82 Pages Posted: 29 Jun 2013 Last revised: 29 Aug 2013
Date Written: May 9, 2013
In the pursuit of improved and cheaper ways to produce new drugs, both government and industry are turning to universities to play an expanded role in the innovation process. Many of the larger U.S. research universities are experimenting with ways of moving into spaces traditionally reserved for commercial actors. This Article begins with challenges facing the pharmaceutical industry and the related pressures on universities and investigates two questions. First, the Article considers whether universities offer any advantages over firms and governments in managing not only drug discovery, but also post-discovery drug development. Second, it considers the implications of an expanded university role in drug development for the existing framework governing university technology development and transfer. The Article uses an experiment with drug development capacity currently underway at Emory University as a case study with which to explore these questions. This experiment takes Emory much further along the path of drug development than most universities have ventured. The case study illustrates the comparative advantages that the university, as a unique organizational form, might offer over firms and government labs in managing drug development. At the same time, it illustrates the challenges of protecting the public interest in access to and use of publicly funded research results without jeopardizing product development goals. The Article concludes with some proposed legal and regulatory changes designed to increase the flexibility of universities to engage in drug development while also increasing their accountability and responsibility for managing development activities in ways that further their public knowledge mandate.
Suggested Citation: Suggested Citation
Vertinsky, Liza, Making Knowledge and Making Drugs? Experimenting with University Innovation Capacity Issue (May 9, 2013). Emory Law Journal, Vol. 62, No. 4, pp. 741-821, 2013; Emory Legal Studies Research Paper 13-256. Available at SSRN: https://ssrn.com/abstract=2286342