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 - 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

Multi-site Efficacy and Safety Trial of Intrapartum Azithromycin in Low- and Middle-Income Countries

This study will test whether an antibiotic taken during labor can prevent infections in mothers and newborns in seven low- and middle-income countries. It will be conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) through their Global Network for Women’s and Children’s Health Research (Global Network) in partnership with the Bill & Melinda Gates Foundation.

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.

The Science of Caregiving, Bringing Voices Together

The National Institute of Nursing Research hosted a two-day Summit to gather a variety of stakeholder perspectives on the spectrum of caregiving issues and research for conditions and illnesses that may occur across the lifespan.

Cancer Research Fund

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

Dr. Anita Roberts Memorial Fund

The Dr. Anita Roberts Memorial Fund awards travel scholarships for graduate students and post-doctoral fellows to present their work at a national meeting.

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.

Sports and Health Research Program: Pilot Projects on Sports-Related Brain and Spinal Cord Injury Research

Pilot Projects on Sports-Related Brain and Spinal Cord Injury Research was a component of the Sports and Health Research Program (SHRP) that funds pilot projects for research on sports-related traumatic brain injury and spinal cord injury research.

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.