[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]


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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 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.

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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