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 quickPredict 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.

Prediction of Cardiotoxicity Potential Using Targeted Metabolomics and Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes [SPS 2018]

Presented at the Safety Pharmacology Annual Meeting in Washington, DC; September/October 2018

Cardiac safety is one of the leading causes of late-stage compound attrition in the pharmaceutical industry and accounts for 28% if safety-related withdrawals of FDA-approved drugs from the market. Current cardiac safety preclinical evaluations are heavily focused on electrophysiological assessment and fail to evaluate cardiomyopathy and other forms of structural cardiotoxicity…

Cardio quickPredict: A New Way to Evaluate Cardiotoxicity Potential [SOT 2018 – Presentation Slides]

Presented at the Society of Toxicology Annual Meeting and ToxEXPO in San Antonio, Texas, March 2018 by Stemina’s Associate Director of Toxicology, Jessica Palmer.Predicting cardiotoxicity remains a challenge. Cardiovascular toxicity is a major cause leading to compound attrition throughout the drug discovery and development process as well as withdrawal of FDA-approved drugs from the market…

Application of a Human Pluripotent Stem Cell-Based Assay for Developmental Toxicity Screening [Tox Forum 2018 – Presentation Slides]

Presented at The Toxicology Forum’s 42nd 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…

Developmental Toxicity Potency of Valproate Analogues in a Human Pluripotent Stem Cell-Based Assay -[Northland Chapter of SOT, 2017 – Slides]

Presented at the Annual Meeting of the Northland Chapter of the Society of Toxicology (September 2017) by Jessica Palmer, Associate Director of Toxicology.

Development and validation of alternative models for developmental toxicity testing is essential for reducing the number of animals used for toxicity testing. While replacing animal models has been at the forefront of the toxicology field for over a decade…

Prediction of Developmental Toxicity Potential Dictated by In Vivo Exposures with a Biomarker-Based Human Pluripotent Stem Cell Assay – [Teratology Society 2017 – Slides]

Presented at the Teratology Society’s 57th Annual Meeting in Denver, Colorado in June 2017 by Stemina’s Associate Director of Toxicology, Jessica Palmer.

Previous approaches for evaluating the accuracy of alternative test methods have been based on the classification of a chemical as either a positive or negative, with no other distinction…