AAADV 2026 Workshop to Confront the Hardest Questions in Global Cancer Drug Development

Cancer drug development is entering a period defined not by a shortage of promising medicines, but by increasingly difficult decisions about which therapies should move forward, how they should be tested, and what evidence should be required before they reach patients. These questions will take center stage at the 2026 Accelerating Anticancer Agent Development and Validation (AAADV (搜索)搜索该词条) Workshop, taking place November 5–6, 2026, at the North Bethesda Marriott Hotel & Conference Center, with participation available in person and virtually.

The two-day program will bring together leaders from academia, regulatory agencies, industry, biostatistics, and patient advocacy to discuss major issues in modern oncology drug development and regulation.

A Cancer Drug Development Landscape in Transition

The scale and geography of oncology drug development are changing rapidly. Between 2015 and 2024, early-stage cancer drug development programs increased from 3,720 to 11,115 worldwide. While the number of U.S.-origin programs increased from 1,811 to 4,051, their share of the global total declined from 48.7% to 36.5%. During the same period, China-origin programs rose from 381 to 4,152, increasing China's share from 10.2% to 37.4%.

The regulatory picture is changing as well. Between 2020 and 2025, the U.S. FDA (搜索)搜索该词条 approved 87 novel oncology drugs, while China's National Medical Products Administration (NMPA) approved 94. From 2023 onward, the NMPA's annual number of approvals exceeded that of the FDA. Yet only 14 medicines among the 181 approvals during this six-year period were approved by both agencies.

The result is a development environment in which trial geography, patient populations, control arms, regulatory expectations, endpoints, and standards of care can determine not only whether a medicine succeeds, but where and when patients may ultimately receive it.

When Strong Results Are Not the End of the Question

Ivonescimab查看药品详情 provides a timely example of the challenges posed by region-specific evidence. The phase III HARMONi-6 trial, presented at the 2026 ASCO Annual Meeting, evaluated ivonescimab plus platinum-doublet chemotherapy against tislelizumab查看药品详情 plus chemotherapy in previously untreated advanced squamous non-small cell lung cancer (搜索)搜索该疾病. Median overall survival was 27.9 months versus 23.7 months, respectively, with a hazard ratio for death of 0.66.

Yet the study was conducted entirely in China, and its control arm reflected Chinese clinical practice rather than the standard used for this indication in the United States. These differences raise broader questions about how evidence generated in one region should be interpreted elsewhere and when additional multiregional evidence is scientifically necessary.

From Regulatory Uncertainty to Real-World Decisions

Day 1 will open with remarks from Richard L. Schilsky, MD, FACP, FSCT, FASCO, followed by introductions from Renzo Canetta, MD, and sponsor acknowledgements from H. Kim Lyerly, MD. The first keynote will be delivered virtually by Monica Bertagnolli, MD, President of the National Academy of Medicine, on "The Right Treatment to the Right Patient at the Right Time."

The opening scientific session, "Balancing Benefit and Risk in Regulatory Decision-Making," will examine how regulators and investigators should manage uncertainty before and after approval. Moderated by Lola A. Fashoyin-Aje, MD, MPH, the session will feature Robert M. Califf, MD, MACC, discussing uncertainty and pre- and post-approval evidence generation; Harald Enzmann, MD, PhD, addressing regulatory benefit-risk frameworks and evidentiary standards; and Scott Evans, PhD, MS, focusing on optimizing benefit-risk assessment through trial design. Thomas R. Fleming, PhD, will lead the moderated discussion.

Can Cancer Drug Development Become Truly Global?

Globalization will remain a major focus throughout the first day. Richard Pazdur, MD, Founding Director and former Director of the FDA Oncology Center of Excellence, will join Richard L. Schilsky for a fireside chat on the globalization of cancer drug development.

That discussion will lead directly into the session on Multi-Regional Clinical Trials, moderated by Jaap Verweij, MD, PhD, and co-moderated by Scott Evans. The session will bring together regulatory, statistical, and industry perspectives through presentations from Eva Skovlund, MSc Pharm, PhD, on European regulatory considerations for evidence generation; Lola Fashoyin-Aje on designing research that addresses patients' needs; and Susan Galbraith, MBBChir, PhD, on multiregional oncology development programs for global regulatory decision-making.

The underlying issue is increasingly consequential: patients may ultimately bear the cost when similar scientific questions must be answered repeatedly across jurisdictions because trial designs and regulatory expectations were not sufficiently aligned from the beginning.

