Public-Private Partnerships for Neuropsychiatric Drug Development: A Perspective.

There is a long-standing interest in developing biomarkers for neuropsychiatric disorders that might assist in drug development or clinical management. To date, however, progress has been limited in part because of the limited nature of the studies and the absence of the types of large-scale networks that would be required for clinical validation. The first public-private partnership (PPP) for biomarker validation-the Alzheimer's Disease Neuroimaging Initiative (ADNI)-was formed in 2004 to focus on the development of amyloid deposition in the brain as a potential biomarker of Alzheimer's disease pathology. Over the past 20 years, ADNI has achieved many of its initial deliverables, while others remain a work in progress. ADNI also serves as a point of reference for other more recently established PPPs. Key components for PPP development include processes for identifying stakeholders and deliverables, governance and management, funding, and data access/sharing. These issues are discussed in relationship to more recently developed PPPs. Given the extensive investment needed for biomarker development within the pre-competitive space, PPPs provide a critical path for the development of next-generation tools for central nervous system (CNS) drug development.