CE 7: Navigating Genetic Toxicology through Drug Development: Interface of Practice, Strategy, and Regulatory Principles

Genetic toxicology is integral to pharmaceutical development, providing a scientific framework for the identification and mitigation of genotoxic risks associated with new chemical entities, metabolites, and impurities. This course critically examines the implementation of genotoxicity risk assessment throughout the drug development continuum. The course is designed to present information in a stage-specific manner, starting with early discovery screening to de-risk drug candidates, regulatory assays to support IND filing, and continuing on through post-marketing. The course reviews multiple regulatory requirements, most notably ICH S2(R1) and M7, for the evaluation of drugs and genotoxic impurities, ensuring compliance and harmonization across ICH regions. Strategic approaches are explored, including tiered testing paradigms that combine in silico computational modeling, in vitro assays, and in vivo studies to generate comprehensive safety data packages. Modern methodologies, including new approach methodologies and advanced modeling techniques, are highlighted for their potential to enhance the predictive power of genotoxicity assessments, reduce animal use, and improve translational relevance. The course further addresses the follow-up and resolution of unexpected positive findings, such as Ames-positive results, as per the recent FDA guidance. Before the course concludes with an interactive case study, the FDA will provide their perspectives on navigating positive genotoxicity results. Designed for professionals in nonclinical safety, regulatory affairs, and drug discovery, this course equips participants with the requisite knowledge to ensure patient safety and manage the genotoxicity complexities of contemporary drug development.

CE Course Chair: Dana Minnick, PhD, DABT, RAC – SciLucent, Inc.
CE Course Chair: Rohan Kulkarni, MSc, PhD – Enveda
CE Course Speaker: Lisa Beilke, MSPH, PhD, DABT, ATS – Toxicology Solutions, Inc.
CE Course Speaker: Steven Bryce – Litron Laboratories
CE Course Speaker: Matt Tate, PhD – Scantox
CE Course Speaker: Zheng Li, PhD, DABT – US FDA