CAMBRIDGE, Mass., May 8 /PRNewswire/ -- In response to ever increasing
cardiac toxicity found in market drugs, Gwathmey Preclinical Testing
Services, Inc. today announced the launch of new Cardionomics(TM) services
and the formation of its Cardionomics(TM) 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major drugs had to be withdrawn in that period due to cardiac side effects.
When major drugs have to be withdrawn, the financial and safety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(TM) 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(TM) 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(TM) 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(TM) Services. All Cardionomics(TM) 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(TM) 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: http://www.gwathmey.com , or call 617-491-
0022 ext. 107.
SOURCE Gwathmey Preclinical Testing Services, Inc.
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Related links:
http://www.gwathmey.com
CONTACT:
Marie T. Oates for Gwathmey Preclinical
Testing Services, Inc., +1-617-290-7795
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