Cardiocore

Cardiocore CMO presents at the Society of Toxicology 48th Annual Meeting

Washington, DC – 23.February.2009 – Cardiocore, a premier centralized cardiac testing lab, announced today that its Chief Medical Officer, Dr. Lawrence Satin, MD, FACC, will discuss the evaluation of QT prolongation and Torsades de pointes in accordance with ICH S7B and E14 guidelines, at the Society of Toxicology 48th Annual Meeting, on March 17th, at the Baltimore Convention Center, in Baltimore, Maryland.


At the meeting, Dr. Satin, one of the world’s leading research cardiologists and a pioneer in cardiac safety testing for clinical trials, will present Current Status of Pre-Clinical Assessment of Cardiac Safety in the Development of Non-Cardiac Drugs, and the Latest Update to The Guidance for Industry E-14.


Although a negative integrated pre-clinical assessment does not negate the need to evaluate the cardiac safety of new chemical entities in the United States, concern remains high for the continued industry practice of abolishing exploratory development of new compounds on the basis of a single positive hERG test. In November 2008, the FDA Interdisciplinary Review Team for QT assessment issued a clarification to the original E-14 Guidance for Industry, that was originally published in October 2005. Dr. Satin’s discussion will examine the potential impact of this latest update on the conduct of Through QT trials.


Details about this SOT meeting may be accessed through Cardiocore’s web site at http://www.cardiocore.com/news/events/.


 
About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 16 years. Services include centralized electrocardiography (ECG), Holter, echocardiography (ECHO), multigated acquisition scans (MUGA), and consulting services such as protocol development, scientific reporting and statistical analyses. The company is experienced in the design and the implementation of cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. www.cardiocore.com


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