Accelerating Medicines Partnership (AMP)

AMP Graphic.

Updated June 16, 2014

AMP RA/SLE Program Overview

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.

AMP RA/SLE Program Research Phases

The success of this research program will depend on careful progression of individual projects along a predetermined set of steps to ensure standardization of procedures to minimize technical variability. Projects are expected to progress in three phases: Research Phase 0 and Research Phase I will be conducted during the UH2 (Exploratory) funding period, Research Phase II will be conducted during the UH3 (Implementation) funding period.

Research Phase 0: Testing of different means of obtaining and prepping tissue and some initial analytic runs will be conducted with the goal of developing standardized methods in small number of homogenous samples in at least two diseases. Samples must include affected organ specimens in addition to peripheral blood and could be newly obtained or already available.

Photo showing an X-ray image of hand with joint damage from rheumatoid arthritis.

A horizontal X-ray image depicting joint damage from rheumatoid arthritis. (Photographer: Camazine Scott)

Research Phase I: Analysis of a standardized analytic(s) successfully established in Research Phase 0, in blood and tissue cells, plus trial runs of additional selected analytics. The number of samples will be sufficient to inform power calculations and establish the feasibility of larger studies of the tissue analytic and sample type, source and acquisition approach. At least one Research Phase I study in RA and one Research Phase I study in lupus are expected to be completed by the end of the second year of the project. Research Phase I will include analysis of samples from individuals without RA or lupus, such that a systems biology approach can be used to identify pathways that distinguish disease and non-disease tissue (i.e., comparison between disease and non-disease).

Research Phase II. Testing in larger patient populations will be conducted as determined by power calculations, priority, and budget. Patient stratification is expected for comparison within a disease (e.g., RA: treatment responder vs. non-responder, early vs. established RA, comparison among disease-modifying anti-rheumatic drugs (DMARD) treated groups; lupus: before treatment vs. after treatment, comparison among types of kidney disease, etc.). Initiation of Research Phase II studies requires a favorable recommendation by the AMP RA/SLE Steering Committee and approval by the NIH Program Official.

Image depicting the AMP RA/SLE Program Research Phases

 

AMP RA and Lupus Network Structure

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.

Image depicting the AMP RA and Lupus Network structure

Archived AMP FOAs

Accelerating Medicines Partnership (AMP) in Rheumatoid Arthritis and Lupus: Network Leadership Center (UM2) RFA-AR-14-015

Accelerating Medicines Partnership (AMP) in Rheumatoid Arthritis and Lupus: Network Research Sites (UH2/UH3) RFA-AR-14-016

The webinar to discuss the FOAs was held on April 9, 2014.