devTOX quickPredictTM Accurately Predicts the Developmental Toxicity Potential of the ICH S5(R3) Guideline Reference Compounds [BDRP, 2022]

Presented by Jessica Palmer at the Society for Birth Defects and Research Meeting; June, 2022

There have been increased efforts in the pharmaceutical and chemical industries to incorporate new approach methods (NAMs) in vitro,, ex vivo, or in silico) earlier in the product development pipeline prior to in vivo testing.

devTOX quickPredictTM Accurately Predicts the Developmental Toxicity Potential of the ICH S5(R3) Guideline Reference Compounds [SOT, 2022]

Presented by Jessica Palmer at the Society for Toxicology Meeting; March, 2022

There have been increased efforts in the pharmaceutical and chemical industries to incorporate new approach methods (NAMs) (in vitro, ex vivo, or in silico) earlier in the product development pipeline prior to in vivo testing.

A Targeted Metabolomics-Based Assay Using Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes Identifies Structural and Functional Cardiotoxicity Potential [WC11, 2021]

Presented by Jessica Palmer at the 11th World Congress on Alternatives and Animal Use in the Life Sciences; August, 2021

Implementing screening assays that identify functional and structural cardiotoxicity earlier in the drug development pipeline has the potential to improve safety and the cost and time required to bring new drugs to market.

Defining the Reproducibility and Applicability Domain of devTOX quickPredictTM, a Human Pluripotent Stem Cell-Based Developmental Toxicity Assay [WC11, 2021]

Presented by Jessica Palmer at the 11th World Congress on Alternatives and Animal Use in the Life Sciences; August, 2021

Assessing the accuracy, reproducibility, and applicability domain of new approach methods (NAMs) is necessary step for establishing confidence in these methods and enabling their use in a regulatory setting.

A Human Pluripotent Stem Cell-Based Assay, devTOX quickPredictTM, Accurately and Reproducibly Predicts the Developmental Toxicity Potential Across a Diverse Set of Chemicals [SOT, 2021]

Presented by Jessica Palmer at the Society for Toxicology Meeting; March, 2021

Tyrosine kinase inhibitors (TKI) have greatly improved the treatment and prognosis for a wide range of cancers. Unfortunately, numerous TKIs produce cardiotoxic effects, which were not well predicted during preclinical studies.

In Vitro to In Vivo Extrapolation for Developmental Toxicity Potency of Valproic Acid Analogues [ASCCT, 2020]

Presented by Jessica Palmer at the American Society for Cellular and Computational Toxicology; October, 2020

Previous work showed that the potency ranking from devTOXqP assay was consistent with in vivo developmental toxicity potency, but whether the assay could quantitatively predict in vivo exposure exerting developmental toxicity was unknown.

Biomarker-Based Prediction of Tyrosine Kinase Inhibitor Cardiotoxicity using Human iPSC-Derived Cardiomyocytes [SPSM, 2019]

Presented by Jessica Palmer at the Safety Pharmacology Society Meeting in Barcelona, Spain; September, 2019

Tyrosine kinase inhibitors (TKI) have greatly improved the treatment and prognosis for a wide range of cancers. Unfortunately, numerous TKIs produce cardiotoxic effects, which were not well predicted during preclinical studies.

Developmental Toxicity Testing of Gaseous Chemicals with a Human Pluripotent Stem Cell-Based Assay [TSAM, 2019]

Presented at the Teratology Society Annual Meeting in San Diego, California; June 2019

Innovative in vitro toxicity screening assays aimed at reducing or replacing the use of animals in chemical safety testing are critical to meet the safety requirements across industries.

Next Generation Products Predicted to Have No Potential to Induce Developmental Toxicity in the devTOX quickPredictTM Assay [BTSAC, 2019]

Presented by Imperial Brands at the British Toxicology Society Annual Congress, in Cambridge, UK; April 2019

There is a growing scientific consensus that next generation products (NGPs) present a less harmful alternative to cigarettes for adult smokers. However, further research is required to adequately assess if NGP aerosols present a developmental risk to the unborn foetus.

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…