[Federal Register Volume 60, Number 54 (Tuesday, March 21, 1995)]
[Notices]
[Pages 14954-14955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6855]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Opportunity for a Cooperative Research
Agreement (CRADA) for the Scientific and Commercial Development of
Diagnostic and/or Therapeutic Agents for Hyperpigmentary Lesions
AGENCY: National Institutes of Health, PHS, DHHS.
ACTION: Notice.
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SUMMARY: The National Cancer Institute (NCI), seeks a pharmaceutical or
cosmetic company that can effectively pursue the scientific and
commercial generation and development of agents inhibiting
pigmentation. The project is of scientific importance since it will
characterize mechanisms whereby melanocyte function is compromised to
produce hyperpigmented lesions. As such, this research will seek to
provide insights into mechanisms responsible for clinically abnormal
hyperpigmentation such as occurs in postinflammatory hyperpigmentation
and other pigmentary diseases. NCI has successfully characterized the
melanogenetic functions of several pigmentary genes that are important
to the regulation of mammalian pigmentation. The NCI has produced a
number of specific antibodies which recognize those gene products as
well as a number of oligonucleotides and cDNAs whereby expression of
their encoding genes can be quantitated. The selected sponsor will
collaborate in a project aimed at using those probes to characterize
melanocyte function in hyperpigmentary conditions and to develop agents
useful commercially to down regulate melanogenic function.
ADDRESSES: Inquiries and proposals regarding this opportunity should be
addressed to Mark Noel or Bert Zbar (Telephone (301) 496-0477,
Facsimile (301) 402-2117), Office of Technology Development, National
Cancer Institute, Bldg 31, Room 4A49, National Institutes of Health,
9000 Rockville Pike, Bethesda, MD 20892
DATES: Proposals must be received at the above address by no later than
May 22, 1995.
SUPPLEMENTARY INFORMATION: ``Cooperative Research and Development
Agreement'' or ``CRADA'' means the anticipated joint agreement to be
entered into by NCI pursuant to the Federal Technology Transfer Act of
1986 and Executive Order 12591 of October 10, 1987 to collaborate on
the specific research project described below.
The NCI is seeking a pharmaceutical or cosmetic company which can
lend [[Page 14955]] resources and scientific expertise to a project
aimed at identifying mechanisms responsible for abnormal melanocyte
function in clinical hyperpigmentary conditions. Little is known about
the level of abnormal function of melanocytes in a number of clinical
conditions of hyperpigmentation, such as occurs in postinflammation,
wound healing and/or photodamaged/age pigmented lesions. This proposed
study will employ a number of antibodies specific for melanogenic
proteins to examine melanocyte function, and thus levels of melanogenic
protein expression, in such lesions. DNA probes specific for the
encoding genes will be used to characterize the level of abnormal
regulation of any gene products so identified. Approaches will be
designed to attempt to correct abnormal expression of such genes, or
the function of their encoded proteins and thus down-regulate
pigmentation in vitro, with the ultimate goal of developing
commercially useful therapeutic agents to treat conditions of epidermal
hyperpigmentation. Since pigment production is inherently associated
with photoprotection against UV-induced carcinogenesis, further benefit
of these studies towards photoprotection may evolve. The CRADA will
allow the selected partner to provide expertise and resources, in
collaboration with NCI, for the preclinical development of agents
useful in the treatment of epidermal hyperpigmentary conditions.
Further clinical development of such agents may also be made subject to
this agreement, or a separate agreement at a later date, and upon
mutual agreement of the parties.
The expected duration of the CRADA will be three (3) to five (5)
years.
The role of the National Cancer Institute, the Division of Cancer
Biology, Diagnosis and Centers includes:
1. NCI will provide specific antibodies and probes useful to examine
expression of pigmentary genes in hyperpigmented tissues.
2. NCI will perform enzymatic assays that measure melanogenic protein
function in hyperpigmented tissues.
3. NCI will examine melanocyte function via expression of pigmentary
genes in hyperpigmentary lesions.
4. NCI will screen potential inhibitors or down-regulators of
melanogenic activity using in vitro techniques with melanocytes in
culture.
5. NCI will collaborate with the corporate partner on the design of
experiments and evalutation of results.
The role of the successful corporate partner will include:
1. Supply expertise in melanocyte function in hyperpigmentary
disorders.
2. Supply potential melanogenic inhibitors or down-regulators of
melanogenic activity for testing.
3. Provide funds to support a postdoctoral fellow and associated
expenses of the study.
4. The corporate partner will collaborate with the NCI on the design of
experiments and the evaluation of results.
Criteria for choosing the collaborating company will include:
1. Experience in the study of hyperpigmentary disorders.
2. Ability to provide adequate amounts of potential melanogenic
inhibitors or down regulators of melanogenic activity for the
preclinical studies which are subject to the research plan.
3. Experience and ability to produce, package, market and distribute
pharmaceutical and/or cosmetic products, including experience with the
regulatory approval process and with the FDA.
4. Willingness to cooperate with the NCI in the collection, evaluation,
maintenance and publication of data from the investigation.
5. Willingness to share costs of the laboratory studies.
6. An agreement to be bound by DHHS rules involving the use of human
and animal subjects, and human tissue.
7. Provisions for equitable distribution of patent rights to any
inventions. Generally the rights of ownership are retained by the
organization which is the employer of the inventor, with (1) an
irrevocable, nonexclusive, royalty-free license to the Government (when
a company employee is the sole inventor) or (2) an option to negotiate
an exclusive or nonexclusive license to the company on terms that are
appropriate (when the Government employee is the sole inventor or where
a joint invention arises)
Thomas Mays,
Director, Office of Technology Development, National Cancer Institute.
[FR Doc. 95-6855 Filed 3-20-95; 8:45 am]
BILLING CODE 4140-01-P
