshan D'Souza

Bootstrapping and Simaerep: Statistical Outlier Detection in Protocol Deviation Reporting
Frederik Collin, MS

Operational Impact, Scaling, and Limitations: From Algorithm to Practice
Karin Jonczak

Speakers

Frederik Collin

Senior Data Scientist, Boehringer Ingelheim, Germany

Roshan D'Souza

Head of Quality Excellence Digital, PDQ, Roche, United Kingdom

Karin Jonczak

Clinical Capabilities Lead, Director, Bristol Myers Squibb, United States

Ioannis Spyroglou

Associate Director, Data Science, MSD, United States

Ioannis Spyroglou, Ph.D., is Associate Director, Data Science in QA Analytics and Digital Innovation at Merck, and is based in Prague, Czech Republic. He co-leads Generative AI initiatives and develops solutions for quality assurance across different quality functions. Previously... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 10: Stats-EvidenceGeneration-RWE, Session

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

10:15am EDT

#611: Future of Enhanced Product Development: Enabled Through new ICH Guidelines

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

111AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-26-606-L04-P; CME 1.25; RN 1.25

This workshop will delve into how the science and risk-based approaches outlined in ICH Q2(2) and Q14 connect to emerging revisions in ICH Q1(R1) and Q6(R1), highlighting their combined impact on product control strategies.

Learning Objectives

Recognize how ICH guideline revisions influence analytical development in the future; Discuss the health authority view on impact that analytical measurements have on the development of the future products; Explain how to apply platform analytical procedures as a follow-up to Workshop 1.

Chair

Timothy Graul, PHD

Speaker

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Margaret Ruesch, PHD

Shifting Analytical Procedure Development from a Reactive Activity into a Proactive, Strategic Pillar of Product Development
Philip Floyd, PHD

EMA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Peter Richardson

ANVISA Perspective on Connecting Analytical Procedure Development to Emerging Revisions in ICH Q1(R1) and Q6(R1) and Combined Impact on Product Control Strategies
Carolina Lopes Krahn, MSC

Speakers

Philip Floyd

Global Vice President, Analytical R&D, AbbVie, United States

Phil currently serves as Global VP, Analytical R&D within Development Sciences at AbbVie and previously spent 22 years at GSK with last role as Head of US Analytical Development. Phil received his PhD in Analytical Chemistry at U. of Illinois under Jonathan Sweedler, at Beckman Institute... Read More →

Timothy Graul

Senior Director, Pfizer, United States

Timothy W. Graul is a Senior Director in the CMC Advisory Office at Pfizer Inc. He received his B.S. in Chemistry at James Madison University and Ph.D. in Analytical Chemistry at Florida State University. After completing studies, Tim joined Pfizer Analytical R&D and supported the... Read More →

Carolina Lopes Krahn

Health Regulation Specialist, ANVISA, Brazil

Pharmaceutical professional with a degree in Industrial Clinical Pharmacy and a Master’s degree in Pharmaceutical Sciences. Has been working as Health Regulation Expert for Anvisa for over 12 years working as a drug product registration reviewer, quality management professional... Read More →

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 →

Margaret Ruesch

Vice President, Pfizer, United States

Margaret Ruesch is the Vice President of Analytical Research & Development, Biotherapeutics Pharmaceutical Sciences organization. Analytical R&D is responsible for developing in-depth product and process understanding, testing clinical trial materials, authoring investigational and... Read More →

Wednesday June 17, 2026 10:15am - 11:30am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Workshop

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

#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

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 →

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

10:15am EDT

#616: How to Accelerate Utilization of Decentralized Clinical Trial: What are Issues to Perform Decentralized Clinical Trial?

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

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-611-L04-P; CME 1.25; RN 1.25

Share the gap of Decentralized Clinical Trial (DCT) regulation in the EU, US and Japan. The speakers also touch how to overcome them. The session is helpful for sponsor which plan the trials.

Learning Objectives

Explain DCT regulations in Japan, the US, and Europe and how to overcome their differences.

Chair

Junko Sato, PHD

Speaker

DCT in Japan
Ruri Matsumoto, RPH

Experiences and expactation to DCT
Rasmus Enggaard, MPHARM, MSC

Speakers

Rasmus Enggaard

Therapy Area Head, CardioRenal/Liver/RareD, Novo Nordisk A/S, United States

Rasmus Enggaard is the Therapy Area Head for CardioRenal, Liver, and Rare Diseases in U.S. Clinical Development & Operations at Novo Nordisk, where he is responsible for execution of a broad and complex clinical trial portfolio. His work focuses on operational excellence, scalable... Read More →

Ruri Matsumoto

Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Junko Sato

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

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

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

09: RD-Quality-Compliance, Session | 02: ClinicalTrialOps-Innovation, Session

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

11:40am EDT

#618 CH: Regulatory Excellence as an Enabler for Sustainable Manufacturing in Africa

Wednesday June 17, 2026 11:40am - 12:10pm EDT

Content Hub

Component Type: Workshop
Level: Intermediate

This session will explore how regulatory system strengthening and harmonization can act as a catalyst for regional pharmaceutical manufacturing in Africa, ensuring access to quality-assured medicines and building a resilient health ecosystem.

Learning Objectives

1. Discuss the role of regional regulatory harmonization initiatives in reducing duplication, and improving patient access 2. Examine how collaboration between manufacturers and regulators can streamline product development, improve compliance, and reduce time-to-market for essential medicines 3. Share lessons learned to inform future efforts and actions to support supply chain resilience

Wednesday June 17, 2026 11:40am - 12:10pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

12: Content-Hubs, Workshop

Audience Intermediate
Level Intermediate
format csv
Tags Workshop

12:20pm EDT

#619 CH: The End of the Static Protocol: How Digital Blueprints Will Orchestrate the Next Generation of Clinical Trials

Wednesday June 17, 2026 12:20pm - 12:50pm EDT

Content Hub

Component Type: Workshop
Level: Intermediate

What if protocols weren’t documents - but executable trial blueprints? Learn how protocol digitization into structured USDM content, combined with clinical operational data, enables orchestration across systems to streamline and improve trials.

Learning Objectives

Identify how digital protocols and structured USDM models improve clinical operations and accelerate trial timelines through ecosystem orchestration. Evaluate how site operational data generates insights that streamline execution and improve protocol design. Learn how industry peers are approaching protocol digitization, including key challenges and lessons learned.

