Bridging the Gap Between Preclinical and Clinical Evaluation of Therapeutic Candidates

Session 3

Public-Private Partnership: The NIH/FDA/PhRMA/FNIH Biomarkers Consortium

Barbara Mittleman, M.D.
Office of the Director, National Institutes of Health

Public-Private Partnerships (PPP) offer the opportunity to leverage NIH resources to accomplish our mission to improve the public health through biomedical research more rapidly, more efficiently, or in ways that we could not if we worked alone. The resources relevant to PPPs include monetary, expertise, personnel, reagents and technologies, data, scientific infrastructure, etc., and can come from a wide variety of potential partners including other Federal agencies, state or local governmental organizations, private industry, professional societies, patient advocacy groups, philanthropists, and others. The establishment of a PPP requires a clear delineation of the roles and responsibilities of all partners as well as articulation of policies relating to intellectual property, data access and data sharing, publication, human subjects protections, conflicts of interest and confidentiality. Although each PPP will be structured to best serve its scientific aim and goals, common principles underlying all NIH PPPs include a commitment for scientific rigor, improvement in public health, inclusivity and fairness, and an intent to translate basic discovery to improvements in public health. In this discussion both the principles and approaches to PPPs in general as well as specific examples of PPPs will be discussed. A particular emphasis will be placed on the Biomarker Consortium, a PPP with a significant cancer-related component and the goal of providing new biomarkers through the stages of discovery, development and qualification.

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