Collaborative academic medical product development: An 8-year review of commercialization outcomes at the Institute of Translational Health Sciences.

Abstract

The Institute of Translational Health Sciences (ITHS), a Clinical and Translational Science Award (CTSA)-funded program at the University of Washington (UW), established the Drug and Device Advisory Committee (DDAC) to provide product-specific scientific and regulatory mentoring to investigators seeking to translate their discoveries into medical products. An 8-year retrospective analysis was undertaken to evaluate the impact of the DDAC programs on commercialization metrics. Tracked metrics included the number of teams who consulted with the DDAC, initiated a clinical trial, formed a startup, or were successful obtaining federal small business innovation awards or venture capital. The review includes historical comparisons of the startup rates for the UW School of Medicine and the Fred Hutchinson Cancer Research Center, two ITHS-affiliated institutions that have had different DDAC utilization rates. Between 2008 and 2016, the DDAC supported 161 unique project teams, 28% of which went on to form a startup. The commercialization rates for the UW School of Medicine increased significantly following integration of the DDAC into the commercialization programs offered by the UW technology transfer office. A formalized partnership between preclinical consulting and the technology transfer programs provides an efficient use of limited development funds and a more in-depth vetting of the business opportunity and regulatory path to development.