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.

Working Groups

  • Cardiac Biomarkers Working Group

    This working group is dedicated to investigating preclinical cardiac biomarkers of hypercoagulability denoting increased thrombotic risk across diverse patient populations. In order to qualify novel and sensitive biomarker assays, we undertook preliminary pilot studies and have just completed a more comprehensive comparative study of distinct procoagulant and hypofibrinolytic stimuli. Data analyses and manuscript preparation are in progress, with submission in a peer reviewed journal planned for early 2025.

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

  • Cardiac Compound Tool (CCT) Database Subteam

    The Cardiac Safety Steering Team established this subteam in early 2020 to develop and provide a structured resource for use when identifying compounds appropriate in a planned committee study. The database was published April 2024.

    Additional compound suggestions will be reviewed annually.

    HESI Staff:
    Jennifer Pierson, MPH

  • Integrative Strategies Working Group

    This working group completed their partnership with the University of Surrey and Imperial College London on a mathematical model to predict blood pressure changes. The resulting manuscript was published in 2024. The new subteam exploring blood pressure measurements expanded to include a focus on developing nonclinical data in support of draft FDA guidance on pressor effects. This expansion resulted in new members joining the team. The interlaboratory study to assess changes in BP in the canine in vivo cardiovascular model is underway. This study is using telemetry recording methods to detect positive and negative effects as a result of drug exposures for compounds with known BP effects in the clinic.

    Leadership Team:
    Michael Pugsley, PhD (Cytokinetics)

    HESI Staff:
    Jennifer Pierson, MPH
    Claire O’Brien, PhD

  • 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:
    Todd Bourcier, PhD (US Food and Drug Administration)
    Jean-Pierre Valentin, PhD (UCB Biopharma)

    HESI Staff:
    Jennifer Pierson, MPH

  • 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

  • Past Working Groups

    FDA U01 Validating Stem Cell Technology: HESI has been awarded a multi-year U01 grant from the US FDA on the “Evaluation of Integrated Human-Relevant Approaches to Identify Drug Induced Cardiovascular Liabilities.” This grant supports 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.”

    FDA BAA Ion Channel Patch Clamp Study: HESI received a Broad Agency Announcement (BAA) award from the US FDA to manage a multi-site study on manual and automated patch clamp platforms. The original study included 4 ionic currents (hERG, Nav1.5 peak, Nav1.5 late and Cav1.2) and 14 compounds and has been expanded to include a total of 28 compounds. The project aims to collect additional information on inter-laboratory variability as well as support the FDA in silico model. Learn more about the recommended ion channel protocols and in silico model here.

Congratulations to the Cardiac Safety 2025 Early Career Seminar Series Awardees

This award offers postdoctoral or early career researchers working in cardiovascular safety science an opportunity 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 receive a $500.00 USD award and are invited to present their research via a public webinar with HESI Cardiac Safety Committee scientists and other invited guests. Webinar dates are listed below.

2025 Awardees

Past Award Winners

Past Award Winners

HESI Staff

Leadership Team

  • Jean-Pierre Valentin, PhD, HDR, ERT, FRSB, FRCPath, DSP

    UCB

  • Ksenia Blinova, PhD

    US Food and Drug Administration

Committee Events

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Safety Pharmacology Society Annual Meeting 2024

September 22, 2024 – September 25, 2024

San Diego, California, USA

We are thrilled to see the announcement from the Safety Pharmacology Society that the 2024 Distinguished Service Award (DSA) recipient is Dr. Norman Stockbridge!

Read more

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Committee Publications

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The incidence of spontaneous arrhythmias in telemetered beagle dogs, Göttingen Minipigs and Cynomolgus non-human primates: A HESI consortium retrospective analysis

Journal of Pharmacological and Toxicological Methods, 2023

Emmanuel Boulay, LoĂŻs S. Miraucourt, Michael K. Pugsley, ...

Members of the HESI Cardiac Safety Committee pooled retrospective data to explore the incidence of spontaneous arrhythmias and effect of telemetry implants in species typically used in safety pharmacology studies.

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The Challenges of Predicting Drug-Induced QTc Prolongation in Humans

Toxicological Sciences, 2022

Jean-Pierre Valentin, Peter Hoffmann, Catherine Ortemann-Renon, ...

New publication in Toxicological Sciences by the HESI Cardiac Safety Committee shows that nonclinical models used to predict cardiac safety during drug development do not absolutely replicate the clinical conditions; however, best practices can be used to improve the nonclinical assay quality and achieve the ...

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

Journal of Pharmacological and Toxicological Methods, 2021

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

The study (Pugsley et al., 2021. Journal of Pharmacological and Toxicological Methods) focused on the effects of high versus low dietary fat on the development of Type 2 diabetes in obese male ZDF rats, including biomarkers to detect early signs of hypercoagulability and vascular injury in the absence of overt thrombosis. Results ...

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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, ...
  • HESI - Health and Environmental Sciences Institute

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 ...

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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, ...
  • HESI - Health and Environmental Sciences Institute

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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Posters

Click box below to view full poster

Variability of manual patch clamp hERG data generated using standardized protocols and following ICH S7B Q&A 2.1 best practices

SPS2024

Assessing Variability of hERG Data Generated Using a Mock Action Potential Waveform and Automated Patch Clamp Platforms – A HESI-Coordinated, Multi-Laboratory Comparison of 28 Drugs Across 3 Platforms

SPS2024

The Impact of Collaborative Science on Cardiovascular Safety Evaluation – A 10-Year Update of the HESI Cardiac Safety Committee

SPS2023

Development of a Pharmaceutical Database to support the Nonclinical Evaluation of Drug-Induced Cardiac Toxicity

SPS2023

Heart Rate Corrected JTp and TpTe as Proarrhythmia Biomarkers in Safety Pharmacology Non-Human Primate Studies: Outcome from a HESI Consortium Prospective Study

SPS2023

Center for Translational Sciences

The Cardiac Safety Committee is part of the Center for Translational Sciences. This HESI Center serves as a focal point for staff to share strategic approaches, scientific developments, management best practices and innovations with other related HESI committees.

Other Committees in the Center for Translational Sciences are:

For questions about the Center contact:

 

Contact Us

Health and Environmental Sciences Institute (HESI)

hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-8403

740 15th Street NW, Suite 600
Washington, DC 20005

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