SOURCES SOUGHT
A -- Collaborative Network for Clinical Research on Immune Tolerance
- Notice Date
- 12/8/2005
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- RFP-NIH-NIAID-DAIT-07-33
- Response Due
- 12/16/2005
- Archive Date
- 1/30/2006
- Description
- The NIAID supports a broad range of basic, translational, and clinical research on the underlying mechanisms of immune tolerance, and the evaluation of tolerance induction strategies in animal models and in clinical trials. Tolerance induction strategies aim to selectively block or prevent deleterious immune responses, while leaving protective immunity intact. The successful induction of immune tolerance to treat and prevent immune-mediated disorders is a major goal of these efforts. Advances in tolerance induction will provide valuable new therapeutic strategies that will not require life-long, systemic immunosuppressive therapy with its deleterious side effects. For example, in transplantation, donor-specific immune tolerance - a selective blockade of immune responses directed against the graft - would enable long-term graft survival without the complications and risks of systemic immunosuppressive therapy (e.g., infection, malignancy, and atherosclerosis). In asthma and allergic diseases, the goal of tolerance research is to develop methods to prevent immune responses to allergens, such as cockroach and house dust mite, that cause or exacerbate these diseases. In autoimmune diseases, researchers are developing novel approaches to block the immune responses that cause the body to mistakenly attack its own organs, tissues, or cells. The purpose of this solicitation is to recompete the ?Collaborative Network for Clinical Research on Immune Tolerance,? first awarded in 1999, and to expand the required work to include nonclinical research and product development, bioinformatics, and data collection, validation, and analysis. One award is expected to be made in response to this solicitation. The NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all requirements set forth in the Statement of Work; consequently, the Contractor may need to utilize the expertise and services of subcontractors to perform the tasks required. The Contractor shall be responsible for all work performed under this contract, including that performed by subcontractors. The scope of work to be performed by the Network includes: The design and conduct of Phase I-IV clinical trials of investigational approaches intended to lead to a functional state of immune tolerance; The design and conduct of mechanistic studies and the development of tolerance assays as integral components of these clinical trials; Focused product development and nonclinical studies (e.g., toxicology, pharmacology, and pharmacokinetics, etc.) essential for the subsequent evaluation of experimental tolerance induction therapies in humans; and The provision of bioinformatics, data management and analysis resources. The Network will require strong leadership to provide for the overall scientific direction, coordination and management of complex research studies involving a large number of geographically distributed facilities, subcontractors, and Network personnel. The Network will also establish collaborations with pharmaceutical and biotechnology companies, other NIH sponsored clinical research programs, and private research organizations to identify and evaluate tolerance induction therapies, conduct mechanistic studies, and perform assays to assess the induction, maintenance, and loss of tolerance. Sources Sought Notice Information: Type of Requirement 0 New Requirement X Re-competition (Contract No.: N01-AI-15416) 0 Expansion (Contract/RFP No.:______________) Place of Performance X Place of performance is unknown at this time 0 Place of performance is known. Address or general location:__________________ Potential sources must demonstrate and document the following in their capability statements: Scientific and technical expertise, capacity, and personnel to establish and direct a multi-institutional consortium of national and international experts in human immune tolerance, including the design and conduct of Phase I-IV clinical trials to evaluate potential tolerance induction strategies for asthma and allergic diseases, autoimmune diseases, and transplantation; associated mechanistic studies; the design and conduct of assays studies and the development of new assays to assess the induction, maintenance, and loss of tolerances in humans; nonclinical product development; and product manufacturer, bioinformatics and data validation and analysis, and the solicitation, evaluation and execution of subcontracts and the monitoring of subcontractor performance. Interested Small Business organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Written capability statements should be received by the NIAID Contracting Officer by December 16, 2005. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. No facsimile transmissions will be accepted. This notice is for information and planning purposes only and does not commit the Government to award a contract now or in the future. This is not a request for proposals. The Government does not intend to award a contract based on responses under this announcement. Any proprietary information should be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Point of Contact Erin Goldstein, Contracting Officer, Phone 301 496-6423, FAX (301) 402-0972, Email eg108r@nih.gov
- Record
- SN00948013-W 20051210/051208211845 (fbodaily.com)
- Source
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