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Press Release

Chriss Swaney

For immediate release:
December 4, 2002

Carnegie Mellon Students to Develop New Web Site to Help Tissue Engineering Companies Streamline FDA Applications

WHAT: Carnegie Mellon students are developing a new Web site to help tissue engineering companies navigate the complex U.S. Food and Drug Administration (FDA) regulatory process. Under the direction of Civil Engineering Professor Mitch Small, graduate and undergraduate students from the Department of Engineering and Public Policy, the Social and Decision Sciences Department, and the H. John Heinz III School of Public Policy and Management are creating models to help companies understand how to classify products when applying for FDA approval, which can take years.

The average development time for getting a drug to market is 15 years with a cost of more than $800 million, according to the Pharmaceutical Manufacturing Association. Two of the nationšs largest tissue engineering companies - Organogenesis and Advanced Tissue Sciences - recently filed for bankruptcy after spending more than $500 million to get products to market, including one product designed as a skin substitute for burn victims, industry analysts said.

A panel of industry experts, including TissueInformatics Inc. Senior Vice President David Smith, will assess student presentations at Carnegie Mellon. "We are extremely interested in the work being done in the areas of tissue engineering public policy by Carnegie Mellon students," said Smith, a chief counsel at the Pittsburgh-based company, which is developing products to accelerate the development of new tissue engineering products.

WHEN: 3 p.m., Wednesday, Dec. 4, 2002

WHERE: Baker Hall, Room 129, Carnegie Mellon University


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