Cleveland, OH (PRWEB) April 17, 2014
ChanTest, the world’s most trusted ion channel expert, announces a complementary webinar entitled “Making Sense of the CiPA Initiative: a Paradigm Shift in Cardiac Safety”. The webinar will be moderated by Cambridge Healthtech Associates™ (CHA) and is scheduled to take place on April 24th, at 2PM EDT (11AM PST).
Dr. Philip Sager, member of the FDA Cardiovascular and Renal Drugs Advisory Committee and the CSRC Executive Committee, will be explaining the CiPA initiative. Dr. Sager, one of the authors of the recent CiPA white paper, will discuss this initiative with the CEO of ChanTest, Dr. Arthur ‘Buzz’ Brown.
The purpose of the paper is to: “move towards a consensus on defining a new paradigm in the field of cardiac safety in which proarrhythmic risk would be primarily assessed using nonclinical in vitro human models based on solid mechanistic considerations of torsades de pointes proarrhythmia. This new paradigm would shift the emphasis from the present approach that strongly relies on QTc prolongation (a surrogate marker of proarrhythmia) and could obviate the clinical Thorough QT study during later drug development.”
Additional information and registration details can be found here.
The webinar will include presentations by Dr. Philip Sager, Chair of the Scientific Programs Committee and co-author of the recent CiPA paper and Dr. Arthur “Buzz” Brown, Founder, President and CEO at ChanTest. The webinar will be moderated by Dr. Ernie Bush, Scientific Director at CHA.
Dr. Sager will discuss the current approach to cardiovascular safety assessments during drug development, the important limitations with this current methodology, and a potential new approach to drug-induced arrhythmia development. See the paper here.
Dr. Brown will then discuss the present nonclinical (S7B) and clinical (E14) assays for cardiac risk assessment of non-cardiac drugs and how regulators arrived at them. The initial concern was with Torsade de Pointes, a potentially lethal ventricular arrhythmia. TdP occurred infrequently but it was always associated with delayed repolarization and QTc prolongation. The rarity of TdP shifted emphasis to the detection of delayed repolarization. The shortcomings of this approach have become obvious and the CiPA initiative is meant to re-direct emphasis towards predicting the likelihood of TdP.
We invite everyone interested in discussing the new CiPA initiative to join the webinar.
Making Sense of the CiPA Initiative: Paradigm Shift in Cardiac Safety
DATE: Thursday, April 24, 2014
TIME: 2pm EDT (11am PDT)
DURATION: 1 Hour
About ChanTest® – The Ion Channel Expert
ChanTest’s mission is to serve the drug discovery and development needs of customers worldwide. Since its start in 1998, the Contract Research Organization has tested compounds for more than 300 global pharmaceutical and biotechnology companies. ChanTest also partners with these companies to accelerate the drug development process for the release of better, safer drugs.
ChanTest offers integrated ion channel and GPCR services (GLP and non-GLP) and reagents. The company’s library of validated ion channel cell lines, and nonclinical cardiac risk assessment service portfolio, is the most comprehensive commercial library available today.
Because of ChanTest’s influential role in the cardiac safety field, along with the company’s uncompromising commitment to quality, an independent survey has named ChanTest the “most trusted and most used fee-for-service provider” since 2006. ChanTest is based in Cleveland, Ohio.
Visit http://www.chantest.com to learn more about ChanTest.
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