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 Open Innovation Challenge Call for Submissions: Characterizing Drug Exposures During In Vitro Cardiovascular Safety Mechanistic Assay Systems
HESI announces a new Open Science Challenge: Innovation in Characterizing Drug Exposures During In Vitro Cardiovascular Safety Mechanistic Assay Systems. This challenge comes from the HESI Cardiac Safety Committee U01 Advisory Team. They are seeking ideas (theory or tested) to help understand the robustness and reproducibility of mechanistic in vitro assay systems. Idea submissions are due 23 July 2021. A later call for proposals will be issued to fund and test the winning idea(s). Learn more about the Open Science Challenge call for submissions here.

Working Groups

  • Stem Cell Working Group

    This group is working to understand and characterize use of stem cell–derived cardiomyocytes in cardiac safety assessments. An article that included best practices for use of stem cell cardiomyocytes in cardiac safety assessments was published in Regulatory Toxicology and Pharmacology. A new group is planning a study to explore in vitro assay ability to detect cardiotoxicity.

    Leadership Team:
    Gary Gintant, PhD (AbbVie)
    Godfrey Smith, PhD (University of Glasgow)

    HESI Staff:
    Jennifer Pierson, MPH

  • Pro-Arrhythmia Working Group

    This working group is dedicated to investigating mechanisms of proarrhythmic risk. They continue to collaborate with the CiPA Initiative and ICH, and recently published its anticipated high throughput systems (HTS) ion channel work. A new subteam is scoping a conduction/ sodium channel paper to discuss the history and challenges surrounding this topic.

    Leadership Team:
    John Koerner, PhD (US Food and Drug Administration)
    Jean-Pierre Valentin, PhD (UCB Biopharma)

    HESI Staff:
    Jennifer Pierson, MPH

  • Integrative Strategies Working Group

    This working group has examined the sensitivity within a preclinical species to assess the function of contractility. They continue their partnership with University of Surrey and Imperial College London on a mathematical model to predict blood pressure changes. The Implanted Telemetry Subteam explored the impact of telemetry lead placement in toxicology studies (a collaboration with the Pro-Arrhythmia Working Group).

    Leadership Team:
    Michael Pugsley, PhD (Cytokinetics)
    Brian Berridge, DVM, PhD (National Institute of Environmental Health Sciences, National Toxicology Program)

    HESI Staff:
    E’Lissa Flores, PhD

  • Cardiac Biomarkers Working Group

    This working group is dedicated to investigating preclinical cardiac biomarkers of hypercoagulability induced under a thrombotic state, in both normal and diseased states. A manuscript was submitted detailing a study investigating the effects of doxorubicin in Zucker diabetic fatty rats. A new study is in the planning stages using xenobiotics to induce the procoagulant state and confirm measurements of biomarkers of interest.

    Leadership Team:
    Eric Schultze, PhD (Eli Lilly & Company)
    Marjory Brooks, DVM (Cornell University)

    HESI Staff:
    E’Lissa Flores, PhD

  • Cardiac Compound Tool (CCT) Database Subteam

    The Cardiac Safety Steering Team established this new subteam in early 2020 to develop and provide a structured resource for use when identifying compounds appropriate in a planned committee study. Delivery of this publicly accessible database is anticipated by the end of 2020.

    HESI Staff:
    Jennifer Pierson, MPH

  • COVID-19 Subteam

    This subteam was organized in May 2020 in response to the ongoing pandemic. Subteam members identified that emerging treatments for the novel coronavirus may have cardiotoxicities. The group is exploring how to gather cardiac safety data on five emerging therapies, whether prospective or retrospective, and develop a publication.

    HESI Staff:
    Jennifer Pierson, MPH

HESI Staff

Leadership Team

  • Brian Berridge, DVM, PhD

    National Institute of Environmental Health Sciences, National Toxicology Program

  • Norman Stockbridge, MD, 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

Read more

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Committee Publications

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

Regulatory Toxicology and Pharmacology, 2020

Gintant G, Kaushik EP, Feaster T, Stoelzle-Feix S, Kanda Y, ...

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 ...

Read more

Use of the ZDF Rat to Model Dietary Fat Induced Hypercoagulability is Limited by Progressive and Fatal Nephropathy

Journal of Pharmacological and Toxicological Methods, 2020

Pugsley MK, Brooks MB, Fishman CE, Katavolos P, Chiang AY, ...

Zucker diabetic fatty (ZDF) rats are used widely as an animal model of metabolic syndrome and insulin resistance. Our study focused on the effects of high versus low dietary fat on the development of Type 2 diabetes in obese male ZDF rats (fa/fa), including biomarkers to detect early signs of hypercoagulability and vascular injury ...

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

Journal of Pharmacological and Toxicological Methods, 2020

Rossman EI, Cools F, Cordes J, Dhuyvetter D, Doyle JM, ...

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 ...

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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

Nature Scientific Reports, 2020

Kramer J, Himmel HM, Lindqvist A, Stoelzle-Feix S, Chaudhary KW, ...

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 ...

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

Journal of Pharmacological and Toxicological Methods, 2019

Pfeiffer-Kaushik ER, Smith GL, Cai B, Dempsey GT, ...

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 ...

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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

Frontiers in Pharmacology, 2019

Ribeiro A, Guth BD, Engwall M, Eldridge S, Foley CM, Guo L, ...

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 ...

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