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Executive Summary

"FDA may expend up to $ 3 mil." to renovate part of its facilities at the National Center for Toxicological Research (NCTR) in Arkansas "for a national biotechnology cooperative," FDA Commissioner Frank Young announced at an Oct 11 biotechnology conference in Laguna Niguel, Calif. FDA plans to make the new facilities available to small biotech companies and academic groups who do not have access to similar "state-of-the-art" facilities for their research. The FDA initiative will be a "demonstration project" for which the agency will "solicit industry and academic advice in terms of its structure and purpose," Young remarked. The $ 3 mil. in funding for "biotechnology demonstration projects for developing public or private cooperatives" was earmarked by a provision in the Senate bill of the total FDA FY 1989 appropriations of $ 531.4 mil., signed into law on Oct 1 ("The Pink Sheet" Oct 3, p. 3). Young indicated that FDA may seek further increases in funding for the biotechnology project in fiscal 1990. Collaboration between the government and small biotech companies is a goal of FDA's Action Plan. Other aspects of the plan include increased consultation before IND and during clinical trials to reduce the time required for testing and approval, and the involvement of the Patent Office and other government agencies to insure intellectual property protection. Promoted as a revitalization plan for the biotechnology industry, the pilot project is focused on increasing biotech competitiveness in the world market by providing funding for facilities that might normally require significant capital investment. According to the FDA commissioner, NCTR, based in Jefferson, Ark., has 400,000 square feet of "high-level containment" available to the demonstration project. "It need only be renovated," maintained Commissioner Young, "which can be done much more inexpensively than new construction." The facility, which has a total of 1 mil. sq. ft., was used until 1959 for the development of biological weapons and has since been primarily used for testing of cancer agents in animals. Renovation of the facilities may take up to three years. The project will include individual labs as well as a core facility with sophisticated instruments and scale-up capacity to be shared by the companies or academic groups. NCTR activities already include animal breeding. Acreage surrounding the facilities could be potentially used for experimentation with large animals, an FDA spokesman said. Once the project is underway, FDA will contract with a consortium of universities to run the facilities. Commissioner Young also announced plans for a second "cooperative biotechnology laboratory" with "200,000 square feet of laboratory space," located in Chicago. According to Young, the new center will be able to house two fermentation vats "for scale-up work of a proprietary nature." "FDA has joined with the Illinois Institute of Technology (IIT), the IIT Research Institute, and the University of Illinois to establish a National Laboratory for Food Safety and Technology," the commissioner said. Nothing that small U.S. firms in the food technology industry are often not able to "develop their own inventions," Young commented that FDA's intention is keep such products in the U.S. rather having those companies license their inventions to, for example, the Japanese."

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