Wednesday June 17, 2026 12:20pm - 12:50pm EDT
Content Hub The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

12: Content-Hubs, Workshop

Audience Intermediate
Level Intermediate
format csv
Tags Workshop

12:30pm EDT

#620 RT: Roundtable Discussion: Can You Complete Your Submission in 10 weeks?

Wednesday June 17, 2026 12:30pm - 1:30pm EDT

Zone B

Component Type: Session
Level: Intermediate

Join the Medical Writing Community for a follow up round table discussion tied to session: Can You Complete Your Submission in 10 weeks? (Wednesday, June 17 | 12:30pm - 1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Steve Sibley, MS
Sharon Wolfe-Schwartz, MS

Speakers

Steve Sibley

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

Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

12:30pm EDT

#621 RT: Roundtable Discussion: International Regulatory Cooperation with the African Medicines Agency

Wednesday June 17, 2026 12:30pm - 1:30pm EDT

Zone A

Component Type: Session
Level: Intermediate

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: International Regulatory Cooperation with the African Medicines Agency Wednesday, June 17 | 12:30pm -1:30pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Chaitanya Koduri, DDS, MHS

Wednesday June 17, 2026 12:30pm - 1:30pm EDT
Zone A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

1:45pm EDT

#622: Pharmacovigilance to Strengthen Vaccine Confidence and Address Hesitancy: Lessons from Brazil and Beyond

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

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-612-L04-P; CME 1.00; RN 1.00

This forum will explore how pharmacovigilance strengthens vaccine confidence and reduces hesitancy through safety monitoring, transparent communication, and healthcare professional training, with lessons from Brazil and international perspectives.

Learning Objectives

Describe how pharmacovigilance can strengthen vaccine confidence and address hesitancy; Identify strategies to empower healthcare professionals to improve safety data reporting; Discuss global and national approaches to transparent risk–benefit communication in immunization.

Chair

Mayra Martho Moura Oliveira, BSN

Speaker

Pharmacovigilance as a Trust-Building Tool: From Surveillance to Confidence
Patrícia Mouta Nunes Oliveira, MD

The role of healthcare professionals: how training and information dissemination transform trust in vaccines.
Vera Lúcia Gattás, PHD

Speakers

Vera Gattás

QPPV, Instituto Butantan , Brazil

Graduated in Nursing from Escola Paulista de Medicina - Depto. Nursing (1979); Master in Public Health from the Faculty of Public Health of the University of São Paulo - USP (1996) and PhD in Tropical Diseases and International Health from the Institute of Tropical Medicine at USP... Read More →

Patricia Mouta

Pharmacovigilance specialist, Biomanguinhos/Fiocruz, Brazil

Dr. Patrícia Mouta is a Medical Doctor and Patient Safety specialist with extensive experience in pharmacovigilance and vaccine safety. Since 2011, she has worked as a Safety Physician at Bio-Manguinhos/Fiocruz, a leading public manufacturer of vaccines and biopharmaceuticals in... Read More →

Mayra Oliveira

pharmacovigilance manager, Instituto Butantan, Brazil

Since graduating as a nurse in 2007, I have built a solid career in immunization, working across different areas including vaccination clinics, clinical research coordination, and clinical operations management. Over the years, I progressed into vaccine safety and currently serve... Read More →

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

01: ClinSafety-PV-RM, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Tags Session

1:45pm EDT

#624: Optimizing Protocol Data Collection to Reduce Site and Patient Participation Burden

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

108B

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-613-L04-P; CME 1.00; RN 1.00

This session presents results of a recent TransCelerate–Tufts CSDD study highlighting trends, benchmarking protocol data collection practices, and offering new, practical strategies to simplify protocol designs and reduce participant and site burden.

Learning Objectives

Analyze new benchmarks on the distribution of protocol data across core, standard, and non-core endpoints; Identify procedures associated with non-core and non-essential endpoints and their contribution to patient and site burden; Discuss strategies to evaluate protocol data collection, simplify design and lower participation burden.

Chair

Kenneth Getz, MBA

Speaker

New Benchmarks on Clinical Trial Data Collection Practices and their Impact
Kenneth Getz, MBA

Frameworks and Tools Guiding Optimization of Protocol Data Collection
Jackie Cole, MS

Speakers

Jackie Cole

Director, Design and Innovation, Clinical Operations, Gilead Sciences, United States

Jackie Cole is a clinical development innovator with more than two decades of experience across clinical operations and site engagement. At Gilead, she serves as Director of Design & Innovation, driving enterprise-wide innovation strategies that reshape how trials are designed and... Read More →

Kenneth Getz

Tufts Center for the Study of Drug Development, Tufts University School of Medicine, United States

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

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 03: Data-Tech-AI, Session | 04: MedAffairs-SciComm, Session

Audience Intermediate
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Data Management & Data Standards
Tags Session

1:45pm EDT

#623: Designing the Future: Emulation of Clinical Trials Using Real-World Data

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

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-614-L04-P; CME 1.00; RN 1.00

Panelists that conduct trial emulation with real-world data to design better trials will present work from oncology and COPD/asthma. Presentations followed by discussion on data-driven trial design and its challenges.

Learning Objectives

Explain how trial emulation using real-world data can be used to enhance design of future clinical trials; Discuss the need for clinical trials design to take a data-driven approach and how this can lead to larger patient pools and trials that are more generalizable to clinical practice; Discuss the challenges of emulating trial endpoints, eligibility criteria, and other design elements.

Chair

Leo Russo, MS

Speaker

Panelist
Jingchuan Serena Guo, MD, PHD

Panelist
Donna Rivera, PHARMD, MSC, FISPE

Speakers

Jingchuan Serena Guo

Associate Professor, Purdue University, United States

Donna Rivera

Executive Vice President-Clinical Evidence Modernization, Canal Row Advisors, United States

Leo Russo

Advisor, Get Real Institute, United States

I bridge the gap between clinical trials and real-world outcomes, ensuring breakthrough therapies deliver on their promise to patients. Leading teams across pharmaceutical development for 25+ years, I've pioneered trial emulation, AI analytics, and pragmatic designs that generate... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Forum | 10: Stats-EvidenceGeneration-RWE, Forum

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

1:45pm EDT

#625: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences

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

109AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-618-L04-P; CME 1.00; RN 1.00

This session presents AI consortium working group assessments on regulatory frameworks, use case classification, and validation approaches. Participants engage with practical tools while demystifying real AI deployments and regulatory requirements.

