[Federal Register Volume 66, Number 176 (Tuesday, September 11, 2001)]
[Notices]
[Pages 47232-47233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute: Development of Inhibitors of the 
Hypoxia Inducible Factor (HIF-1) Transcriptional Activation Pathway

    An opportunity is available for a Cooperative Research and 
Development Agreement (CRADA) for the purpose of collaborating with the 
National Cancer Institute (NCI), Division of Cancer Treatment and 
Diagnosis (DCTD), Developmental Therapeutics Program (DTP), Screening 
Technologies Branch (STB), on further research and development of small 
molecule inhibitors of the Hypoxia Inducible Factor 1 (HIF-1) 
transcriptional activation pathway.
AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
DHHS.

ACTION: Notice of opportunities for cooperative research and 
development.

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 
15 U.S.C. 3710, as amended; and Executive Order 12591 of April 10, 
1987), the National Cancer Institute (NCI) of the National Institutes 
of Health (NIH) of the Public Health Service (PHS) of the Department of 
Health and Human Services (DHHS) seeks a Cooperative Research and 
Development Agreement (CRADA) with a pharmaceutical or biotechnology 
company to develop novel small molecule inhibitors of the Hypoxia 
Inducible Factor 1 (HIF-1) transcriptional activation pathway. Any 
CRADA for the biomedical use of this technology will be considered. The 
CRADA would have an expected duration of one (1) to five (5) years. The 
goals of the CRADA include the rapid publication of research results 
and timely commercialization of products, diagnostics and treatments 
that result from the research. The CRADA

[[Page 47233]]

Collaborator will have an option to elect a non-exclusive or exclusive 
commercialization license to subject inventions arising under the CRADA 
and which are subject of the CRADA Research Plan.

ADDRESSES: Proposals and questions about this CRADA opportunity may be 
addressed to Dr. Bjarne Gabrielsen, Technology Transfer Branch, 
National Cancer Institute-Frederick, Fairview Center, Room 502, 
Frederick, MD 21701 (phone: 301-846-5465, fax: 301-846-6820).
    Scientific inquiries should be directed to: Giovanni Melillo, M.D., 
DTP-Tumor Hypoxia Laboratory, Bldg 432, Rm 218, National Cancer 
Institute, Frederick, MD 21702 (phone 301-846-5050; FAX 301-846-6081; 
e-mail: [email protected]) or Robert H. Shoemaker, Ph.D., 
Screening Technologies Branch, Bldg 440, National Cancer Institute, 
Frederick, MD 21702.

EFFECTIVE DATE: Inquiries regarding CRADA proposals and scientific 
matters may be forwarded at any time. Confidential CRADA proposals, 
preferably two pages or less, must be submitted to the NCI on or before 
October 11, 2001. 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

    DHHS scientists within the DTP-STB Tumor Hypoxia Laboratory have 
developed a number of human tumor cell lines engineered to express the 
luciferase reporter gene in an HIF-1 dependent fashion. These 
engineered cell lines express high levels of luciferase when cultured 
under hypoxic conditions and can be used as a tool for discovering 
small molecules that inhibit HIF-1 transcriptional activity.

Technology Sought

    Accordingly, DHHS now seeks collaborative arrangements for the 
joint elucidation, evaluation and development of small molecules that 
inhibit the HIF-1 pathway. The successful Collaborator should possess 
experience in the following areas at a minimum: preclinical research 
and drug development of HIF-1 inhibitors, performance of in vitro 
assays targeting HIF-1 transcriptional activity, development of in 
vitro and in vivo models targeting hypoxia induced angiogenesis. For 
collaborations with the commercial sector, a Cooperative Research and 
Development Agreement (CRADA) will be established to provide equitable 
distribution of intellectual property rights developed under the CRADA. 
CRADA aims will include rapid publication of research results as well 
as development of the technology toward commercialization.
    The role of the National Cancer Institute-Screening Technologies 
Branch (STB) in this CRADA will include, but not be limited to:
    1. Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    2. Providing the Collaborator with pertinent available reagents for 
investigation/evaluation.
    3. Planning research studies and interpreting research results.
    4. 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 technical expertise and/or financial support (e.g. 
facilities, personnel and expertise) for CRADA-related research as 
outlined in the CRADA Research Plan.
    4. Accomplishing objectives according to an appropriate timetable 
to be outlined in the CRADA Collaborator's proposal.
    5. The willingness to commit best effort and demonstrated resources 
to the research, development and commercialization of this technology.
    6. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this area of 
technology.
    8. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    9. 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.
    10. The willingness to accept the legal provisions and language of 
the CRADA with only minor modifications, if any. These provisions 
govern patent rights to CRADA inventions.

    Dated: August 24, 2001.
Kathleen Sybert,
Chief, Technology Transfer Branch, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 01-22793 Filed 9-10-01; 8:45 am]
BILLING CODE 4140-01-P