Positioning Translational Research in the Biomedical Ecosystem: From Basic Research to Biomedical Entrepreneurship
Open AccessRecent Covid-19 vaccine developments have demonstrated the importance of the rapid transfer of scientific knowledge to the commercial sector. Since 2006, the National Institutes of Health (NIH) has been providing over $500 million annually to the Clinical and Translational Science Awards (CTSA) program to improve the translational research environment. This dissertation examines the effects of translational research on exploitable knowledge production and biomedical entrepreneurship at the regional level. In this work, I specifically focus on two types of knowledge: biomedical patents, and clinical trials. I further extend the analysis to identify regional conditions promoting biomedical entrepreneurship. Overall, there are three central research questions addressed in this study: 1) To what extent does translational research increase biomedical entrepreneurship? 2) To what extent do biomedical patents and clinical trials serve as effective forms of knowledge connecting translational research to biomedical entrepreneurship? 3) What configurations of conditions are associated with high levels of biomedical entrepreneurship in a region? To answer these questions, I construct three analytical models—Simple, Complex, and Collective models—based on the knowledge spillover theory of entrepreneurship (KSTE), as well as entrepreneurial ecosystem approaches. I test my research hypotheses and propositions across 381 metropolitan statistical areas (MSAs) in the United States using 10 years of panel data. The NIH’s CTSA program is used as a proxy measure for translational research, while the NIH’s Small Business Innovation Research (SBIR) program serves as a measure of regional biomedical entrepreneurship. The results show that the CTSA program increases regional SBIR grants, but that the magnitude is small. More specifically, I find that the CTSA program increases the number of regional biomedical patents, but it does not increase the number of clinical trials conducted. In addition, biomedical patents have a strong correlation with regional SBIR grants, but clinical trials do not. Path analysis indicates that the effect of the CTSA program on regional SBIR grants is not strongly conveyed through biomedical patents or clinical trials. The in-depth analysis focusing on the interdependencies among regional conditions presents two different pathways that lead to high biomedical entrepreneurship: (1) a combination of public biomedical R&D;, biomedical patents, and human capital; and (2) a combination of public biomedical R&D;, biomedical patents, clinical trials, high population density, and large regional economies. The presence of translational research and the private sector turns out not to be an essential condition in these pathways. Based on three different analytical approaches, I conclude that translational research funded by the CTSA program has a fairly limited impact on exploitable knowledge production and regional biomedical entrepreneurship in the U.S. From my findings, I present four policy recommendations to enhance the effect of translational research on regional entrepreneurship and to improve the methods used to measure the impact of public R&D; programs.
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