Learning Objectives

Apply standardized AI use case classification frameworks to drug development and research-related scenarios; Recognize risk-based, practical assessment, governance and validation approaches for AI systems across regulatory contexts and use cases; Demonstrate utilizing aligned terminology for cross-jurisdictional AI discussions.

Chair

Sridevi Nagarajan, PHD

Speaker

Panelist
Carrie Nielson, MPH

Panelist
Michael Lingzhi Li, PHD

Panelist
Joaquim Berenguer Jornet, MS

Panelist
Venkatraman Balasubramanian, MBA

Panelist
Leon Rozenblit, JD, PHD

Panelist
Christina Mack, MPH

Speakers

Joaquim Berenguer Jornet

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

Michael Lingzhi Li

Assistant Professor, Harvard Business School, United States

Michael Lingzhi Li is an Assistant Professor in the Technology and Operations Management unit at Harvard Business School. His research focuses on the end-to-end development of decision algorithms based on machine learning, causal inference and operations research. He examines the... Read More →

Christina Mack

CSO RWE and SVP AAIS, IQVIA, United States

Christina Mack, Ph.D. is senior vice president of Applied AI Science within the AI and Technology Solutions (ATS) business, where she is responsible for driving scientific and technical innovation across the organization that has direct impact on patient health. Dr. Mack also leads... Read More →

Sridevi Nagarajan

DIA Communities Chair for AI in Healthcare, Ayusarogya, United Kingdom

An influential and data-driven executive professional with a robust background in the Pharmaceutical and Public Health sectors, bringing a unique blend of expertise in leading digital transformation initiatives and leveraging data to guide corporations through complex business changes... Read More →

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States

Carrie Nielson is a Director of Epidemiology at Gilead Sciences, where she focuses on regulatory policy for RWE and on rigorous observational research methods that support reliable evidence generation. She collaborates with industry, academic, and regulatory colleagues, including... Read More →

Leon Rozenblit

Executive Director, Q.E.D. Institute, United States

Leon Rozenblit is a nationally recognized thought leader at the intersection of clinical research informatics and AI governance. As Co-Founder and Executive Committee member of the DCI Network at Beth Israel Deaconess Medical Center, Harvard Medical School, he has co-organized two... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
109AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum

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

1:45pm EDT

#630: Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization

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

112AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-620-L04-P; CME 1.00; RN 1.00

Examine evolving extractables and leachables (E&L) regulatory guidance focusing on ICH harmonization efforts to support complex generic development through aligned risk management approaches and streamlined global regulatory frameworks.

Learning Objectives

Evaluate current global regulatory frameworks for E&L assessment in complex generic products; Analyze risk-based approaches for leachable impurity control across different jurisdictions; Synthesize harmonization opportunities to streamline product development and regulatory submissions.

Chair

Allison Radwick

Speaker

Panelist
Chaitanya Koduri, DDS, MHS

Panelist
Karthik Balasubramanian, PHD, MS

Panelist
James Wabby, MHS

Panelist
Ji Guo, PHD

Speakers

Karthik Balasubramanian

Dir Project/Program Management, External Manufacturing, Teva Pharmaceuticals, United States

Dr. Karthik Balasubramanian, Ph.D is Director, Program and Project Management at Teva Pharmaceuticals. He has over 20 years of experience in all phases of medical device and combination product development, from R&D to Technical Operations. Prior to joining Teva, he has worked in... Read More →

Ji Guo

Chemist, OPQ, CDER, FDA, United States

Dr. Ji Guo is a chemist in the Office of Policy for Pharmaceutical Quality (OPPQ) within the Office of Pharmaceutical Quality (OPQ) at the FDA's Center for Drug Evaluation and Research (CDER). Her work encompasses scientific review of drug quality issues, policy analysis, and collaboration... Read More →

Chaitanya Koduri

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

Dr. Chaitanya Koduri serves as the Director of International Government and Regulatory Engagement in the Global External Affairs division of the United States Pharmacopeia. In this capacity, Dr. Koduri oversees international regulatory partnerships involving the United States Pharmacopeia... Read More →

Allison Radwick

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

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

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
112AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session

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

1:45pm EDT

#629: Inside the Biotech Breakthroughs: How Investors and Founders Build Winning Companies

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

103A

Component Type: Session
Level: Intermediate

This candid panel looks inside notable biotech breakthroughs to explore what “success” really takes beyond the headlines. Through case studies from leading venture groups and founders, speakers will unpack key decisions, near misses, pivots, and partnership strategies, translating them into practical lessons for emerging companies and their partners.

Learning Objectives

Describe the strategic and operational decisions that shape successful biotech trajectories from idea to inflection point; Analyze real-world case studies to identify patterns in pivots, near misses, financing, and partnership strategies; Translate investor and founder perspectives into practical lessons for emerging companies and their partners.

Chair

Robert Tepper

Speaker

Panelist
Abbie Celniker, PHD

Panelist
Gabriela Apiou, PHD

Speakers

Gabriela Apiou

Investigator, Assitant Professor (M), Massachusetts General Hospital, United States

Gabriela Apiou, PhD, is an Assistant Professor of Dermatology at Massachusetts General Hospital (MGH) and Harvard Medical School, the inaugural Endowed MGH Research Institute Chair in Translational Sciences, and Director of the MGH Wellman Center for Photomedicine’s Translational... Read More →

Abbie Celniker

Partner, Third Rock Ventures, United States

Robert Tepper

Co-founder and Partner, Third Rock Ventures, United States

Bob Tepper is a co-founder and Partner of Third Rock Ventures and a distinguished physician-scientist with more than 30 years of experience building and operating leading research and development organizations in the biotech industry. Bob focuses on the formation, development, and... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

05: PersonalizedMed-ComboProd-Diagnostics, Session | 18: Lift-Series, Session

Audience Intermediate
Area Biotech-ClinTech-Pathway, Student and Early Career Pathway
Level Intermediate
format csv
Interest Area Biotechnology & Investors
Feature Topics Biotech-ClinTech-Pathway,Student and Early Career Pathway
Tags Session

1:45pm EDT

#631: Bold Leadership: Embolden Your Team for Smart Risk-Taking

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

202AB

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-621-L04-P; CME 1.00; PDU 1.00 PMI 21663K6JS3; RN 1.00

This workshop helps break through habitual thinking and guide teams toward inventive, high-impact strategies. Participants will engage in activities to encourage team engagement, uncover hidden constraints, and practice leading with confidence.

