[Federal Register Volume 64, Number 63 (Friday, April 2, 1999)]
[Notices]
[Pages 15979-15980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8097]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Grants and Cooperative Agreements
Availability
AGENCY: National Cancer Institute, National Institutes of Health, PHS,
DHHS.
ACTION: Notice for CRADA Opportunities.
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SUMMARY: New HIV treatments and diagnostic methods: Opportunities for
Cooperative Research and Development Agreements (CRADAs) for the joint
evaluation and development of inhibitors for multidrug resistant HIV
and of methods to measure the biological and biochemical fitness of HIV
protease mutants, and to assay new protease inhibitors using these
methods.
Pursuant to the Federal Technology Transfer Act of 1986 (FTTA, 15
U.S.C. Sec. 3710; and Executive Order 12591 of April 10, 1987, as
amended by the National Technology Transfer and Advancement Act of
1995), 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 Cooperative Research and
Development Agreements (CRADAs) with pharmaceutical or biotechnology
companies to evaluate and develop new treatments and diagnostic methods
for the multidrug resistant HIV-infected population. 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 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 Development &
Commercialization Branch, National Cancer Institute--Frederick Cancer
Research & Development Center, Fairview Center, Room 502, Frederick, MD
21701 (phone: 301-846-5465, fax: 301-846-6820).
Scientific inquiries--Dr. John Erickson, Director, Structural
Biochemistry Program, National Cancer Institute--Frederick Cancer
Research & Development Center, P.O. Box B, Building 560, Room 12-68,
Frederick MD, 21702-1201 (phone: 301-846-1979; FAX: 301-846-6066).
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
May
[[Page 15980]]
3, 1999. Guidelines for preparing full CRADA proposals will be
communicated shortly thereafter to all respondents who have been
selected.
SUPPLEMENTARY INFORMATION:
Technology Available
DHHS scientists in the Structural Biochemistry Program, NCI-
Frederick Cancer Research and Development Center (SBP) have developed
certain structural and biochemically-based technologies that are
believed to be of value in the diagnosis and treatment of drug
resistant HIV. Using these technologies, SBP scientists have developed
strategies for designing inhibitors to multidrug resistant HIV, and for
predicting resistance-potentials of HIV protease inhibitors. Recent
evidence indicates that multidrug resistant HIV strains are appearing
in the drug-naive population at an increasing rate. Thus, the SBP
research is believed to be at a stage that is ripe for the development
of new treatments and diagnostic methods for the multidrug resistant
HIV-infected population. SBP is interested in a multi-disciplinary but
highly focussed approach to the biochemical and virologic evaluation of
protease inhibitors against clinically-derived drug resistant mutant
viruses, as well as in the structure-based design and chemical
synthesis of new protease inhibitors for testing.
The successful Collaborator should possess experience in the
following areas at a minimum: Experience with pre-clinical and clinical
drug development for antiretroviral compounds; ability to generate
site-directed mutant viruses for measurement of phenotypic resistance
with specific expertise in HIV; application of automation and robotics
technologies to cell culture-based antiviral assays and to enzyme-based
biochemical assays with specific expertise in HIV; application of
automation and robotics technologies to cell culture-based assays
designed to measure phenotypic resistance; application of database and
bioinformatics technologies for the manipulation, storage and analysis
of high throughput assay data, including the development of software as
required; and, the use of high throughput assay methods to evaluate
protease inhibitors against multidrug resistant HIV mutants.
DHHS now seeks collaborative arrangements for the joint evaluation
and development of methods to biochemical and virologic evaluate
protease inhibitors against clinically-derived drug resistant mutant
viruses, as well as in the structure-based design and chemical
synthesis of new protease inhibitors for further analysis. 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 full and 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 to the research project.
2. Providing the Collaborator with HIV drug resistant gene
sequences and protease inhibitors for 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 Government
activities.
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: March 25, 1999.
Kathleen Sybert,
Director, Technology Development & Commercialization Branch, National
Cancer Institute, National Institutes of Health.
[FR Doc. 99-8097 Filed 4-1-99; 8:45 am]
BILLING CODE 4140-01-P
