[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Notices]
[Pages 14395-14397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute (NCI) Collaborative Development of 
Methods for Selective T Cell Depletion To Improve Bone Marrow 
Transplantation Procedures

    Opportunities for Collaborative Research and Development Agreements 
are available for collaboration with the Biological Resources Branch 
(BRB), Developmental Therapeutics Program (DTP), Division of Cancer 
Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) to 
develop methods that could be applicable, in the setting of clinical 
bone marrow transplants, to deplete selected populations of T cells 
prior to the infusion of donor cells into the recipient. Selective T 
cell population depletion has been suggested as a possible approach to 
the goal of reducing the incidence of Graft versus Host Disease (GVHD) 
associated with bone marrow transplants, with the goal of also 
retaining clinical antitumor efficacy.
AGENCY: National Cancer Institute, National Institutes of Health, PHS, 
DHHS.

ACTION: Notice of opportunities for cooperative research and 
development agreements (CRADAs).

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SUMMARY: Pursuant to the Federal Technology Transfer Act of 1986 (15 
U.S.C. 3710a; and Executive Order 12591 of April 10, 1987) as amended, 
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 one or more Cooperative Research 
and Development Agreements (CRADAs) with pharmaceutical or medical 
device companies to discover and develop potential new methods of ex 
vivo depletion of selected populations of donor T cells with the goal 
of reducing Graft versus Host Disease (GVHD) in the transplant 
recipient, while still retaining antitumor efficacy. Each CRADA would 
have an expected duration of one (1) to five (5) years. The goals of 
the CRADA include the rapid publication of research results and timely 
commercialization of products, and methods of treatment or prevention 
that may result from research. The CRADA collaborator will have an 
option to negotiate an exclusive or non-exclusive license to subject 
inventions arising under the CRADA and which are a subject of the CRADA 
Research Plan.
    Proposals and questions about this CRADA opportunity may be 
addressed to Donna L. Bialozor, Technology Development Specialist, 
Technology Development & Commercialization Branch, National Cancer 
Institute-Frederick, 1003 West Seventh Street, Fairview Center, Room 
502, Frederick, MD 21701 (Phone 301-846-5465; Fax: 301-846-6820; E-
mail: [email protected]).
    Scientific inquiries should be submitted to Dr. Stephen Creekmore, 
Chief, Biological Resources Branch (BRB), Developmental Therapeutics 
Program (DTP), National Cancer Institute-Frederick Research & 
Development Center, Building 1052, Room 251, NCI-Frederick, P.O. Box B, 
Frederick, MD 21702-1201 (Phone: 301-846-1100; Fax: 301-846-5429; E-
mail: [email protected]).
    Inquiries regarding CRADA proposals and scientific matters may be 
forwarded at any time. Confidential, preliminary CRADA proposals, 
preferably five pages or less, must be submitted to the NCI within 90 
days from the date of this publication. Guidelines for preparing final 
CRADA proposals will be submitted shortly thereafter to all respondents 
with whom initial confidential discussions will have established 
sufficient mutual interest. CRADA proposals submitted at a later date 
may be considered if a suitable CRADA collaborator has not been 
selected.

Technology Available

    The Biological Resources Branch (BRB) of the Developmental 
Therapeutics Program (DTP) is an NCI extramural research activity with 
a mission to evaluate and support development of innovative

[[Page 14396]]

biopharmaceutical approaches to cancer therapy. To this end, the BRB 
has established contracts to manufacture biopharmaceuticals to be used 
in late preclinical and early clinical studies. The goal of these 
efforts is to provide scientific and technical expertise and key 
resources for the development of selected concepts through phase I/II 
and proof-of-concept clinical trials. Through its contract resources, 
the BRB possesses scientific and technical expertise in process 
development, manufacture, purification, vial filling, documentation, 
testing, and release of a wide range of monoclonal antibody, 
recombinant protein, natural product, peptide, oligonucleotide, viral, 
and bacterial-based clinical agents, devices, and vaccines. DTP also 
possesses expertise in toxicological and pharmaceutical support for 
these efforts. Depending on the circumstances and subject to future 
review and approval, the NCI may elect to provide resources for 
regulatory affairs support and IND filing through the Regulatory 
Affairs Branch of the Cancer Therapy Evaluation Program (CTEP), or 
through the offices of the outside collaborators. NCI may also elect to 
provide resources for design and execution of clinical trials at 
collaborating extramural sites, or intramural NCI clinics, or through 
the efforts of CTEP. Background and contact information for BRB and DTP 
resources are available at the following web sites: http://www.ncifcrf.gov/brb/ and http://www.dtp.nci.nih.gov.

