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

FDA Cardiac Safety Workshop

Silver Spring, Maryland, USA

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

Read more

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Committee Publications

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Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Adverse Drug-Induced Inotropic Effects in Early Drug Development. Part 1: General Considerations for Development of Novel Testing Platforms

Drug-induced effects on cardiac contractility can be assessed through the measurement of the maximal rate of pressure increase in the left ventricle (LVdP/dtmax) in conscious animals, and such studies are often conducted at the late stage of preclinical drug development. Detection of such effects earlier in drug research using ...

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A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium

Results from this limited retrospective electrocardiogram analysis suggest that JTpca and Tpeca may discriminate selective IKr blockers and multichannel blockers and could be considered in the context of an integrated comprehensive proarrhythmic risk assessment.

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The evaluation of endpoint variability and implications for study statistical power and sample size in conscious instrumented dogs.

The HESI Cardiac Safety Committee designed and conducted studies to evaluate inherent variability in telemetry implanted dogs. This paper discusses details of the statistical methods used to evaluate a primary endpoint for measuring blood pressure changes.

Read more

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