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.

Bespoke Gene Therapy Consortium (BGTC)

The Bespoke Gene Therapy Consortium (BGTC) is a program in development. Building on the successful Accelerating Medicines Partnership model, the BGTC represents a 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. By developing a operational playbook that invokes the use of streamlined templates, master regulatory files, and uniform production processes, it is anticipated that following a pilot phase, 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 it moves more broadly into the era of genome editing.

The Moderate Alcohol and Cardiovascular Health Trial (MACH15)

The Moderate Alcohol and Cardiovascular Health Trial (MACH15) was a longitudinal, international clinical trial to determine the effects of moderate alcohol use on cardiovascular disease and diabetes. 

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. 

Osteoarthritis Initiative

The Osteoarthritis Initiative was a public-private collaboration to improve the efficiency of drug development and clinical trials for the treatment of osteoarthritis, which affects more than 30 million adults in the United States.

Baby Connectome Project

The Baby Connectome Project (BCP) is a four-year study of children from birth through five years of age, intended to provide a better understanding of how the brain develops from infancy through early childhood and the factors that contribute to healthy brain development.

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 - Workshop: Developing an Evidentiary Criteria Framework for Safety Biomarkers Qualification

This workshop aimed at creating alignment among scientific stakeholders including the FDA, the NIH, the biopharmaceutical industry, academic researchers and patient groups regarding a proposed framework for determining the levels of evidence required to qualify biomarkers for use in drug development.

Biomarkers Consortium - Use of Targeted Multiplex Proteomic Strategies to Identify CSF-Based Biomarkers in Alzheimer’s Disease

The AD Targeted Cerebrospinal Fluid (CSF) Proteomics Project, completed in Q2Y15, completed an initial validation of a multiplexed panel of known biomarkers, examined BACE levels and enzymatic activity, and set up the initial validation of a mass spectroscopy panel using AD cerebrospinal fluid samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI).