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 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.

The Dr. Franklin A. Neva Memorial Fund

The Dr. Franklin A. Neva Memorial Fund supports an annual lecture on a topic related to clinical tropical medicine and associated pathophysiology as part of the Laboratory of Parasitic Diseases’ (LPD) ongoing lecture series. It honors the legacy of Franklin A. Neva, M.D., a renowned virologist, parasitologist, clinician and former director of the Laboratory of Parasitic Diseases (LPD) at the National Institute of Allergy and Infectious Diseases (NIAID).

Global Health Fund

The Global Health Fund supports FNIH programs that are designed to alleviate widespread suffering in the developing world. Program focus includes research and training on diseases such as malaria and HIV, as well as conditions like malnutrition that afflict hundreds of millions of people globally.

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.