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 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.
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 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.
What We Do
- Key Initiatives
- The Heart Truth®
- Research Areas
- Education & Training
- Programs in Development
- Working with the National Institutes of Health
- Accomplished Projects
- FNIH Lurie Prize
- Biogen Idec Inc.
- Bristol-Myers Squibb
- Eli Lilly and Company
- GlaxoSmithKline Intellectual Property Development Limited
- Janssen Research & Development, LLC
- Merck Sharp & Dohme Corp.
- Pfizer, Inc.
- Sanofi US Services Inc.
- Takeda Pharmaceuticals
- Alliance for Lupus Research
- Alzheimer’s Association®
- American Diabetes Association
- Arthritis Foundation
- Geoffrey Beene Foundation Alzheimer’s Initiative
- JDRF International
- The Lupus Foundation of America
- Lupus Research Institute
- Pharmaceutical Research and Manufacturers of America
- Rheumatology Research Foundation
Learn More about the Three AMP Initiatives
Alzheimer’s Disease (AD)
This project aims to identify theragnostic biomarkers that predict clinical outcomes and use human AD brain tissue to identify biologic nodes and networks linked to AD development and progression.
Rheumatoid Arthritis and Lupus
This project aims to molecularly deconstruct and compare these two major autoimmune diseases by integrating individual proteomic and genomic data to provide a systems level understanding of disease mechanisms.
Type 2 Diabetes (T2D)
This project aims to create a publicly available knowledge portal for the purpose of housing and analyzing integrated genomics data, and collecting new gene sequencing data in T2D and its complications.
New AMP Project Proposals
The AMP Executive Committee will consider new program proposals to complement current AMP initiatives starting in September 2014. Proposals may be within or outside a currently AMP covered disease area. Proposed research initiatives should fit the core mission of AMP and target areas of high unmet medical need likely to gain AMP stakeholder financial support.