Call for Case Studies for the 2027 STP Annual Symposium Session:
ICH S1B(R1) WoE Approaches for Carcinogenicity Assessment: Lack of Translational Relevance of Rat Mode of Action
Drs. Thomas Nolte and Arun Pandiri, co-chairs of Session 4 for the 2027 Annual Symposium in Denver, Colorado, June 27–30, would like to request case study presentations (15 minutes) for the session tentatively titled “Carcinogenicity Assessment Tool Box: It’s Not Just About Rodent Studies Anymore.” The symposium theme is “The Pathology of Neoplasia from Cause to Cure,” and our session will focus on novel ICH S1B(R1) Weight of Evidence approaches, particularly successful rat carcinogenicity waivers where the justification centered on the lack of translational relevance of rodent tumor mechanisms to humans.
The ideal case would describe a compound that is considered highly likely to be tumorigenic in rats, but not in humans, through a well-supported mode of action that renders a 2-year rat carcinogenicity study of no added value, consistent with Category 3a scenarios described by Bourcier et al. 2024. Novel mechanistic examples would be of particular interest, including cases involving species-specific biology or receptors, rodent-specific physiological responses, or secondary pharmacology with clear human irrelevance. We expect this session to be well attended and highly interactive, so please consider sharing an interesting precedent, or case study that could provide practical “how-to” insights for the STP membership. If you have a case you would be willing to present or discuss, please reach out to Dr. Arun Pandiri with a brief, non-confidential summary by July 15, 2026.