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Tuesday, June 16
 

8:00am EDT

#500: Transforming Obesity Patient Care: Past, Present, and Future Innovation in the Age of GLP-1 Therapies
Tuesday June 16, 2026 8:00am - 9:00am EDT
114
Component Type: Session
Level: Intermediate

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

Learning Objectives

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

Chair

Maria Vassileva, PHD

Speaker

Panelist
Robert M. Califf, MD

Panelist
Brad Jordan, PHD

Panelist
W. Scott Butsch, MD, MSC


Speakers
avatar for W. Scott Butsch

W. Scott Butsch

International Medical Vice President - Obesity, Novo Nordisk A/S, Denmark
avatar for Robert Califf

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 →
avatar for Brad Jordan

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.
avatar for Maria Vassileva

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

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
avatar for Alberto Grignolo

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 →
avatar for Joseph Kannarkat

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 →
avatar for Sean Khozin

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 →
avatar for Beth Meagher

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 →
avatar for Stacy Hurt, MBA, MHA

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 →
avatar for Maria Vassileva

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 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

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
avatar for Alison Cave

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 →
avatar for Ayaka Kubota

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 →
avatar for Jingyu (Julia) Luan

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 →
avatar for Steffen Thirstrup

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 →
avatar for Maria Vassileva

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 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

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
avatar for Brad Jordan

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.
avatar for Jingyu (Julia) Luan

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 →
AM

Alison Matsui

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

Katherin Ruiz

Consultant, Global Scientific Communications, Eli Lilly and Company, United States
avatar for Maria Vassileva

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 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
avatar for Maria Paula Bautista Acelas

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 →
avatar for Efrat Dotan

Efrat Dotan

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

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 →
avatar for Lia Ridout

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 →
AR

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

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
RD

Ronald DePinho

Professor, Cancer Biology, The University of Texas MD Anderson Cancer Center, United States
avatar for Laura Okpala

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 →
avatar for Bradley Watts

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 →
avatar for Tom Whitehead

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

4:15pm EDT

#555: Adapting Regulatory Frameworks to Address Mass Distribution of Unapproved or Unauthorized Medicines
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118C
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-589-L04-P; CME 1.00; RN 1.00

This forum will address the rise of illegal mass manufacturing of unapproved medicines, which threatens patient safety. Participants will discuss current regulations and the need for new rules to ensure drug supply chain integrity and promote safety.

Learning Objectives

Describe the landscape for the exponential growth in the distribution of unapproved or unauthorized medicines; Identify risks associated with illegal large-scale manufacturing of unregulated and untested compounded drugs; Discuss regulator perspectives on the issues relating to the mass distribution of unapproved medicines; Explain current regulatory frameworks and how to adapt them.

Chair

Brad Jordan, PHD

Speaker

TBD
Shabbir Safdar

Panelist
Andrew Funk, PHARMD, RPH

ANVISA Perspective
Renato Lopes Hurtado, MSC, RPH


Speakers
avatar for Andrew Funk

Andrew Funk

Director, Member Relations/Government Affairs, NABP, United States
Andrew Funk, PharmD, Director of Member Relations and Government Affairs, NABP Andrew Funk is the Director of Member Relations and Government Affairs for the National Association of Boards of Pharmacy (NABP). With more than a decade of experience in pharmacy regulation—including... Read More →
RL

Renato Lopes Hurtado

head the Management of Inspection and Health Surveillance of Medicines and Pharm, ANVISA, Brazil
Manager of the Medicines and Pharmaceutical Ingredients Inspection Department (GIMED) at Anvisa, the Brazilian Health Regulatory Agency. A pharmacist with a Master’s and a PhD candidate (UnB), he is a certified Lead Auditor (ISO 9001/19011). His career features extensive experience... Read More →
avatar for Brad Jordan

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.
SS

Shabbir Safdar

Executive Director, Partnership for Safe Medicines, United States
Shabbir Imber Safdar is the executive director of the Partnership for Safe Medicines and hosts the True Crime and Medicine Safety and the Imitation Nation "all things counterfeit" podcast. He sits on the editorial board of the Journal of Illicit Trade, Financial Crime, and Compliance... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
118C The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Session
 
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DIA 2026 Global Annual Meeting
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  • 00: Plenary
  • 01: ClinSafety-PV-RM
  • 02: ClinicalTrialOps-Innovation
  • 03: Data-Tech-AI
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  • 05: PersonalizedMed-ComboProd-Diagnostics
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