Doctoral Dissertation Research: Positioning translational research in the biotech ecosystem: From basic research to more exploitable knowledge

生物医学领域的新科学发现本身并不能成为可行的临床治疗方法或商业产品。在复杂的生物医学发展过程中，有许多步骤需要经历，有许多障碍需要克服。转化研究已经出现，以提高转化过程的速度和提高生物医学生产力。自2006年以来，美国国立卫生研究院（NIH）的临床和转化科学奖（CTSA）计划支持了60多家机构，以改善临床和转化研究环境。虽然目前的文献研究了美国国立卫生研究院转化研究项目的影响，但其分析的范围通常仅限于在接受者水平上发表。本研究通过将分析范围扩大到更广泛的层面来分析NIH CTSA计划对生物技术创业的影响。此外，本项目试图确定高水平生物技术创业条件的有效组合，特别强调转化研究的作用。这些结果将有助于更全面地了解转化研究在生物技术企业活动背景下的影响，并帮助我们评估转化研究对公共卫生的潜在利益。本研究借鉴创业生态系统方法和创业知识溢出理论，分析转化研究对生物技术创业的影响。总的分析框架是，转化研究通过增加企业家可获得的商业可利用的知识储备来增加生物技术创业精神。为了进行实证检验，该项目使用联邦创新项目，如小企业创新研究，作为生物技术创业的代理。本研究还考虑和审查生物医学专利，以及其他形式的可利用知识。实证方法强调了拥有转化研究计划如何在结果上产生差异。数据通过各种来源收集，包括美国国立卫生研究院、美国国家科学基金会和人口普查局等联邦机构。研究结果将主要通过出版物传播，并将为翻译研究和创业生态系统领域的文献做出贡献。此外，像美国国立卫生研究院这样的联邦机构将有机会对CTSA项目对生物医学企业的贡献进行仔细的实证评估。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

Novel scientific discoveries in the biomedical sector do not become viable clinical treatments or commercial products by themselves. There are numerous steps to go through and obstacles to overcome along the complex biomedical developmental process. Translational research has emerged to increase the speed of the conversion process and improve biomedical productivity. Since 2006, the National Institutes of Health (NIH)’s Clinical and Translational Science Awards (CTSA) program has supported over 60 institutions in order to improve the clinical and translational research environment. While current literature examines the effect of the NIH translational research program, the scope of its analysis is generally restricted to publication at the recipient level. This study analyzes the effect of the NIH CTSA program on biotech entrepreneurship by expanding the scope of analysis to a broader level. In addition, this project attempts to identify the effective combinations of conditions for a high level of biotech entrepreneurship with a specific emphasis on the role of translational research. The results will contribute to a more comprehensive understanding of the effect of translational research in the context of biotech entrepreneurial activity and help us to assess the potential benefit of translational research to the public health. The research draws on the entrepreneurial ecosystem approach and the knowledge spillover theory of entrepreneurship to analyze the effects of translational research on biotech entrepreneurship. The overarching analytical framework is that translational research increases biotech entrepreneurship by increasing the commercially exploitable knowledge stock that is available to entrepreneurs. For the empirical testing, the project uses federal innovation programs such as the Small Business Innovation Research as a proxy for biotech entrepreneurship. This study also considers and examines the biomedical patent, among other forms of exploitable knowledge. The empirical methods highlight how having the translational research program makes differences in the outcomes. Data is collected through various sources including federal agencies such as the National Institutes of Health, the National Science Foundation, and the Census Bureau. The findings will be principally disseminated through publication and will contribute to the literature in the translational research and entrepreneurial ecosystem fields. Additionally, federal agencies like the NIH will have access to a careful empirical appraisal of the CTSA program’s contribution to biomedical enterprises.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.