Date: 2014-02-04
Type of information: R&D agreement
Compound:
Company: FDA (USA), NIH (USA), AbbVie (USA - IL), Biogen Idec (USA - MA), BMS (USA - NY), GSK (UK), Johnson & Johnson (USA - NJ), Lilly (USA - IN), Merck&Co (USA - NJ), Pfizer (USA - NY), Sanofi (France), Takeda (Japan), American Diabetes Association (USA), Foundation for the NIH (USA), Geoffrey Beene Foundation (USA), Lupus Foundation of America (USA), PhRMA (USA), Rheumatology Research Foundation (USA), USAgainstAlzheimer’s (USA)
Therapeutic area: Autoimmune diseases - Neurodegenerative diseases - Metabolic diseases
Type agreement: collaboration
R&D
Action mechanism:
Disease: Alzheimer’s disease, type 2 diabetes, rheumatoid arthritis, systemic lupus erythematosus
Details: * On February 4, 2014, NIH, 10 biopharmaceutical companies and several nonprofit organizations have launched a partnership to transform the current model for identifying and validating the most promising biological targets of disease for new diagnostics and drug development. The Accelerating Medicines Partnership (AMP) aims to distinguish biological targets of disease most likely to respond to new therapies and characterize biological indicators of disease, known as biomarkers. Through the Foundation for the NIH (FNIH), AMP partners will invest more than $230 million over five years in the first projects, which focus on Alzheimer’s disease, type 2 diabetes, and the autoimmune disorders rheumatoid arthritis and systemic lupus erythematosus (lupus).
A critical and groundbreaking element of the AMP is the agreement that the data and analyses generated will be made publicly available to the broad biomedical community. The three- to five-year, milestone-driven pilot projects in these disease areas could set the stage for broadening AMP to other diseases and conditions.
AMP has been more than two years in the making, with intense interactions between scientists in the public and private sectors, progressive refinement of the goals, strategy development support from the Boston Consulting Group, and scientific project and partnership management by the FNIH. Through this effort, AMP partners have developed research plans and are sharing costs, expertise, and resources in an integrated governance structure that enables the best informed contributions to science from all participants.
The research highlights for each disease area are:
Alzheimer’s disease:
• Identify biomarkers that can predict clinical outcomes by incorporating an expanded set of biomarkers into four major NIH-funded clinical trials, which include industry support, designed to delay or prevent disease.• Conduct large-scale, systems biology analyses of human patient brain tissue samples with Alzheimer’s disease to validate biological targets that play key roles in disease progression, and increase understanding of molecular networks involved in the disease, to identify new potential therapeutic targets.
Type 2 diabetes:
•Build a knowledge portal of DNA sequence, functional genomic and epigenomic information, and clinical data from studies on type 2 diabetes and its heart and kidney complications. The portal will include existing data and new data from studies involving 100,000–150,000 individuals. The rich collection of curated and collated information in this portal will provide an opportunity to identify the most promising therapeutic targets for diabetes from the growing mountain of potentially relevant data.
• Focus on DNA regions that might be critical for the development or progression of type 2 diabetes and search for natural variations in targeted populations that might predict the likelihood of success of drug development aimed at these targets.
Rheumatoid arthritis and lupus:
• Collect and analyze tissue and blood samples from people with rheumatoid arthritis and lupus to pinpoint biological changes at the single cell level, to allow comparisons across the diseases and provide insights into key aspects of the disease process.
• Identify differences between rheumatoid arthritis patients who respond to current therapies and those who do not, and provide a better systems-level understanding of disease mechanisms in RA and lupus.
Highly collaborative steering committees with representation from public- and private-sector partners will be established for each disease area to oversee the research plans. The steering committees will be managed by FNIH under the direction of an AMP executive committee comprised of leaders from NIH, industry, the FDA, and patient advocacy organizations.
Financial terms:
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