Learning Objectives

Analyze psychological and organizational factors that inhibit idea generation; Explain how to adopt techniques for leading scenario exploration.

Chair

Larissa Wilsie, MBA, MS, PMP

Speaker

Workshop Exercise 2
Nathan Kreischer, MS, PMP

Workshop Exercise 1
Amanda Adamek, MBA, PMP

Speakers

Amanda Adamek

Organon, United States

Nathan Kreischer

Director, Global Project & Alliance Management, Merck & Co., Inc., United States

Nathan is a Director within Global Project & Alliance Management at Merck. He has almost 20 years of experience in the Pharmaceutical industry spanning Basic Research, Sales, Clinical Research and Project/Program Management. He has successfully lead teams through strategy development... Read More →

Larissa Wilsie

Sr. Director, PPM Business Development, GlaxoSmithKline, United States

A cell biologist by training, Larissa moved into project management in 2013 and has worked across therapeutic areas, supporting programs from early stage development through post-approval activities. She has been able to apply PM skills in a variety of settings beyond drug development... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
202AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Workshop

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

1:45pm EDT

#632: Program Manager: Jack of All Trades, Master of None?

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

203AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-622-L04-P; CME 1.00; PDU 1.00 PMI 21668R8O1J ; RN 1.00

The program manager role can be found within many functional areas, including discovery research, manufacturing, regulatory, and, the ultimate jack of all trades, the global program manager.

Learning Objectives

Recognize the diversity of PM role with respect to technical expertise and background required; Describe the importance of explicit roles and responsibilities and recognize the importance of not leaving anything unspoken or assume anything.

Chair

Rosa Tarng, MA

Speaker

Panelist
Simina Grigoriu, PHD

Speakers

Simina Grigoriu

Director, R&D Operations, Accent Therapuetics, United States

Simina is an early-stage clinical program manager who draws on over a decade of experience spanning the continuum from drug discovery to early clinical development. Trained in structural biology and protein sciences, she led Protein & Structural Sciences teams before moving into program... Read More →

Rosa Tarng

Early Development Leader, GSK, United States

Rosa Tarng is a drug development professional with over 20 years of industry experience. Rosa is currently an Early Development Leader at GSK. Prior experience includes leading Research and Translational program management teams as well as managing drug development programs and portfolios... Read More →

Wednesday June 17, 2026 1:45pm - 2:45pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Session

Audience Intermediate
Area Cross-Functional Collaboration
Level Intermediate
format csv
Credit Type ACPE, CME, PMI, RN
Interest Area Project Management & Strategic Planning
Feature Topics Cross-Functional Collaboration
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

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

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 →

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

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 →

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

1:45pm EDT

#637: Destigmatizing 483 Observations

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

117

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-627-L04-P; CME 1.00; RN 1.00

Hear from regulators and industry on the challenges and opportunities in supporting sponsors through 483 observations. Panelists will discuss their impact on monitoring strategies and the role that centralized monitoring plays in mitigating violations.

Learning Objectives

Discuss the impact of 483 observations on Risk-Based Quality Management (RBQM) strategies; Describe how perceptions about the criticality of 483 observations are influencing clinical monitoring strategy decisions; Identify opportunities to mitigate anxiety related to 483 observations and to support cohesion between sponsors, CROs, and regulatory agencies to enable future adoption of centralized monitoring strategies.

Chair

Erin Brown, MPH

Speaker

Panelist
Cris McDavid, MS

Panelist
Nicole Stansbury

Panelist
David C. Burrow, JD, PHARMD

Panelist
Tracy Vanderslice

Speakers

Erin Brown

Director, Industry Intelligence and Messaging, Association of Clinical Research Organizations (ACRO), United States

Erin Brown is the Director of Industry Intelligence and Messaging for the Association of Clinical Research Organizations (ACRO), where she leads survey development, collection, and analysis related to risk-based quality management (RBQM) adoption, FDA regulatory trends, and other... Read More →

David Burrow

Director, Office of Scientific Investigations, OC, CDER, FDA, United States

David Burrow is the Director of the Office of Scientific Investigations (OSI) within the Office of Compliance in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). He leads CDER's Bioresearch Monitoring (BIMO) program, overseeing clinical... Read More →

Cris McDavid

Senior Director, GCDO, Parexel International, United States

Cris McDavid is a seasoned clinical research leader with over 20 years of global clinical trial delivery experience. Cris leads Parexel Risk-Based Quality Management (RBQM) operations and Integrated Data Delivery (IDD), driving strategic process and technology implementation across... Read More →

Nicole Stansbury

Senior Vice President Global Clinical Operations, Premier Research, United States

Nicole Stansbury, Senior Vice President, Global Clinical Operations, joined Premier research in April 2023 where she has responsibilities covering study start up, site management and monitoring, central monitoring and clinical trial management. Nicole has been a lead for the ACRO... Read More →

Tracy Vanderslice

Vice President, Clinical Operations, Gilead Sciences, United States

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

09: RD-Quality-Compliance, Session

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

1:45pm EDT

#638: Real World Evidence Throughout the Product Life Cycle: Case Studies and Real-Life Examples

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

116

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-628-L04-P; CME 1.00; RN 1.00

Use of Real-World Evidence (RWE) in regulatory assessments has increased in recent years with use cases spanning across the development, initial authorisation and post-marketing monitoring of medicines. Examples across lifecycle and therapeutic areas will be discussed.

Learning Objectives

Discuss the use of RWE to support regulatory decisions; Identify use cases based on regulatory assessment, stage of lifecycle and therapeutic area; Examine real-world examples of RWE use to identify effective practices and apply insights to future evidence-generation strategies.

