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
Tags Session

10:15am EDT

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

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

108B

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

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

Learning Objectives

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

Chair

Pete Fronte, MBA

Speaker

Panelist
Alpa Patel

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

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

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

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

Speakers

Ruma Bhagat

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

Osa Eisele

Executive Director, Amgen, United States

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

Pete Fronte

Founder and Chief Executive Officer, Altura, United States

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

Maggie McGuire Kuhl

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

Rakesh Patel

CEO, Neighborhood Healthcare (FQHC), United States

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

Alpa Patel

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

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

02: ClinicalTrialOps-Innovation, Forum

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

10:15am EDT

#507: Paying Fair: Regulatory and Ethical Challenges in Research Participant Compensation

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

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-26-557-L04-P; CME 1.25; RN 1.25

We will share case examples and trends from 24,000 records, analyze ethical challenges involved in paying participants, and discuss how protective policies or administrative practices can result in unjust treatment.

Learning Objectives

Explain the ethical considerations that govern payment to research participants; Evaluate the potential for institutional and administrative policies to inadvertently create unjust treatment of research participants; Apply the Belmont Principles of Beneficence and Justice to real-world cases involving payment to research participants and propose strategies for ethical decision-making.

Chair

Kelly Fitzgerald, PHD

Speaker

Panelist
Karla Childers, MS

Panelist
Wenora Johnson

Panelist
Sam Whitaker

Panelist
Robin Kuprewicz, MA

Speakers

Karla Childers

Vice President, Bioethics, Policy & Partnerships, Johnson & Johnson, United States

Karla Childers is Vice President, Bioethics, Policy & Partnerships in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility has... Read More →

Kelly FitzGerald

Executive IRB Chair and Vice President of IBC Affairs, WCG , United States

Kelly FitzGerald is the IRB Executive Chair and Vice President of IBC Affairs at WCG IRB where she oversees the operation of both the IRB and several hundred institutional IBCs. Kelly is a certified IRB professional and holds a B.S. in Chemical Engineering from the University of New... Read More →

Wenora Johnson

Administrative Support & Research/Patient Advocate, United States

Robin Kuprewicz

Clinical Trials Director, Georgetown University, United States

Robin Kuprewicz is the Clinical Trials Director for the Georgetown University Huntington's Disease Care, Education and Research Center. She holds a Masters in Medical Anthropology and has ten years of experience in clinical trials. She has helped Huntington's Disease participants... Read More →

Sam Whitaker

Founder & CEO, Mural Health, United States

Tuesday June 16, 2026 10:15am - 11:30am EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Ethics, Trust and Responsible Innovation, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Safety & Pharmacovigilance,Patient Engagement
Feature Topics Ethics, Trust and Responsible Innovation,Patient-Centered Design and Experience
Tags Session

10:15am EDT

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

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

108A

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

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

Learning Objectives

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

Speaker

Moderator
Andrew Studna

Panelist
Samantha Hadfield

Panelist
Nick Scott

Speakers

Samantha Hadfield

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

Nick Scott

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

Andrew Studna

Senior Editor, Applied Clinical Trials, United States

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

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

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

10:15am EDT

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

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

112AB

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

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

Learning Objectives

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

Chair

Alberto Grignolo, PHD

Speaker

Panelist
Beth Meagher, MA

Panelist
Sean Khozin, MD, MPH

Panelist
Stacy Hurt, MBA, MHA

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

Panelist
Joseph Kannarkat, MD

Speakers

Alberto Grignolo

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

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

Joseph Kannarkat

Physician, Johns Hopkins University School of Medicine, United States

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

Sean Khozin

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

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

Beth Meagher

Principal, Deloitte Consulting, United States

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

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel, United States

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

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

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

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

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

10:15am EDT

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

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

103A

Component Type: Session
Level: Intermediate

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

Learning Objectives

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

Chair

Dan Sndyer

Speaker

Panelist
Peter Schaeffer, MBA, PMP

Panelist
Laura Hilty

Panelist
Jeff B Lee, MBA

Speakers

Laura Hilty

Principal, HealthX Ventures, United States

Jeff Lee

Board Director, Medstar Health Research Institute, United States

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

Peter Schaeffer

Digital and Process Optimization Leader, GlaxoSmithKline, United States

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

Dan Sndyer

The Playbook, United States

Dan Sndyer

The Playbook, United States

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

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

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

10:15am EDT

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

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

201AB

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

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

Learning Objectives

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

Chair

Jingyu (Julia) Luan, PHD

Speaker

Panelist
Steffen Thirstrup, MD, PHD

Panelist
Alison Cave

Panelist
Maria Vassileva, PHD

Panelist
Ayaka Kubota, RPH

Speakers

Alison Cave

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

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

Ayaka Kubota

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

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

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

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

#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

#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

1:45pm EDT

#529: Early Outcomes and Strategic Learnings from the DIA Obesity Consortium’s Initial Collaborative Phase

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

108A

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-654-L04-P; CME 1.25; RN 1.25

This session summarizes the work of the DIA Obesity Consortium with focus on the agreements that have been reached about which are the endpoints that should be included in Phase 3 clinical trials for the development of obesity drugs. The work is a result of the discussions among 10 companies, FDA, EMA, and many other advisors from patient advocacy organizations across the Americas and Europe.

