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​FDA-AACR Regulatory Science and Policy Workshop 

FDA-AACR Workshop on Non-clinical Models for Safety Assessment of Immuno-oncology Products

Date: Sept. 6, 2018
Location: Marriott Wardman Park, Maryland Ballroom, 2660 Woodley Rd NW, Washington, D.C. 20008

Read the agenda. Read the speaker bios. Read the guest blog written by the workshop cochairs. See the shareable flyer. Read the multi-stakeholder summary blog written by workshop participants.

View the slides.* Read the transcript: Morning SessionAfternoon Session.

Workshop videos*: Morning Session A. Morning Session B. Morning Session C. Afternoon Session A. Afternoon Session B.

*Some speakers have elected to have some or all of their slides withheld. 

Purpose: Discuss current challenges and opportunities for non-clinical models to predict toxicities of immune checkpoint inhibitors and stimulators in patients. The workshop will provide a forum for academic, industry, and regulatory experts to discuss developing non-clinical models that are both predictive and practical for human safety assessment.

Background:  The development of non-clinical models that can predict toxicities of immune checkpoint inhibitors and stimulators in patients is an extremely important and timely issue for the cancer community. There are 50 agents targeting PD-1 or PD-L1 in clinical development, and more than 1100 trials combining anti-PD-1/L1 agents with other therapies, yet retrospective analyses indicate that animal toxicity for many of these agents is minimal and does not predict adverse effects in patients. In addition, the recent observation of worse overall survival in two randomized trials that evaluated anti-PD-1/L1 agents in combination with immunomodulatory drugs underscores the need for cross-sector collaboration in this area. With advances in nonclinical models to study the pharmacodynamics of immune checkpoint inhibitors and stimulators, the question remains whether any of these models could be adapted to assess the safety of immuno-oncology products.

Workshop Cochairs: 

John K. Leighton, PhD, Director, Division of Hematology Oncology Toxicology, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 

Haleh Saber, PhD, Deputy Director, Division of Hematology Oncology Toxicology, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 

Julie Schneider, PhD, Regulatory Scientist, Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration