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 that applications are now being accepted for the committee’s new Early Career Seminar Award Series. This award offers an opportunity for postdocs to share their research, learn from, and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies, and pharmaceutical companies. Selected candidates will receive a $500 USD award and will be invited to present their research on a public webinar with Cardiac Safety Committee members and other invited guests. Webinar dates will be scheduled with the awardees in Q1 2022.

The deadline to apply is 15 November 2021. To learn more and to apply, please click 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

Filter

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

Moving Towards Better Predictors of Drug‐Induced Torsades de Pointes

Drug-induced torsades de pointes (TdP) remains a significant public health concern that has challenged scientists who have the responsibility of advancing new medicines through development to the patient, while assuring public safety.

Read more

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

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 ...

Read more

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