Notice Number: NOT-AR-14-013

Key Dates
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

Related Announcements
NOT-AR-14-014

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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 Program Project or Center with Complex Structure Cooperative Agreement (UM2) activity code. Details of the planned FOA are provided below. The FOA will be open to all qualified domestic applicant organizations.

Research Initiative Details

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 Leadership Center. The Leadership Center will have the major responsibility for: (i) overall scientific direction and coordination of AMP RA/Lupus research activities; (ii) monitoring and assessing progress and performance; and (iii) the provision of centralized scientific/technical research resources for all projects undertaken.

The AMP RA/Lupus Leadership Center will consist of the following components:

• Research Leadership, Coordination and Management Group responsible for the overall scientific and operational leadership of AMP RA/Lupus Network,
•  Data Coordination and Statistical Research Group responsible for the provision of overall data management and statistical support,
•  Systems Biology and Bioinformatics Group responsible for the application of existing and newly developed bioinformatics and systems biology tools and methods to analyze and interpret AMP RA/Lupus Network-generated data, and,
•  Tissue Acquisition Research and Repository Group responsible for standardization, quality control, inventory and coordination of distribution of clinical samples.
•  The program directors/principal investigators of the Leadership Center Research Groups will be members of the AMP RA/Lupus Research Leadership Committee and will work collaboratively with the AMP RA/Lupus Research Sites, NIH staff and the AMP RA/SLE Steering Committee.

To be responsive to the upcoming FOA, the applications for the Leadership Center will need to address all of the main requirements summarized below:

• Demonstrate capability to provide scientific leadership.
•  Demonstrate capability to manage large, complex, multisite, milestone-driven clinical projects.
•  Describe approaches to ensure quality of data and consistency of the experimental approaches, statistical plans and the proposed analyses across all research sites.
• Propose statistical plans for pilot and feasibility (Phase 0), disease-specific pathway analysis (Phase I), and within-disease pathway comparisons (patient stratification - Phase II) clinical studies.
• Focus on systems biology and bioinformatics needs of AMP RA/Lupus Network and development of an AMP RA/Lupus Portal; leveraging resources such as ImmPort (https://immport.niaid.nih.gov/immportWeb) and with the long-term goal of integration with the NIH Knowledge Portal, a data aggregation and interrogation tool being developed by the AMP Consortium.
•  Propose milestones to measure progress of the Leadership Center and its components.
• Describe the availability of a Central IRB service at the institution and/or the willingness to use a commercial or Central IRB for these studies. 

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

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)
Telephone: 301-594-5032
Email: [email protected]
Website: http://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_Lupus/default.asp