Dr Steve Jenkinson, VP Drug Discovery and Safety Assessment, Metrion

The evaluation of cardiac safety continues to be a major concern in the realm of new drug applications, particularly due to unforeseen cardiomyopathy side effects. Accordingly, cardiac safety is a required FDA evaluation for all drug candidates, regardless of their drug class. This seminar will center on assessing the safety of the Comprehensive in Vitro Proarrhythmia (CiPA) library for determining cardiotoxicity risk by leveraging the automated Lumencor Volta Scanner. The CiPA library with its array of compounds ranging in safety from nontoxic to toxic to human cardiomyocytes is a well-accepted tool for characterizing sensitivity and selectivity for therapeutic safety. The CiPA library will be tested at three specific time points: baseline, 1-hour, and 24-hours post exposure. Dose response curves will be generated to evaluate potency and reproducibility. Subsequently, an analysis of the safety profiles for each compound will be conducted to predict the risk of cardiotoxicity, focusing on parameters such as QTc and QRS interval length.