[Federal Register: September 15, 1998 (Volume 63, Number 178)] [Notices] [Page 49360-49361] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr15se98-93] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute: Opportunities for Cooperative Research and Development Agreements (CRADAs) for the Development and Evaluation of Chemokine or Chemokine Receptor Neutralizing Antibodies for Their Anti-Angiogenic Effects and Potential as Treatments for Cancer AGENCY: National Institutes of Health, PHS, DHHS. ACTION: Notice of opportunities for cooperative research and development agreements. ----------------------------------------------------------------------- SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. Sec. 3710; Executive Order 12591 of April 10, 1987 as amended by the National Technology Transfer and Advancement Act of 1995), the National Cancer Institutes (NCI) of the National Institutes of Health (NIH) of the Public Health Service (PHS) of the Department of Health and Human Services (DHHS) seeks Cooperative Research and Development Agreements (CRADAs) with pharmaceutical or biotechnology companies. Any CRADA for the biomedical use of this technology will be considered. The CRADAs would have an expected duration of one (1) to five (5) years. The goals of the CRADAs include the rapid publication of research results and timely commercialization of products, diagnostics and treatments that result from the research. The CRADA Collaborators will have an option to negotiate the terms of an exclusive or nonexclusive commercialization license to subject inventions arising under the CRADAs. ADDRESSES: Proposals and questions about this CRADA opportunity may be addressed to Dr. Thomas M. Stackhouse, Technology Development & Commercialization Branch, National Cancer Institute-Frederick Cancer Research and Development Center, P.O. Box B, Frederick, MD 21702-1201, Telephone: (301) 846-5465, Facsimile: (301) 846-6820. EFFECTIVE DATE: Organizations must submit a confidential proposal summary preferably one page or less, to NCI on or before September 29, 1998. Guidelines for preparing full CRADA proposals will be communicated shortly thereafter to all respondents with whom initial confidential discussions will have established sufficient mutual interest. SUPPLEMENTARY INFORMATION: Technology Available Recent publications show inhibition of angiogenic factors such as Interleukin-8 (IL-8) and another chemotactic cytokine GRO, reduce the growth of melanomas by interfering with the angiogenic effects of these tumors. DHHS scientists are working toward the identification and evaluation of other chemokines with angiogenic effects such as SDF- 1alpha. DHHS would like to test the effect of neutralizing antibodies to these chemokines and chemokine receptors on the growth, in animal models, of human tumors such as breast, prostate or lung. Publications outlining these developments are available on request, and descriptions of other (unpublished) advances can be obtained under a Confidential Disclosure Agreement. DHHS now seeks collaborative arrangements to test and develop such potential therapeutic antibodies. The successful CRADA collaborator will provide expertise and experience in the preparation of totally humanized anti-chemokine or anti-chemokine receptor antibodies, and will provide sufficient quantities of the humanized antibodies to complete the studies to be outlined under the Research Plan of the CRADA. NCI and the CRADA collaborator will perform tests using these humanized antibodies in various combinations, including combinations with other anti-tumor biologicals, such as humanized antibodies to epidermal growth factor receptors, which are known to have some anti- tumor activity. The Cooperative Research and Development Agreement (CRADA) will provide for distribution of intellectual property rights developed under the Agreement. CRADA aims will include rapid publication of research results as well as timely exploitation of any commercial opportunities. The role of the National Cancer Institute in this CRADA will include, but not be limited to: 1. Providing intellectual, scientific, and technical expertise and experience related to chemokines and chemokine receptors to the research project. 2. Planning and conducting some of the research studies in cell lines and [[Page 49361]] animal models and interpreting research results. 3. Publishing research results. The role of the CRADA Collaborator may include, but not be limited to: 1. Providing significant intellectual, scientific, and technical expertise or experience to the research project. 2. Planning research studies and interpreting research results. 3. Providing samples of the subject compounds to test, optimize and develop for their anti-angiogenic and anti-tumor potential. 4. Providing technical and/or financial support to facilitate scientific goals and for further design of applications of the technology outlined in the agreement. 5. Publishing research results. Selection criteria for choosing the CRADA Collaborator may include, but not be limited to: 1. The ability to collaborate with NCI on the research and development of this technology. This ability can be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to ongoing research and development. 2. The demonstration of adequate resources to perform the research and development of this technology (e.g. facilities, personnel and expertise) and accomplish objectives according to an appropriate timetable to be outlined in the CRADA Collaborator's proposal. 3. the willingness to commit best effort and demonstrated resources to the research and development of this technology, as outlined in the CRADA Collaborator's proposal. 4. The demonstration of expertise in the commercial development and production of products related to this area of technology. 5. The level of financial support the CRADA Collaborator will provide for CRADA-related Government activities. 6. The willingness to cooperate with the National Cancer Institute in the timely publication of research results. 7. The agreement to be bound by the appropriate DHHS regulations relating to human subjects, and all PHS policies relating to the use and care of laboratory animals. 8. The willingness to accept the legal provisions and language of the CRADA with only minor modifications, if any. These provisions govern the distribution of patent rights to CRADA inventions. Generally, the rights of ownership are retained by the organization that is the employer of the inventor, with (1) the grant of a license for research and other Government purposes to the Government when the CRADA Collaborator's employee is the sole inventor, or (2) the grant of an option to elect an exclusive or nonexclusive license to the CRADA Collaborator when the Government employee is the sole inventor. Dated: September 4, 1998. Kathleen Sybert, Acting Director, Office of Technology Development, National Cancer Institute, National Institutes of Health. [FR Doc. 98-24810 Filed 9-11-98; 3:08 pm] BILLING CODE 4140-01-M