​​​​FDA-AACR: Immuno-oncology Drug Development Workshop

Oct. 13-14​, 2016 | ​8 a.m. – 5 p.m.
Hyatt Regency Washington on Capitol Hill, Washington, D.C.

*Audio recordings, transcripts and presentation slides are now available.

The goal of this workshop was to develop a path forward for evaluating an immuno-oncology-focused nonclinical and clinical development paradigm. Ideally, this workshop would help redefine biological outcome measures and clinical endpoints, leading to innovative clinical trial designs and statistical methods in the development of immuno-oncology clinical trials.

Workshop agenda, bios and transcripts

View final agenda
View bios of speakers and panelists
View/download Day 1 transcript 
View/download Day 2 transcript

Audio recordings

Day 1 - Introduction
Day 1 - Session 1, Part 1 
Day 1 - Session 1, Part 2
Day 1 - Session I Panel Discussion
Day 1 - Session 2A
Day 1 - Session 2A Panel Discussion
Day 1 - Session 2B
Day 1 - Session 2B Panel Discussion
Day 2 - Introduction and Session IIIA, Part 1
Day 2 - Session IIIA, Part 2 and Panel Discussion
Day 2 - Session IIIB
Day 2 - Session IIIB Panel Discussion
Day 2 - Session IV
Day 2 - Session IV Panel Discussion and Concluding Remarks

Slide presentations

View/download presentation slides – Day 1
View/download presentation slides – Day 2
(please note: not all speakers have given permission to post their slides in these master slide decks)

This two-day workshop provided an interdisciplinary forum to foster robust scientific discussion in the following sessions:

•​ Session I: Considerations in the preclinical evaluation of immuno-oncology (IO) products
• Session IIA: ​Considerations for dose-finding
• Session IIB: ​Evaluation of immune-mediated adverse events
• Session IIIA: Endpoints for IO products: Considerations for unique efficacy based on unique biology of checkpoint inhibitors
• Session IIIB: Use of alternate efficacy endpoints with I-O products
• Session IV: Considerations for novel trial designs

Workshop Co-chairs:

  • Maitreyee Hazarika​, MD, ​medical officer, Division of Oncology Products 2, Office of Hematology Oncology Products, Center for Drug Evaluation and Research, FDA​
  • Marc Theoret, MD, lead medical officer, Division of Oncology Products 2, Office of Hematology Oncology Products, Center for Drug Evaluation and Research, FDA
  • Suzanne L. Topalian, MD, member, AACR Regulatory Science and Policy Subcommittee
    Professor, Surgery and Oncology, Johns Hopkins University School of Medicine
    Director, Melanoma Program, Johns Hopkins Kimmel Cancer Center
    Associate Director, Bloomberg-Kimmel Institute for Cancer Immunotherapy
  • Jedd D. Wolchok, MD, PhD, Lloyd J. Old/Virginia and Daniel K. Ludwig chair in clinical investigation chief; Melanoma and Immunotherapeutics Service director; Parker Institute for Cancer Immunotherapy at MSK; associate director, Ludwig Center for Cancer Immunotherapy; member, Ludwig Cancer Research; professor of medicine, Weill Medical College of Cornell University; Memorial Sloan Kettering Cancer Center