Hegemony in the marketplace of biomedical innovation:Consumer demand and stem cell science

AbstractThe global political economy of stem cell therapies is characterised by an established biomedical hegemony of expertise, governance and values in collision with an increasingly informed health consumer demand able to define and pursue its own interest. How does the hegemony then deal with the challenge from the consumer market and what does this tell us about its modus operandi? In developing a theoretical framework to answer these questions, the paper begins with an analysis of the nature of the hegemony of biomedical innovation in general, its close relationship with the research funding market, the current political modes of consumer incorporation, and the ideological role performed by bioethics as legitimating agency. Secondly, taking the case of stem cell innovation, it explores the hegemonic challenge posed by consumer demand working through the global practice based market of medical innovation, the response of the national and international institutions of science and their reassertion of the values of the orthodox model, and the supporting contribution of bioethics. Finally, the paper addresses the tensions within the hegemonic model of stem cell innovation between the key roles and values of scientist and clinician, the exacerbation of these tensions by the increasingly visible demands of health consumers, and the emergence of political compromise

Responsible personalised medicine: Exploring the ethical, legal, social, political and economic issues of manufacturing, distribution, access and reimbursement. A Report of the Responsible Personalised Medicine Project, UCL Future Targeted Manufacturing in Healthcare Hub

This report provides an overview of the ethical, legal, social, political and economic (ELSPE) issues underpinning the “manufacturing, business and regulatory challenges” that confront the development and delivery of affordable and accessible new targeted biological medicines. We specifically focus on the evolving definitions and its implication for the public understanding of personalised medicine (section 1), issues of manufacturing and distribution of Personalised Therapies (section 2) and institutional readiness (section 3) specifically focusing on emerging regulatory and reimbursement pathways (section 3.2) and how these are shaping or being shaped by ‘real world evidence’ (section 3.3). This is followed by our reflection on the implications of and for the entangled, complex and contingent interrelationships between personalised medicine, society and responsibility (section 4). Finally we conclude with discussion of the gaps and priorities for future ELSPE research on manufacturing of advanced biotherapeutics in terms of access, reimbursement, skills and infrastructure, regulation, responsible research and innovation (RRI) and the international political economy of emerging personalised medicine markets (section 5). This is a necessarily narrower review of the spectrum of ELSPE issues that attend personalised medicine activities and reflects this report’s aims to focus on those aspects of personalised medicine addressed by the UCL’s Future Targeted Manufacturing in Healthcare Hub

Machine Learning and Big Data for Neuro-Diagnostics: Opportunities and Challenges for Clinical Translation

In this report, we examine some developments in neurodiagnostics that make use of machine learning and other algorithms, with a particular focus on the potentials and challenges for clinical translation. As the ultimate aim of development of diagnostic algorithms is for their use in the diagnosis and treatment of patients, we focus particularly on the possibilities and challenges of clinical translation. We draw attention to the challenges faced in relating probabilistic predictions derived from such algorithms to individualised clinical interventions, and we highlight the importance of trust in the relationships that enable clinical translation of technologies – trust between researchers, clinicians, patients, and regulators

Assessing responsible innovation training

There is broad agreement that one important aspect of responsible innovation (RI) is to provide training on its principles and practices to current and future researchers and innovators, notably including doctoral students. Much less agreement can be observed concerning the question of what this training should consist of, how it should be delivered and how it could be assessed. The increasing institutional embedding of RI leads to calls for the alignment of RI training with training in other subjects. One can therefore observe a push towards the official assessment of RI training, for example in the recent call for proposals for centres for doctoral training by UK Research and Innovation. This editorial article takes its point of departure from the recognition that the RI community will need to react to the call for assessment of RI training. It provides an overview of the background and open questions around RI training and assessment as a background of examples of RI training assessment at doctoral level. There is unlikely to be one right way of assessing RI training across institutions and disciplines, but we expect that the examples provided in this article can help RI scholars and practitioners orient their training and its assessment in ways that are academically viable as well as supportive of the overall aims of RI

Assessing Responsible Innovation Training

There is broad agreement that one important aspect of responsible innovation (RI) is to provide training on its principles and practices to current and future researchers and innovators, notably including doctoral students. Much less agreement can be observed concerning the question of what this training should consist of, how it should be delivered and how it could be assessed. The increasing institutional embedding of RI leads to calls for the alignment of RI training with training in other subjects. One can therefore observe a push towards the official assessment of RI training, for example in the recent call for proposals for centres for doctoral training by UK Research and Innovation. This editorial article takes its point of departure from the recognition that the RI community will need to react to the call for assessment of RI training. It provides an overview of the background and open questions around RI training and assessment as a background of examples of RI training assessment at doctoral level. There is unlikely to be one right way of assessing RI training across institutions and disciplines, but we expect that the examples provided in this article can help RI scholars and practitioners orient their training and its assessment in ways that are academically viable as well as supportive of the overall aims of RI

Not Anytime Soon: The Clinical Translation of Nanorobots and Its Biocompatibility-Interdisciplinarity Critique

Medical nanorobots combine the hype, hope and discontents of the wider AI, biorobotics and nanotechnology domains into a single artefact with the single overarching promise of shifting biomedicine and healthcare away from systemic (whole body) therapeutics. Instead, nanorobots are expected to deliver targeted therapeutics by autonomously travelling to hard-to-access target sites within the human body to zap cancerous cells, deliver drugs or genes, make incisions or imaging data, and more. Drawing on an exhaustive review of literature informed by discussions with basic scientists, policymakers, regulators and sociologists, this chapter looks beyond the hype and hope to explore the complexity of technical and non-technical realities of routinising nanorobots into clinical practice though the lens of existing regulatory frameworks for clinical translation. Findings show that inadequate considerations of the biological compatibility (biocompatibility) of nanorobots with human in-vivo environments, in upstream development processes, challenge clinical translatability. This, I argue, is rooted in the overwhelmingly design-driven upstream processes focused on attaining ever-higher levels of bio-intelligence, but mostly at the expense of biological considerations. To a large extent, lack of meaningful integration with multidisciplinary downstream knowledge (e.g., clinical tacit knowledge, regulatory expertise) undoubtedly amplify the design focus. However, it is its underpinnings in weak interdisciplinary engagement throughout the development process, that, I contend, is the overarching critique of the nanorobotics domain’s commitment to translation or its likelihood anytime soon

Responsible use of exoskeletons and exosuits: Ensuring domestic security in a European context

This article aims to focus attention on the threat to domestic law and order posed by the misuse of wearable robotic exoskeletons and exosuits intended for beneficial uses such as rehabilitative care and industrial production. Threats to domestic law and order from the misuse of exoskeletons by rogue users range from creating havoc in public spaces, violent crime and endangerment of civilian(s) to enhanced burglary techniques. Drawing on existing legal-institutional frameworks and law enforcement apparatus, this article conceptualises a general framework for the responsible end use of exoskeletons and exosuits. It calls for proactive inward-looking state strategies to manage the bads of exoskeleton and exosuit acquisition, possession and trade while encouraging good uses. Importantly, this article does not suggest that the legal-institutional mechanisms discussed for managing misuse are the only ones relevant to the issue except as a guide for encouraging further discussion in the area