[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Notices]
[Pages 25219-25220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12110]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute: VHL and MET Mutation Detection
Technology: Opportunities for Cooperative Research and Development
Agreements (CRADAs) for the Joint Evaluation and Development of Methods
to Detect Mutation in Both Gene Sequences Using Nucleic Acid Array
Technology
The methods may include but are not limited to spectroscopic
partitioning techniques and DNA chip technology. The NCI is looking for
multiple CRADA Collaborators to develop independently different aspects
of this VHL and MET mutation detection technology.
AGENCY: National Cancer Institute, National Institutes of Health, PHS,
DHHS.
ACTION: Notice for CRADA Opportunities.
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SUMMARY: Pursuant to Federal Technology Transfer Act of 1986 (FTTA, 15
U.S.C. 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 methods to detect mutations in both the MET and
VHL gene sequences using nucleic acid array technology. 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 publications of research results and
timely commercialization of products, diagnostics and treatments that
result from the research. The CRADA Collaborators will have an option
to elect a non-exclusive or exclusive commercialization license to
subject inventions arising under the CRADAs that are related to the DNA
array technology of the collaborators, which are the subject of the
CRADA Research Plan, for diagnostics and research supply and can apply
for background licenses to the existing patents listed below, subject
to any pre-existing licenses already issued for other fields of use.
Licensing by NIH is subject to 35 U.S.C. 207 and 37 CFR Part 404.
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 & Development Center, Fairview Center, Room 502, Frederick, MD
21701 (phone: 301-846-5465, fax: 301-846-6820).
Scientitific inquiries--Dr. Berton Zbar, Chief, Laboratory of
Immunobiology, National Cancer Institute-Frederick Cancer Research &
Development Center, P.O. Box B, Building 560, Room 12-68, Frederick MD,
21702-1201 (phone: 301-846-1288 FAX: 301-846-6145).
EFFECTIVE DATE: Inquiries regarding licensing and scientific matters
may be forwarded at any time. Confidential CRADA proposals, preferably
one page or less, must be submitted to NCI on or before July 6, 1998.
Guidelines for preparing full CRADA proposals will be communicated
shortly thereafter to all respondents who have been selected.
SUPPLEMENTARY INFORMATION:
Technology Available
DHHS scientists have identified mutations in the proto-oncogene c-
MET, and the von Hippel-Lindau disease (VHL) tumor suppressor gene in
human cancers. c-MET is the receptor for hepatocyte growth factor/
scatter factor. Germline mutations in the MET gene have been detected
in affected members of families with an inherited predisposition to
develop papillry renal carcinomas; somatic mutations in the MET gene
have been detected in a subset of papillary renal carcinomas. All
mutations detected in the MET gene to date were located in the tyrosine
kinase domain; all mutations were missense.
The VHL gene is mutated in patients with von Hippel-Lindau disease,
and in sporadic clear cell carcinomas of the kidney. Disease-causing
mutations include gender deletions (partial or complete), missense and
nonsense and frame shift mutations.
About 30,000 individuals develop kidney cancer each year. We
anticipate that the novel mutation detection techniques for the MET and
VHL genes will be used in patients with sporadic and inherited
predispositions to renal cancer. Possible uses would include diagnosis
and prognosis of kidney cancer. In addition, these new methods might be
applied to the study of other types of human neoplasia.
DHHS now seeks collaborative arrangements for the joint evaluation
and development of methods to detect mutations in both gene sequences
using nucleic acid array technology. The methods may include but are
not limited to spectroscopic partitioning techniques and DNA chip
technology. 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. The successful CRADA partner will
collaboratively develop and test known mutations within the genes from
samples provided by the government. CRADA aims will include rapid
publication of research results as well as full and timely exploitation
of any commercial opportunities.
NCI's VHL/MET Patents and Patent Applications
1. Von Hippel-Lindau(VHL) Disease Gene and Corresponding cDNA and
Methods for Detecting Carriers of the VHL Disease Gene; United States
Patent 5,654,138, issued August 5, 1997.
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 samples of the subject gene
sequences 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.
[[Page 25220]]
3. Providing technical expertise and/or financial support for (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.
8. The willingness to cooperate with the National Cancer Institute
in the timely publication of research results.
9. The agreement to be bound by the appropriate DHHS regulating to
human subjects, and all PHS policies relating to the use and care of
laboratory animals.
10. The willingness to accept the legal provisions and language of
the CRADA with only minor modifications, if any. These provisions
govern the equitable distribution of patent rights to CRADA inventions.
Dated: April 26, 1998.
Kathleen Sybert,
Acting Director, Technology Development & Commercialization Branch,
National Cancer Institute, National Institutes of Health.
[FR Doc. 98-12110 Filed 5-6-98; 8:45 am]
BILLING CODE 4140-01-M
