Use of animals and/or animal derived products to demonstrate safety or efficacy supports drug development and, in some cases, is required by law to release drug product. Much progress has been made since the early days of drug testing to remove or minimize the use of animals in facilitating release testing of drug products. New technologies are helping us limit animal usage while providing more precise and accurate results. This session will take a look at some of those tests such as potency and endotoxin and review ongoing activities working to reduce or eliminate the use of animals in release testing. The goal of this session is to inspire change by providing actionable information and review ongoing efforts to reduce our reliance on those who share our planet.
Session Speakers: 08:30 - 08:55 Recombinant Factor C: An Approved and Sustainable Bacterial Endotoxins Test IP Jay Bolden, Eli Lilly and Company
08:55 - 09:20 Transition of an Animal-based Bioassay: Somatropin Case Study V Kevin Carrick, US Pharmacopeia (USP)
09:20 - 09:45 Removing Animals and Reagents Derived from Animals for Testing V Robin Levis, CBER, FDA