The National Institutes of Health, FDA, 10 biopharmaceutical companies, the Pharmaceutical Research and Manufacturers of America, and several nonprofit organizations have launched an unprecedented public/private 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. It will begin with 3- to 5-year pilot projects in three disease areas: Alzheimer’s disease, type 2 diabetes, and the autoimmune disorders of rheumatoid arthritis and lupus.
The AMP partners have developed research plans and are sharing costs, expertise, and resources—$230 million—in an integrated governance structure. The investment in Alzheimer’s disease for first pilot study is about $130 million, with NIH contributing $67.6 million and industry kicking in $61.9 million. Approximately $58 million will be devoted to diabetes, with NIH picking up more than $30 million and industry about $28 million. For the rheumatoid arthritis and lupus project, the investment will be split almost equally between NIH and industry at a tab of almost $42 million.
“Our most critical health challenges require new, innovative ways to develop medicines and vaccines,” said Rupert Vessey, MD, head of early development and discovery sciences, Merck Research Laboratories, an AMP partner. “Collaborations such as this, that exchange data, share insights, and generate knowledge will be important to unraveling the mysteries of the diseases that cause suffering for individuals and are a burden to our society.”
The results of this partnership will be in the pre-competitive space and shared among the AMP partners as well as the broader scientific community. Any targets identified through AMP have the potential to become the focus of a drug development program by biopharmaceutical companies.
Developing a new drug, from early discovery through FDA approval, takes more than a decade and has a failure rate of more than 95%. As a consequence, each success costs more than $1 billion. The most expensive failures happen in late-phase clinical trials, with a lack of drug efficacy currently estimated as responsible for 59% of phase 2 failures and 52% of phase 3 failures.