Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed)

Cardiovascular toxicity is a leading cause of drug attritionin drug development. Proarrhythmia, QT prolongation and Torsade de Point (TdP)contribute the most to this attrition and these outcomes drive the effortsspent to eliminate them from the drug discovery pipeline. Currently, theseendpoints are evaluated through invivo preclinical studies followed by a thorough-QT (TQT) study inthe clinical phase. T FDA seeks new assays to replace non-clinical cardiotoxicity assessments.Specific interest is in assays based on human cells or materials, collectivelycovering the spectrum of cardiotoxic drug effects.