martes, 8 de agosto de 2017

FDA’s got a breakthrough approach for evaluating cardiac safety of new drugs: Register for CE credit for FDA’s Sept. 14 Grand Rounds webcast to find out!

fda header
Science Rounds Picture

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 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.

Did You Miss Our Last Grand Rounds?

Don't worry! Dr. Marc Allard's entire presentation on Genome Trakr is now available for your viewing pleasure.

And keep up with the latest advancements in regulatory science through FDA's academic partners, the FDA Centers of Excellence in Regulatory Science and Innovation, which feature the CERSI Lecture Series as well as workshops, publications, research, and fellowships

No hay comentarios: