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.

Biomarkers Consortium - NiP-Metastatic Prostate Cancer

The NiP- Metastatic Prostate Cancer Project will re-examine the Cou302 database to further optimize the radiographic progression-free survival (rPFS) endpoint to include additional factors that may influence overall survival. The model in development will be a first-in-prostate cancer predictive model to incorporate imaging

Partnership for Accelerating Cancer Therapies (PACT)

https://fnih.org/sites/default/files/final/pdf/APPENDIX%20D_PACT%20Guidelines_v2_01142019_0.pdfThe Partnership for Accelerating Cancer Therapies (PACT) is a five-year public-private research collaboration totaling $220 million launched by the National Institutes of Health, the FNIH and 12 leading pharmaceutical companies as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the FNIH.

Cancer Research Fund

The Cancer Research Fund enables individuals to support cancer research at the National Cancer Institute (NCI).

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.

Lung-MAP: Master Protocol for Treatment of Non-Small Cell Lung Cancer

Lung-MAP is an umbrella protocol which contains a screening component and multiple independently conducted and analyzed treatment sub-studies. The overarching hypothesis is that the umbrella master protocol will establish genomic screening for a large population of previously treated Non-small cell Lung Cancer (NSCLC) patients and evaluate targeted therapies (or combinations) in biomarker-driven sub-studies and immunotherapy combinations in patients previously exposed to standard checkpoint inhibitor therapy and lead to regulatory approval of efficacious regimens.

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 - Identification and Validation of ctDNA Quality Control Materials

The ctDNA Quality Control Materials project seeks to develop a set of nationally recognized standards to enable the production of suitable quality control materials that can be submitted for FDA clearance for widespread use in ctDNA testing. Once successfully developed and disseminated, these quality control materials will provide confidence in interpretation of ctDNA biomarker assay results, paving the way for more effective clinical research, therapeutic decision-making, regulatory evaluation, and reimbursement applications.

Biomarkers Consortium - Chemotherapeutic Impact on the Immune MicroEnvironment

Project results will help determine the effect of chemotherapy on malignant and non-malignant cells including immune cells. New biomarkers characterizing the TME before and after chemotherapy may be discovered that reflect cell composition, cell states, and cell-cell interaction.

Biomarkers Consortium – CSC Scientific Symposium

The Cancer Steering Committee (CSC) Scientific Symposium reviews advances in the field of biomarker and regulatory science that are relevant to the development of new public-private partnerships for precompetitive biomarkers. This review assists the CSC with planning future public- private partnerships in this area.