title: The social management of biomedical novelty: Facilitating translation in regenerative medicine.
abstract: Regenerative medicine (RM) is championed as a potential source of curative treatments for a variety of illnesses, and as a generator of economic wealth and prosperity. Alongside this optimism, however, is a sense of concern that the translation of basic science into useful RM therapies will be laboriously slow due to a range of challenges relating to live tissue handling and manufacturing, regulation, reimbursement and commissioning, and clinical adoption. This paper explores the attempts of stakeholders to overcome these innovation challenges and thus facilitate the emergence of useful RM therapies. The paper uses the notion of innovation niches as an analytical frame. Innovation niches are collectively constructed socio-technical spaces in which a novel technology can be tested and further developed, with the intention of enabling wider adoption. Drawing on primary and secondary data, we explore the motivation for, and the attempted construction of, niches in three domains which are central to the adoption of innovative technologies: the regulatory, the health economic, and the clinical. We illustrate that these niches are collectively constructed via both formal and informal initiatives, and we argue that they reflect wider socio-political trends in the social management of biomedical novelty.
authors.affiliation: Science and Technology Studies Unit, Department of Sociology, University of York, Heslington, York, YO10 5DD, North Yorkshire, United Kingdom. Electronic address: john.gardner@york.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Gardner
authors.affiliation: Science and Technology Studies Unit, Department of Sociology, University of York, Heslington, York, YO10 5DD, North Yorkshire, United Kingdom. Electronic address: andrew.webster@york.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Webster
mesh_terms: D004059:Diffusion of Innovation; D006801:Humans; D044968:Regenerative Medicine / Q000458:organization & administration*; D057170:Translational Research, Biomedical / Q000458:organization & administration*; D006113:United Kingdom
keywords: Cell therapies; Clinical adoption; Innovation; Regulation; Reimbursement; Technological niche; United Kingdom