This meeting was held 18-19 June 2015.
Cardiac Safety Committee
Cardiac Safety Committee
The mission of the HESI Cardiac Safety Technical Committee is to: improve public health by reducing unanticipated cardiovascular-related adverse effects from drugs or chemicals; and develop innovative approaches to support early detection and prediction as well as improved understanding of cardiovascular toxicology and pathobiology.
Stan Parish, PhD
Jennifer Pierson, MPH
Brian Berridge, PhD
Norman Stockbridge, PhD
US Food and Drug Administration
Committee Members and Fact Sheet
Cardiac News and Notes
(CNN) Quarterly Newsletter
Committee SharePoint Login
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 extracellular vesicle (EV) profiles.
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 no established translation to humans. The goal of these studies was to determine whether assessment of alternate measures of cardiac inotropy could detect drug-induced changes in the contractile state of the heart using drugs known to have clinically relevant positive and negative effects on myocardial contractility. This study also evaluated drug-induced effects on lusitropy (relaxation) parameters of the heart.
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.
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.
Evaluating whether a new medication prolongs QT intervals is a critical safety activity that is conducted in a sensitive animal model during non-clinical drug development.