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

生物修饰技术和实验空间：健康研究转化和评估的组织和监管影响。

• 批准号: ES/P002943/1
• 负责人: Michael Morrison
• 金额: $ 77.82万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2017
• 资助国家: 英国
• 起止时间: 2017 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=ES%2FP002943%2F1
• 关键词: Biomodifying; technologies; experimental; space; organisational

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.

今天，生物医学创新的发展可以在机器人、数字系统或新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形式为标志的领域，这些形式涉及改变“自然”生物过程。三个关键的发展形成了该项目的焦点：“基因编辑”的到来，其目标是了解和消除疾病相关的突变，诱导多能干细胞的创造，可以控制以创造不同类型的组织用于细胞治疗，以及生物材料的3D打印的出现，旨在创造用于身体修复和更新的新结构。这些发展都可以被描述为“生物修饰技术”，也就是说，那些修改活的生物组织在新的和越来越多的病人为导向和定制的方式。这些不仅在生物医学意义上很重要，而且在重塑21世纪生物医学创新景观的方式上也很重要。这些技术不仅在生物材料的安全、质量控制和可追溯性标准方面挑战现有的治理框架，同样，也许更重要的是，它们为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、重要商业参与和高度可转让性的“门户”技术，开辟了深远的可能性。我们需要理解和预测这样的发展，如果我们要建立一个明智的和建设性的批判性的社会科学的生物医学创新今天。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，并以基于强大的、参与的社会科学的方式来实现这一目标，该社会科学绘制并分析了创新的影响。该项目将通过开发用于分析“实验空间”的概念框架，通过分析生物改良技术科学的空间特征，这些空间中工作的估值过程以及该领域的监管和治理景观建立了一个框架。第一个要素侧重于开发生物改良技术的地点，动员它们的地理网络，以及它们定义的基于知识的地形，生物医学科学家通过这些地形建立新的模型，标准，试验和临床应用。第二个要素借鉴了最近关于价值意义的社会科学工作-有时被称为“估值研究”。在这里，我们感兴趣的是发现价值和利益是如何定义的，由谁定义，以及根据什么标准定义。我们的第三个元素借鉴了社会科学的监管和治理工作，特别是，工作，探讨监管，法律和新的生物学之间的紧张关系。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种技术在医院，诊所，公司中的当前和未来影响，以及它们对卫生系统的更广泛影响。该项目将使用混合方法进行英国实地调查，结合各种文献的文献分析，包括学术文献和灰色文献，与正在研究的每个领域的一系列关键利益攸关方进行定性半结构化访谈。这些人包括在学术实验室工作的科学家、中小企业代表、患者团体、研究机构、监管机构以及重要服务机构（如生物银行）的高级工作人员。该项目还将获得来自欧洲、美国和东亚其他来源的二级数据，并将产生数据、学术论文和政策报告，为生物医学领域的这些重大发展提供第一次全面的社会科学分析。

项目成果

Genome editing: the dynamics of continuity, convergence, and change in the engineering of life

• DOI: 10.1080/14636778.2020.1730166
• 发表时间: 2020-04-02
• 期刊: NEW GENETICS AND SOCIETY
• 影响因子: 1.8
• 作者: Martin，Paul;Morrison，Michael;Bartlett，Andrew
• 通讯作者: Bartlett，Andrew

The Future of Intellectual Property

知识产权的未来

• 发表时间: 2021
• 作者: Li P

Regulating human stem cell research and therapy in low- and middle-income countries: Malaysian perspectives

• DOI: 10.1080/14636778.2017.1415137
• 发表时间: 2018-01-01
• 期刊: NEW GENETICS AND SOCIETY
• 影响因子: 1.8
• 作者: Aziz, Mohammad Firdaus Bin Abdul;Morrison, Michael;Kaye, Jane
• 通讯作者: Kaye, Jane

Response to Open Peer Commentaries on "Patenting Foundational Technologies: Lessons From CRISPR and Other Core Biotechnologies".

对“基础技术专利申请：CRISPR 和其他核心生物技术的教训”的公开同行评论的回应。

• DOI: 10.1080/15265161.2018.1538395
• 发表时间: 2019
• 期刊: AJOB
• 作者: Feeney O

Making Cells Worthwhile: Calculations of Value in a European Consortium for Induced Pluripotent Stem Cell Banking

• DOI: 10.1080/09505431.2018.1538331
• 发表时间: 2019-01-02
• 期刊: SCIENCE AS CULTURE
• 影响因子: 2.6
• 作者: Morrison, Michael