Chair

Denise Umuhire, MBA, MSC

Speaker

Panelist
Patricia Furlong, BSN

Panelist
Rohini Hernandez, PHD, MPH

Panelist
Motiur Rahman, PHD, MPHARM, MS

Speakers

Patricia Furlong

Founding President and Chief Executive Officer, Parent Project Muscular Dystrophy, United States

Pat Furlong is the Founding President and CEO of Parent Project Muscular Dystrophy (PPMD), the largest nonprofit organization in the United States solely focused on Duchenne muscular dystrophy (Duchenne). Their mission is to end Duchenne. They accelerate research, raise their voices... Read More →

Rohini Hernandez

Director, Center for Observational Research, Amgen, United States

Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Denise Umuhire

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

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

10: Stats-EvidenceGeneration-RWE, Session

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

3:00pm EDT

#629.2 RT: Roundtable Discussion: Insights Regarding Implementation of the ASAP Process

Wednesday June 17, 2026 3:00pm - 3:45pm EDT

TBD

Component Type: Session
Level: Intermediate

Join the Clinical Safety and Pharmacovigilance Community for a follow up round table discussion tied to session: Insights Regarding Implementation of the ASAP Process (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Greg Ball, PHD

Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

3:00pm EDT

Roundtable Discussion: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences

Wednesday June 17, 2026 3:00pm - 3:45pm EDT

TBD

Component Type: Session
Level: Intermediate

Join the AI in Healthcare Community for a follow up round table discussion tied to session: Building AI Governance Frameworks: Classification, Validation and Regulatory Alignment in Life Sciences (Wednesday, June 17 | 2:45pm - 3:45pm EDT). Space is limited.

Learning Objectives

Identify ways to apply concepts and techniques from the session.

Chair

Sridevi Nagarajan, PHD

Speaker

Speaker
Stephanie Rosner, MA, PMP

Wednesday June 17, 2026 3:00pm - 3:45pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

13: Community-Rounds, Session

Audience Intermediate
Level Intermediate
format csv
Tags Session

4:00pm EDT

#643: Utilizing Signal Detection Methodologies: A Toolkit for Diverse Product Types

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

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-629-L04-P; CME 1.00; RN 1.00

This session will share insights into signal detection approaches across different product types, exploring how regulators, industry, and academia are leveraging new technologies and data sources to address current challenges and advance pharmacovigilance practices.

Learning Objectives

Describe challenges in performing signal detection activities across a range of healthcare product types, including devices, combination products, and advanced therapies; Discuss novel approaches and data sources to enhance signal detection; and identify opportunities to incorporate emerging signal detection approaches into your organization's vigilance activities.

Chair

Monica Munoz, PHARMD, PHD

Speaker

Panelist
Judith Maro, MS

Panelist
Jeffery L Painter, JR, JD, MSC

Speakers

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States

Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →

Monica Munoz

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

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

Jeffery Painter

Senior Director, Quantitative Leader for Safety Innovation & Analytics, GlaxoSmithKline, United States

Jeffery Painter is the Quantitative Leader for Safety Innovation and Analytics at GSK, advancing pharmacovigilance through Bayesian methods, semantic similarity, and ontology-driven analytics. He is the author of PVLens, a drug safety reference database derived from regulatory labeling... Read More →

Sarah Vaughan

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

Sarah has worked in pharmacovigilance at the MHRA for the past 20 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

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

4:00pm EDT

#644: 50,000 Participants, Two Countries, One DCT: Oversight That Worked

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

108A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-630-L04-P; CME 1.00; RN 1.00

50,000 participants across two African countries created oversight challenges no checklist could handle. Learn how operational design and informal KRIs shaped oversight—and dual perspectives from operations and quality.

Learning Objectives

Differentiate traditional monitoring from risk-proportionate oversight in mega-scale DCTs; Analyze how operational practices reflected RBQM and QbD principles without labels; Design fit-for-purpose monitoring approaches informed by informal KRIs and real-time signals.

Chair

Leslie Sam

Speaker

Panelist
Lisa Collins

Speakers

Lisa Collins

Founder - Head Clinical Operations, Innomas Clinical Research (Africa), Nigeria

Lisa Ursella Collins is Co-Founder and CEO of Innomas Clinical Research and a global clinical operations and program leader. She works at the intersection of clinical execution, quality, and operational risk—translating development strategy into disciplined delivery. Through Innomas... Read More →

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session | 09: RD-Quality-Compliance, Session

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

4:00pm EDT

#647: Not Can, but Should: How do we WANT AI/ML to Transform Clinical Development?

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

111AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-632-L04-P; CME 1.00; RN 1.00

Visionary leaders will debate three options for the ideal AI-transformed future state of the clinical trials enterprise. Attendees will appraise these big ideas, consider market implications, and reflect on their roles in getting us there.

Learning Objectives

Evaluate three “big goals" for AI transformation of clinical development (eg, 10xing drugs reaching the market, eliminating human trial participants); Discuss the infrastructure implications of each goal (eg., with more drug candidates advancing, how will the system need to adapt?); Identify necessary, accompanying regulatory changes (eg, how will we meet increased demand for reviews?)

Chair

Morgan Hanger, MPA

Speaker

Panelist
Tala Fakhouri, PHD, MPH

Panelist
Henry Wei, MD

Panelist
Gabriel Westman, MD, PHD, MSC

Speakers

Tala Fakhouri

Vice President, AI & Digital Policy, Real-World Research, Parexel International, United States

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

Morgan Hanger

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

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

Henry Wei

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

Gabriel Westman

Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Forum | 02: ClinicalTrialOps-Innovation, Forum

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

4:00pm EDT

#648: Medical Affairs: Drivers of Scientific Impact and Strategic Value in Healthcare

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

105AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-634-L04-P; CME 1.00; RN 1.00

Discover how Medical Affairs drives strategic value across the drug lifecycle through scientific leadership, data-driven insights, and digital fluency to improve patient outcomes.

Learning Objectives

Discuss Medical Affairs’ evolving role in driving scientific credibility and impact; Describe how digital fluency, data analytics, and AI transform it into a tech-enabled function; Identify best practices and leadership insights for advancing capabilities in a patient-centric, data-driven ecosystem.

Chair

Ranjini Prithviraj, PMP

Speaker

Panelist
Donna A. Holder, PHARMD

Panelist
Alexander Condoleon

Panelist
Sarah Jarvis, MBA

Speakers

Alexander Condoleon

Chief Medical Affairs Officer, Medical Engagements & Impact, Pfizer, United States

Donna Holder

Principal, HDMA Advisory, United States

Donna Holder has over 30+ yrs experience in the pharma. She now serves as an advisor to Medical Affairs organizations within the pharmaceutical industry. She was recently the Executive Director & Head of Digital Strategy and Innovation in Global Oncology Medical Affairs at Daiichi... Read More →

Sarah Jarvis

Global Medical & Evidence Lead, ZS Associates, United States

Sarah Jarvis leads our Global Medical & Evidence consulting space at ZS. Based now in San Francisco, California, Sarah has worked in the lifesciences industry for over 25 years and has focused exclusively on working with medical affairs clients for the past 20+ years at ZS. ZS has... Read More →

Ranjini Prithviraj

Director, Global Medical Affairs, Publication Management, Regeneron Pharmaceuticals, United States

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

04: MedAffairs-SciComm, Session

Audience Intermediate
Area Student and Early Career Pathway
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Medical Affairs & Scientific Communication
Feature Topics Student and Early Career Pathway
Tags Session

4:00pm EDT

#651: Regulatory CMC and Product Quality Hot Topics Discussion

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

118C

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-636-L04-P; CME 1.00; RN 1.00

This interactive forum will bring together senior industry experts to discuss their perspectives on critical hot topics impacting Regulatory CMC and Product Quality.

Learning Objectives

Discuss current regulatory CMC challenges, including the use of AI, digitization, and emerging technologies in pharmaceutical quality systems; Examine how to analyze strategies for managing global regulatory complexity, supply chain resiliency, and international harmonization.

Chair

Celeste Frankenfeld Lamm

Speaker

Panelist
Peter Richardson

Panelist
Mahesh R. Ramanadham, PHARMD, MBA

Panelist
Kevin Fitzpatrick, RPH

Panelist
Yoshihiro Matsuda, DrMed

Speakers

Kevin Fitzpatrick

Senior Vice President, Quality Assurance, AbbVie, United States

Kevin Fitzpatrick is Senior Vice President of Quality Assurance at AbbVie. Kevin was appointed to his current role in June 2025 after serving as Vice President, Quality Assurance, Biologics. Kevin has been with AbbVie/Abbot for 26 years, supporting CMC strategy and execution of AbbVie’s... Read More →

Celeste Frankenfeld Lamm

Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States

Celeste Frankenfeld Lamm, Ph.D., is a Senior Director of Quality and Reg CMC Policy at Merck & Co., where she leads a team of policy professionals who work to capture and align subject matter expertise around manufacturing quality and regulatory science, and translate it into meaningful... Read More →

Yoshihiro Matsuda

Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Matsuda is a pharmacist and a Principal Senior Scientist for Quality at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He received his Bachelor of Pharmaceutical Sciences from Toho University in 1997 and his Master’s degree from Toyama Medical and Pharmaceutical... Read More →

Mahesh Ramanadham

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

Acting Director for the Division of Inspection Assessment within OPQ/OPF. His division is primarily responsible for the center level discipline review of facilities and inspections in support of drug applications. He joined the Agency in November 2009 after graduating with his PharmD... Read More →

Peter Richardson

Senior Quality Specialist, European Medicines Agency, Netherlands

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Forum | 03: Data-Tech-AI, Forum

Audience Intermediate
Area Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC
Feature Topics Digital Enablement and Modernization
Tags Forum

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

#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

4:00pm EDT

#659: Real World Evidence in Regulatory Decision-Making: Challenges, Innovations, and Impact

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

203AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-642-L04-P; CME 1.00; RN 1.00

This session highlights innovative Real World Data (RWD) methods, including AI, for enhancing Real World Evidence (RWE) for regulatory decisions. Through case studies and discussion, it will examine practical integration strategies for these innovations.

Learning Objectives

Define the key challenges and limitations in the use of real-world evidence (RWE) for regulatory decision-making; Illustrate how innovative methodologies can be integrated into study design and analysis to enhance the robustness and credibility of RWE; Describe practical insights, informed by multi-stakeholder perspectives, for developing a framework of regulatory acceptability of RWE.

Chair

Alison Cave

Speaker

Advancing Real-World Evidence for Regulatory Decision-Making: Academic perspective
Olaf Klungel, FISPE

Advancing Real-World Evidence for Regulatory Decision-Making: industry perspective
Gracy G Crane, MS

Advancing Real-World Evidence for Regulatory Decision-Making: FDA perspective
Motiur Rahman, PHD, MPHARM, MS

Speakers

Alison Cave

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

Gracy Crane

Policy Lead, Roche, United Kingdom

Olaf Klungel

Professor of Pharmacoepidemiologic Methods, Utrecht University, Netherlands

Olaf Klungel is Professor of Pharmacoepidemiologic Methods, chair of the division of Pharmacoepidemiology & Clinical Pharmacology and the scientific director of the Utrecht Institute for Pharmaceutical Sciences (UIPS) at Utrecht University. He is also member of the Methodology working... Read More →

Motiur Rahman

Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States

Wednesday June 17, 2026 4:00pm - 5:00pm EDT
203AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

10: Stats-EvidenceGeneration-RWE, Session

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

4:00pm EDT

#657: Great Science Isn’t Enough: Building Value Early in Emerging Biotech

Wednesday June 17, 2026 4:00pm - 5:15pm EDT

103A

Component Type: Session
Level: Intermediate

As a closing session, this discussion brings together key themes from the day to examine how innovators can better connect science to market realities. It will highlight practical ways to optimize product value for investors, payers, and regulators

Learning Objectives

Understand the factors that shape product value; Identify critical early decisions (indication, endpoints, evidence) that influence downstream access and partnering outcomes; Define opportunities to better align development strategy with payer, provider, and investor expectations.

Chair

Mark Twyman

Speaker

Panelist
Michael Kuchenreuther

Speakers

Michael Kuchenreuther

Director Research & Analytics, Numerof & Associates, United States

Mark Twyman

Senior Consultant & Engagement Manager, Numerof & Associates, United States

Wednesday June 17, 2026 4:00pm - 5:15pm EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Session | 18: Lift-Series, Session

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

8:00am EDT

#700: Insights Regarding Implementation of the ASAP Process

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

118AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-653-L04-P; CME 1.00; RN 1.00

We will focus on insights regarding implementation of the ASAP process, how it has been beneficial to implement, and results from a survey across a targeted sample of forward-thinking pharma companies (big and small).

