[Federal Register Volume 63, Number 178 (Tuesday, September 15, 1998)]
[Notices]
[Pages 49360-49361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24810]
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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.
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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