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Feb 4, 2014

NIH Coaxes Big Biopharma to AMP Up Drug Development

  • The NIH today said it is joining 10 biopharma giants and several nonprofit groups today to launch the Accelerating Medicines Partnership (AMP), whose partners will spend more than $230 million over five years through the alliance-building Foundation for the NIH (FNIH) on its first of several three- to five-year, milestone-driven pilot projects designed to speed up the validation of disease targets, and thus bring new drugs to market faster.

    The 10 biopharmas include AbbVie, Biogen Idec, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson unit Janssen Research and Development, Merck & Co., Sanofi, and Takeda.

    Nonprofit partners joining the FNIH include the Alzheimer’s Association, the American Diabetes Asociation, the Geoffrey Beene Foundation Alzheimer’s Initiative, the Lupus Foundation of America, the Pharmaceutical Research and Manufacturers Association (PhRMA), the Rheumatology Research Foundation, and USAgainstAlzheimer's.

    The first pilot projects will focus on Alzheimer’s disease, type 2 diabetes, and the autoimmune disorders rheumatoid arthritis and systemic lupus erythematosus (lupus). The NIH said that the AMP aims to characterize biomarkers and distinguish biological targets of disease most likely to respond to new therapies.

    Data and analyses generated through AMP projects will be made publicly available to the broad biomedical community.

    “We are investing a great deal of money and time in avenues with high failure rates, while patients and their families wait. All sectors of the biomedical enterprise agree that new approaches are sorely needed,” NIH director Francis S. Collins, M.D., Ph.D., said in a statement.

    The AMP has been more than two years in the making, using that time to bring together scientists in the public and private sectors, refine its goals, develop its strategy with support from the Boston Consulting Group, and develop a framework for scientific project and partnership management through the FNIH. The AMP's partners have developed research plans and have agreed to share costs, expertise, and resources.

    The pilot projects include:

    • 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 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.
    • 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; Provide a better systems-level understanding of disease mechanisms in rheumatoid arthritis and lupus.
    • Type 2 diabetes: Focus on DNA regions that might be critical for the development or progression of type 2 diabetes; Search for natural variations in targeted populations that might predict the likelihood of success of drug development aimed at these targets; 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,” according to the NIH.

    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 the FNIH under the direction of an AMP executive committee consisting of leaders from the NIH, industry, the FDA, and patient advocacy organizations.



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