OPPORTUNITY FOR A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT

Notice Date

October 26, 2001

Contracting Office

NIH/TDCB, 6120 Executive Blvd., Suite 450, Rockville, MD 20852

ZIP Code

20852

E-Mail Address

Technology Transfer Specialist (brandk@mail.nih.gov)

Description

The National Cancer Institute (NCI) seeks a Cooperative Research and Development Agreement (CRADA) Collaborator to organize completion of an Investigational New Drug (IND) application and all relevant Institutional Review Board (IRB) approvals necessary for determining clinical efficacy of NIH-patented drugs for the treatment of cerebral vasospasm, which is a relatively common event after hemorrhage from cerebral aneurysms and which often produces cerebral infarction and may be fatal. DATES: Interested parties should notify the Technology Transfer Branch of the NCI in writing of their interest in filing a formal proposal no later than October 31st, 2001. Potential CRADA Collaborators will then have an additional thirty (30) days to submit a formal proposal. CRADA proposals submitted thereafter may be considered if a suitable CRADA Collaborator has not been selected. Note that this is not a contract or grant solicitation. Under CRADAs, NIH can only receive financial support, not distribute it. SUPPLEMENTARY INFORMATION: Pursuant to the Federal Technology Transfer Act of 1986 et seq., the NCI is seeking a commercial partner to provide preclinical and clinical evaluation of existing technology held by NCI for the treatment of cerebral vasospasm. The proposed term of the CRADA can be up to three (3) years. NCI has patented compounds demonstrated in preclinical animal studies to reduce the risk of cerebral vasospasm following subarachnoid hemorrhage. NCI believes that further investigation into these nitric oxide-releasing compounds may demonstrate them to be an effective treatment for cerebral vasospasm. Additionally, other clinical applications may be possible. PARTY CONTRIBUTIONS: The role of the NCI in the CRADA may include, but not be limited to: 1. Providing intellectual, scientific, and technical expertise and experience to the project. 2. Providing the CRADA Collaborator access to patent rights NIH holds to various nitric oxide-containing compounds. 3. Publishing research results jointly with the collaborator. 4. Collaborating in needed preclinical toxicology studies and GMP drug preparations. The role of the CRADA Collaborator may include, but not be limited to: 1. Developing a protocol in concert with participating clinicians for the responsible evaluation of NIH's drugs as potential therapies for cerebral vasospasm. 2. Organizing and overseeing preclinical toxicology studies required for FDA approval of the clinical protocol. 3. Organizing and overseeing the clinical trials. 4. Publishing research results jointly with the NIH. Selection criteria for choosing the CRADA Collaborator may include, but not be limited to: 1. Demonstrated ability to move a drug from proof of concept (see reference 1) through preclinical evaluation and clinical trials. 2. The willingness to accept the legal provisions and language of the CRADA. These provisions govern the distribution of future 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 exclusive option to the CRADA Collaborator to elect an exclusive or non-exclusive license to inventions for which Government employees are the sole inventors thereon. CONTACT INFORMATION: Inquiries and proposals regarding this opportunity should be addressed to: Kevin Brand, Esq. Fairview Center 1003 W. Seventh St., Suite 502 Frederick, MD 21702 ph. (301) 846-5465 fx. (301) 846-6820 email: brandk@mail.nih.gov

Web Link

CRADA Opportunities (http://ttb.nci.nih.gov/availtech.html)

Record

Loren Data Corp. 20011030/SPMSC004.HTM (W-299 SN5116D4)