Day 1 — Thursday, November 5, 2026
Session 1: Multi-Regional Clinical Trials
Examines global drug development strategies and the challenge of enhancing access and generalizability while maintaining rigor in trial design and conduct — building on the Workshop’s long-standing engagement with the FDA, EMA, PMDA, NMPA, and other authorities.
Session 2: Benefit–Risk in Regulatory Decision-Making
Addresses the suitability of single pivotal trials and confirmatory evidence, and the increasingly central role of post-market evidence in assessing clinical benefit.
Session 3: Dose Optimization for Novel Therapeutics
Tackles dose selection strategies for combination therapies and the unique considerations raised by radiopharmaceuticals and cell therapies — one of the most active areas in modern oncology development.
Day 2 — Friday, November 6, 2026
Session 4: Me Too or Not Me Too: Generics, Biosimilars, and Novel Formulations
Explores trial design considerations, patient selection, and safety implications as the oncology pipeline increasingly includes follow-on molecules and reformulations of established agents.
Fireside Chat: Regulatory Perspectives on Oncology Drug Development
A marquee conversation between Richard L. Schilsky, MD (Professor Emeritus, University of Chicago; former Chief Medical Officer of ASCO) and Richard Pazdur, MD (former founding Director of the FDA Oncology Center of Excellence) — two figures whose combined perspective spans academic leadership, cooperative-group research, and the full arc of modern FDA oncology review.
Session 5: Failure to Launch: Lessons from Complete Response Letters
Presents case studies of non-approved regulatory submissions, distilling key regulatory and development insights that are rarely discussed in public forums.
Session 6: Immune-Related Adverse Events & Safety
Focuses on safety considerations in novel therapies, management of immune-related toxicities, and the implications for trial design and regulatory review.