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Thursday, June 18 • 5:00pm - 6:00pm
#535 OD: ON DEMAND - Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges

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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.


David J Pepperl, PhD


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

avatar for David Pepperl

David Pepperl

Senior Consultant and Nonclinical Group Leader, Biologics Consulting
Dr. David Pepperl is a Sr. Consultant and nonclinical group leader at Biologics Consulting in Alexandria, VA, and has 20 years’ experience in nonclinical development of drugs and biologics. With a background in both pharmacology/toxicology and cell and molecular biology, Dr. Pepperl... Read More →
avatar for Larry Davis

Larry Davis

Vice President, Medical and Clinical Affairs, EVERSANA
Larry is Professor of Practice, Clinical and Regulatory Affairs in the Henry E. Riggs School of Applied Life Sciences at the Keck Graduate Institute and currently VP, Medical and Clinical Affairs at EVERSANA. He is a pharmaceutical industry professional with over 20 years of experience... Read More →

Michael Merchlinsky

Scientific Program Manager, BARDA

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session