The Cardiac Safety Committee convened a 2-day workshop to discuss mechanistic approaches to cardiovascular safety assessment.
Cardiac Safety Committee 2018 Workshop
May 15, 2018 – May 16, 2018
Boston, Massachusetts, USA
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.
The Cardiac Safety Steering Team is proud to present the second webinar series featuring the 2024 Early Career Seminar Series Awardees.
This competitive award is given to postdoctoral or early career scientists who have compelling research related to cardiovascular safety and risk assessment.
Three awardees were selected for the 2024 Seminar Series:
For webinar link contact: HESI Cardiac Safety cardiacsafety@hesiglobal.org
Past Award Winners
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
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.
Leadership Team:
Jose Vicente Ruize, PhD (US Food and Drug Administration)
Jean-Pierre Valentin, PhD (UCB Biopharma)
HESI Staff:
Jennifer Pierson, MPH
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
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)
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
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.”
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.
Associate Director for Program Development & Resourcing
jpierson@hesiglobal.orgUCB
US Food and Drug Administration
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May 15, 2018 – May 16, 2018
Boston, Massachusetts, USA
The Cardiac Safety Committee convened a 2-day workshop to discuss mechanistic approaches to cardiovascular safety assessment.
June 18, 2015 – June 19, 2015
Alexandria, Virginia, USA
This meeting was held 18-19 June 2015.
December 11, 2014
Silver Spring, Maryland, USA
This update workshop brought together global regulators, academicians, drug developers, and CRO scientists. The focus of the workshop was on providing information on the latest project developments with the goal for there to be a high level of participant interaction.
October 13, 2013 – October 17, 2013
Research Triangle Park, North Carolina, USA
This workshop was co-sponsored by the HESI Cardiac Safety Committee.
September 2, 2013 – September 4, 2013
Interlaken, Switzerland
HESI gave several presentations at Eurotox 2013.
July 23, 2013
Silver Spring, Maryland, USA
British Journal of Pharmacology, 2017
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 ...
Journal of Pharmacological and Toxicological Methods, 2017
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 ...
PLOS One, 2017
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 ...
Journal of Pharmacological and Toxicological Methods, 2017
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 ...
Science Translational Medicine, 2016
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.
Journal of Pharmacological and Toxicological Methods, 2016
The implementation of the ICH S7B and E14 guidelines has been successful in preventing the introduction of potentially torsadogenic drugs to the market, but it has also unduly constrained drug development by focusing on hERG block and QT prolongation as essential determinants of proarrhythmia risk.
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