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.

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.

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.