Title: Advances and Strategies in Using Target-Humanized Mice for IND-Enabling Toxicology Studies
Description:
As therapeutic modalities become increasingly complex and human-specific, identifying a pharmacologically relevant species for safety assessment can be challenging. Target-humanized mice, in which mouse target genes are replaced with their human counterparts, provide a fit-for-purpose in vivo approach that recapitulates human-specific biology and pharmacology and enables the assessment of clinically relevant toxicity. These models can be particularly valuable for biologics with limited species cross-reactivity or multiple therapeutic targets, while also enabling large, synchronized study cohorts, shorter breeding timelines, and greater study efficiency.
The use of target-humanized models in toxicology studies is recognized within regulatory frameworks and guidance, including ICH S6(R1) and relevant FDA guidance. Biocytogen has developed more than 2,000 target-humanized mouse models to support drug development worldwide. In this webinar, we will discuss strategies for applying these models to IND-enabling toxicology, with case studies spanning non-GLP studies, GLP general toxicity studies, and reproductive toxicity studies.
Speaker:
Yuan Le, Ph.D., DABT
Former Visiting Scientist, FDA/NCTR
Manager and Principal Scientist, Biocytogen
Panelist:
Jay Zhang, Ph.D.
Regional BD Director, Biocytogen
