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Appendix B Current Research and Development in Biotechnology in the United States and Japan The following information is a compilation of material from business and scientific journals and U.S. and Japanese researchers' personal knowledge and observations. It is not a comprehensive assessment. It is hoped that this summary will serve as a preliminary "road map" for researchers who wish to gain some familiarity with the institutions most actively involved in biotechnology R&D in Japan and the United States. BIOTECHNOLOGY IN JAPAN University: In addition to the inter-university basic research institutes at Okazaki, there are five major Japanese universities with notable biotechnology R&D efforts under way. Major research projects in specific aspects of biotechnology R&D are led by specific professors. The institutions are: University of Tokyo is active in the area of applied biological science research, including applied protein engineering and genetic engineering. Tokyo Institute of Technology has significant research in biosensors. Kyoto University has research focusing on plant cell culture, particularly in cell fusion and the introduction of nucleic acids into whole plant cells. University of Osaka has work under way on gene expression. Tsukoba University deserves mention for its research in plant biotechnology. 29

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30 Corporate: The following Japanese companies are notable for innovations in specific subareas of biotechnology:29 Takeda Chemical Industries, Japan's largest pharmaceuticals firm, where the focus of Takeda's research is on cell differentiation and safe vaccines. Takeda was the first to produce a domestic recombinant DNA pharmaceutical, alpha interferon, in 1988. NEC conducts work on biosensor chips, especially health-care-related chips. Mitsubishi Electric is involved with biosensor chips. Fujitsu is working on biosensor chips for medical diagnostics. Sumitomo Chemical, Mitsubishi Chemical, and Mitsubishi Toatsu Chemical, are active in cell fusion technology, focusing on the improvement of . . rice strains. In addition to these individual company efforts, there has been an increase in the number of private and MITI-funded biotechnology consortia over the past five years. The most notable are: Protein Engineering Research Institute. Funded by the Key Technology Center and organized in 1986 to run for 10 years, this consortium has a staff of 60 researchers from 15 companies, including Kyowa Hairdo, Takeda, Toa Nenryo, Toray, and Mitsubishi Chemical. Plant Cell Culture Technology Center (PCCTC). Also funded by the Key Technology Center, the PCCTC concentrates primarily on the development of plant cell culture technology, including rDNA and cell fusion techniques. Fermentation Research Institute (FRI). FRI is a MITI lab established in 1940 to help Japan create its fermentation technology. Biomchnology-related collaborative projects are designed with international cooperation and collaboration in mind are: Human Frontiers Science Program, proposed at the Venice Summit in 1987 by the Japanese government with an initial budget of $17 million for FY 1989. Research areas will focus on brain functions such as learning and biological functions achieved through molecular approaches such as molecular recognition. ERATO, which has had nine biotechnology projects (three have since concluded) in such areas as bioholonics, bioinformation transfer, and biophotons.30 29 Most of the information provided here on Japanese company and consortia biotechnology R&D is from the U.S. Department of Commerce, Research and Development in Biotechnology-Related Industries in Japan, 1989. 30 Japan Technology Evaluation Program, JTEClI Panel Report on the ERATO Program, December 1988.

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31 BIOTECHNOLOGY IN THE UNITED STATES University: Broken down by subarea, major biotechnology research is conducted at a wide number of institutions, including those listed below: Harvard University, Stanford University, California Institute of Technology, University of California at San Francisco, and University of California at Berkeley: recombinant DNA. University of Wisconsin and University of Minnesota: agricultural biotechnology. Massachusetts Institute of Technology, University of California at Berkeley, California Institute of Technology, Lehigh University: bioprocess technology and applied rDNA research. Corporate: In pharmaceuticals Eli Lilly and Merck dominate in terms of R&D resources and research quality, although Genentech and Cetus are dominant in actual biotechnology products. In the area of human health care products (protein engineering, applied rDNA, monoclonal antibodies), Genentech, Amgen, Centocor, and Cetus are leaders. In agricultural products the corporate leader is Monsanto. A major U.S. biotechnology consortium is the Engineering Research Center at MIT the Biotechnology Process Engineering Center. Founded in 1985' it focuses on fermentation technology, downstream processing, reactor kinetics, and cell culture. The center has a budget of $8 to $10 million, which supports 15 faculty members and about 70 students.