Biovista Inc. and FDA to Collaborate on a Medication Safety Initiative
By Biovista Inc., PRNEMonday, January 11, 2010
CHARLOTTESVILLE, Virginia, January 12 - Biovista Inc. today announced that the U.S. Food and Drug Administration
(FDA) has licensed its technology platform to help analyze, identify, and
better understand the way certain drugs can cause harmful side effects.
The FDA's Office of Clinical Pharmacology, within the Center for Drug
Evaluation and Research (CDER), will test the use of Biovista's Adverse Event
Analysis (AEA) technology and work closely with Biovista scientists to
carefully study the serious side effects of several drugs or classes of
drugs, identified by FDA, to help promote safer use of these medications. The
goal of the collaboration is to explore the possibility of being able to
predict which patients may be most likely to experience adverse reactions to
these medications so that healthcare providers can better protect their
safety.
"We look forward to working with Biovista and using its technology
platform which may help reduce risks associated with using certain
medications and help improve how healthcare providers go about selecting the
drugs they prescribe for their patients," said Lawrence J. Lesko, Ph.D.,
Director of the Office of Clinical Pharmacology at CDER. "This license is an
example of how FDA hopes to work with leading-edge technologies and
collaborators to meet the goals of the agency's Safe Use Initiative."
"We are very pleased to collaborate with FDA in the analysis of drug side
effects, using our AEA technology. CDER's Office of Clinical Pharmacology has
a track record of innovation. We believe FDA's new Safe Use Initiative is a
natural fit for our unique AEA technology, and we look forward to working
closely with FDA and potentially helping to improve the safe use of drug
products," said Aris Persidis, Ph.D., President of Biovista Inc.
About Biovista's Adverse Event Analysis technology
Biovista's AEA technology forms part of the company's Clinical Outcomes
Search Space (COSS(tm)) platform that focuses on mechanism of action-based
correlations between drugs, disease efficacy and adverse events. The AEA
technology cross-correlates over 8,000 diseases and 12,000 adverse events
known to medicine against any target, drug or combination. This enables
researchers to link pre-clinical experimental data directly with potential
clinical outcomes, and to explore the possible risks of adverse events from a
mechanistic perspective. It also helps researchers explain adverse events
after these occur, in cases where these events were unexpected or not
monitored for during trials, and to differentiate the causes of adverse
events among a drug or the underlying disease.
About the Safe Use Initiative
The goal of FDA's Safe Use Initiative is to reduce preventable harm by
identifying specific, preventable medication risks and developing,
implementing and evaluating cross-sector interventions with partners who are
committed to safe medication use.
For more information, please contact: Dr. Aris Persidis Biovista, Inc. arisp@biovista.com +1-434-242-6514
For more information, please contact: Dr. Aris Persidis, Biovista, Inc., arisp at biovista.com, +1-434-242-6514
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