Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting
- 1 July 2019
- journal article
- editorial
- Published by Springer Science and Business Media LLC in Therapeutic Innovation & Regulatory Science
- Vol. 53 (4), 519-525
- https://doi.org/10.1177/2168479018795117
Abstract
A Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA-sponsored Think Tank Meeting was convened in Washington, DC, on May 21, 2018, to bring together scientists, clinicians, and regulators from multiple geographic regions to evaluate progress to date in the Comprehensive In Vitro Proarrhythmia Assay (CiPA) Initiative, a new paradigm to evaluate proarrhythmic risk. Study reports from the 4 different components of the CiPA paradigm (ionic current studies, in silico modeling to generate a Torsade Metric Score, human induced pluripotent stem cell—derived ventricular cardiomyocytes, and clinical ECG assessments including J-Tpeakc) were presented and discussed. This paper provides a high-level summary of the CiPA data presented at the meeting.Keywords
This publication has 14 references indexed in Scilit:
- A new paradigm for drug-induced torsadogenic risk assessment using human iPS cell-derived cardiomyocytesJournal of Pharmacological and Toxicological Methods, 2017
- Improving the In Silico Assessment of Proarrhythmia Risk by Combining hERG (Human Ether-à-go-go-Related Gene) Channel–Drug Binding Kinetics and Multichannel PharmacologyCirculation: Arrhythmia and Electrophysiology, 2017
- Comprehensive Translational Assessment of Human-Induced Pluripotent Stem Cell Derived Cardiomyocytes for Evaluating Drug-Induced ArrhythmiasToxicological Sciences, 2016
- A New Perspective in the Field of Cardiac Safety Testing through the Comprehensive In Vitro Proarrhythmia Assay ParadigmSLAS Discovery, 2016
- Late sodium current block for drug‐induced long QT syndrome: Results from a prospective clinical trialClinical Pharmacology & Therapeutics, 2015
- Differentiating Drug-Induced Multichannel Block on the Electrocardiogram: Randomized Study of Dofetilide, Quinidine, Ranolazine, and VerapamilClinical Pharmacology & Therapeutics, 2014
- Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research ConsortiumAmerican Heart Journal, 2014
- Improving the Assessment of Heart Toxicity for All New Drugs Through Translational Regulatory ScienceClinical Pharmacology & Therapeutics, 2013
- Simulation of the Undiseased Human Cardiac Ventricular Action Potential: Model Formulation and Experimental ValidationPLoS Computational Biology, 2011
- Pharmacological and Regulatory Aspects of QT ProlongationPublished by Wiley ,2008