The 2026 agenda is organized around six 90-minute plenary blocks — each combining focused talks with moderated panel discussion, and a signature fireside chat. Together, the sessions trace the arc of a modern oncology development program, from global trial strategy through post-market evidence.
8:30 AM
Registration & Breakfast
9:30 AM
Welcome, Introductions & Sponsor Acknowledgements
Richard L. Schilsky, MD, FACP, FSCT, FASCO
Program Committee Member, AAADV Workshop
Opening Remarks on Behalf of the AAADV Workshop Foundation
Renzo Canetta, MD
Board member, AAADV Foundation; Chair, Program Committee, AAADV Workshop
Workshop Overview & Program Committee Acknowledgements
H. Kim Lyerly, MD
Executive Director, AAADV Workshop Foundation
Sponsor Acknowledgements
10:00AM
Keynote I
The Right Patient, on the Right Trial, at the Right Time
Monica Bertagnolli, MD (Virtual)
President, National Academy of Medicine
10:30 AM
Keynote II
Globalization of Cancer Drug Development: A Fireside Chat
Richard L. Schilsky, MD, FACP, FSCT, FASCO
Professor Emeritus, University of Chicago; Chair, AAADV Workshop Foundation; Program Committee Member, AAADV Workshop
Richard Pazdur, MD
Founding Director (former), FDA Oncology Center of Excellence
11:00 AM
Session 1
Balancing Benefit and Risk in Regulatory Decision-Making
Moderator: Thomas R. Fleming, PhD (Virtual)
Professor of Biostatistics, University of Washington; Board member, AAADV Workshop Foundation; Program Committee Member, AAADV Workshop
Robert M. Califf, MD, MACC
Former Commissioner, U.S. FDA; Donald F. Fortin Distinguished Professor of Cardiology, Duke University School of Medicine
Managing/Addressing Uncertainty in Drug Development: Balancing Pre- and Post-Approval Evidence Generation
Harald Enzmann, MD, PhD
Head, European and International Affairs, BfArM; former Chair, EMA CHMP
Overview of Regulatory Benefit-Risk Assessment Frameworks
Scott Evans, PhD, MS
Professor and Founding Chair, Biostatistics and Bioinformatics, George Washington University; Board Member, AAADV Workshop Foundation; Program Committee Member, AAADV Workshop
Considerations for Designing and Analyzing Oncology MRCTs
12:30 PM
Lunch Break
Lunch: Day 1
1:00 PM
Session 2
Multi-Regional Clinical Trials (MRCTs)
Moderator: Jaap Verweij, MD, PhD
Professor Emeritus, Erasmus University Medical Center; Board Member, Cancer Drug Development Forum; Program Committee Member, AAADV Workshop
Eva Skovlund, MSc Pharm, PhD
Professor of Medical Statistics, Norwegian University of Science and Technology (NTNU), Trondheim; Special adviser Norwegian Medical Products Agency. Member, EMA-CHMP
Considerations for Evidence Generation in Multiregional Clinical Trials: A European Regulatory Perspective
Susan Galbraith, MBBChir, PhD (Virtual)
Executive Vice President, Oncology Hematology R&D, AstraZeneca; Board Member, AAADV Workshop Foundation
Multiregional Oncology Development Programs for Global Regulatory Decision-Making: An Industry Perspective
Scott Evans, PhD, MS
Professor and Founding Chair, Biostatistics and Bioinformatics, George Washington University; Board Member, AAADV Workshop Foundation; Program Committee Member, AAADV Workshop
Key Considerations for Designing and Analyzing Oncology MRCTs
3:30 PM
Session 3
Dose Optimization for Novel Therapeutics
Moderator: Vivek Subbiah, MD
Associate Director for Drug Development & Precision Oncology, Stanford Cancer Institute; Professor of Medicine, Stanford University; Program Committee Member, AAADV Workshop
Tim Yap, MD (Virtual)
MD Anderson Cancer Center
Project Optimus: Implications for Early Oncology Trials
Patricia LoRusso, DO
Yale University
Dose Optimization in Novel Modalities: ADCs, Bispecifics, and Beyond
Murad Melhem, MD
GlaxoSmithKline (GSK)
The Industry Perspective: Implementing Optimized Dose-Finding Strategies
5:30 PM - 7:00 PM
Session X
Cancer Drug Development in China
Moderator:
Ke Liu, MD, PhD
Chief Development Officer, Marengo Therapeutics, Inc.
