Independent Expert, Philadelphia, PA, USA.
Adv Neurobiol. 2024;40:67-85. doi: 10.1007/978-3-031-69491-2_3.
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.
长期以来，人们一直致力于开发神经精神疾病的生物标志物，这些标志物可能有助于药物开发或临床管理。然而，迄今为止，进展有限，部分原因是研究的局限性以及缺乏临床验证所需的那种大规模网络。第一个公私合作伙伴关系（PPP）——阿尔茨海默病神经影像学倡议（ADNI）——成立于 2004 年，专注于大脑中淀粉样蛋白沉积作为阿尔茨海默病病理学的潜在生物标志物的开发。在过去的 20 年里，ADNI 已经实现了其最初的许多目标，而其他目标仍在进行中。ADNI 也是其他最近成立的 PPP 的参考点。PPP 开发的关键组成部分包括确定利益相关者和可交付成果、治理和管理、资金以及数据访问/共享的流程。这些问题与最近开发的 PPP 有关。鉴于在竞争前领域开发生物标志物所需的大量投资，PPP 为开发新一代中枢神经系统（CNS）药物开发工具提供了一条关键途径。
