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Press Release Contact: Marie T. Oates
617-290-7795
Increased Drug Related Cardiac Toxicity Leads Gwathmey Preclinical Testing Services to Create Novel Cardionomics™ Services for Preclinical Cardiac Safety Screening of Drug Candidates
Cambridge, MA, May 9, 2008 - In response to ever increasing cardiac toxicity found in market drugs, Gwathmey Preclinical Testing Services, Inc. today announced the launch of new Cardionomics™ services and the formation of its Cardionomics™ Advisory Board to provide new methods and technologies to improve cardiac safety of drug candidates.
Cardiac toxicity has played a major role in shutting down the sales of major drugs over the past 30 years. It is estimated that 28 percent of major drugs had to be withdrawn in that period due to cardiac side effects. When major drugs have to be withdrawn, the financial and safety consequences for the global pharmaceutical industry can be huge in terms of patient related morbidity and mortality, lost revenue and large-scale legal actions.
“Breakthroughs in the basic understanding of cardiovascular biology combined with powerful new large throughput biotechnological tools have provided the foundation for new, rational, and technologically sophisticated screening methods in cardiovascular therapeutics. Cardionomics takes advantage of these new methodologies with its internal cardiovascular technology and its network of cardiovascular leaders,” said Roger J. Hajjar, M.D., Professor of Medicine, Director, Cardiovascular Research Center, Mount Sinai School of Medicine. Dr. Hajjar will be speaking about innovative approaches to preventing cardiac toxicity in new drugs at the World Pharmaceutical Congress in Philadelphia on May 12, 2008 when he gives a presentation entitled: “Evaluation of Cardiotoxicity of Novel Molecular Therapies.”
“The topic of cardiac safety of new drugs is one that has long been a priority for pharmaceutical companies. Cardiac drug safety has taken on additional urgency in recent years. Gwathmey Preclinical Testing Services, Inc. has developed its new suite of Cardionomics™ Services to help answer a growing need among drug makers for skilled, specialized, and immediately available cardiac safety screening expertise and technologies. With this new service, we will design and execute stronger preclinical studies to help eliminate the risk of cardiac safety issues in drugs before they hit the pipeline” said Dr. Judith Gwathmey, President and CSO of Gwathmey Preclinical Testing Services, Inc.
Features of Gwathmey Preclinical’s Cardionomics™ Services include:
- Cardiac catheterization
- Pressure-volume determinations
- Isolated perfused hearts
- Telemetry
- Echocardiography
- Electrocardiography
- Isolated muscle studies (animal and human)
- Human heart failure tissue cDNA array for human pharmacogenomics and toxicogenomics
These kinds of pre-clinical services on animal models are typically only available in major university settings, which can make easy and immediate access to them difficult.
“Dr. Judith Gwathmey has a record of performing important work in heart failure over several decades. Cardionomics™ is an extension of her interest and expertise in this arena. Support for development of highly innovative management strategies will facilitate drug discovery, a needed boost for the field of heart failure,” said Gary S. Francis, M.D., Section Head, Clinical Cardiology at the Cleveland Clinic.
Dr. Gwathmey, who conceived this new service concept, is a world-renowned cardiac scientist. She has one of the most cited papers in heart failure research on calcium handling in human myocardium. It has remained in the top fifty most cited papers for over 25 years. Dr. Gwathmey has authored over 160 manuscripts on cardiovascular disease including arrhythmias, cardiac myocyte function, ischemia and global heart function in normal and disease states. She is the author of the highly regarded text book: “Heart Failure: Basic Science and Clinical Medicine,” cited by the New England Journal of Medicine.
In support of the new services, Gwathmey Preclinical Testing Services, Inc. has assembled a world-class physician and researcher advisory board for its Cardionomics™ Services. All Cardionomics™ Advisory Board members are highly-sought after scientists with vast experience and significant industry and academic excellence, as well as specialized expertise in running clinical trials. Furthermore, the panel members have taken concepts from the bench side all the way to clinical trials and therefore have extensive experience in navigating the FDA field.
“The Cardionomics Services and Advisory Board provide a unique approach and solution to prevent new drugs from posing cardiac risk. This kind of original and innovative thinking is typical of Dr. Gwathmey, who has been at the forefront of heart failure research for over 20 years,” said Michael Bristow, M.D., Ph.D. founder of Myogen, and founder and CEO of ARCA Biopharma.
Gwathmey Preclinical Testing Services, Inc. Cardionomics™ Advisory Board Members include:
Gary Francis, M.D.
Section Head, Clinical Cardiology
Cleveland Clinic
Roger J. Hajjar, M.D.
Professor, Medicine / Cardiology Professor
Mt. Sinai Department of Gene and Cell Medicine
Barry M. Massie, M.D., F.A.C.C.
Chief, Cardiology Division
VA Hospital
University of California, San Francisco
Michael Rosen, M.D.
Professor of Pharmacology and Pediatrics
Columbia University College of Physicians and Surgeons
Stephen F. Vatner, M.D.
Chair, Cell Biology and Molecular Medicine, Professor
University of Medicine and Dentistry of New Jersey
About Gwathmey Preclinical Testing Services, Inc.
Gwathmey Preclinical Testing Services, Inc. supports biotechnology and pharmaceutical companies to meet their scientific and financial goals through a disciplined approach that maximizes quality, throughput and process efficiency. We are continually performing process improvement, through the skills of thought leaders and an expert team which can deliver cost-saving solutions to complex problems.
Clients are guaranteed a speedy start and completion of all projects. Gwathmey's team asks the right questions in order to optimize project design, enabling our clients to make stronger research and business decisions.
For more information, please visit: www.gwathmey.com, or call 617-491-0022 ext. 107