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. 

Accelerating Medicines Partnership - Parkinson's Disease

In 2016, the AMP Executive Committee approved the planning of an AMP effort to confront the challenges presented by Parkinson’s disease (PD). This complements current efforts in the areas of Alzheimer’s disease, type 2 diabetes and the autoimmune disorders of rheumatoid arthritis and systemic lupus erythematosus (lupus). A critical component of this partnership is that all members have agreed to make the AMP Parkinson’s disease (AMP PD) data and analyses publicly available to the broad biomedical community.

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.

International Summit in Human Genetics and Genomics

The International Summit in Human Genetics and Genomics is a five-year initiative (2016-2020) designed to help developing nations build and expand their knowledge base, infrastructure, systems and technologies in genetics and genomics. Each fall, researchers from abroad travel to the National Institutes of Health in Bethesda, Maryland for one month of in-person training at the National Human Genome Research Institute (NHGRI). The Summit helps them to understand the prevalence and basis of genetic diseases in their nations and to address these public health challenges. The 2019 Summit will be held on August 28 - September 28, 2019.

Accelerating Medicines Partnership - Alzheimer's Disease

The Accelerating Medicines Partnership Alzheimer’s Disease Project (AMP-AD) is a precompetitive partnership among government, industry, and nonprofit organizations that focuses on discovering novel, clinically relevant therapeutic targets and on developing biomarkers to help validate existing therapeutic targets. 

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 – 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