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, 2020
Human stem cell-derived cardiomyocytes (hSC-CMs) hold great promise as in vitro models to study the electrophysiological effects of novel drug candidates on human ventricular repolarization. Two recent large validation studies have demonstrated the ability of hSC-CMs to detect drug-induced delayed ...
Journal of Pharmacological and Toxicological Methods, 2020
Zucker diabetic fatty (ZDF) rats are used widely as an animal model of metabolic syndrome and insulin resistance. Our study focused on the effects of high versus low dietary fat on the development of Type 2 diabetes in obese male ZDF rats (fa/fa), including biomarkers to detect early signs of hypercoagulability and vascular injury ...
Journal of Pharmacological and Toxicological Methods, 2020
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 ...
Nature Scientific Reports, 2020
Automated patch clamp (APC) instruments enable efficient evaluation of electrophysiologic effects of drugs on human cardiac currents in heterologous expression systems. Differences in experimental protocols, instruments, and dissimilar site procedures affect the variability of IC50 values characterizing drug block ...
Journal of Pharmacological and Toxicological Methods, 2019
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 ...
Frontiers in Pharmacology, 2019
Contractility of the myocardium engines the pumping function of the heart and is enabled by the collective contractile activity of its muscle cells: cardiomyocytes. The effects of drugs on the contractility of human cardiomyocytes in vitro can provide mechanistic insight that can support the prediction of clinical cardiac drug ...
hesi@hesiglobal.org
Phone: +1-202-659-8404
Fax: +1-202-659-3859
740 15th Street NW, Suite 600
Washington, DC 20005
Sign up for our monthly e-newsletter.