Virtual and in-person at the
North Bethesda Marriott Hotel & Conference Center
November 5–6, 2026
· North Bethesda, MD
Featured Speakers
Leaders in Regulatory Sciences & Clinical Development
Former Director, FDA Oncology Center of Excellence
Former Commissioner, U.S. Food and Drug Administration
Former Director, FDA Center for Biologics Evaluation and Research
President, National Academy of Medicine
Vice Chair, Farallon Capital Management
Dates
Nov 5–6, 2026
Location
North Bethesda, MD
Format
In-Person & Virtual
About the Workshop
Advancing the science, methodology, and regulatory framework of cancer drug development.
The AAADV Workshop Foundation is a 501(c)(3) nonprofit convening clinical investigators, regulators, industry leaders, biostatisticians, and patient advocates. Now in its third decade, the annual workshop is one of the field’s most influential global forums. The 2026 program spans two days of keynotes, a regulatory fireside chat, and expert sessions:
Benefit–Risk in Regulatory Decision-Making
Evolving global frameworks and evidentiary standards.
Multiregional Clinical Trials
Generalizable evidence across global development programs.
Dose Optimization
Dose selection for combinations, radiopharmaceuticals, and cell therapies.
Immune-Related Adverse Events
Managing toxicities and implications for trial design.
“Me Too” or Not
Generics, biosimilars, and novel formulations in established classes.
Failure to Launch
Lessons from recent Complete Response Letters.
Cancer Drug Development in China
China’s growing role in global oncology medicines.