Learning Objectives

Identify key clinically meaningful endpoints used in GLP-1 trials; Describe current opportunities and challenges in obesity drug development; Explain how the public private partnership led by Drug Information Association is advancing trial endpoint alignment.

Chair

Maria Vassileva, PHD

Speaker

Panelist
Katherin Ruiz

Panelist
Alison Matsui, MPH

Panelist
Brad Jordan, PHD

Panelist
Jingyu (Julia) Luan, PHD

Speakers

Brad Jordan

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

Jingyu (Julia) Luan

Executive Regulatory Science Director, AstraZeneca, United States

Alison Matsui

Senior Principal PCOR Scientist, Genentech, A Member of the Roche Group, United States

Katherin Ruiz

Consultant, Global Scientific Communications, Eli Lilly and Company, United States

Maria Vassileva

Chief Science and Regulatory Officer, DIA, United States

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108A The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Therapeutic Pathways
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations
Feature Topics Therapeutic Pathways
Tags Session

1:45pm EDT

#531: Tolerability in Immuno-Oncology: Patient Experience as a Core Element of Clinical Trials

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

107AB

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-571-L04-P; CME 1.25; RN 1.25

Update on a DIA study advancing patient experience data to assess tolerability in immuno-oncology trials, highlighting conceptual model progress and stakeholder insights for regulatory decisions.

Learning Objectives

Describe recent developments from the DIA study integrating patient experience into immuno-oncology tolerability assessments; Examine findings from literature and KOL interviews; Identify strategies for operationalizing a multidimensional tolerability framework; Recognize multistakeholder perspectives to support trial design, data collection, and benefit–risk evaluation.

Chair

Devin Peipert, PHD

Speaker

Panelist
Efrat Dotan, MD

Panelist
Maria Paula Bautista Acelas, MSC

Panelist
Lia Ridout

Speakers

Maria Paula Bautista Acelas

Scientific Program Manager, Research Partnerships, DIA, United States

Maria Paula offers expert guidance in scientific content development and project management for DIA’s global research partnerships, meetings, and programs. She is dedicated to advancing impactful, patient-centric scientific content that generates evidence to support the integration... Read More →

Efrat Dotan

Executive Medical Director, Ann B Barshinger Cancer Institute, Lancaster General, Penn Center for Cancer Care Innovation, United States

Devin Peipert

Professor of Health Outcomes Measurement, University of Birmingham, United Kingdom

Prof Peipert holds a 125th Anniversary Chair in the Department of Applied Health Sciences at the University of Birmingham, where he is affiliated with the Centre for Patient Reported Outcomes Research (CPROR) and the Birmingham Health Partners Centre for Regulatory Science and Innovation... Read More →

Lia Ridout

Patient Advocate, -, United States

Lia Ridout is a passionate survivor advocate in the lung cancer community. Diagnosed with stage 3b ALK+ non-small cell lung cancer in 2017, despite having no known risk factors, she became dedicated to advocating for patients. In recent years, she has expanded her focus to include... Read More →

Angela Rylands

Global Head of Patient Centred Outcomes, Kyowa Kirin, United Kingdom

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
107AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

02: ClinicalTrialOps-Innovation, Session

Audience Advanced
Area Therapeutic Pathways, Patient-Centered Design and Experience
Level Advanced
format csv
Credit Type ACPE, CME, RN
Interest Area Clinical Development & Operations,Patient Engagement
Feature Topics Therapeutic Pathways,Patient-Centered Design and Experience
Tags Session

1:45pm EDT

#530: The Synthetic AI Patient Persona: Augmenting Patient Centricity in Clinical Trials

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

108B

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-570-L04-P; CME 1.25; RN 1.25

This pilot explored using synthetic AI patient personas to review clinical trial materials when real patient input was challenging due to time pressure. Alignment with actual patient feedback and potential for scalability was demonstrated.

Learning Objectives

Describe how synthetic AI patient personas can augment real patient input to personalize and improve patient trial experience; Identify the data requirements and limitations for building synthetic AI personas.

