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.

Development of an In Vitro Assay to Predict Cardiotoxicity Potential Using Targeted Metabolomics and Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes [SOT 2018]

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.

Cardiac safety is one of the leading causes of late-stage compound attrition in the pharmaceutical industry and accounts for 28% of the safety-related withdrawals of FDA-approved drugs from the market. Metabolic perturbations are one of the primary mechanisms of cardiotoxicity elicited by pharmaceuticals…

Development of a Targeted Biomarker Assay to Predict Cardiotoxicity Potential Using Metabolomics and Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes [ACT 2017]

Presented at the American College of Toxicology’s 38th Annual Meeting in Palm Springs, California in November 2017 by Stemina’s Associate Director of Toxicology, Jessica Palmer.

Cardiac safety is one of the leading causes of late-stage compound attrition in the pharmaceutical industry and accounts for 28% of the safety related withdrawals of FDA-approved drugs from the market…

EU-ToxRisk Case Study: Developmental Toxicity Potency of Valproate Analogues in Human Pluripotent Stem Cell-Based Assay [WC-10 (2017)]

Presented at the 10th World Congress on Alternatives and Animal Use in the Life Sciences in Seattle, August 2017, by Stemina’s Associate Director of Toxicology, Jessica Palmer.

The development and use of alternative models of safety screening in place of animal models has been at the forefront of the toxicology field for over a decade; however, application of these assays in a regular setting is still poorly understood…

Comparative Retrospective Analysis of In Vivo and In Vitro Developmental Toxicity Predictions [SOT 2017]

Presented at the Society of Toxicology’s Annual Meeting & ToxExpo in Baltimore, March 2017, by Stemina’s Associate Director of Toxicology, Jessica Palmer.

Development and validation of in vitro models for developmental toxicity testing is essential for reducing the number of animals used toxicity testing. These assays have the potential to reduce or replace animal use in chemical safety testing for multiple industries, as well as to support ongoing worldwide…