2026 AAADV Workshop

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AAADV Workshop Foundation Unveils Program for 2026 Workshop, Convening the Architects of Modern Oncology Drug Regulation

Two-day program on November 5–6, 2026 will bring together five landmark FDA and NIH leaders, six plenary sessions, and a marquee fireside chat on the future of oncology drug development

BETHESDA, Md. — The AAADV Workshop Foundation today released the official program agenda for the 2026 Accelerating Anticancer Agent Development and Validation (AAADV) Workshop, to be held November 5–6, 2026, at the North Bethesda Marriott Hotel & Conference Center in Bethesda, Maryland, with in-person and virtual participation. Now in its third decade, the AAADV Workshop remains one of the oncology community’s most influential forums for clinical and translational investigators, regulators, industry leaders, biostatisticians, and patient advocates working to advance the science, methodology, and regulatory framework of cancer drug development.
The 2026 program reflects the workshop’s evolution into a truly global, multi-stakeholder venue. Over two days, attendees will engage with six plenary sessions, three keynote addresses, and a headline fireside chat — each designed to tackle the most consequential questions facing oncology drug development today: how to design rigorous multi-regional trials, how to weigh benefit and risk, how to optimize dose for novel modalities, and how to learn from both successes and failures in the regulatory arena.

An Extraordinary Slate of Confirmed Keynote Speakers

Five leaders whose careers have collectively shaped the modern era of oncology drug regulation and biomedical research

Richard Pazdur, MD

Richard Pazdur, MD

Founding Director (former), FDA Oncology Center of Excellence
26-year FDA veteran widely credited with transforming modern oncology drug regulation; founded the Oncology Center of Excellence and led Project Orbis and other landmark review-modernization initiatives.

Robert Califf, MD

Robert Califf, MD

Former Commissioner, U.S. Food and Drug Administration
Cardiologist and twice-confirmed FDA Commissioner; founder of the Duke Clinical Research Institute and a global authority on clinical-trial methodology, evidence generation, and regulatory science.

Peter Marks, MD, PhD

Peter Marks, MD, PhD

Former Director, FDA Center for Biologics Evaluation and Research
Hematologist-oncologist who led CBER through the COVID-19 vaccine response and the modern era of cell, gene, and tissue therapy regulation; co-architect of Operation Warp Speed.

Monica Bertagnolli, MD

Monica Bertagnolli, MD

President, National Academy of Medicine
Surgical oncologist and former Director of the U.S. National Institutes of Health and the National Cancer Institute; longtime leader in cooperative-group cancer clinical trials and equitable research.

Thomas G. Roberts, Jr., MD

Thomas G. Roberts, Jr., MD

Vice Chair, Farallon Capital Management
Medical oncologist and healthcare investor; former attending oncologist at Massachusetts General Hospital and Harvard Medical School instructor; past Chair of the Conquer Cancer Foundation of ASCO.

Program Highlights

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.

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.

2026 Workshop Agenda

Save the date: November 5–6, 2026 · Bethesda, MD · In-person and virtual

Registration opens [date TBA]. Patient-advocate scholarships available — applications open [date TBA].

Why the 2026 Workshop Matters

Since 2004, the AAADV Workshop has brought together clinical and translational investigators with experts in trial design, trial execution, and regulatory science to examine the safety and efficacy of new anticancer agents — with patients who participate in clinical development at the center of the conversation. The forum has hosted cumulative attendance in the thousands and has been co-sponsored over the years by Duke University, the U.S. National Cancer Institute, the FDA, the American Association for Cancer Research, ASCO, and Susan G. Komen. In 2025, the program reorganized under the AAADV Workshop Foundation, a 501(c)(3) created to broaden access through unrestricted educational grants, expand virtual participation, and partner year-round with the Triangle Center of Excellence in Regulatory Science and Innovation. The 2026 Workshop is the first full program delivered under this model — and its agenda reflects the Foundation’s expanded mission to serve a global oncology community, including investigators working on rare cancers, pediatric cancers, and rare molecular subtypes of common cancers.

From the Program Committee

“The 2026 program reflects what the AAADV Workshop has always done best — convening the people who actually make oncology drug development work, and giving them the space to talk candidly about what is working, what is not, and what comes next. This year’s agenda, from multi-regional trials through dose optimization and the lessons of Complete Response Letters, is built for the reality of modern cancer therapeutics.”

The 2026 AAADV Workshop Program Committee

Renzo Canetta, MD

Renzo Canetta, MD

(Chair)

H. Kim Lyerly, M.D.

H. Kim Lyerly, MD

AAADV Chair
Duke University

Tom Fleming

Thomas Fleming, PhD

Professor, Department of Biostatistics University of Washington School of Medicine

Richard L. Schilsky

Richard Schilsky, MD

Professor emeritus
University of Chicago

Scott Evans, PhD

Scott Evans, PhD

Elad Sharon, MD

Elad Sharon, MD

Terrell Baptiste

Terrell Baptiste

Dr. Jaap Verweij

Jaap Verweij, MD, PhD

Vivek Subbiah, MD

Vivek Subbiah, MD

Lola Fashoyin-Aje

Lola Fashoyin-Aje, MD, MPH

AAADV WORKSHOP FOUNDATION BOARD

H. Kim Lyerly, MD Renzo Canetta, MD Richard L. Schilsky, MD Thomas Fleming, PhD Scott Evans, PhD Peter Marks, MD, PhD Susan Galbraith, MB, BChir, PhD Eric Rubin, MD

Registration, Scholarships, and Updates

Additional speaker announcements, registration information, and scholarship opportunities for patient advocates will be posted in the coming months at www.AAADV.org. The AAADV Workshop Foundation invites members of the oncology community to follow the Foundation on LinkedIn for ongoing program announcements.

About the AAADV Workshop Foundation

The AAADV Workshop Foundation is a 501(c)(3) nonprofit organization dedicated to advancing the science, methodology, and regulatory framework of cancer drug development. Through its annual workshop and year-round educational programming — including collaborations with the Triangle Center of Excellence in Regulatory Science and Innovation — the Foundation supports investigators, regulators, industry leaders, biostatisticians, and patient advocates working to bring safe and effective cancer therapies to patients worldwide. More information is available at www.AAADV.org.

2026 Workshop Agenda