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Hamner Institutes and UNC Launch International Drug Safety Institute

Published: Wednesday, June 17, 2009
Last Updated: Wednesday, June 17, 2009
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Scientific collaboration aims at improving drug safety and advancing drug development.

The Hamner Institutes for Health Sciences and the University of North Carolina at Chapel Hill have announced the launch of The Institute for Drug Safety Sciences, strategically located on The Hamner's 56-acre campus in RTP.

The Institute will be led by Dr. Paul Watkins, one of the world's leading experts in drug-induced liver injury who currently serves as the Verne S. Caviness Distinguished Professor of Medicine at UNC. As founding director for this research Institute, Watkins has assembled a core group of internal scientists and academic partners to develop new global drug safety initiatives in collaboration with the bio/pharmaceutical industry, the NIH and FDA.

A major initial focus will be to develop new computational models and in vitro assays, starting with evaluating liver toxicity and expanding into cardiovascular and kidney drug side effects.

The Institute for Drug Safety Sciences, which includes a 14,000-square-foot, state-of-the-art research laboratory, was unveiled at a grand opening on June 11. The event featured a keynote from Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, which oversees the approval and regulation of all U.S. medications.

The June 11 event built on a MOU signed by The Hamner and UNC in April 2008 and a $10M funding commitment established in September 2008. The Hamner-UNC partnership capitalizes on the scientific strengths of a leading university and an independent research institute, which are committed to accelerating advances in human therapeutics and public health, both in N.C. and internationally.

In March 2009, scientists at the Institute for Drug Safety Sciences launched their first research initiative in the study of drug-induced liver injury by forming a partnership with Entelos, a leading Silicon Valley computational modeling company. Besides being a main cause of acute liver failure in the U.S., liver toxicity is also the major reason global regulatory agencies take action on drugs, including denying approval for drug development candidates or withdrawing drugs from the marketplace.

By creating a virtual liver model, researchers hope to predict how pharmaceutical drugs and chemical agents damage the liver. The project supports the FDA's "Critical Path Initiative," which aims to reduce the time it takes to develop and approve safe and effective medical products.

The Institute for Drug Safety Sciences has also signed an agreement with the Shanghai Center for Disease Control to conduct a study in patients who have experienced liver toxicity as a result of taking drugs to treat tuberculosis. Knowledge from this study in China will enable the Institute to create strategies to develop safer drugs in the U.S., China, and worldwide.

Recently, The Hamner announced a translational research and business development partnership with China Medical City and Newsummit Biopharma to establish an Institute for International Drug Development to further enhance the process of taking drugs from the "bench to the bedside."

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