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Executive Summary

NIH SMALL BUSINESS TECHNOLOGY TRANSFER GRANTS: PILOT PROGRAM will commence with the National Institutes of Health's mid- September release of a request for applications (RFA) inviting small businesses to submit proposals for fiscal year 1994 STTR awards. The institutes intend to send out approximately 8,000 solicitations for 40 NIH-wide FY 1994 Phase I awards. The grants, for $100,000 each, will be selected through a peer review process conducted by the specific institute bestowing the award. NIH has not yet forecast the number of proposals that it expects in response to the RFAs. Applications will be accepted through Dec. 1. The STTR program provides that a portion of NIH's extramural research or R&D effort is reserved for award to small business concerns for Cooperative Research & Development agreements (CRADAs) with non-profit research institutions. The program was established as Title II ("Small Business Technology Transfer Act of 1992") of the Small Business R&D Enhancement Act, which became law Oct. 28. The STTR Act authorizes federal agencies to establish STTR Pilot Programs if their FY 1994, 1995 or 1996 extramural budgets for research or R&D exceed $1 bil. The agencies involved in the STTR program are HHS, the National Science Foundation, the Department of Defense, the National Aeronautics and Space Administration and the Department of Energy. A Small Business Administration directive on the STTR program published in the Aug. 10 Federal Register states that "not less than 40% of the work conducted" under the program "is to be performed by the small business concern, and not less than 30% of the work is to be performed by the non-profit research institution." Both the small business and the research institution involved in an STTR collaboration must be U.S.-based. Research institutions that may participate in the program include colleges and universities, not-for-profit research institutions and "contractor-operated federally funded research and development center[s]." While NIH prepares to embark upon its initial solicitation of research proposals for the STTR program, the institutes' Small Business Innovation Research grants program continues to flourish. Twenty NIH institutes funded $98.5 mil. in research through the SBIR program in FY 1992. The funds were used for 550 Phase I grants, 47 Phase I contracts, 140 Phase II grants and 14 Phase II contracts. Estimates for FY 1993 SBIR grant awards from the 20 institutes totals $118.3 mil., a 20.1% increase in funding. Three recent SBIR grantees include the transgenic animal R&D firm GenPharm International; the antisense company Isis Pharmaceuticals and the gene therapy start-up GeneMedicine. On Aug. 24, GenPharm International announced receipt of two Phase II SBIR grants from the National Institute of Allergy and Infectious Diseases. Under one SBIR grant, GenPharm will attempt to develop novel immunodeficient mice using the company's gene targeting technology. The other award supports the development of specific transgenic animals that express immunoglobulin genes. Both areas of research were initially supported through Phase I SBIR grants. With the two new grants, GenPharm has received support from NIH totaling $1 mil., the company noted. On Aug. 17, Isis Pharmaceuticals announced receipt of two NIH- funded SBIR Phase II awards -- one is from the National Cancer Institute and the other from NIAID -- totaling almost $1 mil. The NCI award will allow Isis "to gain additional insights into the life cycle of the papillomavirus, and complements the company's work being undertaken" in Phase II trials of ISIS 2105, which is being tested as a treatment for human genital warts, the company said. The NIAID award will involve a 27-month study to delineate further antisense oligonucleotides that demonstrated "potent antiviral activity" against the herpes simplex virus-1 in Phase I. An additional NIH-sponsored SBIR grant was recently awarded to GeneMedicine ("The Pink Sheet" Aug. 9, T&G-10). The grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases is for research in skin disease therapies using a novel DNA expression vector (HK1).

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