DIA 2020 Virtual Global Annual Meeting

Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

David J Pepperl, PhD

Speaker

The FDA Animal Rule: FDA Guidance, Product Approvals, and Remaining Challenges
Larry J Davis, PharmD

Approval of Medical Countermeasures Under the FDA Animal Rule: TPOXX, a Therapeutic Antiviral Against Smallpox
Michael Merchlinsky, PhD