SOURCES SOUGHT
A -- Collaborative Network for Clinical Research on Immune Tolerance
- Notice Date
- 3/23/2005
- Notice Type
- Sources Sought
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Program 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- Reference-Number-N01-AI-15416
- Response Due
- 5/9/2005
- Archive Date
- 5/24/2005
- Description
- The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), has a contract with the University of California, San Francisco, entitled ?Collaborative Network for Clinical Research on Immune Tolerance? (also referred to as the Immune Tolerance Network or ITN). The contract number is N01-AI-15416. The period of performance for the contract is September 30, 2001 through September 29, 2006. The Immune Tolerance Network (ITN) is an international consortium of over 80 investigators in the U.S., Canada, Europe, and Australia dedicated to the clinical evaluation of novel, tolerance-inducing therapies in autoimmune diseases, asthma and allergic diseases, and rejection of transplanted organs, tissues, and cells. To understand the underlying mechanisms of action of the candidate therapies and to monitor tolerance, the ITN has established state-of-the art core laboratory facilities to conduct integrated mechanistic studies, and to develop and evaluate biomarkers and assays to measure the induction, maintenance, and loss of tolerance in humans and animal models of disease. The NIAID intends to negotiate with the University of California, San Francisco for non-clinical and preclinical studies to evaluate the safety and/or efficacy of selected compounds for the prevention and treatment of autoimmune diseases, especially type 1 diabetes. This work will include, but not be limited to: preclinical toxicology and pharmacology studies in animal models; production of batches or lots of candidate drugs for the conduct of animal efficacy and human safety studies in accordance with Good Laboratory Practices; and studies to validate properties of test compounds. The development and use of assays and biomarkers to assess the induction, maintenance, and loss of tolerance in humans and animal models, and studies to determine the mechanism of action of tolerance induction strategies are major components of the ITN work statement. To carry out this work, the Contractor has established sixteen (16) core laboratories that perform mechanistic and tolerance assays for all clinical trials conducted by the Network. The preclinical and non-clinical work to be undertaken in the expanded statement of work will require the development and use of tolerance assays, biomarkers, and mechanistic studies, which will be integrated into ITN clinical studies, in accordance with current practices. It is essential to perform this work in the ITN core laboratories to ensure the utility and comparability of such assays and surrogate markers within and across ITN clinical trials. Potential Sources must demonstrate and document: 1. Ability to perform the required mechanistic studies and tolerance assays, and ensure the successful completion of assays and studies in development in humans and relevant animal models. 2. Scientific and technical capacity and expertise to successfully move potential tolerance induction therapies for autoimmune diseases through preclinical evaluation to trials in a clinical immunology research network. AUTHORITY: The original contract was awarded using full and open competition procedures. NIAID intends to negotiate this one-time expansion under the authority of 41 U.S.C. 253 (c) (1), as set forth in FAR 6.302-1 (a) (2) (ii) and HHSAR 306.302-1 (a) (2) (ii). NIAID believes that the University of California, San Francisco is the only source with the requisite unique capabilities to accomplish this additional effort. See Numbered Note 22. No Collect calls will be accepted. Point of Contact Erin Goldstein, Contracting Officer, Phone 301 496-0612, Fax 301 402-0972, Email EGoldstein@niaid.nih.gov Lawrence Butler, Acting Branch Chief, Phone 301 496-0195 Fax 301402-0972 EmailLButler@niaid.nih.gov
- Record
- SN00773931-W 20050325/050323211758 (fbodaily.com)
- Source
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