2026 AAADV WORKSHOP: AGENDA

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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.

Times are displayed in the Eastern Time Zone (EST).

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

Program Committee Chair, AAADV Workshop Foundation

Sponsor Acknowledgements

10:00 AM

Keynote I

The Right Treatment to the Right Patient at the Right Time

Monica Bertagnolli, MD​

President, National Academy of Medicine​

10:30 AM

Session 1

Balancing Benefit and Risk in Regulatory Decision-Making

Moderator: Lola A. Fashoyin-Aje, MD, MPH​

Vice President, Regulatory Science & Strategy, AstraZeneca; Former Director, Office of Oncologic Diseases, FDA; Member, AAADV Workshop Foundation Program Committee​

Robert M. Califf, MD, MACC​

President, National Academy 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

Optimizing Benefit-Risk Assessment Through Design: What to Do Before and After the Trial Is Completed

Moderated Discussion: Thomas R. Fleming, PhD

Professor of Biostatistics, University of Washington; Member, AAADV Workshop Foundation Program Committee

1:00 PM

Keynote II

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​

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

Lola A. Fashoyin-Aje, MD, MPH

Vice President, Regulatory Science & Strategy, AstraZeneca; Former Director, Office of Oncologic Diseases, FDA; Member, AAADV Workshop Foundation Program Committee

Designing Clinical Research that Addresses Patients' Needs: 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

Moderated Discussion

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

GSK

The Industry Perspective: Implementing Optimized Dose-Finding Strategies

Moderated Discussion: Zeeshan Rasheed, MD

GSK​

5:30 PM

Session X

Cancer Drug Development in China

Moderators:

Ke Liu, MD

Marengo Therapeutics

Ke Liu, MD​

Ruijin Hospital, Shanghai Jiao Tong University​

Speakers:

Xiaoyuan Chen, PhD​

Tsinghua University; Former NMPA Reviewer

Presentation title forthcoming

Hui Zhou, MD, PhD

Chief R&D Officer, Oncology, Innovent Biologics

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​

Opening Remarks on Behalf of the AAADV Workshop Foundation

10:30 AM

Session 4

Mitigating IO Toxicity

Co-Chairs

Elad Sharon, MD, MPH

Dana-Farber Cancer Institute and Harvard Medical School

Brandi Heckman-Stoddard, PhD, MPH

National Cancer Institute, National Institutes of Health

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

Session concludes with a moderated discussion and Q&A.

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

Advocate-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

Belatamab 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

Madlyn and Leonard Abramson Professor of Clinical Oncology
Director, Tara Miller Melanoma Center
Vusolimogene oderparepvec

Invited Discussant: Kristin McJunkins

Advocate, Yale University

5:00 PM

Closing Remarks

Wrap-up and acknowledgements

2026 Workshop Registration