Welcome & framing remarks
Co-Moderator:
Jun Ren, MD, PhD (Virtual)
Ruijin Hospital, Shanghai Jiao Tong University
Panelist:
Xiaoyuan Chen, PhD
Professor, Tsinghua University; former NMPA reviewer
Evolution in Regulatory System and Clinical Trial Regulation in China
Dan Zhang, MD
Co‐Founder and Co‐Chairman, Jiangsu Hengrui Biopharma
Why Speed Matters: China’s Clinical and Manufacturing Advantage
Head, Global Regulatory Affairs, Hengrui USA / Jiangsu Hengrui Pharmaceutical
Oncology Drug Development in China — A Chinese Pharma Perspective
Innovent Bio
Moderated Discussion:
Ke Liu, MD, PhD
Marengo Therapeutics. Inc
Jun Ren, MD, PhD (Virtual)
Ruijin Hospital, Shanghai Jiao Tong University
In person: Xiaoyuan Chen, Jian Wang, Dan Zhang and Ke Liu. All other Session X speakers are virtual.
9:00 AM
Breakfast
9:45 AM
Introductory Remarks
H. Kim Lyerly, MD
Executive Director, AAADV Workshop Foundation
10:00 AM
Keynote III
Expediting the Expedited: Advancing the Pace of Medical Product Development
Peter Marks, MD, PhD
Former Director, FDA Center for Biologics Evaluation and Research; Board Member, AAADV Workshop Foundation; Program Committee Member, AAADV Workshop
10:30 AM
Session 4
Mitigating I(o) Toxicity
Moderators:
Elad Sharon, MD, MPH
Dana-Farber Cancer Institute and Harvard Medical School; Program Committee Member, AAADV Workshop
Brandy Heckman-Stoddard, PhD, MPH
National Cancer Institute, National Institutes of Health
Speakers
Speakers
Kevin N. Heller, MD
Venture Partner, Oncology, Harbour BioMed
Historical Perspective on Infliximab Labeling for Immune-Related Adverse Events: On-Label for Ipilimumab, Off-Label for Infliximab
Tomas G. Neilan, MD, MPH, MRCPI
Director, Cardio-Oncology Program, Massachusetts General Hospital; Professor of Medicine, Harvard Medical School
The Largest Myocarditis Trial in the Field: Lessons from an IND-Exempt 183-Patient Study
Professor Dr. Robert Zeiser, MD (Virtual)
Department of Hematology and Oncology, University of Freiburg, Germany
Novel therapies for acute GVHD and immune mediated side effects after ICI
12:00 PM
Lunch Break
Lunch Break — Day 2
1:00 PM
Keynote IV
Price Is What You Pay, Value Is What You Get
Thomas G. Roberts, MD
Farallon Capital Management
1:30 PM
Session 5
Me Too or Not Me Too
Moderator: Eric Rubin, MD
Former Senior Vice President, Clinical Oncology, Merck; Board Member, AAADV Workshop Foundation; Program Committee Member, AAADV Workshop
Speakers
Ronald Alan Peck, MD
Veritas Oncology, LLC
Beyond “Me Too”: Potential Evolution of PD-(L)1 Therapy
Edith Perez, MD
Cornerstone Network; Professor Emeritus, Mayo Clinic
ERBB-Targeted Therapies: Increased Understanding of the Initial Target and Its Expansion; Patient Selection, Comparator Choice, and Non-Inferiority vs. Superiority Considerations
Samer Al Hadidi, MD, MS (CRDSA), FACP
Harold C. Simmons Comprehensive Cancer Center
BCMA Saturation: Redundancy or Real Choice?
Invited Discussant: Christine Hodgdon
Guiding Researchers & Advocates to Scientific Partnerships – GRASP
3:30 PM
Session 6
Failure to Launch
Moderator: H. Kim Lyerly, MD
Executive Director, AAADV Workshop Foundation
Speakers
Meera Mohan, MD, MS, FACP
Associate Professor of Medicine, Lymphoma/Myeloma, UT MD Anderson Cancer Center
Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone
Renzo Canetta, MD
Board member, AAADV Foundation; Chair, Program Committee, AAADV Workshop
Camrelizumab (PD-1) and Rivoceranib (VEGFr) for HCC: Combination of Two Non-Approved Components
Lynn M. Schuchter, MD
Milday and Leonard Abramson Professor of Clinical Oncology; Director, Tara Miller Melanoma Center
Vusolimogene Oderparepvec and Nivolumab
Invited Discussant: Kristin McJunkins
Advocate; Yale College
5:00 PM
Adjourn
Closing Remarks
H. Kim Lyerly, MD
Executive Director, AAADV Workshop Foundation
Wrap-up and acknowledgements