The National Institutes of Health (NIH) announced a partnership with ten drug makers, as well as eight non-profit organizations, to accelerate the discovery of new therapies for Alzheimer’s disease, type 2 diabetes, rheumatoid arthritis, and lupus. Under the collaboration, termed the Accelerating Medicines Partnership (AMP), the companies and the NIH have agreed to contribute scientists, along with relevant data and samples from clinical trials, and to share costs. The goal is to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets of disease.
NIH director Francis Collins noted “currently, we are investing a great deal of money and time in avenues with high failure rates,” adding “all sectors of the biomedical enterprise agree that new approaches are sorely needed.” Through AMP, which will be managed through the Foundation for the NIH (FNIH), NIH and industry partners are sharing expertise and resources — $230 million — in an integrated governance structure that enables the best informed contributions to science from all participants. Collins stated in his blog about AMP, “[t]his unprecedented public-private effort will strive to identify better targets so we can develop better drugs at a faster pace.”
AMP Partners:
|
Government |
Industry |
Non-Profit Organizations |
|
|
|
According to NIH, “[a] critical component of the partnership is that industry partners have agreed to make the AMP data and analyses publicly accessible to the broad biomedical community.”
NIH reports that, currently, “developing a new drug — from early discovery through Food and Drug Administration (FDA) approval — takes well over a decade and has a failure rate of more than 95 percent. As a consequence, each success costs more than $1 billion.” The most expensive and difficult failures happen in “late phase clinical trials, with a lack of drug efficacy currently estimated as responsible for 59 percent of Phase II failures and 52 percent of Phase III failures.” Therefore, NIH concludes, “it’s essential to do a better job of pinpointing the right biological targets early in the process.”
Mikael Dolsten, M.D., Ph.D., President of Worldwide Research and Development at Pfizer addresses this challenge, stating: “The AMP rallies scientific key players of the innovation ecosystem in a more unified way to address one of the key challenges to Biopharma drug discovery and development.” The novel collaboration, he believes, will “leverage the strengths of both industry and NIH to ensure we expedite translation of scientific knowledge into next generation therapies to address the urgent needs of Alzheimer’s, diabetes and RA/lupus patients.”
President Obama weighed in on AMP as well:
Today, my Administration is taking action to accelerate the development of life-saving drugs and to help identify new treatments and cures for diseases like Alzheimer’s and diabetes. This new public-private partnership – the Accelerating Medicine Partnership – combines the considerable resources of America’s government with the innovation of our private sector companies in an effort to find new answers to today’s domestic and global public health challenges.
A number of companies declined the AMP collaboration (FirstWordPharma). Amgen noted that the project overlaps with its own efforts to use human genetics in the discovery of new medicines. Roche reportedly did not participate because the program dropped schizophrenia from the initial focus, the disease the Swiss drugmaker was most interested in. However, FirstWordPharma notes that a Roche spokesman stated that the company is “very open” to joining AMP in the future. AstraZeneca also declined to join, but a spokeswoman says it “will continue to see how [the project] develops.”