Grants and cooperative agreements; availability, etc.: targeted anticancer, antiviral, and antimicrobial drug leads; chemical optimization,

[Federal Register: November 8, 2002 (Volume 67, Number 217)]

[Notices]

[Page 68143-68144]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr08no02-99]

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.

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: shoemaker@dtpax2.ncifcrf.gov.)

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