MEASUREMENT AND TREATMENT DEVELOPMENT ACTIVITIES ON COGNITION IN SCHIZOPHRENIA Release Date: March 11, 2002 NOTICE: NOT-MH-02-003 RFP-NIMH-02-DM-0006 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) The National Institute of Mental Health (NIMH) has issued Request for Proposals (RFP) No. NIMH-02-DM-0006 entitled "Measurement and Treatment Development Activities on Cognition in Schizophrenia" under Full and Open Competition procedures using North American Industry Classification System 541720. NIMH seeks the support of a Contractor who will: (1) Design and conduct a comprehensive survey to explore the feasibility of NIMH entering into agreements with pharmaceutical and biotechnology companies to obtain access to compounds and/or compound libraries with the aim of identifying New Chemical Entities (NCEs) of potential utility to enhance cognition in schizophrenia. (2) Develop a comprehensive list of lead compounds potentially accessible for government/industry collaborative development. (3) Based on face-to-face interviews with key industry decision makers, define approaches to management of intellectual property issues bearing on government/industry collaboration that would impact NIMH"s ability to negotiate access to a compound for collaborative development and/or human clinical trials. (4) Arrange and chair industry/government/academic consensus-oriented conferences regarding state-of-the-art measurement methods, experimental designs, conflict of interest and intellectual property issues, and pharmacological agents of potential utility in remedying cognitive deficits in schizophrenia. (5) Prepare/author one or more reports for the Schizophrenia Bulletin that focus on some or all of the following substantive issues: a) review of major neuropharmacological approaches to modulation of cognition and working memory in schizophrenia with emphasis on potential translation implications of pharmacological circuit-based models to human clinical trials, b) review of pharmacological agents of potential utility in remedying cognitive deficits in human subjects with schizophrenia, c) comprehensive assessment of extant and experimental measures of cognition in schizophrenia, d) comprehensive assessment of methodological issues related to evaluating efficacy of augmentation strategies to remedy cognitive deficits in schizophrenia including selection of optimal experimental populations, management of differential side effect profiles of alternative agents, differentiating primary effect on cognition from secondary effects on other dimensions of schizophrenia psychopathology, e) comprehensive assessment of legal, ethical and intellectual property issues impacting government/industry collaboration to develop augmentation strategies to remedy cognitive deficits in schizophrenia, and f) comprehensive assessment of prospect for development of imaging-based biomarkers linked to efficacy in remedying cognitive deficits in schizophrenia. The contractor may be required to create a new instrument that conforms to the specific characteristics of an optimal assessment tool for cognition, and establish the reliability, validity and pharmacosensitivity of such a new instrument. The contractor also may be required to design and conduct a small proof-of-concept augmentation trial of a lead compound. Plans are to award a contract by September 30, 2002. RFP No. NIMH-02-DM-0006 was released on February 4, 2002 and the receipt date for proposals is April 4, 2002 with an expected award date of September 30, 2002. The RFP may be accessed through http://www.fedbizopps.gov or the NIMH Contract website at http://www.nimh.nih.gov/grants/indexcon.cfm. It is the offeror"s responsibility to monitor the above internet sites for the release of this solicitation and amendments, if any. Please note that the RFP for this requirement will include the Statement of Work, Deliverables, Reporting Requirements, Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offeror will be contained in the electronic RFP package. Following proposal submission and the initial review process, offerors comprising the competitive range will be requested to provide additional documentation to the Contracting Officer. All responsible sources are encouraged to submit a proposal that will be considered by the NIMH. This announcement does not commit the Government to award a contract. INQUIRIES For further information, contact Suzanne Stinson, Contracting Officer, at 301-443-4116 or sstinson@mail.nih.gov. Collect calls will not be accepted.
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