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Notice

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

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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).

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: bialozod@mail.nih.gov).

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: creekmor@mail.ncifcrf.gov).

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 Start Printed Page 14396biopharmaceutical 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 Start Printed Page 14397Collaborator when the Government employee is the sole inventor.

Start Signature

Dated: February 22, 2001.

Kathleen Sybert,

Chief, Technology Development & Commercialization Branch, National Cancer Institute, National Institutes of Health.

End Signature End Preamble

[FR Doc. 01-6039 Filed 3-9-01; 8:45 am]

BILLING CODE 4140-01-P