Publications : 2025

Snyder K, Greene N, De Nieu M, Anger L, Shah F. Developing predictive models to facilitate interpretation of toxicology study results. Symposium co-chair, Symposium S04, American College of Toxicology (ACT) 46th Annual Meeting, Phoenix, AZ, November 2025.

Abstract

The requirement by FDA for the generation and submission of standardized CDISC-SEND-formatted toxicology study data has enabled the construction of large databases of toxicology study data that can be used to build predictive models. The Nonclinical Topics Working Group of the Pharmaceutical Users Software Exchange (PHUSE) has initiated a project to facilitate collaboration among regulators, pharmaceutical companies, contract research organizations, and software vendors to collaboratively develop open source software solutions to improve the fidelity and accessibility of these methods. More specifically, supervised machine learning models will be trained to detect and characterize patterns in toxicology study endpoints that are associated with the documented conclusions of expert toxicologists, e.g. target organs of toxicity, and then applied to streamline the interpretation of newly generated toxicology study data. Additional study interpretations, e.g. adversity of findings, NOAEL determination, clinical translatability, structure activity relationship – will be explored for development of predictive models. This symposium will provide an update on the progress of this project as well as perspective on the applicability of its deliverables from a diverse set of stakeholders.