OPPORTUNITY FOR A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) FOR THE DEVELOPMENT OF MACROMOLECULAR SUBSTRATES

Notice Date

December 12, 2000

Contracting Office

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

ZIP Code

20852

Description

Cooperative Research and Development Agreement (CRADA) Announcement Development of Macromolecular Substrates National Institutes of Health Clinical Center Small synthetic substrates are commonly used in a broad variety of clinical, industrial, and research assays to measure the activities of proteases and other enzymes that hydrolyze macromolecules. One significant drawback to the synthetic substrates, however, is that they typically are substantially smaller than the natural substrates. The small size of synthetic substrates can lead to inaccurate estimates of enzyme activity where there is the possibility of steric hindrance of the enzyme's active site. To overcome this limitation in the art, the National Institute of Health Clinical Center (NIHCC) has developed macromolecular substrates for enzymes such as proteinases and endosaccharidases that contain small chromogenic- or flourogenic-enzyme substrates linked to a carrier polymer such as polyethylene glycol. Use of the macrosubstrates could increase the accuracy of a broad variety of enzymatic assays. Also, variable-sized macrosubstrates can be used to measure steric hindrance of proteinase active sites and to expand target sites in screening for antibodies, aptamers, or other molecules that inhibit proteinases by steric hindrance. The NIHCC has prepared efficient substrates for proteases including thrombin, coagulation factor Xa, chymotrypsin, elastase, and trypsin. Some characteristics of these substrates are improved substrate cleavage specificity, the ability to evaluate accessibility of active sites of enzymes, and high aqueous solubility. A major advantage of macromolecular substrates over the current state of the art is that they are not cleaved by proteases bound to alpha-2-macroglobulin. Consequently, the substrates may be superior for a number of diagnostic and research applications, such as measuring coagulation factors, heparin, or inhibitors in plasma, where complexes of proteases with alpha-2-macroglobulin interfere with measurements using other chromogenic substrates. The NIHCC is interested in entering into a Cooperative Research and Development Agreement (CRADA) for the further development and commercialization of the substrates. The collaborating company should have the expertise to serve as a partner for further research and development as well as the capacity to serve as a source of production and commercial distribution of the developed substrates, or have the ability to develop commercial applications of substrates. The proposed duration of the collaboration is two (2) years. The NIHCC has filed a patent application on the technology. Any successful CRADA collaborator may need to negotiate a license on the patent application in order to commercialize developments under this CRADA. Contact information to obtain information on the patent application is listed below. PROPOSALS: Interested parties should submit a one page statement of interest that outlines the research project they would like to conduct and addresses the seven (7) evaluation criteria listed below. The statement of interest should be submitted in writing no later than fifteen (15) days from the date of this announcement. CRADA proposals submitted thereafter may be considered if a suitable CRADA collaborator has not been found. ADDRESS: Proposals and questions about this opportunity may be addressed to David A. Steffes, Technology Development and Commercialization Branch, National Cancer Institute, Tel: (301) 496-0477, Fax: (301) 402-2117, e-mail steffesd@exchange.nih.gov. 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. However, as this is not a contract or grant proposal, the NIHCC cannot contribute funding. Depending on the nature of the research to be conducted, it may be necessary for the collaborator to contribute resources to the project. 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. CRADA proposals will be evaluated under the following criteria: -Corporate research and development competencies Degree to which the proposed project meshes with the scientific interests and mission of the NIHCC laboratory -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

Record

Loren Data Corp. 20001214/SPMSC002.HTM (W-347 SN5086T7)