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COLLABORATIVE NETWORK FOR CLINICAL RESEARCH ON IMMUNE TOLERANCE (UM1): RFA-AI-12-043
Components of Participating Organizations
National Institute of Allergy and Infectious Diseases
Application Receipt Date(s): March 07, 2013
The purpose of this FOA is to solicit applications for the Collaborative Network for Clinical Research on Immune Tolerance (hereinafter referred to as ’Network’). The major objective of the Network is to develop new tolerogenic approaches for the treatment of disease in three clinical areas: asthma and allergic diseases; autoimmune diseases; and immune-mediated rejection of transplanted solid organs, tissues and cells. The scope of research to be carried out by the Network includes: 1) the design and conduct of clinical trials at all phases to evaluate the safety and efficacy of investigational products and approaches for the induction and maintenance of immune tolerance in humans; 2) the design and conduct of mechanistic studies and the development of tolerance assays as integral components of the clinical trials undertaken; and 3) the provision of bioinformatics, data collection, validation and analysis resources. On a selective basis, the Network may also support limited product development and nonclinical studies (e.g., toxicology, pharmacology, pharmacokinetics, etc.) essential for the subsequent evaluation of promising tolerance induction approaches in humans. For the purpose of this FOA and the resulting grant award, immune tolerance is broadly defined as a selective elimination of pathogenic immune responses to relevant antigens (e.g., alloantigens, autoantigens or allergens) by any of a variety of approaches, including deletion, induction of anergy, immune deviation, sequestration, or suppression, while preserving protective immunity and does not require ongoing treatment with the intervention.
Network Structure: The Network will consist of multiple functional elements to carry out the broad scope of research delineated above. These components include:
Leadership Group – with responsibility for: 1) scientific planning and priority setting; 2) soliciting and evaluating proposed research projects and determining those projects to be supported; 3) …
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