Biomodifying technologies and experimental space: organisational and regulatory implications for the translation and valuation of health research.

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Developments in biomedical innovation today can be seen in areas such as robotics, digital systems or new imaging techniques - and increasingly in areas marked by highly sophisticated forms of medical biology and biotechnology that involve altering 'natural' biological processes. Three key developments form the focus for this project: the arrival of 'gene-editing' whose goal is to understand and remove disease-related mutations, the creation of induced pluripotent stem cells that can be controlled to create different types of tissue for cell therapy, and the emergence of 3D printing of biological material which aims to create novel structures for bodily repair and renewal. These developments can all be described as 'biomodifying technologies', that is, those that modify living biological tissue in novel and increasingly patient-orientated and customised ways. These are not simply important in a biomedical sense but also in the ways in which they are reshaping the landscape of biomedical innovation in the 21st century. Not only do these technologies challenge existing governance frameworks in terms of standards for safety, quality control, and traceability of biological materials, equally and perhaps more importantly, they raise new questions for health systems and social science inasmuch as these are 'gateway' technologies with wide-ranging applications, significant commercial engagement and high levels of transferability, which open up far-reaching possibilities. We need to understand and anticipate such developments if we are to build an informed and constructively critical social science of biomedical innovation today. More broadly, this contributes towards the ESRC's core priority and delivery plan aim of supporting research that can promote economic growth and development, and to do so in a way that is based on robust, engaged social science that maps and analyses the implications of innovation.The project will contribute towards STS theory through the development of a conceptual framework for the analysis of 'experimental space', a framework built through the analysis of the spatial characteristics of the science of biomodifying technologies, the processes of valuation at work in these spaces, and the regulatory and governance landscape of the field. The first element focuses on the sites at which biomodifying technologies are developed, the geographical networks through which they are mobilised, and, the knowledge-based terrain they define, through which biomedical scientists build new models, standards, trials and clinical applications. The second element draws on recent social science work on the meaning of value - sometimes called 'valuation studies'. Here we are interested in discovering how values and benefits are defined, by whom, and according to what criteria. Our third element draws on social science work on regulation and governance, in particular, work that explores the tensions between regulation, law, and new biologies. Together these approaches help us to build and analyse datasets that will allow us to understand the current and future impact of the three technologies in the hospital, the clinic, the firm and the wider implications they will have for the health system.The project will use a mixed methods approach for UK fieldwork combining documentary analysis of various literatures, including the academic and grey literatures, with qualitative semi-structured interviews with a range of key stakeholders in each of the fields being studied. These include scientists working in academic laboratories, representatives of SMEs, patient groups, research agencies, regulators, and senior staff in important service organisations (e.g. biobanks). Secondary data from other European, US and East Asian sources will also be secured.The project will result in data, academic papers and policy reports that will offer the first comprehensive social science analysis of these major developments in biomedicine.