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NIH, Industry Launch $230M Translational Drugs, Diagnostics Push

NEW YORK (GenomeWeb News) – The National Institutes of Health said today it plans to spend nearly $230 million in a partnership with 10 pharmaceutical firms and several non-profit groups to jumpstart efforts to find targets for new drugs and diagnostics.

NIH created the Accelerating Medicines Partnership (AMP) as a new model for spurring development of drugs toward US Food and Drug Administration approval, a process which has a failure rate of 95 percent and which can take a decade and cost more than $1 billion

Creating, sharing, and exploring genomic, functional genetic, epigenetic, and clinical data sets will be core activities for the program partners.

In the first five years of the program, NIH and its AMP partners will invest the $229.5 million through the Foundation for the NIH to fund projects that seek targets that are most likely to respond to new therapies and develop new biomarkers. NIH's private and non-profit partners plan to share costs, footing the bill for roughly half of the overall program, as well as expertise and resources through an integrated governance structure, NIH said.

The first phase of the partnership will focus on Alzheimer's disease, type 2 diabetes, and the autoimmune disorders rheumatoid arthritis and systemic lupus erythematosis, but after that the program could widen to include other diseases and disorders.

All of the data and analyses these projects generate will be opened up for use by the biomedical research community, NIH said.

"Currently, 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 Collins said in a statement.

Although basic scientific advances are opening "new windows" of opportunity for new therapeutics, moving them toward clinical applications and FDA clearance will require NIH and drug companies to work together, he said. "We believe this partnership is an important first step and represents the most sweeping effort to date to tackle this vital issue."

The partnership was developed through a two-year process that involved "intense interactions" between private and non-profit partners and FNIH, and strategic development support from the Boston Consulting Group.

To fund all of the AMP projects, NIH will provide $118.9 million and industry partners will provide $110.6 million.

The Alzheimer's disease program will receive $129.5 million over five years. The goal of this program will be to identify biomarkers to predict clinical outcomes by incorporating an expanded group of markers into four major NIH-funded clinical trials.

The program also will involve large-scale systems biology analyses of brain tissue samples, with the aim of validating targets that are involved in disease progression, and will expand knowledge about the molecular networks involved in the disease and seek out new drug targets.

The type 2 diabetes program will use $58.4 million to create a knowledge portal of DNA sequence, and functional genomic, epigenomic, and clinical data information from studies involving 100,000 to 150,000 individuals. NIH expects that this portal will enable researchers to identify promising therapeutic targets for diabetes. The program also will home in on DNA regions that might be involved in the development of type 2 diabetes, and seek out variations in targeted populations that could predict the efficacy of drugs aimed at these targets.

The program focused on rheumatoid arthritis and lupus will receive $41.6 million. The partners will collect and analyze tissue samples from people with these disorders for activities at the single cell level that would enable comparisons across diseases. They also will seek to identify patients who respond to current therapies and those who do not, and seek to provide a "systems-level understanding" of the mechanisms involved in these diseases.

The AMP partners include AbbVie; Biogen Idec; Bristol-Myers Squibb; GlaxoSmithKline; Johnson and Johnson; Lilly; Merck; Pfizer; Sanofi; Takeda; the Alzheimer's Association; the American Diabetes Association; the Lupus Foundation of America; the Geoffrey Beene Foundation; PhRMA; the Rheumatology Research Foundation; and USAgainstAlzheimer's.