Evaluation of the reference chemicals suggested in the draft ICH S5(R3) guideline with a human pluripotent stem cell-based developmental toxicity assay [SOT, 2019]

Presented at the Society of Toxicology Annual Meeting and ToxExpo in Baltimore, Maryland; March 2019.

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.

Predicting Tyrosine Kinase Inhibitor Cardiotoxicity with a Biomarker-Based Human iPSC-Derived Cardiomyocyte Assay [SOT, 2019]

Presented at the Society of Toxicology Annual Meeting and ToxExpo in Baltimore, Maryland; March 2019.

Tyrosine kinase inhibitors (TKI) have greatly improved the treatment and prognosis for a wide range of cancers but often cause cardiotoxic effects. We developed an in vitro assay, Cardio quickPredict, for predicting cardiovascular liability based on changes in human iPSC-derived cardiomyocytes (iPSC-CM) metabolism and cell viability, which identifies both functional and structural cardiotoxicants.

Identify Functional and Structural Cardiotoxicants with the Biomarker-Based Cardio quickPredictTM Assay [SOT, 2019]

Presented at the Society of Toxicology Annual Meeting and ToxExpo in Baltimore, Maryland; March 2019.

Preclinical cardiac safety evaluations are heavily focused on electrophysiological assessment and often fail to identify structural cardiotoxicants. Stemina’s Cardio quickPredict assay accurately identifies compounds that elicit both structural and/or functional cardiotoxic effects. We will discuss how the assay can be used for early cardiac safety assessment.