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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Can Nonclinical Repolarization Assays Predict the Results of Clinical Thorough QT Studies? Results from a Research Consortium.

British Journal of Pharmacology, 2017

Park EJ, Gintant GA, Bi D, Kozeli D, Pettit SD, Pierson JB, ...

The strengths and limitations of three nonclinical repolarization assays used to define the risk of clinical drug-induced delayed ventricular repolarization (a surrogate marker of the rare but potentially lethal arrhythmia Torsades de Pointes) were compared during a retrospective analysis of an anonymized database of 150 ...

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Cardiac contractility: Correction strategies applied to telemetry data from a HESI-sponsored consortium

Journal of Pharmacological and Toxicological Methods, 2017

E. Boulay, M.K. Pugsley, V. Jacquemet, A. Vinet, M.V. Accardi, ...

Heart rate correction methods are frequently used when analyzing data collected during the drug development process to better understand the QT interval. There is variability in this methodology and the optimal heart rate correction formula is often debated. This paper details a study that explored the ...

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Non-Lethal Endotoxin Injection: A Rat Model of Hypercoagulability

PLOS One, 2017

Marjory B. Brooks, James R. Turk, Abraham Guerrero, ...

This article characterizes a time course model of inflammation and hemostatic activation in rats treated with bacterial endotoxin (lipopolysaccharide, LPS) through a combination of traditional histologic and clinicopathologic endpoints and analyses of novel circulating biomarkers, including microRNA (miRNA) and ...

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An evaluation of the utility of LVdP/dt40, QA interval, LVdP/dtmin and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs

Journal of Pharmacological and Toxicological Methods, 2017

Michael K. Pugsley, Brian Guth, AlanY. Chiang, ...

The importance of drug-induced effects on the inotropic state of the heart is well known. Unlike hemodynamic and cardiac electrophysiological methods, which have been routinely used in drug safety testing for years, the non-clinical assessment of drug effects on myocardial contractility is used less frequently with ...

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Enhancing quality of life as a goal for anticancer therapeutics

Science Translational Medicine, 2016

Syril D. Pettit, Steven E. Lipshultz, Charles S. Cleeland, ...

Advances in cancer therapy has resulted in more cancer survivors, and now quality of life throughout treatment and surviving years is becoming a new focus for the scientific community. There are often unintended toxicities related to cancer therapies. HESI established the THRIVE program to address quality-of-life research.

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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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