Accelerating Medicines Partnership

Accelerating Medicines Partnership, AMP

The Mission

Accelerated Medicines Partnerships

This unprecedented public private partnership brings together the National Institutes of Health, (NIH), 10 biopharmaceutical companies and several not-for-profit organizations, in a mission to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets of disease.  This is the first pre-competitive public private partnership of its kind, since a main goal of the collaboration will be to generate pre-competitive, disease-specific data that will be made publicly available.   

AMP currently has projects in three disease areas — Alzheimer’s Disease, Type 2 Diabetes and Rheumatoid Arthritis and Systemic Lupus Erythematosus (Lupus) — each project will last from three to five years in duration.

Scientists from NIH and industry have developed research plans for each project, which aim to characterize effective molecular indicators of disease—biomarkers—and to distinguish biological targets most likely to respond to new therapies.

The Partnership

The projects will be performed by lead investigators from academia and managed by the Foundation for the NIH (FNIH), a preeminent leader in the design and execution of public private partnerships.  FNIH acts as a neutral convener, which brings together all the stakeholders and secures the funding and scientific expertise while establishing the governance of the partnership and providing program and project management for all initiatives.

The AMP Partners include the Food and Drug Administration (FDA) and the NIH from the government sector; AbbVie, Biogen Idec, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Research & Development, Eli Lilly and Company, Merck & Co., Inc., Pfizer, Inc., Sanofi, and Takeda Pharmaceuticals from the industry sector.

Additional support is provided by the non-profit sector partners Alliance for Lupus Research, The Alzheimer’s Association, the American Diabetes Association, Arthritis Foundation, The Foundation for the NIH, Geoffrey Bean Foundation, Juvenile Diabetes Research Foundation, Lupus Foundation of America, The Lupus Research Institute, PhRMA, Rheumatology Research Foundation, and US Against Alzheimer’s.

The Opportunity

As a result of the technological revolution in genomics, proteomics, imaging and more, biomedical researchers have been able to identify changes in genes, proteins and other molecules that cause disease and influence disease progression. Clinicians use this information to determine the presence of disease through biomarkers with the use of diagnostic tests. Biopharmaceutical companies use this information to develop therapies that target specific genes and molecules in order to interfere with their processes and modify the course of disease. In the last five years, researchers have identified more than 1,000 new biological changes that hold promise as biomarkers and drug targets, offering a potential revolution in diagnostics and therapeutics.

While technological advances have produced a wealth of data on the biological cause of disease, moving these discoveries into treatments has been far more difficult. Not all biological insights lead to effective drug targets and choosing the wrong target can result in failures late in the drug development process, costing time, money and ultimately, lives. Developing a new drug 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 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, it is essential to do a better job of pinpointing the right biological targets early in the process.

The Strategy

The entire biomedical research community and the general public have a shared interest in compressing the timelines, reducing the costs, and increasing the success rates of new targeted therapies. Given the amount and complexity of the data, this goal will require a systematic approach in which government, academia, industry and patient groups work collaboratively to sort through the flood of disease targets and find the ones most likely to prove responsive to treatments.

Ultimately, AMP’s goal is to increase the number of new diagnostics and therapies for patients, reducing the time and cost of developing them. By optimizing the process for identifying and validating clinically relevant disease targets for drug design, AMP aims to increase efficiency through:

  • Reducing development time: accelerating the hard work of sorting through a large number of candidates to identify the best biological targets for drug development could save months or even years of early stages of discovery.
  • Improving prospects for success: with disease targets and biomarkers that have been validated rigorously with human data, higher confidence about efficacy should be achieved, allowing researchers to move the most promising compounds quickly into the pipeline with the expectation of fewer failures in late stage clinical trials.
  • Lowering costs: shorter development timeframes and fewer late-stage drug failures should reduce the cost of delivering new and effective medicines to patients.

Improve the process by:

  • Providing better understanding of biological targets and identification of valid biomarkers to enable more robust clinical trials — in part by testing therapies on patients most likely to respond to them based on the molecular profiles of their disease.

Increase the number and effectiveness of new targeted therapies via:

  • Understanding the biological pathways underlying disease and the specific biological targets that can alter disease to lead to more rational drug design and better tailored therapies.
  • Reducing the number of failures in Phase II and Phase III clinical trials to increase the number of new drugs developed per $1 billion of research and development investment.
  • Increasing expected returns to enhance the attractiveness of investing in drug development.

The duration of this program is anticipated to be 5 years.

FNIH is responsible for raising and distributing private sector funds for AMP, and convening the governing committees that oversee the partnership on behalf of all the stakeholders. FNIH is also providing ongoing central project management support for the research initiatives in each of the three disease areas.