Chair

Robina Weermeijer

Speaker

Panelist
Jason Binder, MA

Panelist
Himanshu Manchanda, PHD

Panelist
Sabina Kineen

Speakers

Jason Binder

Founder & CEO, Ember, United States

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

Sabina Kineen

Lived Experience Expert, Fabry Support & Information Group, United States

Sabina Kineen is a dedicated patient advocate and speaker with a passion for equitable access to clinical trials and healthcare. As both a patient and caregiver, she brings a unique, lived perspective that drives her work in health literacy, patient engagement, and reducing disparities... Read More →

Himanshu Manchanda

Machine Learning Scientist, Bayer, Germany

Robina Weermeijer

Boehringer Ingelheim, Netherlands

Robina Weermeijer is a Trial Patient & Site Engagement Lead within Global Clinical Development Operations, based in Amsterdam. With a strong focus on enhancing patient and site experiences in clinical trials, she works to elevate patient and site voices. In addition, she plays a key... Read More →

Tuesday June 16, 2026 1:45pm - 3:00pm EDT
108B The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA

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

Audience Basic
Area Artificial Intelligence, Patient-Centered Design and Experience
Level Basic
format csv
Credit Type ACPE, CME, RN
Interest Area Health Technology & AI,Patient Engagement
Feature Topics Artificial Intelligence,Patient-Centered Design and Experience
Tags Session

1:45pm EDT

#543: Global Regulatory Perspectives on Bayesian Design and Analysis Informing Regulatory Decision Making

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

116

Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-581-L04-P; CME 1.25; RN 1.25

Bayesian statistical methods are gaining increasing importance in drug development, with growing regulatory recognition across major global health authorities. Recent developments highlight this momentum: the U.S. Food and Drug Administration (FDA) released a draft guidance in early 2026 on the use of Bayesian methodology in clinical trials, while China’s Center for Drug Evaluation (CDE) issued a draft guidance in 2026 focused on Bayesian approaches for external data borrowing. In parallel, the European Medicines Agency (EMA) has published a concept paper and is currently seeking public consultation (Q1–Q2 2026) as a first step toward developing formal guidance. This session brings together key contributors to these regulatory initiatives to provide a unique, cross-regional perspective on the evolving role of Bayesian design and analysis in informing regulatory decision-making. Speakers will present the scope, principles, and current thinking reflected in their respective documents, as well as discuss areas of alignment, divergence, and ongoing uncertainty across regions. Given that all three agencies are actively shaping their positions, this session offers a timely opportunity for dialogue between regulators and industry. Through case examples and panel discussion, participants will gain insight into how Bayesian methods are being evaluated in practice, including considerations for trial design, external data integration, and evidentiary standards. The session will also highlight opportunities for stakeholder engagement, particularly in the context of EMA’s ongoing public consultation. Attendees will leave with a clearer understanding of global regulatory expectations and practical strategies for incorporating Bayesian approaches into drug development programs in a rapidly evolving regulatory landscape.

Learning Objectives

Summarize key elements of recent FDA (2026) and CDE (2026) draft guidances and EMA concept paper on Bayesian methods; Compare regulatory perspectives and areas of alignment and divergence across regions; Explain applications of Bayesian approaches in clinical trial design, analysis, and regulatory decision-making; Identify current expectations, implementation challenges, and opportunities for industry engagement in shaping future guidance.

Chair

May F Mo, MBA, MS

Speaker

Panelist
Juan Jose Abellan

Panelist
Andrew Thomson, PHD, MA, MSC

Speakers

Juan Jose Abellan

Statistician, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands

May Mo

Associate Vice President, Biostatistics, Amgen, United States

May Mo is an Associate Vice President of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal platform organization with specialized statistical expertise in areas such as Innovative... Read More →

Andrew Thomson

Consultant, Regnitio, Netherlands

Dr Thomson is a consultant providing expert advice on clinical trial design, analysis and interpretation. He spent over 18 years as a regulator in the EU system, where he held a variety of quantitative roles, initially at the UK regulator, MHRA and subsequently at EMA. In his time... Read More →

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

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

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

4:15pm EDT

#548: Clinical Research Training for Community Cancer Centers: A Pilot to Extend Clinical Trials into Diverse Catchment Areas

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

108A

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-584-L04-P; CME 1.00; RN 1.00

This pilot project aimed to upskill community cancer centers to carry out clinical trials. ACCC and ACRP identified needs and provided self-study and instructor-led training that improved learner knowledge and confidence.

Learning Objectives

Describe the challenges faced by research-naïve and low trial capacity programs at community cancer centers in conducting clinical research; Recognize the role of professional training in preparing community cancer centers to implement clinical trials; Integrate learnings from a training pilot that helped advance foundational knowledge and confidence among clinic healthcare staff.

Chair

David Vulcano Landis, MBA

Speaker

Panelist
Ruma Bhagat, MPH

Panelist
Pete Fronte, MBA

Speakers

Ruma Bhagat

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

Pete Fronte

Founder and Chief Executive Officer, Altura, United States

Susan Landis

CEO, Association of Clinical Research Professionals (ACRP), United States

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

David Vulcano Landis

CEO, Association of Clinical Research Professionals (ACRP), United States

David is a well-known thought leader and change agent in the clinical research industry through numerous associations, boards and initiatives. He currently serves as the Chief Executive Officer of the Association of Clinical Research Professionals and previously served as the Vice... Read More →

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

02: ClinicalTrialOps-Innovation, Session

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

#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 →