Research 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.

Programs are displayed in alphabetical order by research topic.

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Biomarkers Consortium

The project seeks to analyze volumetric CT imaging trial data from completed industry phase II solid tumor trials to improve quantitative prediction of phase III results.

Biomarkers Consortium

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

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.

Cancer

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.

Cancer

The ctDNA Quality Control Materials project seeks to develop a set of nationally recognized standards to enable the production of suitable reference materials that can be submitted for FDA clearance for widespread use in ctDNA testing. Once successfully developed and disseminated, these reference 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.

Cancer

The FNIH is seeking funding to support the Single Cell Mass Accumulation Rate as a Biomarker for Drug Efficacy in Multiple Myeloma and Leukemia (MAR) project, to develop a predictive response biomarker that directly measures drug effects on single living tumor cells to allow for rapid therapeutic adaptation for patients facing treatment resistance.

Cancer

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

Cancer

The Dean R. O'Neill Renal Cell Cancer Research Fund supports a Fellow in the laboratory of Dr. Richard Childs at the National Heart, Lung, and Blood Institute (NHLBI) to explore treatments for renal cell carcinoma.

Cancer

The Dr. Edward T. Rancic Memorial Fund for Cancer Research supports a Fellow in the laboratory of Dr. Richard Childs at the National Heart, Lung, and Blood Institute (NHLBI) to explore treatments for renal cell carcinoma.

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.