FDA Grand Rounds: Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs—Sept. 14, 2017
“Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs” will address the public health and regulatory need for a new paradigm to assess cardiac safety of new drugs; the cutting edge science that underpins that paradigm; the current status of ongoing validation studies; and the expected impact of this novel mechanistic, model-informed approach.
David Strauss, MD, PhD
Director, Division of Applied Regulatory Science
FDA’s Center for Drug Evaluation and Research
In the 1990s to 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. Learn more about this presentation.
David Strauss, MD, PhD, is a leader in translational sciences regulatory research. Before serving in his current role as Director of the Division of Applied Regulatory Science in FDA’s Center for Drug Evaluation and Research (CDER), Dr. Strauss was Senior Advisor for Translational and Experimental Medicine in CDER’s Office of Clinical Pharmacology and a medical officer and premarket medical device reviewer in the Center for Devices and Radiological Health.
Thursday, September 14, 2017
12:00pm – 1:00pm EST
Register for the webcast here.
The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.