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.

HESI Cardiac Safety Committee Request for Proposals

 

The HESI Cardiac Safety Committee seeks research proposals for studies involving human-relevant, mechanism-based assays evaluating cardiac safety liabilities. In 2019, the HESI Cardiac Safety Committee was awarded a U01 grant from the U.S. FDA on the “Evaluation of Integrated Human-Relevant Approaches to Identify Drug-Induced Cardiovascular Liabilities.” This grant will support HESI in funding and managing novel, in vitro experimental studies to develop targeted mechanistic data to inform drug safety assessment for key cardiac “failure modes.” HESI Cardiac Safety Committee members identified six main failure modes, CV liabilities contributing to drug attrition, as follows:

1. Vasoactivity changes (blood pressure/heart rate)
2. Inotropy changes (contractility/ejection fraction)
3. Action potential changes (electrophysiology)
4. Cardiomyocyte/Myocardial injury (myocardial necrosis/hypertrophy)
5. Valvular injury/proliferation (regurgitant flow)
6. Endothelial injury/coagulation (hemorrhage, thrombosis)

HESI is seeking proposals for a 12-month sub-award under this grant for studies involving human-relevant, mechanism-based assays evaluating cardiac safety liabilities.

Read More About the RFP

Letter of Intent Form

Biosketch Template

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

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

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 simpler, in vitro test systems would be a valuable addition to our strategies for identifying the best possible drug development candidates.

Read more

Assessing drug-induced long QT and proarrhythmic risk using human stem cell-derived cardiomyocytes in a Ca2+ imaging assay: Evaluation of 28 CiPA compounds at three test sites

A consortium, multi-site approach to testing in vitro assay technology for prediction of drug-induced TdP. The authors sought to test calcium transient assays using the CiPA 28 drugs.

Read more

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