Technology Sought

    BRB now seeks potential collaborators having expertise in one or 
more of the component approaches, molecules, or devices for development 
in the clinical setting of bone marrow transplantation:
    (1) Monoclonal antibodies directed at normal T cell populations;
    (2) Other targeting molecules appropriate for ex vivo selection of 
appropriate populations of donor T-cells;
    (3) Devices that employ these targeting molecules to deplete 
appropriate populations of donor T-cells;
    (4) Alternative approaches to the problem of ex vivo depletion of 
selected populations of donor T-cells.
    Primary consideration will be given to collaborators having 
significant and relevant preclinical and/or clinical experience in the 
development of these or similar approaches, molecules, or devices.

Collaborators Sought

    Accordingly, DHHS now seeks collaborative agreements for the joint 
BRB and Collaborator discovery, research and development of novel, 
clinically useful approaches for the selective ex vivo depletion of 
donor T-cell populations, for use in the setting of bone marrow 
transplantation. For collaborations with the commercial sector, a 
Cooperative Research and Development Agreement (CRADA) will be 
established to provide for equitable distribution of intellectual 
property rights developed under the CRADA. CRADA aims will include 
rapid publication of research results as well as timely exploitation of 
commercial opportunities.
    At a minimum, the successful Collaborator should either possess 
broad experience in, or possess highly specialized experience or unique 
expertise in one or more of the areas particularly pertinent to drug or 
device lead-discovery and development within the scope of this project.
    NCI will provide no funding to the Collaborator inasmuch as 
financial contributions by the U.S. Government to non-Federal parties 
under a CRADA are not authorized under the Federal Technology Transfer 
Act (15 U.S.C. 3710a(d)(1)).

NCI and Collaborator Responsibilities

    The role of the National Cancer Institute in this CRADA may 
include, but not be limited to:
    (1) Providing intellectual, scientific, and technical expertise and 
experience to the research project.
    (2) Providing facilities for process development and production of 
monoclonal antibodies or relevant targeting molecules, to support 
preclinical development of these approaches.
    (3) Providing the Collaborator(s) with process development, 
production and QC test data for evaluation.
    (4) Provision of Quality Assurance and Quality Control of targeting 
molecules with or without devices used in T cell depletion, to support 
preclinical development of these approaches.
    (5) Planning preclinical (in vivo and in vitro testing) research 
studies and interpreting research results.
    (6) Publishing research results.
    (7) Depending on the results of these preclinical investigations, 
NCI may elect to provide additional support for clinical-grade (cGMP) 
production of the targeted monoclonal antibodies or molecules derived 
from the CRADA. Commitment of substantial resources would require 
specific review and approval by the NCI's Division of Cancer Treatment 
and Diagnosis.
    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) Providing monoclonal antibody clones or other production 
expression systems and test data to the research project.
    (3) Providing other targeting molecules and test data to the 
research project.
    (4) Providing devices that can employ targeting molecules, along 
with test data to the research project.
    (5) Planning research studies and interpreting research results.
    (6) Publishing research results.
    Selective criteria for choosing the CRADA collaborator may include, 
but not be limited to:
    (1) The ability to collaborate with the NCI on research and 
development of this technology involving discovery, optimization, 
production, testing, and biological evaluation. This ability can be 
demonstrated through experience, expertise, and the ability to 
contribute intellectually in this or related areas of drug discovery, 
research, and development.
    (2) The demonstration of adequate resources to perform the 
research, development and commercialization of this discovery, 
optimization and biological evaluation technology (e.g., facilities, 
personnel, and expertise) and to 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, development and commercialization of this 
technology as defined above.
    (4) The willingness to cooperate with the National Cancer Institute 
in the timely publication of research results.
    (5) 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.
    (6) 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. 
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 non-exclusive license to the CRADA

[[Page 14397]]

Collaborator when the Government employee is the sole inventor.

    Dated: February 22, 2001.
Kathleen Sybert,
Chief, Technology Development & Commercialization Branch, National 
Cancer Institute, National Institutes of Health.
[FR Doc. 01-6039 Filed 3-9-01; 8:45 am]
BILLING CODE 4140-01-P