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.

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.

Biomarkers Consortium - Vol-PACT Phase II: Advanced metrics and modeling with Volumetric CT for Precision Analysis of Clinical Trial results

Vol-PACT is designed to analyze volumetric CT imaging trial data from completed industry phase II/III solid tumor trials to improve quantitative prediction of phase III trial results. The project seeks to develop novel imaging methods to more accurately measure cancer response and progression

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.