This article is a summary of a half-day continuing education course jointly sponsored by the Society for Toxicologic Pathology (STP) and the Health and Environmental Sciences Institute (HESI) at the annual meeting of the STP in Baltimore, MD, held June 16-19, 2024. Presenters discussed pathology, toxicology, immunotoxicology, and regulatory implications of findings in the immune system in context of development of immunomodulatory therapeutics. Interpretation of pathology findings requires knowledge of immune system morphology and function including species-specific differences and spontaneous findings in animal model systems. A weight of evidence (WoE) approach is required to integrate pathology findings and immunotoxicology assay results to assess translatability to humans. Communication and collaboration among scientists of various disciplines can be instrumental in optimal generation and interpretation of appropriate data for development of immunomodulatory therapeutics.
Keywords: hematolymphoid; immune system; immunopathology; immunosafety; immunotoxicology.