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ON DEMAND - Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges
Session Chair(s)
David J Pepperl, PHD
Senior Consultant and Nonclinical Group Leader
Biologics Consulting, United States
Using the animal rule approach, sponsors must generate clinically meaningful data in a biologically relevant animal model. Given the many challenges posed in bridging animal data to humans, the Animal Rule poses significant challenges for sponsors. This session will provide an introduction and overview of the Animal Rule, its nuances, intended use and role in clinical development when human clinical trials are either not feasible or ethical. The speakers will address different clinical strategies using the Animal Rule as well as various challenges and incentives associated with this approach. Specific “real world” case studies using the animal rule will also be presented for audience consideration.
Learning Objective : Describe key provisions of the FDA Animal Rule and current guidance as they relate to development of both drugs and biologics when Human clinical trials are not ethical or feasible; Identify key themes in development of drugs and biologics under the Animal Rule; Recognize key incentives and challenges of the Animal Rule pathway; Define several “real world” examples as well as benefits garnered and key challenges faced in developing novel drugs and biologics under the Animal Rule.
Speaker(s)
The FDA Animal Rule: FDA Guidance, Product Approvals, and Remaining Challenges
Larry J Davis, PHARMD
Keck Graduate Institute, United States
Professor of Practice, Clinical and Regulatory Affairs
Approval of Medical Countermeasures Under the FDA Animal Rule: TPOXX, a Therapeutic Antiviral Against Smallpox
Michael Merchlinsky, PHD
BARDA, United States
Scientific Program Manager