Learning Objectives

Describe the steps to implement the ASAP process at a smaller company with limited resources; Identify specific effficiencies achieved when applying the ASAP process to platform products or product families with shared componentts; Recognize how the ASAP process has been beneficial to implement for various projects.

Chair

Greg Ball, PHD

Speaker

Insights Regarding Implementation of the ASAP Process
Barbara Hendrickson, DrMed, MD

Advantages of Earlier Systematic and Strategic Safety Planning
Famina Hemani, PHARMD

Practical Implementation of ASAP Concepts
Shital Patel, PHARMD

Practical Implementation of ASAP Concepts
Cynthia McShea, MPH

Speakers

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States

Famina Hemani, PharmD, is a Pharmacovigilance leader with over 20 years of experience in pharmacy and biopharma, including more than a decade in strategic safety leadership. She has built and scaled PV functions from early clinical development through pre-commercialization across... Read More →

Famina Hemani

Vice President, Head of Pharmacovigilance, Tourmaline Bio, United States

Cynthia McShea

Head, Safety Statistics, UCB Biosciences, United States

Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she... Read More →

Shital Patel

Associate Safety Lead, UCB, United States

Shital Patel

Associate Safety Lead, UCB Biosciences, United States

Thursday June 18, 2026 8:00am - 9:00am EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

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

8:00am EDT

#701: No Report Left Behind: Human-Centered Safety Reporting

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

103A

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-643-L04-P; CME 1.00; RN 1.00

Human-centered safety reporting empowers participants to speak up sooner. This session explores how consent innovation, safety processes, and clinical operations partner to reduce missed reports, protect patients, and strengthen trial integrity.

Learning Objectives

Identify the key factors that contribute to patients underreporting adverse events and assess the resulting impact on safety, operations, and compliance; Describe approaches for applying human-centered strategies—such as engaging people living with the condition and using ongoing comprehension checks—to clarify reporting expectations; Evaluate site-level and technology-enabled practices that support more complete and timely reporting.

Chair

Lani Hashimoto

Speaker

Panelist
Stacy Hurt, MBA, MHA

Panelist
Jennifer Miller, PHD

Speakers

Lani Hashimoto

Consultant, Patient Experience, Hashimoto Consulting Services, United States

Dedicated to connecting patients to research, Lani's lived experience as a trial participant & as a caregiver further inspired her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient experience & the importance of patient... Read More →

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

Jennifer Miller

Associate Professor of Medicine; Co-Director, Program for Biomedical Ethics, Yale School of Medicine, United States

Jennifer E. Miller, PhD, is an Assistant Professor in NYU School of Medicine and President of Bioethics International. She is also the Creator of the Good Pharma Scorecard, an index that ranks new drugs and pharmaceutical companies on their ethics and public health performance to... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
103A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

01: ClinSafety-PV-RM, Session

Audience Intermediate
Area Patient-Centered Design and Experience
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance
Feature Topics Patient-Centered Design and Experience
Tags Session

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

#703: How RA/QA Leaders can Optimize AI and Reduce Risk as Industry Moves from the Wild West to its Inevitable Second Phase - Categorization

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

111AB

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-645-L04-P; CME 1.00; RN 1.00

AI adoption in RA/QA is currently fragmented and uncertain, mirroring earlier technology booms like those of the early 2000s. This session explains why AI will inevitably organize into structured categories and how that shift will reshape decision-making and the marketplace. Executives will gain a clear framework for making confident, risk-aware AI decisions now and as the landscape matures.

Learning Objectives

Analyze the current AI landscape in RA/QA and explain why AI maturity and market structure are inevitable; Differentiate near-term AI actions, deferred investments, and avoidable risks using a category-driven lens; Apply a practical framework to guide compliant, defensible AI decisions across quality and regulatory functions.

Chair

Nicholas Capman, MBA

Speaker

Considerations for AI tool validation and implementation
Benjamin C Eloff, PHD

Pragmatic AI Deployment in RA/QA: Maximizing ROI While Maintaining Human Control
Fatima Sabar, MSC

AI and the Path to Submission Ready RWE: Enabling Compliance and Data Quality
Carrie Nielson, MPH

Speakers

Nicholas Capman

President & CEO, The FDA Group, United States

Nicholas Capman is CEO of The FDA Group, where since 2007 he has led the company’s evolution from a specialized services firm into a service + software organization integrating AI-driven capabilities to strengthen FDA compliance. He is passionate about advancing innovation responsibly... Read More →

Benjamin Eloff

Vice President, Healthcare Innovation Catalysts, United States

Ben Eloff brings nearly 20 years of federal leadership in advancing medical innovation and regulatory science. At FDA, he pioneered the first Bayesian device trial and co-authored the agency’s real-world evidence guidance. He led the launch of public-private initiatives including... Read More →

Carrie Nielson

Director of Epidemiology, Gilead Sciences, United States

Fatima Sabar

CEO, Bluenote Health, United States

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

Thursday June 18, 2026 8:00am - 9:00am EDT
111AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

03: Data-Tech-AI, Session | 09: RD-Quality-Compliance, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Regulatory
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
Tags Session

8:00am EDT

#705: Fighting Medical Disinformation (Without Actually Starting a Fight)

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

108A

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-647-L04-P; CME 1.00; PDU 1.00 PMI 2166KJ1ZXS; RN 1.00

We’ll discuss whether drug development professionals have an ethical obligation to confront misinformation, effective ways to approach these conversations without confrontation, and what techniques and messages work best in different settings.

