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

当今生物医学创新的发展可以在机器人、数字系统或新的成像技术等领域看到--而且越来越多地出现在以高度复杂的医学生物学和生物技术为标志的领域，这些领域涉及改变“自然”的生物过程。该项目的三个关键进展构成了该项目的重点：目标是了解和移除与疾病相关的突变的“基因编辑”的到来，创造可控制的诱导多能干细胞以产生不同类型的细胞治疗组织，以及生物材料3D打印的出现，旨在为身体修复和更新创造新的结构。这些发展都可以被描述为“生物修饰技术”，也就是那些以新颖的、日益面向患者和定制的方式修改活的生物组织的技术。这些不仅在生物医学意义上很重要，而且在它们重塑21世纪生物医学创新版图的方式上也是重要的。这些技术不仅在生物材料的安全、质量控制和可追踪性标准方面挑战了现有的治理框架，而且可能更重要的是，它们对卫生系统和社会科学提出了新的问题，因为这些技术是具有广泛应用、重大商业参与和高水平可转让的“门户”技术，从而打开了深远的可能性。如果我们今天要建立一门见多识广、具有建设性的生物医学创新社会科学，我们就需要理解和预见这样的发展。更广泛地说，这有助于实现ESRC的核心优先事项和交付计划目标，即支持能够促进经济增长和发展的研究，并以一种基于强大的、参与的社会科学的方式做到这一点，该社会科学绘制和分析创新的影响。该项目将通过开发一个分析“实验空间”的概念框架来促进STS理论，该框架是通过分析生物生物技术科学的空间特征、在这些空间中工作的估值过程以及该领域的监管和治理格局而建立的。第一个要素侧重于开发生物生物技术的地点，动员这些技术的地理网络，以及它们定义的基于知识的领域，生物医学科学家通过这些领域建立新的模型、标准、试验和临床应用。第二个要素借鉴了最近关于价值含义的社会科学研究--有时被称为“估值研究”。在这里，我们感兴趣的是如何定义价值和利益，由谁定义，根据什么标准定义。我们的第三个要素借鉴了关于监管和治理的社会科学工作，特别是探索监管、法律和新生物学之间的紧张关系的工作。这些方法共同帮助我们构建和分析数据集，使我们能够了解这三项技术在医院、诊所、公司以及它们将对卫生系统产生的更广泛影响的当前和未来影响。该项目将使用混合方法进行英国实地考察，结合对包括学术文献和灰色文献在内的各种文献的文献分析，并与正在研究的每个领域的一系列关键利益相关者进行定性的半结构化访谈。这些人包括在学术实验室工作的科学家、中小企业、患者团体、研究机构、监管机构的代表，以及重要服务组织(如生物库)的高级员工。来自其他欧洲、美国和东亚来源的次要数据也将得到保护。该项目将产生数据、学术论文和政策报告，这些数据、学术论文和政策报告将首次对生物医学的这些重大发展进行全面的社会科学分析。

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.