[Federal Register Volume 65, Number 136 (Friday, July 14, 2000)]
[Notices]
[Pages 43775-43776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17827]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institutes of Health Clinical Center: Cooperative 
Research and Development Agreement (CRADA) Opportunity for the 
Development of Medical Magnetic Imaging Methods for Diagnostic or 
Therapeutic Purposes

AGENCY: National Institutes of Health (NIH), PHS, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health Clinical Center (NIHCC), 
Laboratory of Diagnostic Radiology Research, has developed technology 
in the area of Magnetic Resonance Imaging (MRI) and in vivo cell 
tracking and wishes to further develop the technology through a 
collaboration with a company or institution having expertise in the 
areas of medical imaging and/or medical diagnostics. Companies with 
expertise in transplantation of cells, including neural cells, stem 
cells, transgenic cells, or other cell types, and companies with 
expertise in therapeutic cell research, including the possible 
therapeutic use of stem cells, are encouraged to apply. The NIHCC's 
Laboratory of Diagnostic Radiology Research (LDRR) has developed a 
compound and technique for magnetically tagging cells--without the use 
of radioisotopes--and imaging those cells using MRI. The NIHCC system 
of magnetic tagging transfers nanoparticles of iron oxide into a cell 
via a monoclonal antibody to the cell's transferrin receptor. The cells 
internalize the iron particles in the endosomes. In early neurological 
disease studies related to repair of demyelination, LDRR researchers 
tagged oligodendrocyte precursor cells in vitro and introduced the 
tagged cells into myelin-deficient rats. The researchers followed the 
migration and integration of these cells in the spinal cord by non-
invasive techniques and found that the distribution of the tagged 
precursor cells correlated with the extent of myelination. Thus, this 
non-invasive tracking method may be useful in human transplantation 
studies and for diagnostic procedures. In the proposed project, other 
cell types, including tumor or other transplantable cells could be 
labeled and tracked. Additionally, direct in vivo labeling methods 
using this tagging system could be developed. Clinical applications 
using imaging of the tagged cells could be investigated. Also, new 
methods which use the magnetic tag applied to a variety of therapeutic 
compounds or other clinically relevant molecules could be developed. 
Research data suggests that the iron tag does not impair the viability, 
migration or other cellular functions of the labeled cells.
    The NIH has filed a patent application on the technology and is 
currently preparing to file a second related application that involves 
a new method for magnetic tagging of cells. Any successful CRADA 
collaborator may need to negotiate a license on the patent applications 
in order to commercialize developments under this CRADA. Contact 
information to obtain information on the patent applications is listed 
below.
    The proposed duration of the collaboration is two (2) years.

ADDRESSES: Proposals and questions about this opportunity may be 
addressed to Steven Galen, Technology Development Coordinator, NIHCC, 
tel: (301) 594-4509, fax: (301) 402-2143 or David A. Steffes, 
Technology Development and Commercialization Branch, National Cancer 
Institute, Tel: (301) 496-0477, Fax: (301) 402-2117.

DATES: Interested parties should submit a one page statement of 
interest that outlines the proposed research project and addresses the 
collaborator's ability to fulfill its collaborative responsibilities. 
The statement of interest should be submitted in writing no later than 
August 14, 2000. CRADA proposals submitted thereafter may be considered 
if a suitable CRADA collaborator has not been found.

SUPPLEMENTARY INFORMATION: A ``Cooperative Research and Development 
Agreement'' or ``CRADA'' is the anticipated joint agreement to be 
entered into by the NIHCC pursuant to the Federal Technology Transfer 
Act of 1986 as amended by the National Technology Transfer and 
Advancement Act of 1995 (Pub. L. 104-113 (Mar. 7, 1996)) and by 
Executive Order 12591 of October 10, 1987.
    Under a CRADA, the NIHCC can contribute facilities, staff, 
materials, and expertise to the effort. The NIHCC Cannot Contribute 
Funding. The CRADA collaborator receives an exclusive option to 
negotiate an exclusive or non-exclusive license to Government 
intellectual property rights arising under the CRADA in a pre-
determined field of use and may qualify as a co-inventor of new 
technology developed under the CRADA.
    Background information, including reprints of this announcement and 
issued patents pertaining to the technology, is available from the 
above-referenced address. Patent applications and pertinent information 
not yet publicly described can be obtained under a Confidential 
Disclosure Agreement.
    The CRADA objective is the development and timely commercialization 
of imaging techniques and clinical diagnostic and therapeutic methods 
based on the magnetic tagging procedures developed by the NIHCC.
    CRADA proposals will be evaluated under the following criteria:
     Corporate research and development competencies.
     Demonstrated ability to collaborate productively in 
research programs.
     The nature of resources to be contributed to the 
collaboration.
     Key staff expertise, qualifications and relevant 
experience.
     Willingness to assign technical staff to on-site 
collaborative efforts.
     Ability to commercialize new discoveries effectively.
     For collaborations involving stem cells, whether the 
proposed study complies with current federal regulations and NIH policy 
concerning stem cell research.
    The roles of the NIHCC for the proposed CRADA may include the 
following responsibilities. Additional responsibilities may be added if 
the parties agree to other relevant and scientifically appropriate 
collaborative research projects.
    1. Participate in identification of various cell types to label 
with the magnetic tagging system.
    2. Participate in imaging studies for detection and tracking of 
various labeled cell types.
    3. Participate in development of methods for in vivo labeling of 
cells.
    4. Participate in development of methods to magnetically tag 
clinically relevant molecules.
    5. Participate in development of diagnostic and therapeutic 
magnetic imaging methods using magnetically tagged compounds or cells.
    6. Jointly publish research results.
    The roles of the Collaborator for the proposed CRADA may include 
the following responsibilities. Additional responsibilities may be 
added if the parties agree to other relevant and scientifically 
appropriate collaborative research projects.
    1. Development of methods to label various cell types with the 
magnetic tagging system.
    2. Participate in imaging studies for detection and tracking of 
various labeled cell types.
    3. Participate in development of methods for in vivo labeling of 
cells.

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    4. Participate in development of methods to magnetically tag 
clinically relevant molecules.
    5. Participate in development of diagnostic and therapeutic 
magnetic imaging methods using magnetically tagged compounds or cells.
    6. Jointly publish research results.

    Dated: July 6, 2000.
Kathleen Sybert,
Chief, Technology Development and Commercialization Branch, NCI.
[FR Doc. 00-17827 Filed 7-13-00; 8:45 am]
BILLING CODE 4140-18-U