Learning Objectives

Explain the ethical principles that underlie the obligation of drug development professionals to combat disinformation; Discuss best practices for successful encounters in combatting disinformation; Distinguish the application of different practices in their most appropriate settings

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Perspectives of a Science Reporter
Sydney Lupkin

Effective Messaging to Combat Scientific Mis/Disinformation
Joseph N Cappella, PHD

Speakers

Joseph Cappella

Gerald R. Miller Professor Emeritus of Communication, University of Pennsylvania, United States

Joseph N. Cappella is the Gerald R. Miller Emeritus Professor of Communication at the Annenberg School for Communication. His research has resulted in more than 225 articles and four co-authored books. His research has been supported by grants from NIMH, NIDA, NSF, NCI, NHGRI, and... Read More →

Sydney Lupkin

NPR Pharmaceutical Correspondent, National Public Radio (NPR), United States

Sydney Lupkin is the pharmaceuticals correspondent for NPR. Prior to NPR, she was a correspondent at Kaiser Health News, where she covered drug prices and specialized in data reporting for its enterprise team. She's reported on how tainted drugs can reach consumers, how companies... Read More →

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States

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

Thursday June 18, 2026 8:00am - 9:00am EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

06: ProfDevelop-Program-PortfolioMgmt, Forum

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

8:00am EDT

#706: AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis

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

118C

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-26-648-L04-P; CME 1.00; RN 1.00

The session will show CMC data from an internal system can be transferred to a cloud environment. The session will include a demonstration of structured CMC submissions and show how AI-assisted tools can facilitate review and collaboration.

Learning Objectives

Illustrate a future state in which CMC data from internal systems can be seamlessly transferred to a cloud environment; Demonstrate a structured CMC submission and show how AI-assisted tools can facilitate review and collaboration between industry and regulators.

Chair

Ciby Joseph Abraham, PHD

Speaker

Panelist
Vada Perkins, MS

Panelist
Omar Serang

Speakers

Ciby Abraham

Senior Director and Group Manager, Project and Product Leadership, AstraZeneca, United States

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

Vada Perkins

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

Omar Serang

Chief Cloud Officer, DNAnexus, United States

General Manager and Lead Architect for DNAnexus' Regulatory Solutions. Expertise working at the intersection of cloud technology, genomic science, and regulatory science. Leading the vision and formation of Trusted Regulatory Spaces (TRS) in the cloud for global regulatory stakeholder... Read More →

Thursday June 18, 2026 8:00am - 9:00am EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

07: RegCMC-Product Quality, Session | 03: Data-Tech-AI, Session

Audience Intermediate
Area Artificial Intelligence, Digital Enablement and Modernization
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Interest Area Quality Assurance / Control & CMC,Data Management & Data Standards
Feature Topics Artificial Intelligence,Digital Enablement and Modernization
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

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

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

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 →

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

8:00am EDT

#710: Regulatory and Industry Perspectives on Good Clinical Practice Inspections: Regulatory Approaches, Industry Impact, and Future Harmonization Opportunities

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

107AB

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-650-L04-P; CME 1.00; RN 1.00

Explore Good Clinical Practice Inspections (GCP) inspections from regulatory and industry views, using FDA data to highlight global trends, compliance strategies, and harmonization, with insights on coverage of sites, sponsors, clinical research organizations (CROs), and regions.

Learning Objectives

Recognize FDA GCP inspection scope and trends from FY2016–2018 across US and non-US sites; Compare inspection approaches among regulators; Evaluate opportunities for harmonization and information sharing; Analyze industry strategies for global inspection readiness and compliance.

Chair

Kassa Ayalew, MD, MPH

Speaker

panelist
Thomas Haag

Panelist
Izumi Oba

Panelist
Jong-Hoon Lee, MD

Speakers

Kassa Ayalew

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

Dr. Kassa Ayalew serves as the Division Director for the Division of Clinical Compliance Evaluation within the Office of Scientific Investigation at the FDA’s Center for Drug Evaluation and Research. In this role, he oversees the evaluation of the integrity of efficacy and safety... Read More →

Thomas Haag

Principal Consultant, Cardinal Solutions Consuting, LLC, United States

Tom Haag has a truly innovative vision for quality in clinical research that is focused on delivering outcome data that justifies therapeutic costs. Formerly the Global Head of Digital Development and Transformation QA with Novartis, Tom led on end-to-end quality and data integrity... Read More →

Jong-Hoon Lee

Senior Physician, FDA, United States

Dr. Lee graduated from University of Virginia (BA; Charlottesville, VA) and Virginia Commonwealth University (MD; Richmond, VA), then completed internship at State University of New York at Syracuse (Internal Medicine; Syracuse, NY), residency at George Washington University (Anatomic... Read More →

Izumi Oba

Inspection Deupty Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Thursday June 18, 2026 8:00am - 9:00am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

09: RD-Quality-Compliance, Forum | 02: ClinicalTrialOps-Innovation, Forum

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

8:00am EDT

#711: Role of External Data in Confirmatory Clinical Trial: Current Landscape and Future Perspectives

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

116

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-651-L04-P; CME 1.00; RN 1.00

The session explores the integration of external data in clinical trials to enhance efficiency, reduce sample sizes, and shorten timelines. It covers methodological advances, regulatory perspectives, and best practices for using external controls.

Learning Objectives

Identify the nuances while integrating external data in trial design and analysis; Evaluate regulatory requirements and perspectives; Discuss the possibility of external control trial in their organization.

Chair

Satrajit Roychoudhury, PHD

Speaker

Panelist
Xiaofei Wang, PHD

Panelist
Scott Berry, PHD

Panelist
Kannan Natarajan, PHD

Panelist
Pralay Mukhopadhyay, PHD

Speakers

Scott Berry

President and Senior Statistical Scientist, Berry Consultants LLC, United States

Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests... Read More →

Pralay Mukhopadhyay

Vice President, Medicines Development Leader, Oncology R&D, GSK, United States

Dr. Mukhopadhyay has a proven track record in oncology drug development. He currently works as Vice President, Medicine Development Leader at GlaxoSmithKline. Over the years, he has made significant contributions in the development of several anti-cancer agents in both hematologic... Read More →

Kannan Natarajan

Senior Vice President, Head of Global Biometrics and Data Management, Pfizer, Inc., United States

Kannan Natarajan is the Global Head of Biometrics & Data Management and Chief Statistical Officer of Global Product Development at Pfizer. He is a member of the Global Product Development Leadership Team and Deputy Chair of the Clinical Development Board, a governance body that provides... Read More →

Satrajit Roychoudhury

Executive Director, Statistical Research and Innovation, Pfizer, United States

Xiaofei Wang

Professor, Biostatistics & Bioinformatics, Duke University Medical Center, United States

Xiaofei Wang is Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and Director of Statistics at the Alliance Statistics and Data Management Center. He received his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2003... Read More →

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

10: Stats-EvidenceGeneration-RWE, Forum | 02: ClinicalTrialOps-Innovation, Forum

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

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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