Accelerating Medicines Partnership® Program (AMP®) Concepts in Development
The development of new AMP projects is a multi-step process ensuring that the AMP Executive Committee, the participating NIH Institutes or Centers, other US Government partners, and external stakeholders are engaged and aligned on the plan for project execution.
Each new AMP project starts with the development of a high-level Concept, outlining the critical scientific problem or capability gap that will be addressed, the scientific approach for the project, and why the project aligns with the AMP mission. Concepts are presented to the AMP Executive Committee for approval to move into a Design Phase. Once approved, the FNIH engages with potential Design Phase partners to commit resources and scientific expertise towards the design of the project. Design Phases, co-chaired by a representative from the lead NIH Institute or Center and a representative from the private sector, typically last 9-12 months and culminate in a full project Research Plan developed by the NIH and private sector Design Phase participants. The Design Phase co-chairs provide regular updates to the AMP Executive Committee on the progress of the Design Phase, and present the final project Research Plan to the AMP Executive Committee for approval. After the Research Plan is approved, the FNIH will work to secure participation and funding commitments to support the private sector portion of the project budget, and the NIH Institute(s) and Center(s) will align intramural and/or extramural resources to support the public sector portion of the project budget. Once sufficient partners and resources have been committed to the project, the new AMP Project launches.
The AMP Systems Biology of Inflammation concept proposes to leverage both existing and new multi-omics datasets to develop a new paradigm in approaching diseases and treatments based on shared molecular pathways. In our current paradigm, diseases are defined by their clinical manifestations, yet treatments are developed based on targeting mechanisms. However, specific mechanisms often play a role in the clinical manifestations of only a subset of patients. One solution to this challenge is to shift from a taxonomy of diseases based on a clinical presentation to one based on mechanisms. This new approach provides an integrative mechanistic understanding of diseases so that treatments target pathways irrespective of the clinical label a patient may carry. AMP allows us to identify shared and distinct mechanisms active across multiple diseases. In tandem with unbiased systems biology approaches, the rich molecular and clinical data available through the AMP programs offer an opportunity to quickly recognize dynamic molecular networks at the tissue/cellular level across disease states/traits within a global pathway/pathway interaction context. Leveraging this opportunity, the Project’s goal is to develop a systems biology framework to help define a molecular taxonomy of disease through the lens of inflammation. The Design Phase of the Project will result in a research plan that if funded may further drug development and positioning based on mechanisms active in each individual, irrespective of clinical label; establish blood omics data to link systemic inflammation to tissue-level disease; and increase the understanding of the contribution of chronic inflammation to disease progression and treatment response.
The AMP SBI Design Phase launched on December 14, 2022.
February 11, 2022 Approved AMP SBI Concept
Design Phase Partners
- National Institute on Aging (NIA)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- National Institute for Neurological Disorders and Stroke (NINDS)
- National Human Genome Research Institute (NHGRI)
- National Heart, Lung and Blood Institute (NHLBI)
- National Center for Advancing Translational Sciences (NCATS)
- Office of Data Science Strategy (ODSS)
- AbbVie Inc.*
- Biogen, Inc.*
- Eisai Inc.*
- Gilead Sciences, Inc.*
- Janssen Research & Development, LLC*
- Novartis Pharma AG*
- Pfizer Inc.*
- Regeneron Pharmaceuticals, Inc.*
- Takeda Pharmaceuticals*
*Provided financial support for this project.
Courtney Silverthorn, Ph.D., Associate Vice President, Research Partnerships, email@example.com
For more information about supporting or becoming a partner in this project, please contact Heidi Blythe, Director of Strategic Alliances, firstname.lastname@example.org
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