Notice Number: NOT-AR-14-014
Release Date: February 21, 2014
Estimated Publication Date of Announcement: March 2014
First Estimated Application Due Date: May 2014
Earliest Estimated Award Date: September 2014
Earliest Estimated Start Date: September 2014
The National Institutes of Health (NIH), pharmaceutical companies and nonprofit organizations have together created the Accelerating Medicines Partnership (AMP) to develop new models for identifying and validating promising biological targets for new diagnostics and drug development. A major goal is to generate pre-competitive, disease-specific data that will be publicly accessible to the broad biomedical community for further research (http://www.nih.gov/science/amp/).
The partners have designed a project plan to address relevant challenges for rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) (AMP RA/SLE Program). The goal is to ascertain and define shared and disease-specific biological pathways in order to identify relevant drug targets for the treatment of autoimmune diseases. This program will involve an enhanced systems-level understanding of gene expression and signaling in target tissues from affected end organs (synovium for RA, kidney and skin for lupus) and blood cells. The initial focus of research will be on RA and lupus, with the flexibility to expand in the future to related autoimmune diseases contingent on scientific feasibility and availability of resources.
The NIAMS and NIAID, as participating members of the AMP RA/SLE Program, intend to promote these objectives by publishing two Funding Opportunity Announcements (FOAs) to solicit applications for the development of a Leadership Center and Research Sites. The Leadership Center and the Research Sites awardees will work collaboratively within a network structure to implement the AMP RA/SLE program. The resulting network will be developed by NIH in collaboration with industry partners that will co-fund and actively participate in the scientific direction of the project (http://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp).
This new research network will be established using two interrelated FOAs to support (i) the AMP RA/Lupus Leadership Center, and (ii) AMP RA/Lupus Research Sites, which together will form the AMP RA/Lupus Network. The AMP RA/Lupus Network is defined as the consortium of investigators and institutions funded under both FOAs and will provide the framework for the AMP RA/SLE Program. A diagram of the organizational structure and description of research phases can be found at (http://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp).
The intent of this Notice is to provide potential applicants with lead time to start the process of forming teams, building collaborations, and planning responsive applications.
The FOA is expected to be published in March 2014, with an expected application due date in May 2014. This FOA will utilize the Phase Innovation Awards Cooperative Agreement (UH2/UH3) activity code, with separate funding for the exploratory phase (UH2) and the demonstration phase (UH3), to be submitted in a single application. Details of the planned FOA are provided below. The FOA will be open to all qualified domestic and foreign applicant organizations.
This Notice encourages investigators and teams with expertise and insights in the areas of RA, lupus, tissue analytics, and bioinformatics to consider applying for this new FOA to establish the AMP RA/Lupus Research Sites. The Research Sites will: 1) establish infrastructure, design and implement research strategies to enroll patients with RA or lupus and healthy controls to obtain relevant tissue specimens (Clinical Research Sites); or 2) conduct research in emerging technologies and standardize their application to tissues and cells from patients with RA and/or lupus and healthy controls (Technology Research Sites); or both. Successful applicants will become part of the AMP RA/Lupus Network and work collaboratively with investigators in the AMP RA/Lupus Leadership Center, NIH staff and the AMP RA/SLE Steering Committee.
To be responsive to the upcoming FOA, applications must address all the main requirements summarized below.
Clinical Research Sites Applications:
Technology Research Sites Applications:
Combined Clinical and Technology Research Sites:
All applications should:
This FOA will utilize cooperative agreements with the UH2/UH3 activity code with separate funding for the exploratory phase (UH2) and the demonstration phase (UH3), to be submitted in a single application. Initial milestone-driven, cooperative agreement awards of up to two years will be granted for an exploratory (UH2) phase to establish the infrastructure, plan and demonstrate technical functionality and tissue acquisition capabilities in RA and lupus (Phase 0) and initiate the systems-level analysis of disease-specific pathways to identify differences between disease and control (Phase I). The most promising, milestone-meeting projects will transition to the Phase II (UH3) period of the award (for up to three additional years). The primary focus of the UH3 phase is to scale up the analysis to gain an understanding of key pathways that drive disease progression, severity or response to therapies in RA and/or lupus with the goal of delineating pathways that differ between subsets of patients within each disease.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
Su-Yau Mao, Ph.D.
Yan Wang, M.D., Ph.D.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)