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:
    Florence Poitout, PhD (Charles River Laboratories)
    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
    Alexandra Taraboletti, 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
    Claire O’Brien, PhD

  • Stem Cell Working Group

    This group is working to understand and characterize use of stem cellā€“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
    Alexandra Taraboletti, PhD

  • Past Working Groups

    FDA U01 Validating Stem Cell Technology: HESI has been awarded a multi-year U01 grant from the US FDA on the ā€œEvaluation of Integrated Human-Relevant Approaches to Identify Drug Induced Cardiovascular Liabilities.ā€ 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 ā€œfailure modes.ā€

    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.

    CiPA Project: The CiPA initiative begin following a workshop in July 2013 with the objective to improve the assessment proarrhythmic potential. HESI convened the CiPA Steering Team from 2013-2022 along with several of the work streams in support of novel data generation. The work has concluded and all data is publicly available on the CiPA website (https://cipaproject.org/) as well as additional information and links to ICH S7B/E14.

HESI Cardiac Safety 2026 Early Career Seminar Award Series is Open!

The HESI Cardiac Safety Committee seeks postdoctoral or early career researchers working in cardiovascular safety science or a related field for the Early Career Seminar Award Series. This award offers an opportunity to share your research, learn from and network with experts in the toxicology and safety pharmacology fields from academia, regulatory agencies and pharmaceutical companies.

Award: Selected candidates will receive a $500.00 USD award and be invited to present their research on a public webinar with HESI Cardiac Safety Committee scientists and other invited guests. Webinar dates will be scheduled with the awardees in Fall 2026.

Qualifications and Requirements: Eligible candidates must have a PhD or equivalent degree in biology or related field (cell biology, biochemistry, pathology, biomechanical engineering, or similar); have current post-doc position/appointment or consider themselves an early career scientist (~1-5 years post-academic training) and may not have previously received an award under this program.

Application: To apply, please send 1 PDF document with the following: 1) completed application form, 2) CV, and 3) one reference letter: cardiacsafety@hesiglobal.org.

Deadline for submission is 26 June 2026.

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

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Committee Publications

Filter

Health and Environmental Sciences Institute (HESI) Initiative on Moving Towards Better Predictors of Drugā€Induced Torsades de Pointes

British Journal of Pharmacology, 2008

Bass AS, Darpo B, Breidenbach A, Bruse K, Feldman HS, Garnes D, ...
  • HESI - Health and Environmental Sciences Institute

Knowledge of the cardiac safety of emerging new drugs is an important aspect of assuring the expeditious advancement of the best candidates targeted at unmet medical needs while also assuring the safety of clinical trial subjects or patients.

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Evaluation of Biomarkers to Detect Early Prothrombotic Imbalance in Rat Models of Hypercoagulability Induced by Thromboplastin Infusion and Hypofibrinolysis Induced by Tranexamic Acid

Toxicologic Pathology, 2025

Brooks et al.

In this new Toxicologic Pathology article from theĀ HESI Cardiac Safety Committeeā€™s Biomarkers Working Group, Brooks et al. systematically evaluate a suite of hemostatic biomarkers in rat models of tissue factorā€“driven hypercoagulability (thromboplastin infusion) and impaired fibrinolysis (oral tranexamic acid).

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Enhancing quality of life as a goal for anticancer therapeutics

Science Translational Medicine, 2016

Syril D. Pettit, Steven E. Lipshultz, Charles S. Cleeland, ...
  • HESI - Health and Environmental Sciences Institute

Advances in cancer therapy has resulted in more cancer survivors, and now quality of life throughout treatment and surviving years is becoming a new focus for the scientific community. There are often unintended toxicities related to cancer therapies. HESI established the THRIVE program to address quality-of-life research.

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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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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 ...

Read more

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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 ā€“ A HESI-Coordinated, Multi-Laboratory Comparison of 28 Drugs Across 3 Platforms

SPS2024

The Impact of Collaborative Science on Cardiovascular Safety Evaluation ā€“ 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:

 

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Health and Environmental Sciences Institute (HESI)

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