FDA unveils paradigm-busting model for evaluating cardiac safety of new drugs in Sept. 14 FDA Grand Rounds webcast. Register for CE credit!

FDA Grand Rounds

Don't miss the Sept. 14 FDA Grand Rounds webcast when FDA unveils a new paradigm for evaluating the cardiac safety of new drugs -- the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. Register here for CE Credit Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs Thursday, Sept. 14, 2017 12:00 p.m. -1:00 p.m. EST Presented by  David Strauss, MD, PhD Director, Division of Applied Regulatory Science FDA’s Center for Drug Evaluation and Research 4 things you'll learn from this FDA physician: 1. Why we need a new cardiac safety regulatory assessment model for drugs. 2. The different technologies being used to inform drug safety, including ion channel assays, in silico models, induced pluripotent stem cells, and biomarkers. 3. The potential for mechanistic, model-informed approaches to be used more broadly at FDA. 4. The benefits of research collaborations using public-private partnerships About the Presentation Between 1990 and the early 2000s, multiple drugs were removed from the market because they caused arrhythmias and sudden death.  In response, regulatory guidelines were implemented that have successfully prevented such occurrences by focusing on detecting hERG potassium channel block in cells and QT prolongation on the electrocardiogram.  However, this approach is not very specific because some drugs are flagged as posing a risk and thus can be dropped from development when they are actually safe. A new model, the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative, aims to be a more accurate and comprehensive, mechanistic-based assessment of drug safety.