The price of progress: Funding and financing Alzheimer's disease drug development.

The price of progress: Funding and financing Alzheimer's disease drug development.
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DOI:
10.1016/j.trci.2018.04.008
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发表时间:
2018
期刊:
Alzheimer's & dementia (New York, N. Y.)
影响因子:
--
通讯作者:
Kumar P
Kumar P
中科院分区:
其他
文献类型:
--
作者:
Cummings J;Reiber C;Kumar P

文献摘要

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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一个复杂的金融生态系统,涉及联邦、州、行业、宣传、风险投资和慈善资助方法。我们对有关AD转化研究和药物开发的资金和融资文献进行了专家审查。联邦政府是AD研究的最大公共资助者。国家老龄化研究所、国家精神卫生研究所、国家普通医学研究所和国家推进转化科学中心都为AD药物开发的研究提供资金。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。学术医疗中心主办了许多联邦资助的基础科学研究,并越来越多地参与药物开发。“死亡之谷”的资金来源包括慈善事业和联邦资金,这些资金来自小企业项目和来自种子资本、天使投资者和风险投资公司的私人股本。倡导团体为基础科学和临床试验提供资金。阿尔茨海默病协会是一个倡导组织,拥有与AD药物开发相关的最大研究支持组合。制药公司是全球生物医学研究的最大支持者;公司对后期风险降低的药物最感兴趣。进入第二和第三阶段的药物是通过许可证、并购和共同开发合作获得制药业支持的候选药物。参与支持AD药物开发的供资和融资实体共同构成了一个复杂、互动、动态的金融生态系统。资金来源的相互作用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。有人提出了诸如巨型基金等新的供资办法,进一步整合各组成部分将有助于加快药物开发。
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. We conducted an expert review of the literature pertaining to funding and financing of translational research and drug development for AD. 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. 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.