The Sept. 14 FDA Grand Rounds webcast discusses a new paradigm to assess the cardiac safety of new drugs-- the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative.
Register here for CE CreditDeveloping 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
David Strauss, MD, PhD4 Things You'll Learn From this FDA Physician
Director, Division of Applied Regulatory Science
FDA’s Center for Drug Evaluation and Research
1. Why we need a new cardiac safety regulatory assessment model for drugs.About the Presentation
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
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.