S04-03 Sponsor Perspectives on Implementing WOE Approaches

Abstract

The revision of ICH S1B to allow for a WoE option for carcinogenicity assessments in certain cases is a landmark change in carcinogenicity testing of small molecule pharmaceuticals. This presentation will review the benefits of a WOE approach from a sponsor's perspective. A key is moving from a “check the box” approach of conducting 2-year rat carcinogenicity studies to a more scientifically based approach that considers key pharmacologic and toxicologic properties for the compound. The WoE approach can provide for a substantial reduction in animal use will be realized, as the standard 2-year rat carcinogenicity studies require between 500-700 rats. The current status of implementation will be discussed and include highlights from an industry survey on implementation issues. Drawing on the work on the industry members of the ICH S1B Expert Working Group, best practices for adopting a weight of evidence approach will be included along with case examples to illustrate key points.