The social management of biomedical novelty: Facilitating translation in regenerative medicine

John Gardner,Andrew Webster

doi:10.1016/j.socscimed.2016.03.025

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.

Highlights

An oft-quoted description of Regenerative medicine (RM) defines it as that which “replaces or regenerates human cells, tissues and organs, to restore or establish normal function” (Mason and Dunnill 2008, 4)
We explore some of the innovation challenges posed by the field of regenerative medicine, and we examine attempts to manage and harness its biomedical novelty, within three domains: the regulatory sphere, the health economic sphere, and the clinical development sphere
The construction of socio-technical niches There is considerable variation amongst the potential products and procedures that are defined as being ‘regenerative medicine’, and participants we spoke to indicated that the specific translational challenges encountered in each therapeutic area would vary

Summary

Introduction

An oft-quoted description of RM defines it as that which “replaces or regenerates human cells, tissues and organs, to restore or establish normal function” (Mason and Dunnill 2008, 4). ‘Regenerative medicine’ is applied to therapeutic developments with a history that predates the term, including gene therapy and bone-marrow transplantation. RM has the potential, it is stated, to deliver curative treatments for a range of diseases, including diabetes, neurological conditions, and heart disease, (Department for Business Innovation & Skills 2011), and will “revolutionise patient care in the 21st century” (TSB UK Research Councils 2012, 2). This clinical value holds considerable economic value. RM has been named by the UK government, for example, as one of ‘Eight Great Technologies’ that will drive innovation and propel the UK’s growth, and in which the UK can become a global leader (Willetts 2013)

Methods

Results

Conclusion