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.

Biomarkers Consortium - Neuroscience Symposium

The Neuroscience Steering Committee, led by the FNIH and its co-chairs Dr. Linda Brady, Dr. Hartmuth Kolb, and the emeritus co-chair Dr. Bill Potter, is bringing together experts in the field of neuroscience from industry, NIH, FDA, and academia to present progress to date, next steps, and key obstacles that need to be addressed in order to drive biomarker development in a multitude of neuroscience focus areas. 

Fogarty International Center's 50th Anniversary

The National Institutes of Health (NIH)’s Fogarty International Center celebrated its 50th anniversary of accomplishments and hosted a Scientific Symposium on May 1st, 2018 at the Natcher Auditorium on NIH’s campus. The program convened a series of panel discussions with NIH leaders, Fogarty grantees, and key stakeholders, to identify key gaps in global health research and strategize future research initiatives.

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.

Clayton-Dedonder Mentorship Fellows Program

Clayton-Dedonder Mentorship Fellows Program is designed to enhance the teaching and leadership skills of entry- to mid-level faculty at universities and research institutions in low- and middle-income countries at select training sites funded by the NIH Fogarty International Center.

Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED)

The study was implemented using shared and harmonized protocols across the eight sites to gather an enormous amount of data (physical, cognitive assessments, diet, illness and enteric infection, socio-economic status, etc.) to enable identification and characterization of factors associated with negative impacts on a child’s growth, development and vaccine response early in life.

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