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AMP Related Information
- NIH Accelerating Medicines Partnership Page
- NIAMS Accelerating Medicines Partnership Page
- AMP RA/Lupus Network (Stanford)
- Fact Sheet: AMP — Autoimmune Diseases of Rheumatoid Arthritis and Lupus
- CONNECT in Rheumatoid Arthritis, Lupus and other Autoimmune Conditions (historical)
- AMP RA/SLE Steering Committee Project Plan
- AMP RA/SLE FAQs Updated April 1, 2014
- Letter from Dr. Stephen I. Katz: NIH Announces Funding Opportunities Through the Accelerating Medicines Partnership
- Letter from Dr. Stephen I. Katz: Introducing the Accelerating Medicines Partnership Network in Rheumatoid Arthritis and Lupus
- Overview of the Accelerating Medicines Partnership (AMP)
- What Others are Saying About the AMP’s RA and Lupus Network Awards
- Funding Opportunities
- Funding Process
- Funded Research
- Clinical Research
- Policies & Guidelines
Accelerating Medicines Partnership (AMP)
Updated June 20, 2016
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 ways of identifying and validating promising biological targets for 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) through the 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 foster 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
In September 2014, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute of Allergy and Infectious Diseases (NIAID), as participating members of the AMP RA/SLE Program, funded a collaborative AMP RA/Lupus Network composed of sites across the United States. The Network was developed by NIH in collaboration with industry partners that are co-funding and actively participating in guiding the Network’s scientific direction. The individual projects within the Network are progressing along a predetermined set of steps to ensure standardization of procedures and minimize technical variability.
Research Phase 0
Highlights of the Network’s Phase 0 work include the following:
- Established Network infrastructure for communications and decision-making, as well as policies to allow for timely sharing of data.
- Tested different means of obtaining and prepping tissue and, based on the results, developed standard operating procedures (SOPs) for preparation of synovial (joint) tissue for RA projects and kidney tissue for lupus projects.
- Tested and validated cutting-edge technologies, such as CyTOF (Cytometry by Time of Flight) and RNA-seq (RNA sequencing), in synovial and kidney tissues.
- Developed proposals for pilot projects that will explore other emerging technologies and additional types of biological specimens.
- Established clinical protocols and procedures for Phase I studies.
- Established systems for data management and analysis, including databases for clinical data and biospecimen tracking, and storage of experimental data.
The Phase 0 SOPs that were developed by the Network are anticipated to be widely applicable to studies of human disease tissues. Broad use of harmonized, validated SOPs may allow cross-tissue comparisons that would not otherwise be possible. The AMP RA/SLE initiative may serve as a demonstration of state-of-the-art analysis of human disease tissues.
A horizontal X-ray image depicting joint damage from rheumatoid arthritis. (Photographer: Camazine Scott)
Research Phase I
In Phase I, the Network will use the standardized technologies established in Phase 0 to analyze samples from patients with RA and SLE. Research Phase I will also include analysis of samples from individuals without RA or SLE, such that a systems biology approach can be used to identify pathways that distinguish disease and non-disease tissue:
- SLE Phase I study: The Network will conduct a prospective multi-center study in patients with SLE with active renal disease requiring biopsy. The study will compare RNA-seq and CyTOF signatures from kidney biopsies of SLE patients with biopsies from living kidney donor tissue.
- RA Phase I study: The Network will conduct a prospective multi-center study in patients with late-stage RA and osteoarthritis (OA) requiring arthroplasty. The study will compare RNA-seq and CyTOF signatures from the RA and OA arthroplasties. The RA group will also begin a program to obtain synovial biopsies using minimally invasive ultrasound-guided technology. This program is expected to enhance capacity for RA tissue acquisition for the AMP RA projects.
The Phase I studies will inform sample size calculations and establish the feasibility and design of larger studies to be carried out in Phase II.
Research Phase II
In Phase II, the studies will be conducted in a larger patient population. Subgroups of patients will be compared 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).
AMP RA and Lupus Network Structure
Archived AMP FOAs
The webinar to discuss the FOAs was held on April 9, 2014.