Dr. John Vahle from Eli Lilly

The goal of the seminar is to provide CRL colleagues an overview of these changes in carcinogenicity testing paradigms for small molecule therapeutics.

In August of 2022, The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidance on carcinogenicity testing of pharmaceuticals was revised (ICH S1B(R1)).   The addendum introduces a more comprehensive and integrative approach to assessing human carcinogenic risk of pharmaceuticals.  This integrative approach describes specific WoE criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without data from a 2-year rat carcinogenicity study.  The addendum also provides for use of a plasma exposure ratio-based approach to high dose selection in the rasH2-Tg mouse model.  

Intended audience: Veterinary staff members and Study Directors