Grants and cooperative agreements; availability, etc.: Stem cells that transform to beating cardiomyocytes; therapeutic uses,

[Federal Register: August 13, 2003 (Volume 68, Number 156)]

[Notices]

[Page 48393-48394]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr13au03-90]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood Institute: Licensing Opportunity and Cooperative Research and Development Agreement (CRADA) Opportunity to Develop Therapeutic Uses for the Newly Identified Cardiac Precursor Cells Named ``SPOC'' Cells

AGENCY: National Heart, Lung, and Blood Institute.

ACTION: Notice.

SUMMARY: The National Heart Lung and Blood Institute is seeking licensees and/or CRADA partners to further develop, evaluate, and commercialize therapeutic uses for the newly identified cardiac precursor cells named ``spoc'' cells. The U.S government-owned technology is encompassed within PCT Patent Application No. PCT/US02/ 33860, entitled, ``Stem Cells that Transform to Beating Cardiomyocytes''.

The NHLBI seeks potential Collaborator(s) wishing to provide expertise in (1) genomics/proteomics and analysis; (2) animal models of heart disease; (3) high throughput drug screening.

Prospective collaborators need only be interested in pursuing a focused aspect of the potential applications.

DATES: Only written CRADA capability statements received by the NHLBI on or before September 29, 2003, will be considered during the initial design phase. Confidential information must be clearly labeled. Potential collaborators may be invited to meet with the Selection Committee at the collaborators' expense to provide

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additional information. The Institute may issue an additional notice of CRADA opportunity during the design phase if circumstances change or if the design alters substantially.

Inventions described in the patent application(s) are available for either exclusive or non-exclusive licensing in accordance with 35 U.S.C. 207 and 37 CFR part 404. Respondees interested in licensing the invention(s) should submit an ``Application for License to Public Health Service Inventions.''

FOR FURTHER INFORMATION AND QUESTIONS: Questions about licensing opportunities should be addressed to Fatima Sayyid, M.H.P.M., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804, Tel: 301-435-4521; Fax: 301-402-0220; E-mail: sayyidf@mail.nih.gov. Information about Patent Applications and pertinent information not yet publicly described can be obtained under the terms of a Confidential Disclosure Agreement.

Capability statements and questions about this CRADA opportunity should be submitted to Dr. Vincent Kolesnitchenko, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute, National Institutes of Health, 6705 Rockledge Drive, Suite 6018, MSC 7992, Bethesda, MD 20892-7992; Tel: 301-594-4115; Fax: 301-594-3080; E- mail: kolesniv@nhlbi.nih.gov. SUPPLEMENTARY INFORMATION: A CRADA is an agreement designed to enable certain collaborations between the Government laboratories and non- Government laboratories. It is not a grant, and is not a contract for the procurement of goods/services. The NHLBI is prohibited from transferring funds to a CRADA collaborator. Under a CRADA, NHLBI can contribute facilities, staff, materials, and expertise to the effort. The collaborator typically contributes facilities, staff, materials, expertise, and funding to the collaboration. The CRADA collaborator may elect an option to negotiate an exclusive or non-exclusive license to Government intellectual property rights arising under the CRADA in a predetermined field of use and may qualify as a co-inventor of new technology developed under the CRADA.

Respondees interested in licensing the technology will be required to submit an Application for License to Public Health Service Inventions. Inventions described in the patent application(s) are available for either exclusive or non-exclusive licensing in accordance with 35 U.S.C. 207 and 37 CFR part 404. Information about patent application(s) and pertinent information not yet publicly described can be obtained under the terms of a Confidential Disclosure Agreement.

Technology Description: Spoc cells are a previously unknown subpopulation of stem cells in adult murine skeletal muscle that can be transformed into beating cardiomyocytes in primary tissue culture. These cells are not satellite cells, myofibroblasts or myoblasts or hematopoietic stem cells. A portion of these marked freshly isolated spoc cells, injected into the tail vein of a mouse with an acute myocardial infarct populates the infarct in 2 weeks time; by 3 months they differentiate into cardiac myocytes in the region of the infarct. Spoc cells can be used to isolate orthologue human cells that may be useful in treating chronic and acute heart failure. These cells may also be used to produce cell lines from transgenic animals with targeted genes that are important to cardiac function. Such cell lines will be useful in high throughput pharmaceutical screening projects.

Capability Statements: A Selection Committee will use the information provided in the ``Collaborator Capability Statements'' received in response to this announcement to help its deliberations. It is the intention of the NHLBI that all qualified Collaborators have the opportunity to provide information to the Selection Committee through their capability statements. The Capability Statement should not exceed 10 pages and should address the following criteria:

(1) The ability to collaborate with NHLBI on further research and development of this technology. This ability can be demonstrated through experience and expertise in this or related areas of technology indicating the ability to contribute intellectually to on-going research and development.

(2) Expertise and experience in the following area: genomics/ proteomics and analysis; animal models of heart disease; high throughput drug screening. Prospective collaborators need only be interested in pursuing a focused aspect of the potential applications.

(3) The demonstration of adequate resources to perform the research, development and commercialization of this technology (e.g., facilities, personnel and expertise) and accomplish objectives according to an appropriate timetable to be outlined in the CRADA Collaborator's proposal.

(4) The willingness to cooperate with the NHLBI in the timely publication of research results and to accept the legal provisions and language of the CRADA with only minor modifications, if any.

Dated: July 24, 2003. Lili Portilla, Director, Office of Technology Transfer and Development, National Heart, Lung, and Blood Institute.

Dated: August 4, 2003. Steven M. Ferguson, Acting Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

[FR Doc. 03-20561 Filed 8-12-03; 8:45 am]

BILLING CODE 4140-01-P