背景:推进阿尔茨海默病(AD)的研究和治疗以及寻找有效的治疗方法取决于涉及联邦的复杂金融生态系统,state,工业,倡导,风险投资,和慈善资助方法。
方法:我们对有关AD转化研究和药物开发的资金和资助的文献进行了专家审查。
结果:联邦政府是AD研究的最大公共资助者。国家老龄研究所,国家精神卫生研究所,国家普通医学科学研究所,和国家促进转化科学中心资助AD药物开发研究的所有方面。非国立卫生研究院的联邦资金来自国家科学基金会,退伍军人管理局,食品和药物管理局,以及医疗保险和医疗补助服务中心。学术医学中心主持了许多联邦资助的基础科学研究,并且越来越多地参与药物开发。“死亡之谷”的资金涉及通过小企业计划和来自种子资本的私募股权的慈善事业和联邦资金,天使投资人,和风险投资公司。倡导团体资助基础科学和临床试验。阿尔茨海默氏症协会是与AD药物开发相关的最大研究支持组合的倡导组织。制药公司是全球生物医学研究的最大支持者;公司对后期去风险药物最感兴趣。进入第二阶段和第三阶段的药物是通过许可获得制药业支持的候选人,合并和收购,和共同发展合作。
结论:一起,参与支持AD药物开发的供资和融资实体包括一个综合体,互动式,动态金融生态系统。资金来源互动在很大程度上是非结构化的,可用资金不足以满足对新疗法的所有需求。已经提出了新的筹资方法,如大型基金,更多的组成部分整合将有助于加速药物开发。
BACKGROUND: Advancing research and treatment for Alzheimer\'s disease (AD) and the search for effective treatments depend on a complex financial ecosystem involving federal, state, industry, advocacy, venture capital, and philanthropy funding approaches.
METHODS: We conducted an expert review of the literature pertaining to funding and financing of translational research and drug development for AD.
RESULTS: The federal government is the largest public funder of research in AD. The National Institute on Aging, National Institute of Mental Health, National Institute of General Medical Sciences, and National Center for Advancing Translational Science all fund aspects of research in AD drug development. Non-National Institutes of Health federal funding comes from the National Science Foundation, Veterans Administration, Food and Drug Administration, and the Center for Medicare and Medicaid Services. Academic Medical Centers host much of the federally funded basic science research and are increasingly involved in drug development. Funding of the \"Valley of Death\" involves philanthropy and federal funding through small business programs and private equity from seed capital, angel investors, and venture capital companies. Advocacy groups fund both basic science and clinical trials. The Alzheimer Association is the advocacy organization with the largest research support portfolio relevant to AD drug development. Pharmaceutical companies are the largest supporters of biomedical research worldwide; companies are most interested in late stage de-risked drugs. Drugs progressing into phase II and III are candidates for pharmaceutical industry support through licensing, mergers and acquisitions, and co-development collaborations.
CONCLUSIONS: Together, the funding and financing entities involved in supporting AD drug development comprise a complex, interactive, dynamic financial ecosystem. Funding source interaction is largely unstructured and available funding is insufficient to meet all demands for new therapies. Novel approaches to funding such as mega-funds have been proposed and more integration of component parts would assist in accelerating drug development.