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.
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
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
(please note: not all speakers have given permission to post their slides in these master slide decks)
Workshop Cochairs:
- 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