FDA Grand Rounds

The Sept. 14 FDA Grand Rounds webcast is filling up fast.

Don't miss the chance to ask FDA your questions about its breakthrough approach for evaluating the cardiac safety of new drugs.

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

5 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
5. Answers to your own questions about this breakthrough model.

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.