How Do I Select The Right Species For My Toxicology Program?

Understanding the metabolism profile of your compound is crucial in determining species justification and designing an effective IND-enabling program. This webinar will explore the scientific principles behind species selection for nonclinical studies, with a focus on how in vitro species comparison studies can guide the selection of appropriate in vivo models. By emphasizing the importance of metabolism-driven decisions, this session aims to equip researchers with the knowledge needed to advance their programs toward clinical trials.

Selecting the most relevant species for toxicity studies is a critical step to ensure that your IND submission provides regulators with the data necessary for progression to human clinical trials. This process must be grounded in scientific rationale, beginning with an understanding of the potential variability in drug metabolism across species. The choice of animal models can be complex and is not always straightforward. Comparative studies between animal species and human data help to identify species-specific and human-specific metabolites, ensuring the selection of the most appropriate models to generate the nonclinical safety data required for Phase 1 trials.

The webinar will be presented by Dr. Andrew G. Taylor, Manager of Technical Support for Services at SEKISUI XenoTech, and Dr. Scott E. Boley, Senior Scientific Advisor at Altasciences. They will cover key topics, including the drivers of species selection for nonclinical programs, considerations for rodent and non-rodent species selection, structural characteristics of metabolites across preclinical species, and the role of in vitro species comparison screening studies in shaping these decisions.