Comprehensive Identification of Cardiovascular Safety Liabilities Using a Totality of Evidence
A totality of evidence approach is a recommended way to evaluate the cardiovascular safety of new drugs and to help mitigate the risk of potential issues that could halt or terminate their clinical evaluation. This approach combines data from several different assay platforms and methods, which include:
CiPA7 (Catalog number - CPROFULLPHYSQB2DR): A panel of assays that measure the effect of drugs on seven cardiac ion channels at physiological temperature, to better simulate human testing conditions.
In silico modeling: A computer simulation that integrates the CiPA7 data and predicts the potential risk of a drug to cause cardiac arrhythmia. Please contact our cardiac safety expert for your modeling needs.
Micro-Electrode-Array (MEA) (Catalog number - PCiPAMEADR): A technique that uses iPSC-derived cardiomyocytes to model and record the electrical activity of the cells in the heart in order to detect any unexpected effects of drugs on cardiac transporters and exchangers.
BioMAP® biomarker assays (Catalog number - 89-0050-0903): A phenotypic translational biology platform of human biology and disease models, which employ mixed co-cultures of various primary cell types, including vascular endothelial cells, coronary artery smooth muscle cells, and macrophages, along with an extensive reference database and powerful data analytics, to identify potential toxicity signatures for adverse cardiovascular events, such as organ toxicity, thrombosis, and vascular toxicity, as well as to identify the pathways and targets involved.
This webinar discusses the current challenges and best practices in applying a totality of evidence approach to cardiovascular safety assessment, and provides examples of how different types of data and assay methods can be integrated to generate reliable, comprehensive, and actionable translational evidence for better decision making.