Finding the Right Dose Before the Wrong Dose Finds the Patient

Dose optimization will form another major part of the program. Moderated by Vivek Subbiah, MD, the session on Dose Optimization for Novel Therapeutics will examine combination therapies, novel modalities, and the practical implementation of dose-finding strategies.

Tim Yap, MD, will address dose optimization for combination therapies; Patricia LoRusso, MD, will discuss antibody-drug conjugates, bispecifics, and other emerging modalities; and Murad Melhem, MD, will present the industry perspective on implementing optimized dose-finding strategies. Zeeshan Rasheed, MD, will lead the moderated discussion.

The issue is not simply methodological. Inadequate dose optimization can translate directly into toxicity, reduced treatment tolerance, and shorter treatment duration for patients.

China's Expanding Role Takes Center Stage

The first day will conclude with a dedicated session on Cancer Drug Development in China, reflecting the country's growing role in oncology research and therapeutic innovation. Moderated by Ke Liu, MD, with Jun Ren, MD, PhD, as co-moderator, the session will include Xiaoyuan Chen, PhD, Hui Zhou, MD, PhD, and, pending confirmation, Frank Jiang, MD, PhD.

The session comes at a moment when China now originates more early-stage cancer drug development programs than the United States, making its regulatory environment, research infrastructure, and role in global development increasingly important to the future of oncology.

Day 2: Faster Development, Safer Treatment

Day 2 will begin with a keynote from Peter Marks, MD, PhD, former Director of the FDA Center for Biologics Evaluation and Research, titled "Expediting the expedited: Advancing the pace of medical product development."

Attention will then turn to mitigating immuno-oncology toxicity, with a session moderated by Elad Sharon, MD, MPH, and co-moderated by Brandi Heckman-Stoddard, PhD, MPH. The program will examine the history of infliximab查看药品详情 labeling for immune-related adverse events with Kevin N. Heller, MD; lessons from a 183-patient myocarditis study with Thomas G. Neilan, MD, MPH; and steroid-refractory graft-versus-host disease with Robert Zeiser, MD, participating virtually.

"Me Too or Not Me Too?"

One of the workshop's most provocative sessions will challenge another fundamental question in oncology development: when does another therapy in an established class add meaningful value? Moderated by Eric Rubin, MD, the session will examine the PD-1/PD-L1 (搜索)搜索该靶点 checkpoint inhibitor class with Ronald Alan Peck, MD; BCMA (搜索)搜索该靶点-directed therapies with Samer Al Hadidi, MD, MS, FACP; and ERBB (搜索)搜索该靶点-targeted therapies with Edith Perez, MD, including questions surrounding patient selection, comparator choice, and non-inferiority versus superiority. Christine Hogdon will participate as an invited panel discussant.

Learning From the Programs That Did Not Launch

The workshop will close its scientific program with "Failure to Launch," a case-based discussion of development programs facing complex regulatory obstacles. Moderated by Renzo Canetta, the session will examine camrelizumab查看药品详情 plus rivoceranib查看药品详情 in hepatocellular carcinoma (搜索)搜索该疾病 with Howard Hochster, MD; belantamab mafodotin查看药品详情 in multiple myeloma (搜索)搜索该疾病 with Mehrdad Mobasher, MD; and, pending confirmation, vusolimogene oderparepvec in melanoma (搜索)搜索该疾病 with Lynn Schuchter, MD. Kristin McJunkins will join as invited panel discussant.

Rather than focusing only on successful approvals, the session reflects a central principle behind AAADV (搜索)搜索该词条: drug development can also advance when stakeholders openly examine what did not work, why it did not work, and what those experiences can teach the field.

A Forum Built for the Questions Without Easy Answers

Since 2004, the AAADV (搜索)搜索该词条 Workshop has created a setting for direct discussion among regulators, investigators, biostatisticians, industry leaders, clinicians, and patient advocates. In 2025, AAADV reorganized as an independent 501(c)(3) foundation to broaden access, expand virtual participation, and support year-round educational programming.

Cancer drug development has more potential pathways, targets, biomarkers, modalities, trial designs, regulatory strategies, and geographic options than at any previous point. The challenge is ensuring that this growing complexity does not make meaningful therapies slower, more expensive, or less accessible to the patients who need them. At AAADV (搜索)搜索该词条 2026, those questions will not remain theoretical—they will be placed directly before many of the people responsible for designing, conducting, reviewing, funding, and ultimately translating oncology trials into patient care.