FDA Workshop on Leveraging Human-Relevant Cardiomyocytes in Nonclinical Studies to Provide Mechanistic Insights into Cardiovascular Safety Liabilities
FDA Cardiac Safety Workshop
March 29, 2019
Silver Spring, Maryland, 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.
National Institute of Environmental Health Sciences, National Toxicology Program
US Food and Drug Administration
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
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.
Frontiers in Pharmacology, 2019
Drug-induced effects on cardiac contractility can be assessed through the measurement of the maximal rate of pressure increase in the left ventricle (LVdP/dtmax) in conscious animals, and such studies are often conducted at the late stage of preclinical drug development. Detection of such effects earlier in drug research using ...
Toxicological Sciences, 2019
A consortium, multi-site approach to testing in vitro assay technology for prediction of drug-induced TdP. The authors sought to test calcium transient assays using the CiPA 28 drugs.
International Journal of Toxicology, 2018
Results from this limited retrospective electrocardiogram analysis suggest that JTpca and Tpeca may discriminate selective IKr blockers and multichannel blockers and could be considered in the context of an integrated comprehensive proarrhythmic risk assessment.
Cell Reports, 2018
The HESI Cardiac Safety Myocyte Subteam completed a validation study with the CiPA 28, two commercial human cardiomyocyte cell lines, 5 devices across 10 sites. The results are published here.
Toxicological Sciences, 2018
J Pharmacol Toxicol Methods., 2018
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.
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859
740 15th Street NW, Suite 600
Washington, DC 20005
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