SOT Women in Toxicology Special Interest Group and Drug Discovery Toxicology Specialty Section Webinar Series on Targeted Protein Degraders

Event: SOT Women in Toxicology Special Interest Group and Drug Discovery Toxicology Specialty Section Webinar Series on Targeted Protein Degraders
Description: The HESI TPD Safety Committee will be presenting the work from their Study Design WG, as part of the second webinar on February 6.

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Talk title: Current Practices and Considerations for Preclinical Safety Assessment of Targeted Protein Degraders
Presenter: Katie Stamp, PhD, Bristol Myers Squibb

Abstract: This presentation provides an overview of current practices employed across the pharmaceutical industry and academia to identify and evaluate potential safety concerns associated with TPDs. Insights from stakeholders were gathered through workshops conducted by the HESI TPD Safety Committee (a public private collaborative group of 90 technical experts, representing 23 companies, 5 academic or research institutes, and 2 government agencies) highlighting emerging strategies such as proteomics-based target profiling, degrader selectivity assessment, and species selection for in vivo studies. In addition, case studies and a stakeholder survey were used to collect detailed input on study design considerations, including the use of in vitro systems, analytical methodologies, in vivo selectivity profiling, and data interpretation. Together, these efforts provide a snapshot of safety evaluation strategies currently in use and identify key challenges in translating mechanistic insights into predictive toxicology frameworks. Overall, current practices reflect a pragmatic integration of established small molecule safety principles with emerging, modality-specific approaches tailored to TPDs.