A -- Development and Commercialization of Analytical, Diagnostic and Therapeutic Methodologies in the Management of Older Adult in Patients Chronic Diseases States.

Introductory Summary Paragraph:The general goal of this CRADA is to develop new methods and strategies that can be applied to samples acquired from clinical patients and participants of epidemiologic studies in the Baltimore Longitudinal Study of Aging (BLSA) and can be translated to the diagnosis, prognosis or management of older adult patients in chronic diseases states of late life. NIA is specifically interested in studying osteoarthritis and osteoporosis, sarcopenia, inflammatory mechanisms, cardiovascular disease, and the decline of cognitive and physical function and the development of disability of older adult patients. NIA is currently seeking cooperative partners to work with the Laboratory of Clinical Investigation, Molecular and Clinical Pharmacology Section, in the identification, characterization and commercial development of analytical, diagnostic and therapeutic methods in older adult patients. Potential Areas of Application: Under the present opportunity, the goals of the CRADA are anticipated to include, but not be limited to, the development of the following technology: - Development of novel techniques to measure whole organ function (muscle, heart, brain, bones, joints), - Development of protein, RNA, or DNA-based arrays, chips, and assays applicable to the evaluation of tissues, blood, serum or plasma and urine samples, - Development of data management and statistical analyses programs and systems. Main Advantages of Technology/Invention: The advantage of understanding the mechanisms of aging and age-associated disease, development, and progression is the translation of age specific research into viable commercial products used in the diagnosis, prognosis and/or management of older adult patients. Party Contributions: The role of the NIA in the CRADA may include, but not be limited to: - Provide intellectual, scientific, and technical expertise and experience to the research project, - Provide collaborator with access to existing NIA research data and samples (both already collected and yet to be collected), - Plan research studies and interpret research results, - Conduct research to validate the use of novel markers in diagnostic and clinical settings, - Provide staff, expertise, and materials for the development and testing of promising products, - Provide work space and equipment for testing of any prototype systems developed ; and - Publish study conclusions jointly with the collaborator. Describe the type of collaborator sought and the role of the collaborator on this project: In addition to the specific requirements listed in the Potential Application section above, the NIA seeks a collaborator with experience and ability and who can provide one or more of the following: - Provide significant intellectual, scientific, and technical expertise to the research project, - Provide expertise in the development and manufacture of relevant products; - Provide specialized or unusual equipment and access to necessary proprietary technology and/or data, - Provide technical and/or financial support to facilitate scientific goals and for further design of applications of the technology outlined in the agreement, - Plan research studies, interpret research results, and jointly publish the conclusions, - Demonstrated ability to develop protein, RNA, or DNA-based arrays, chips, and assays, - Demonstrated ability to develop data management and statistical analyses programs and systems, - Demonstrated ability to conduct preclinical and clinical studies. Selection Criteria: Proposals submitted for consideration should address, to the extent possible and to the extent relevant to the proposal, each of the following qualifications: - Expertise in the research and development of high quality software utilizing artificial intelligence, - Demonstrated ability in the production and verification of software products, - Experience in determining and meeting the needs of health care consumers, - Commitment to support the advancement of scientific research, as evidenced by a willingness to jointly publish research results in a prompt manner; and - Willingness to be bound, to the extent applicable, by DHHS and PHS policies regarding: (i) the rapid, public distribution of pure research tools, (ii) the care and handling of animals, and (iii) human subjects research. Response Procedure: Interested parties should notify the Technology Transfer Branch of the NCI in writing of their interest in the CRADA collaboration no later than May 25, 2004. The written notice should briefly address the selection criteria listed above. Scientific questions should be addressed to: Dr. Shari Ling, NIA, Laboratory of Clinical Investigation, Molecular and Clinical Pharmacology Section, GRC, Room 3A06, Baltimore, MD 21224 (Phone (lab) +1 (555) 000-0000; Phone (direct) +1 (555) 000-0000; Fax +1 (555) 000-0000; email: contact@example.gov. Contact Information: Kate Sinclair, NCI Technology Transfer Branch, Executive Plaza South, 6120 Executive Blvd., Suite 450, Rockville, Maryland, 20852 (Phone +1 (555) 000-0000, Fax # +1 (555) 000-0000).