[Federal Register Volume 63, Number 210 (Friday, October 30, 1998)]
[Notices]
[Pages 58403-58404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29074]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute: Opportunities for Cooperative Research
and Development Agreements (CRADAs) for the Joint Evaluation and
Development of Methods to Generate and Expand In-Vitro Modified
Dendritic Cell Populations in Order to Elicit Phenotype Specific Immune
Responses
The NCI is looking for CRADA Collaborators to jointly develop this
dendritic cell immunology technology.
AGENCY: National Cancer Institute, National Institutes of Health, PHS,
DHHS.
[[Page 58404]]
ACTION: Notice for CRADA opportunities.
-----------------------------------------------------------------------
SUMMARY: Pursuant to the 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 generate, expand and modify dendritic
cells to act in an immunologically specific manner. The Collaboration
will focus on the development and evaluation of conditions for specific
immunomodulatory maneuvers focused on induction of Th1 and Tc1 biased
immune responses by dendritic cells. Additionally, the collaboration
will include the characterization of human dendritic cell phenotypic
subsets including the generation of subset specific reagents. These
research efforts would be directed by our evolving understanding of
dendritic cell biology which includes both the characterization of
cytokine expression by dendritic cells (production and regulation of
production) and the characterization of dendritic cell responses to
both known and as yet uncharacterized cytokines.
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 which are the subject of the CRADA
Research Plan.
ADDRESSES: Statements of interest, proposals and questions about this
CRADA opportunity may be addressed to Gary Cuchural, 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 may be addressed to Dr. Edward Nelson,
Immunotherapy Laboratory, NCI Clinical Services Program, National
Cancer Institute-Frederick Cancer Research & Development Center, phone:
301-846-1491; FAX: 301-846-6022.
EFFECTIVE DATE: Confidential CRADA statements of interest describing
the proposed research, preferably one page or less, must be submitted
to NCI on or before December 29, 1998. Guidelines for preparing full
CRADA proposals will be communicated shortly thereafter to all
respondents who have been selected on the basis of mutual scientific
interest.
SUPPLEMENTARY INFORMATION:
Technology Available
The Immunotherapy Laboratory of the NCI Clinical Services Program
at the Frederick Center Research and Development Center has expertise
in the following technological areas:
Experience generating frequent, large dendritic cell (DC)
preparations.
Experience generating in excess of 80 DC preparations,
from both normal donors and cancer patients.
Well established, extensive systems for functional and
phenotypic evaluation of dendritic cell preparations and their
responses to various immune mediators.
Access to Good Manufacturing Practice (GMP) monoclonal
antibody production facility.
Established human tumor antigen systems for final
functional evaluations of immune response.
NCI's Dendritic Cell Patents and Patent Applications:
1. A Method and Compositions for Making Dentritic Cells from
Expanded Populations of Monocytes and for Activating T Cells, filed in
the United States Patent and Trademark Office May 21, 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 data from in-vitro and in-vivo
studies.
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 for (e.g.
facilities, personnel and expertise) 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 the licensing of patent rights to CRADA inventions.
Dated October 21, 1998.
Kathleen Sybert,
Acting Director, Technology Development & Commercialization Branch
National Cancer Institute National Institutes of Health.
[FR Doc. 98-29074 Filed 10-29-98; 8:45 am]
BILLING CODE 4140-01-M
