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 Early Career Seminar Award Series

The HESI Cardiac Safety Committee seeks Postdoctoral or Early Career researchers working in cardiovascular safety science or 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 Q1 2025.
  • 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. Open to both domestic and international applicants.
  • Application: To apply, please send 1 PDF document with the following: 1) completed application form, 2) CV, and 3) one reference letter: to Jennifer Pierson or Claire O’Brien at cardiacsafety@hesiglobal.org.
  • Deadline for Submission: 15 November 2024
Past Award Winners

Past Award Winners

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:
    Jennifer Pierson, MPH
    Claire O’Brien, 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)

  • 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.

    HESI Staff:
    Jennifer Pierson, MPH

  • 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.

HESI Staff

Leadership Team

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

    UCB

  • Norman Stockbridge, MD, PhD

    US Food and Drug Administration

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

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

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Committee Publications

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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.

Read more

An evaluation of the utility of LVdP/dt40, QA interval, LVdP/dtmin and Tau as indicators of drug-induced changes in contractility and lusitropy in dogs

Journal of Pharmacological and Toxicological Methods, 2017

Michael K. Pugsley, Brian Guth, AlanY. Chiang, ...
  • HESI - Health and Environmental Sciences Institute

The importance of drug-induced effects on the inotropic state of the heart is well known. Unlike hemodynamic and cardiac electrophysiological methods, which have been routinely used in drug safety testing for years, the non-clinical assessment of drug effects on myocardial contractility is used less frequently with ...

Read more

Non-Lethal Endotoxin Injection: A Rat Model of Hypercoagulability

PLOS One, 2017

Marjory B. Brooks, James R. Turk, Abraham Guerrero, ...
  • HESI - Health and Environmental Sciences Institute

This article characterizes a time course model of inflammation and hemostatic activation in rats treated with bacterial endotoxin (lipopolysaccharide, LPS) through a combination of traditional histologic and clinicopathologic endpoints and analyses of novel circulating biomarkers, including microRNA (miRNA) and ...

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Cardiac contractility: Correction strategies applied to telemetry data from a HESI-sponsored consortium

Journal of Pharmacological and Toxicological Methods, 2017

E. Boulay, M.K. Pugsley, V. Jacquemet, A. Vinet, M.V. Accardi, ...
  • HESI - Health and Environmental Sciences Institute

Heart rate correction methods are frequently used when analyzing data collected during the drug development process to better understand the QT interval. There is variability in this methodology and the optimal heart rate correction formula is often debated. This paper details a study that explored the ...

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Can Nonclinical Repolarization Assays Predict the Results of Clinical Thorough QT Studies? Results from a Research Consortium.

British Journal of Pharmacology, 2017

Park EJ, Gintant GA, Bi D, Kozeli D, Pettit SD, Pierson JB, ...
  • HESI - Health and Environmental Sciences Institute

The strengths and limitations of three nonclinical repolarization assays used to define the risk of clinical drug-induced delayed ventricular repolarization (a surrogate marker of the rare but potentially lethal arrhythmia Torsades de Pointes) were compared during a retrospective analysis of an anonymized database of 150 ...

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The evaluation of endpoint variability and implications for study statistical power and sample size in conscious instrumented dogs.

J Pharmacol Toxicol Methods., 2018

Chiang AY, Guth BD, Pugsley MK, Foley CM, Doyle JM, Engwall MJ, ...
  • HESI - Health and Environmental Sciences Institute

The HESI Cardiac Safety Committee designed and conducted studies to evaluate inherent variability in telemetry implanted dogs. This paper discusses details of the statistical methods used to evaluate a primary endpoint for measuring blood pressure changes.

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