FDA Grand Rounds: The comprehensive in vitro proarrhythmia assay (CiPA) initiative

Dear All: 

Per an email received today, there will be an FDA Grand Rounds webcast on 14 Sep 2017 (noon-1p EST) in which FDA unveils a new paradigm for evaluating the cardiac safety of new drugs entitled the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. Here is the link to the FDA webpage where you can get further details and register for CE Credit. I provide some of the extended information below my signature.

Context from the email I received: 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.

My futher notes: This is exciting to see! I don’t follow this area as closely as I should, but the idea that preclinical measures offer a way to improve on the current cumbersome approach to evaluating cardiac risk. This idea appears to have been discussed and endorsed (pending ongoing validation studies; see Cavero 2016, DOI 10.1016/j.vascn.2016.05.012) at a 15 Mar 2017 FDA Advisory Committee meeting. Hence, I suspect that everybody who does drug development will want to know about this.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog.html

Extended information about the Grand Rounds
Title: Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
Date: Thursday, Sept. 14, 2017
Time: 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

Per the email, here are 4 things you’ll learn from this webinar:

  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

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