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. 2019 Jul;53(4):519-525.
doi: 10.1177/2168479018795117. Epub 2018 Aug 29.

Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

David G Strauss  1 , Gary Gintant  2 , Zhihua Li  3 , Wendy Wu  3 , Ksenia Blinova  3 , Jose Vicente  3 , J Rick Turner  4 , Philip T Sager  5
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Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting

David G Strauss et al. Ther Innov Regul Sci. 2019 Jul.

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: CiPA; J-Tpeakc; balanced ion channel-blocking drugs; human induced pluripotent stem cell-derived ventricular cardiomyocytes; torsade de pointes; torsade metric score.

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