Cardiac Safety Committee

Mission Statement

The mission of the HESI Cardiac Safety Committee is to improve public health by reducing unanticipated cardiovascular-related adverse effects from drugs or chemicals, and to develop innovative approaches to support early detection and prediction as well as improved understanding of cardiovascular toxicology and pathobiology.

HESI Staff

Leadership Team

  • Brian Berridge, PhD

    National Institute of Environmental Health Sciences, National Toxicology Program

  • Norman Stockbridge, PhD

    US Food and Drug Administration

Committee Events

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FDA Cardiac Safety Workshop

March 29, 2019

Silver Spring, Maryland, USA

FDA Workshop on Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities

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Committee Publications

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Rechanneling the Cardiac Proarrhythmia Safety Paradigm: A Meeting Report From the Cardiac Safety Research Consortium

American Heart Journal, 2014

Sager PT, Gintant G, Turner JR, Pettit S, Stockbridge N

This white paper provides a summary of a scientific proposal presented at a Cardiac Safety Research Consortium/Health and Environmental Sciences Institute/Food and Drug Administration–sponsored Think Tank, held at Food and Drug Administration's White Oak facilities, Silver Spring, MD, on July 23, 2013, with the intention ...

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The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative — Update on progress

Journal of Pharmacological and Toxicological Methods, 2016

Colatsky T, Fermini B, Gintant G, Pierson J, Sager P, Sekino Y, ...

The implementation of the ICH S7B and E14 guidelines has been successful in preventing the introduction of potentially torsadogenic drugs to the market, but it has also unduly constrained drug development by focusing on hERG block and QT prolongation as essential determinants of proarrhythmia risk.

Read more

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