[Federal Register Volume 67, Number 217 (Friday, November 8, 2002)]
[Notices]
[Pages 68143-68144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute: Chemical Optimization of Molecular-
Targeted Anticancer, Antiviral and Antimicrobial Drug Leads

    An opportunity is available for a Cooperative Research and 
Development Agreement (CRADA) for the purpose of collaborating with the 
National Cancer Institute (NCI), Developmental

[[Page 68144]]

Therapeutics Program (DTP), Screening Technologies Branch (STB), on 
further research and development to optimize chemical structures of 
lead compounds exhibiting molecular-targeted anticancer, antiviral and/
or antimicrobial activities.

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) for collaborative optimization of small-
molecule screening leads for potency and pharmaceutical properties 
consistent with clinical development. The leads have been identified by 
STB using high-throughput screening and preliminary structure/activity 
study of 140,000 samples from the NCI Repository addressing 
a number of molecular targets of potential therapeutic significance. 
More specifically, a medicinal chemistry partner is sought for 
collaborative R&D to identify and resolve potential structural 
problems/features related to toxicity, formulation, chemical stability, 
metabolism, etc. Based on this analysis, lead compounds may be directly 
subjected to secondary and in vivo testing or a series of derivatives/
analogs may be designed to obviate problems. In a second stage, in vivo 
active compounds will be subjected to additional analysis and analogs 
will be synthesized to further optimize structure/activity properties. 
Any CRADA for the biomedical use of this technology will be considered. 
The CRADA would have an expected duration of one to five 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 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 Bjarne Gabrielsen, Ph.D., Technology Transfer Branch, 
National Cancer Institute-Frederick, Fairview Center, Room 500, 
Frederick, MD 21701 (phone: 301-846-5465, fax: 301-846-6820).
    Scientific inquiries should be directed to: Robert Shoemaker, 
Ph.D., Chief, Screening Technologies Branch, Developmental Therapeutics 
Program, Bldg. 440, P.O. Box B, National Cancer Institute, Frederick, 
MD 21702 (phone 301-846-6845; FAX 301-846-6844; e-mail: 
[email protected].)

DATES: 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. Review of proposals will 
begin within 90 days from date of this publication and will continue 
until a suitable collaborator(s) is identified. 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

    DTP scientists within the STB have extensive experience with both 
cell-free and cell-based molecular targeted screens and a track record 
of moving screening discoveries into clinical testing. Targeting the 
HIF-1-[alpha] (Hypoxia Inducible Factor-1) and CEBP-[alpha] (CCAAT/
Enhancer Binding Protein [alpha]) signaling pathways relevant to cancer 
are among the current top priorities. Substantial effort has also been 
directed recently towards identification of novel inhibitors of HIV-1 
assembly. Additional opportunities are anticipated.

Technology Sought

    Accordingly, DHHS now seeks collaborative arrangements for chemical 
optimization of drug screening leads. The successful Collaborator 
should possess experience in the following areas at a minimum: 
Evaluation of structural features of lead molecules, design of 
derivative molecules with advantageous properties, solid and solution 
phase synthesis of individual compounds and focused libraries, 
molecular modeling of ADME drug properties, etc. 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 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 
(such as authentic standards for lead molecules) 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 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.
    7. The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    8. 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.
    9. 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: November 1, 2002.
Kathleen Sybert,
Chief, Technology Transfer Branch, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 02-28540 Filed 11-7-02; 8:45 am]
BILLING CODE 4140-01-P