Application of a Human Pluripotent Stem Cell-Based Assay for Developmental Toxicity Screening – Tox Forum 2018 [Presentation Slides]
Presented at The Toxicology Forum’s 42ndh Annual Winter Meeting in Washington, DC in January 2018 by Stemina’s Associate Director of Toxicology, Jessica Palmer.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) recently released the draft S5(R3) Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals. The revised guideline would allow the use of in vitro, ex-vivo, and non-mammalian in vivo embryo-fetal development alternative assays to replace or eliminate in vivo studies in certain circumstances and provides a framework for qualifying alternative test systems for regulatory acceptance. In this presentation, Jessica Palmer suggests how the devTOX quickPredict assay from Stemina Biomarker Discovery could fit into this framework and how companies could use the assay now: early in the drug development process to focus its resources on the compounds mostly likely to pass validation.