Programs

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.

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.

John Laws Decker Memorial Fund

The Dr. John Laws Decker Memorial Fund honors the late NIH Clinical Center Director through the annual John Laws Decker Memorial Lecture and the Distinguished Clinical Teacher's Award.

Dr. John L. Barr Memorial Fund

The Dr. John L. Barr Memorial Fund supports the Intramural Research Training Award (IRTA) fellowship program at the Clinical Center's Pain and Palliative Care Service.

NIH Medical Research Scholars Program

The MRSP is a one-year intensive training program on the NIH campus for up to 50 medical, dental and veterinary students to engage them in research early in their careers.

Principles of Pharmacology Course

The Principles of Clinical Pharmacology Course at the NIH Clinical Center trains scholars and researchers in the clinical pharmacologic aspects of contemporary drug development and utilization. Since 1998, more than 10,000 individuals have taken the lecture-based course. The FNIH supported this program from 2009-2015.

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.

Development & Production of Endotoxin under GMP for Human Clinical Research

Development & Production of Endotoxin under GMP for Human Clinical Research is a program enabling NIH to develop and produce a new strain of endotoxin under good manufacturing practices (GMP) conditions.

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.