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.

Cardiac Safety Committee Early Career Seminar Award Series

The HESI Cardiac Safety Committee is excited to announce the winners for the committee’s new Early Career Seminar Award Series. This award offers an opportunity for postdocs and early career scientists to share their research, learn from, and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies, and pharmaceutical companies. Awardees receive a $500 USD award and are invited to present their research on a public webinar with Cardiac Safety Committee members and other invited guests.

Three awardees were selected for this inaugural Seminar Series:

  • Dr. Julia Hotek, Merck (see event details)
  • Dr. Arvin Soepriatna, Brown University
  • Dr. Shagun Krishna, NTP-NIEHS

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:
    Ksenia Blinova, PhD (US Food and Drug Administration)
    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.

    A 3-phased project was conducted by the HESI Pro-Arrhythmia Working Group starting with a detailed literature review and followed by a collaborative HESI-FDA database of 150 new drug candidates to evaluate how predictive nonclinical studies are to clinical outcomes.

    • Related Publication: The Challenges of Predicting Drug-Induced QTc Prolongation in Humans. Jean-Pierre Valentin, Peter Hoffmann, Catherine Ortemann-Renon, John Koerner, Jennifer Pierson, Gary Gintant, James Willard, Christine Garnett, Matthew Skinner, Hugo M Vargas, Todd Wisialowski, Michael K Pugsley. Toxicological Sciences. 11 February 2022

     

    Leadership Team:
    Jose Vicente Ruize, 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)
    Sandy Eldridge, PhD (National Cancer Institute)

    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 2022.

    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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Committee Publications

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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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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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Current Challenges in the Evaluation of Cardiac Safety During Drug Development: Translational Medicine Meets the Critical Path Initiative

American Heart Journal, 2009

Piccini JP, Whellan DJ, Berridge BR, Finkle JK, Pettit SD, ...

In October 2008, in a public forum organized by the Cardiac Safety Research Consortium and the Health and Environmental Sciences Institute, leaders from government, the pharmaceutical industry, and academia convened in Bethesda, MD, to discuss current challenges in evaluation of short- and long-term cardiovascular safety ...

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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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