Cardiac Safety Committee

Mission Statement

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

Committee Contacts

HESI Staff

 

Stan Parish, PhD
sparish@hesiglobal.org

Jennifer Pierson, MPH
jpierson@hesiglobal.org

Leadership Team

Brian Berridge, PhD 
National Toxicology Program, US Department of Health and Human Services

Norman Stockbridge, PhD
US Food and Drug Administration

Members and Fact Sheet

CiPA in Hindsight Roundtable

Members Corner

Cardiac News and Notes
(CNN) Quarterly Newsletter

Committee SharePoint Login

Interested in CiPA?
Visit the CiPA website

Committee Events

FDA Cardiac Safety Workshop

Silver Spring, USA

FDA Public 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

All Publications

Repolarization Studies Using Human Stem Cell-Derived Cardiomyocytes: Validation Studies and Best Practice Recommendations

Human stem cell-derived cardiomyocytes (hSC-CMs) hold great promise as in vitro models to study the electrophysiological effects of novel drug candidates on human ventricular repolarization. Two recent large validation studies have demonstrated the ability of hSC-CMs to detect drug-induced delayed repolarization and “cellrhythmias” (interrupted repolarization or irregular spontaneous beating of myocytes) linked to Torsade-de-Pointes proarrhythmic risk. These (and other) studies have also revealed variability of electrophysiological responses attributable to differences in experimental approaches and experimenter, protocols, technology platforms used, and pharmacologic sensitivity of different human-derived models.

Read more

Echocardiographic and Hemodynamic Indices of Myocardial Contractility Simultaneously Evaluated in Telemetered Beagle Dogs: A HESI-Sponsored Cross-Company Evaluation

Alterations in cardiac contractility can have significant clinical implications, highlighting the need for early detection of potential liabilities. Pre-clinical methods to assess contractility are typically invasive and their translation to human measures of cardiac function are not well defined. Clinically, cardiac function is most often measured non-invasively using echocardiography. The objective of these studies was to introduce echocardiography into standard large animal cardiovascular safety pharmacology studies and determine the feasibility of this combination.

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Cross-Site and Cross-Platform Variability of Automated Patch Clamp Assessments of Drug Effects on Human Cardiac Currents in Recombinant Cells

Automated patch clamp (APC) instruments enable efficient evaluation of electrophysiologic effects of drugs on human cardiac currents in heterologous expression systems. Differences in experimental protocols, instruments, and dissimilar site procedures affect the variability of IC50 values characterizing drug block potency. This impacts the utility of APC platforms for assessing a drug’s cardiac safety margin. We determined variability of APC data from multiple sites that measured blocking potency of 12 blinded drugs (with different levels of proarrhythmic risk) against four human cardiac currents (hERG [IKr], hCav1.2 [L-Type ICa], peak hNav1.5, [Peak INa], late hNav1.5 [Late INa]) with recommended protocols (to minimize variance) using five APC platforms across 17 sites.

Read more

Electrophysiological Characterization of Drug Response in hSC-Derived Cardiomyocytes Using Voltage-Sensitive Optical Platforms

Voltage-sensitive optical (VSO) sensors offer a minimally invasive method to study the time course of repolarization of the cardiac action potential (AP). This Comprehensive in vitro Proarrhythmia Assay (CiPA) cross-platform study investigates protocol design and measurement variability of VSO sensors for preclinical cardiac electrophysiology assays.

Read more

Considerations for an In Vitro, Cell-Based Testing Platform for Detection of Drug-Induced Inotropic Effects in Early Drug Development. Part 2: Designing and Fabricating Microsystems for Assaying Cardiac Contractility With Physiological Relevance Using Human iPSC-Cardiomyocytes

Contractility of the myocardium engines the pumping function of the heart and is enabled by the collective contractile activity of its muscle cells: cardiomyocytes. The effects of drugs on the contractility of human cardiomyocytes in vitro can provide mechanistic insight that can support the prediction of clinical cardiac drug effects early in drug development. Cardiomyocytes differentiated from human-induced pluripotent stem cells have high potential for overcoming the current limitations of contractility assays because they attach easily to extracellular materials and last long in culture, while having human- and patient-specific properties.

Read more

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