DIA 2026 Global Annual Meeting: Full Schedule

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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

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

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 →

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
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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

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 →

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

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 →

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
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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
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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

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 →

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
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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

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 →

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

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 →

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

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 →

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

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 →

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands

Ana Trullas

Senior scientific specialist, European Medicines Agency, Netherlands

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

Denise Umuhire

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

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

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

08: RegPolicy-Strategy-GlobalCollaboration, Session

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

1:45pm EDT

#538: Innovations in Drug Review: A Global Perspective

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

201AB

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

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

Learning Objectives

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

Chair

Cartier Esham, PHD, MSC

Speaker

Panelist
Max Wegner, PHARMD, RPH

Panelist
Donna Boyce, MS, RAC

Panelist
Brittany Avin McKelvey, PHD

Speakers

Donna Boyce

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

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

Cartier Esham

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

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

Rhonda Hearns-Stewart

Senior Physician, FDA, United States

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

Brittany McKelvey

Senior Director, Regulatory Policy, LUNGevity Foundation, United States

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

Max Wegner

Senior Vice President,Head Regulatory Affairs, Bayer, Germany

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

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

08: RegPolicy-Strategy-GlobalCollaboration, Forum

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

1:45pm EDT

#540: Regulators Approach to Address Drug Shortages

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

115C

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

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

Learning Objectives

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

Chair

Sema Hashemi, MS

Speaker

Panelist
Emily T. Thakur, RPH

Panelist
Grace Chai, PHARMD

Panelist
Gerald Dal Pan, MD, MHS

Speakers

Grace Chai

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

Sema Hashemi

Senior International Policy Advisor, FDA, United States

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 →

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

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

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany

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 →

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 →

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

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

Lesbeth Rodriguez

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

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

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

08: RegPolicy-Strategy-GlobalCollaboration, Session

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

4:15pm EDT

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

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

119AB

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

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

Learning Objectives

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

Chair

Pujita Vaidya, MPH

Speaker

Industry Perspective
M. Khair ElZarrad, PHD, MPH

Duke Margolis Perspective
Valerie J. Parker, MSC

Industry Perspective
Lauren Tobe, JD

Speakers

M. Khair ElZarrad

Vice President, Regulatory Policy, BridgeBio, United States

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

Valerie Parker

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

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

Lauren Tobe

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

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

Pujita Vaidya

Director, Regulatory Science and Policy, Sanofi, United States

Pujita Vaidya has 13+ years of experience in regulatory science and policy, and is a leader in advancing patient-focused drug development (PFDD) throughout the medical product lifecycle. Pujita serves as a Regulatory Science and Policy Director at Sanofi, working to develop, advocate... Read More →

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

08: RegPolicy-Strategy-GlobalCollaboration, Forum

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

4:15pm EDT

#559: China Town Hall

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

202AB

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

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

Learning Objectives

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

Chair

Ling Su, PHD

Speaker

Panelist
Wei Zhang

Panelist
Qinghua Wang, MD

Introduction
Hui Shi

Update on Drug Regulation in China
Huijuan Zhou

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

Speakers

Xiaoyuan Chen

Professor, Tsinghua University School of Basic Medicine, China

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

DIA 2026 Global Annual Meeting

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