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

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.

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Correspondence to David G. Strauss MD, PhD.

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Strauss, D.G., Gintant, G., Li, Z. et al. Comprehensive In Vitro Proarrhythmia Assay (CiPA) Update from a Cardiac Safety Research Consortium / Health and Environmental Sciences Institute / FDA Meeting. Ther Innov Regul Sci 53, 519–525 (2019). https://doi.org/10.1177/2168479018795117

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Keywords

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