What's Hot in 2015: Cardiac Safety Assessment
It's been nearly 10 years since regulators overhauled guidelines to address the problem of drug-induced cardiac arrhythmia. Get ready for another sea change. The US Food and Drug Administration in concert with industry and academic partners has proposed a new strategy that places greater emphasis on accurate prediction of proarrhythmic drug effects through preclinical assessment of multiple cardiac ion channels, coupled with stem cell-derived human cardiomyocytes assays. The "Comprehensive In Vitro Proarrhythmia Assay" (otherwise known as CiPA) is expected to accelerate the development and increase the number of safe drugs that reach the market, benefiting both doctors and patients. Validation of this approach is proceeding at a feverish pace with the goal of reaching finalization by 2016. The unprecedented collaborative efforts of pharmaceutical, academic and contract research laboratories, together with regulatory agencies, will be required to achieve this goal. Stay tuned.