Advancing Biomedical Innovation
No single organization, acting alone, can successfully conquer today’s complex biomedical challenges. The Foundation for the National Institutes of Health (FNIH) has created hundreds of cross-discipline consortia and partnerships whose initiatives have generated new ideas, overcome obstacles and achieved groundbreaking biomedical research results. Its unique affiliation with the National Institutes of Health (NIH) and other government agencies, and long-standing relationships within industry, academia and not-for-profit organizations enable it to draw the right partners into an initiative – people and organizations with the necessary knowledge, abilities and viewpoints. The FNIH then creates an environment where trust and the exchange of new ideas can thrive, resulting in scientific innovations.
FNIH research alliances take different shapes depending on the needs, capabilities and interests of the partners involved. Typically, the FNIH raises funds from the private sector to support programs, and these are matched by NIH funding. In some cases, programs are managed by the NIH, which provides project management and scientific oversight of the work. In other cases, the FNIH provides program management, convening private and federal partners in a forum to collaboratively design and implement the program.
The FNIH and its partners have successfully generated and implemented new research models that are lowering the cost and accelerating the progress of biomedical research nationwide and across the globe. Expert at leading innovation, the FNIH effectively stimulates practical, unconventional thinking to overcome challenges.
As a trusted third party, the FNIH brings extensive capabilities and expertise to the programs it establishes and manages:
- Governance and Oversight: the FNIH establishes and manages a variety of structures appropriate to each partnership (e.g. advisory boards, steering committees)
- Policy Management: the FNIH provides a “safe harbor” for interactions between and among companies, government and academic entities; and creates and implements policies that foster success and support NIH ethical and policy standards
- Program Management: the FNIH drives consensus across multiple and varied stakeholders about appropriate scientific selection and execution of projects
- Project and Financial Management: the FNIH establishes agreements with external partners; provides liaison management, technical and financial oversight; ensures projects meet established deliverables and “go/no go” milestones to ensure project accountability; organizes team meetings and workshops to support planning and cohesion
- Intellectual Property Management: the FNIH provides collaboration agreements and “pre-competitive” structures for handling intellectual property, if needed
- Deal Structure, Fundraising and Relationship Management: the FNIH directly solicits funding and in-kind contributions (e.g., therapeutics for research and clinical care, assays, data, biological samples, research and manufacturing capacity); develops proposals and solicitations; negotiates agreement terms with all parties (e.g., donors/partners, vendors/contractors/grantees, NIH), again including “go/no go” milestones to ensure project accountability; stewards and manages donor/partner funds; reports to donor/partners
FNIH scientific alliances and programs do not stop at basic scientific discovery. The work bridges basic, translational and clinical research, and often culminates in engagement with regulatory agencies such as the Food and Drug Administration or the European Medicines Agency to make new treatments or diagnostic tools available to patients in urgent need.
For example, the flagship Accelerating Medicines Partnership ® Program (AMP®) managed by the FNIH, brings together the resources of NIH and private-sector partners to expedite the search for urgently needed new options to treat major diseases including Alzheimer's disease, Type 2 diabetes, Rheumatoid Arthritis/Lupus, Parkinson's disease and Schizophrenia. In its first five years the Alzheimer’s disease partnership alone yielded more than 500 new candidates for drug therapy, 20 of which have been validated by early experimental evidence.
An international partnership focused on malnutrition in children, Etiology, Risk Factors and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development (MAL-ED), designed and executed the first-of-its kind comprehensive study of early child growth and development. Scientists working at eight sites across three continents determined that both preventing childhood infections and improving nutrition are critical to enhancing children’s growth and cognitive development, while generating a large-scale, high quality dataset for future researchers to draw upon.
In 2018, the FDA awarded the Biomarkers Consortium’s Kidney Safety Project the first-ever clinical safety biomarker – an indicator that researchers can now use to monitor the health of trial volunteers in cases when concern has been raised that an investigational drug may cause kidney injury. This award was a major milestone that will help keep volunteers as well as individual patients healthy and help improve the development of safe and effective medicines.
ACCELERATING MEDICINES PARTNERSHIP and AMP are registered service marks of the U.S. Department of Health and Human Services