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.
Regulatory Toxicology and Pharmacology, 2013
Cardiovascular (CV) safety concerns are a significant source of drug development attrition in the pharmaceutical industry today.
Journal of Pharmacological and Toxicological Methods, 2013
The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals.
International Journal of Toxicology, 2011
There are several recent examples where clinically significant, safety-related, drug effects on hemodynamics or cardiac function were not apparent until large clinical trials were completed or the drugs entered the consumer market.
Toxicologic Pathology, 2010
We investigated the kinetics of circulating biomarker elevation, specifically correlated with morphology in acute myocardial injury.
Journal of Pharmacological and Toxicological Methods, 2010
Cardiovascular safety concerns are a significant cause of attrition in the development of new drugs (Lasser et al., 2002).
American Heart Journal, 2009
In October 2008, in a public forum organized by the Cardiac Safety Research Consortium and the Health and Environmental Sciences Institute, leaders from government, the pharmaceutical industry, and academia convened in Bethesda, MD, to discuss current challenges in evaluation of short- and long-term cardiovascular safety ...
hesi@hesiglobal.org
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