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.
9:00 AM
Registration & Breakfast
9:30 AM
Welcome, Introductions, and Sponsor Acknowledgements
Richard L. Schilsky, MD, FACP, FSCT, FASCO
Professor Emeritus, University of Chicago
Opening Remarks on Behalf of the AAADV Workshop Foundation
Renzo Canetta, MD
Program Committee Chair, AAADV Workshop Foundation
Workshop Overview & Program Committee Acknowledgements
H. Kim Lyerly, MD
Executive Director and co-founder of the AAADV Workshop Foundation
Sponsor Acknowledgements
10:00 AM
Keynote I
Globalization of Cancer Drug Development, A Fireside Chat
Richard L. Schilsky, MD, FACP, FSCT, FASCO​
Professor Emeritus, University of Chicago​
Richard Pazdur, MD​
Founding Director (former), FDA Oncology Center of Excellence​
10:30 AM
Session 1
Balancing Benefit and Risk in Regulatory Decision-Making
Moderator: Thomas R. Fleming, PhD
Professor of Biostatistics, University of Washington; Member, AAADV Workshop Foundation Program Committee
Robert M. Califf, MD, MACC​
Former Commissioner, U.S. Food and Drug Administration; Donald F. Fortin, M.D. 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, Section European and International Affairs, German Federal Institute for Drugs and Medical Devices (BfArM); Former Chair, EMA Committee for Medicinal Products for Human Use (CHMP)​
Overview of Regulatory Benefit-Risk Assessment Frameworks: Evidentiary Standards for Approval of Oncology Medicines
Scott Evans, PhD, MS​
Professor and Founding Chair, Department of Biostatistics and Bioinformatics, George Washington University Milken Institute School of Public Health; Member, AAADV Workshop Foundation Program Committee
Considerations for Designing and Analyzing Oncology MRCTs
1:00 PM
Keynote II
The Right Treatment to the Right Patient at the Right Time
Monica Bertagnolli, MD​ – Virtual
President, National Academy of Medicine​ : Single Participate
1:30 PM
Session 2
Multi-Regional Clinical Trials (MRCTs)
Moderator: Jaap Verweij, MD, PhD​
Professor Emeritus, Erasmus University Medical Center, Rotterdam; Board Member, Cancer Drug Development Forum (CDDF); Member, AAADV Workshop Foundation Program Committee​
Eva Skovlund, MSc Pharm, PhD​
Professor of Medical Statistics, Norwegian University of Science and Technology (NTNU); Senior Researcher, Norwegian Institute of Public Health; Member, EMA-CHMP; Board Member, Cancer Drug Development Forum (CDDF)​
Considerations for Evidence Generation in Multiregional Clinical Trials: A European Regulatory Perspective
Susan Galbraith, MBBChir, PhD
Executive Vice President, Oncology Hematology Research and Development, AstraZeneca; Member, AAADV Workshop Foundation Program Committee
Multiregional Oncology Development Programs for Global Regulatory Decision-Making: An Industry Perspective​
Scott Evans, PhD, MS
Professor and Founding Chair, Department of Biostatistics and Bioinformatics, George Washington University Milken Institute School of Public Health; Member, AAADV Workshop Foundation Program Committee
Key Considerations for Designing and Analyzing Oncology MRCTs to Support Robust Evidence Generation
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 (Oncology), Stanford University School of Medicine
Tim Yap, MD — Virtual
MD Anderson Cancer Center
Dose Optimization for Combination Therapies
Patricia LoRusso, MD
Yale University
Dose Optimization in Novel Modalities: ADCs, Bispecifics, and Beyond
Murad Melhem, MD
Glaxo Smith Kline (GSK)
The Industry Perspective: Implementing Optimized Dose-Finding Strategies
Moderator: Zeeshan Rasheed, MD
Glaxo Smith Kline (GSK)
5:30 PM
Session X
Cancer Drug Development in China
Moderators:
Ke Liu, MD
Marengo Therapeutics
Jun Ren, MD, PhD
Ruijin Hospital, Shanghai Jiao Tong University​
Panelists:
Xiaoyuan Chen, PhD​
Tsinghua University; Former NMPA Reviewer
Presentation title forthcoming
Hui Zhou, MD, PhD
Chief R&D Officer, Oncology, Innovent Biologics
Su Liang
Fortvita Biologics
Dan Zheng
Hillgene Biopharma
Jian Wang
Jiangsu Hengrui Pharmaceuticals
9:30 AM
Breakfast
9:45 AM
Introductory Remarks
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​
10:30 AM
Session 4
Mitigating IO Toxicity
Moderators:
Elad Sharon, MD, MPH
Dana-Farber Cancer Institute and Harvard Medical School
Brandi Heckman-Stoddard, PhD, MPH
National Cancer Institute, National Institutes of Health
Speakers
Kevin N. Heller, MD
Executive in Residence, BioHealth Innovation, Rockville, MD
Historical Perspective on Infliximab Labeling for Immune-Related Adverse Events: On-Label for Ipilimumab, Off-Label for Infliximab
Thomas G. Neilan, MD, MPH
Director, Cardio-Oncology Program; Director, Cardiac MR PET CT Program, Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School
The Largest Myocarditis Trial in the Field: Lessons from an IND-Exempt 183-Patient Study and Implications for Regulatory Pathways
Professor Dr. Robert Zeiser, MD – Virtual
Department of Hematology and Oncology, Medical Center – University of Freiburg, Freiburg, Germany
Pending talk of title
1:00 PM
Keynote IV
Price is What you Pay, Value is What you Get
Thomas M. 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
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 Hogdon
Guiding Researchers & Advocates to Scientific Partnership- GRASP
3:30 PM
Session 6
Failure to Launch
Moderator: Renzo Canetta, MD
Program Committee Chair, AAADV Workshop Foundation
Mehrdad Mobasher, M.D., M.P.H.
IFLI - Institute for Follicular Lymphoma Innovation
Belantamab mafoditin combination with pomalidomide
Howard Hochster, MD
Rutgers Cancer Institute of New Jersey
Camrelizumab (PD-1) and Rivoceranib (VEGF) for HCC: Contribution of Each Non-Approved Component in a Study Randomized Against a Different Standard of Care, in the Context of Other Approved Anti-PD-1 and VEGF-R Agents in HCC
Lynn M. Schuchter, MD
Vusolimogene oderparepvev and nivolumab
Madlyn and Leonard Abramson Professor of Clinical Oncology Director, Tara Miller Melanoma Center Vusolimogene oderparepvec
Invited Discussant: Kristin McJunkins
Advocate; Yale College
5:00 PM
Closing Remarks
Wrap-up and acknowledgements