To tackle the human health challenges that face the world today, the FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.

Accelerating Medicines Partnership – Alzheimer's Disease Phase 2

The Accelerating Medicines Partnership Alzheimer’s Disease (AMP AD Phase 2)  is a new precompetitive public-private partnership that will enable precision medicine research for Alzheimer’s Disease through deep and longitudinal molecular analyses across diverse populations to provide insights that will accelerate the development of therapies for Alzheimer’s Disease. 

Bespoke Gene Therapy Consortium (BGTC)

The Bespoke Gene Therapy Consortium (BGTC) is a developing public-private partnership dedicated to making gene therapy a reality for people with rare genetic diseases affecting populations too small to be viable from the current commercial perspective. Building on the successful Accelerating Medicines Partnership model, this program will focus on developing an operational playbook that invokes the use of streamlined templates, master regulatory files, and uniform production processes. It is anticipated that following a pilot phase of 4-6 test cases, a pathway toward the commercial viability of these therapies will be found. This may ultimately have a tremendously positive impact on the larger field of gene therapy if it moves more broadly into the era of genome editing.

Accelerating Medicines Partnership - Parkinson's Disease

In 2016, the AMP Executive Committee approved the planning of an AMP effort to confront the challenges presented by Parkinson’s disease (PD). This complements current efforts in the areas of Alzheimer’s disease, type 2 diabetes and the autoimmune disorders of rheumatoid arthritis and systemic lupus erythematosus (lupus). A critical component of this partnership is that all members have agreed to make the AMP Parkinson’s disease (AMP PD) data and analyses publicly available to the broad biomedical community.

Plasticity and Mechanisms of Cognitive Remediation in Older Adults

Plasticity and Mechanisms of Cognitive Remediation in Older Adults supports a grant for a multicenter clinical research trial on remediating age-related cognitive decline through mindfulness-based stress reduction and exercise.

Accelerating Medicines Partnership - Alzheimer's Disease

The Accelerating Medicines Partnership Alzheimer’s Disease Project (AMP-AD) is a precompetitive partnership among government, industry, and nonprofit organizations that focuses on discovering novel, clinically relevant therapeutic targets and on developing biomarkers to help validate existing therapeutic targets. 

Clinical Center Drug Donations

The Clinical Center In-Kind Drug Donation Program provides pharmaceuticals that are donated through the public-private partnership coordinated by the FNIH to the NIH Clinical Center.

Biomarkers Consortium - Workshop: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification

The FNIH Biomarkers Consortium and FDA hosted a workshop to provide a Framework for Defining the Evidentiary Criteria for Surrogate Endpoint Qualification on July 30-31, 2018. The workshop aimed to create alignment of the biomedical community and regulators on the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on surrogate endpoints and specific clinical outcome measures.

Biomarkers Consortium - Inflammatory Markers for Early Detection and Subtyping of Neurodegenerative and Mood Disorders

This project will aim to standardize and validate measurement methods for inflammatory markers associated with Alzheimer’s Disease and/or Major Depressive Disorder to ultimately identify a unique biosignature of disease. The identified biosignature would greatly assist with medication development, patient diagnosing, and patient selection for clinical trials.

Biomarkers Consortium - Bone Quality Project

The Biomarkers Consortium’s Bone Quality Project aims to evaluate and to identify biomarkers of bone strength and quality changes by analyzing pooled imaging and biochemical data from multiple clinical studies to allow definition of better clinical endpoints.

Biomarkers Consortium - Placebo Data Analysis Project in Alzheimer’s Disease/Mild Cognitive Impairment Clinical Trials

The Biomarkers Consortium’s Placebo Data Analysis Project in Alzheimer’s Disease/Mild Cognitive Impairment Clinical Trials combined placebo data from large clinical trials provided by multiple pharmaceutical companies to create datasets of 3,000 to 5,000 subjects for Alzheimer’s disease (AD) and mild cognitive impairment (MCI) groups. The goal of the project was to develop better measures of disease progression in terms of outcome measures that have both low variability and are sensitive to change, for use in future clinical trials.