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
Opening remarks, workshop overview, and sponsor acknowledgements
10:00 AM
Keynote I
The Right Treatment to the Right Patient at the Right Time – Monica Bertagnolli, MD
Monica Bertagnolli, MD, President, National Academy of Medicine
10:30 AM
Session 1
Enhancing the Benefit-risk Assessment Process for pre- and post-market Regulatory Decision-making
Discussion focused on evolving regulatory frameworks, confirmatory evidence strategies, and post-market evidence generation.
1:00 PM
Keynote II
Globalization of Cancer Drug Development, A Fireside Chat with Richard Pazdur, MD
Richard Pazdur, MD, Founding Director (former), FDA Oncology Center of Excellence
1:30 PM
Session 2
Design & Analysis of Oncology Multiregional Clinical Trials to Facilitate Generalizable Evidence for Regulatory Approval
Exploring global clinical development strategies, patient access, diversity and generalizability, and operational considerations for multi-regional trials.
3:30 PM
Session 3
Dose Optimization for Novel Therapeutics
Discussion on dose optimization strategies for novel agents and combination therapies.
5:30 PM
Evening Session
Cancer Drug Development in China
Co-chaired by Dr. Ke Liu from Marengo Therapeutics.
9:30 AM
Breakfast
9:50 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
Discussion on emerging strategies to identify, monitor, and mitigate immuno-oncology toxicities.
1:00 PM
Keynote IV
Price is What you Pay, Value is What you Get – Thomas G. Roberts, Jr., MD
Thomas G. Roberts, Jr., MD, Farallon Capital Management
1:30 PM
Session 5
Me Too or Not Me Too
Examining differentiation, innovation, and value in increasingly competitive therapeutic landscapes, including generics and biosimilars.
3:30 PM
Session 6
Failure to Launch
Lessons learned from clinical development challenges, regulatory setbacks, and commercialization barriers.
5:00 PM
Closing Remarks
Wrap-up and acknowledgements