The Role of In Vitro Assays in Selecting the Right Species for Your Small Molecule Program
Presenters: Andrew G. Taylor, Ph.D., Manager of Technical Support for Services at XenoTech and Scott Boley, Ph.D., DABT, Senior Vice President of Research at Sinclair Research
Abstract:
Choosing the most relevant species for your toxicity studies is critical to ensure your IND provides the relevant data regulators need to advance your program to clinical trials. But selecting the right species for your nonclinical program must be based on scientific rationale and begins with understanding the potential species-dependent variability in the metabolism of your drug. The decision of which animal model to utilize may not always be obvious. Comparing animal species to human data helps identify human or animal-specific metabolites and can help you identify the most appropriate species to generate the nonclinical safety data needed to progress your program into Phase 1.
This webinar will dive into the scientific rationale driving species selection for your nonclinical program with an emphasis on how in vitro species comparison studies can help to determine the right species for your in vivo program.
Key concepts discussed in this webinar will include:
- Drivers of species selection for nonclinical programs
- Considerations for rodent and non-rodent species selection
- Characteristics and structural assignment of metabolites in different preclinical species
- In vitro species comparison screening studies
About the Presenters:
Andrew G. Taylor, PhD, received his PhD from University of California San Diego. He joined XenoTech as a research scientist in 2017, serving as a Study Director in nonclinical drug interaction contract studies in compliance with Good Laboratory Practices (GLP), OECD Principles of GLP, &/or Japan MOHW GLP Standards and specializing in drug transport and drug metabolism studies. He became the Technical Support Manager for services in 2020 and provides valuable guidance to ensure research needs are being met.
Scott E. Boley, PhD, DABT, has advised sponsors on their nonclinical needs for the last 15 years and managed toxicology programs for over 19 years. He has extensive expertise in drug development as well as the regulatory expectations for a variety of test article types and indications. In his role as Senior Vice President of Research, Scott oversees the Research, Report Services, and SEND groups at Sinclair Research that supports each Sponsor’s nonclinical safety programs. Scott is a diplomate of the American Board of Toxicology and holds a B.Sc. in Biochemistry and a Ph.D. in Biochemistry/Environmental Toxicology from Michigan State University.
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