Entries by Gina Wentling

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.

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.

Reproducibility and Applicability Domain of devTOX quickPredict, a Human Pluripotent Stem Cell-Based Developmental Toxicity Assay [FutureTox IV (2018)]

Presented at FutureTox IV, a Society of Toxicology (SOT) Contemporary Concepts in Toxicology (CCT) meeting, in Arlington, VA; November 2018.

The ICH recently release the draft S5(R3) Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals, which outlines the use of new approach methods (NAMs) in certain circumstances and provides a framework for qualifying a NAM for regulatory acceptance. Part of this framework is to assess the accuracy, demonstrate reproducibility, and define the applicability domain of a NAM…

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…

Human In Vitro Developmental Toxicity Assay Combined with a Read-Across Approach for Chemical Assessment [ASCCT 2018]

Presented at the American Society for Cellular and Computational Toxicology; September 2018

The reproductive and developmental toxicity requirements for registering chemical substances under REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) using whole-animal models could cost up to $8 billion and require the use of up to 22 million animals…

A Human Pluripotent Stem Cell-Based Assay Accurately Predicts the Developmental Toxicity Potency for a Series of Valproate Analogues [Teratology Society 2018]

Presented at the Teratology Society Annual Meeting in Clearwater, Florida; June 2018

Regulatory acceptance of alternative methods for toxicity testing remains a challenge despite international efforts to reduce animal use. Multiple agencies are working to develop a framework to implement the use of new approach methodologies for assessing the effects of chemical exposure on human health…

Applying Discovery Toxicology Approaches for Prediction of Developmental Phenotypes [Teratology Society, 2018]

Presented at the Teratology Society Annual Meeting in Clearwater, Florida; June 2018.

This poster was presented by toxicology professionals from Syngenta, Ltd. The research they discussed was conducted using Stemina’s assays.

The current in vivo tests to identify chemistries with developmental and reproductive toxicity (DART) hazards are resource-intensive, relatively slow, and as such, are often undertaken too late in product development to inform subsequent chemical design, should an effect be seen.