Comprehensive In Vitro Proarrhythmia Assay (CIPA)
The primary goal of the CIPA initiative is to utilize mechanistic understanding of cardiac electrophysiology to create a more predictive biomarker for drug-induced Torsades de Pointes (TdP). The current biomarkers of hERG ion channel block and QT prolongation are highly sensitive endpoints with low selectivity and thus potentially result in unnecessary attrition.
The results from this initiative are expected to lead to modifications or replacement of the existing ICH S7a/b guidelines and elimination of E14 guidelines. An overview of the CIPA program and associated meetings can be found here.
CDI has a strong commitment to the advancement of stem cell-based science and its implementation for new and safer medicines. To that end, CDI is working to further the goals of the initiative, providing not only scientific and logistical input to the Steering and Myocyte committees but also supplying human iPSC-derived cardiomyocytes and the training necessary to reach the stated goals of the project.
ECG Trace of Torsades de Pointes
Drugs with antirhythmigenic properties can trigger abnormal cardiac rhythms including the electrocardiograph shown where a prolonged QT interval leads to ventricular tachycardia. Drug-induced TdP is caused by cardiac ion channel blockage leading to abnormal heart rhythm. If left untreated, TdP can cause sudden death.