A Sociology of Expectations: Retrospecting Prospects and Prospecting Retrospects.

Future expectations and promise are crucial to providing the dynamism and momentum upon which so many ventures in science and technology depend. This is especially the case for pre-market applications where practical utility and value has yet to be demonstrated and where investment must sustained. For instance, clinical biotechnology (including a wide range of genetic therapeutic and engineering applications) has been at the centre of ferocious debates about whether or not promises and expectations will be realised. In some cases, the failure of expectations has severely damaged the reputation and credibility of professions, institutions and industry. The need for a better analytical understanding of the dynamics of expectations in innovation is both necessary and timely

Sociology of low expectations: Recalibration as innovation work in biomedicine

"This article is distributed under the terms of the Creative Commons Attribution 3.0 License (http://www.creativecommons.org/licenses/by/3.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (http://www.uk.sagepub.com/aboutus/openaccess.htm). "Social scientists have drawn attention to the role of hype and optimistic visions of the future in providing momentum to biomedical innovation projects by encouraging innovation alliances. In this article, we show how less optimistic, uncertain, and modest visions of the future can also provide innovation projects with momentum. Scholars have highlighted the need for clinicians to carefully manage the expectations of their prospective patients. Using the example of a pioneering clinical team providing deep brain stimulation to children and young people with movement disorders, we show how clinicians confront this requirement by drawing on their professional knowledge and clinical expertise to construct visions of the future with their prospective patients; visions which are personalized, modest, and tainted with uncertainty. We refer to this vision-constructing work as recalibration, and we argue that recalibration enables clinicians to manage the tension between the highly optimistic and hyped visions of the future that surround novel biomedical interventions, and the exigencies of delivering those interventions in a clinical setting. Drawing on work from science and technology studies, we suggest that recalibration enrolls patients in an innovation alliance by creating a shared understanding of how the “effectiveness” of an innovation shall be judged.This project was funded by the Wellcome Trust (Wellcome Trust Biomedical Strategic Award 086034)

Attitudes Towards Standardization of Mesenchymal Stromal Cells—A Qualitative Exploration of Expert Views

Pharmacopoeial standards ensure quality control of established medicines. It is widely believed that translation of cell therapy medicines will be facilitated by defining and adopting relevant standards. Mesenchymal stromal cells (MSCs) are used extensively for multiple indications in regenerative medicine. They are highly heterogeneous in terms of their biological characteristics and their mechanisms of action, making standardization a challenging undertaking. Furthermore, the use of MSCs in therapy appears to attract diverse views, ranging from concern and caution to enthusiastic positivity. We conducted semi-structured interviews with 20 expert stakeholders from academia, industry, regulatory agencies, non-governmental organizations and clinicians to explore their views, experiences, recommendations, and concerns regarding standardization of MSCs. Qualitative thematic analysis of transcribed records led to development of a consensus framework, which identified 5 key themes to facilitate exploration of the interviews’ content. On the basis of our findings, we conclude that (1) there is undoubtedly an appetite for standardization, particularly in development of assays that enable comparison or benchmarking across manufacturers, processes, and cell sources; (2) stakeholder groups are not homogeneous in their concerns and attitudes; (3) careful consideration must be given to the points along the development timeline at which different standardization approaches could be beneficial; and (4) the roles of standards could be promoted further for specific aspects of advanced therapy medicinal product (ATMP) development and regulation such as qualification of decentralized manufacturing sites. A unified cross-stakeholder approach will help to advance MSC therapeutics and other cell therapy medicines

A cloud resource management model for the creation and orchestration of social communities

Managing resources, context and data in mobile clouds is a challenging task. Specific aspects of spontaneity, large interaction space and dynamic interaction share a metaphorical resemblance to chemistry, chemical reactions and solutions. In this paper, it is argued that by adopting a nature-inspired chemical computing model, a mobile cloud resource management model can be evolved to serve as the basis for novel service modelling and social computing in mobile clouds. To support the argument, a chemistry inspired computation model, Chemistry for Context Awareness (C2A), is extended with Higher Order Chemical Language (HOCL) and High Level Petri-net Graph (HLPNG) formalisms. A scenario and simulation-based evaluation of the proposed model, focusing on two applications dynamic service composition and social communities identification, is also presented in this paper. The formal encoding of C2A validates its assumptions, enabling formal execution and analysis of context-based interactions that are derived using C2A principles

The coughing body : etiquettes, techniques, sonographies and spaces

Abstract: With newfound relevance in the context of Covid-19, we focus on the coughing body, building on an in-depth qualitative study of three UK lung infection clinics treating people with cystic fibrosis. Conceptually we take our cue from Norbert Elias and the way something as physiologically fundamental as coughing becomes the focus of etiquette and technique, touching also on themes central to Mary Douglas’ anthropology of pollution. This is explored through four themes. First, we show how coughing becomes a matter of biopolitical citizenship expressed through etiquettes that also displace pollution anxieties to surroundings. Second, coughing is a question of being assisted to cough through the mediation of professional skills, interventions and devices. Third, coughing is seen to be central to the sonographic soundscape of the healthcare environment whereby people learn to recognise (and sometimes misrecognise) each other through the ‘sound’ of the cough. Finally, coughing properly can be seen to have both a ‘time and a place’ including the retreat of the cough from public space into risky confined spaces. Our conclusion speculates on the way these insights shed light on aspects of life that, until the Covid-19 pandemic, lay largely hidden

Stretching and challenging the boundaries of law: varieties of knowledge in biotechnologies regulation

The paper addresses the question of adaptation of existing regulatory frameworks in the face of innovation in biotechnologies, and specifically the roles played in this by various expert knowledge practices. We identify two overlapping ideal types of adaptation: first, the stretching and maintenance of a pre-existing legal framework, and second, a breaking of existing classifications and establishment of a novel regime. We approach this issue by focusing on varieties of regulatory knowledge which, contributing to and parting of political legitimacy, in principle enable the making of legally binding decisions about risks and benefits of technologies. We base the discussion around two case studies, one of animal biotechnology ethical regulation, the other of ‘advanced therapy’ medicinal product regulation, both in the context of European Union frameworks. Specifically, we explore the knowledge configurations constituting expert committees and other institutional formations of expert regulatory knowledge in their political context. We show that where sectoral and moral boundaries are challenged, different modes of regulatory knowledge beyond scientific forms – legal, procedural, moral, economic and industrial – can shape regulatory innovations either by maintenance of regimes through commensuration and stretching, or through differentiation and separation creating new frameworks. We conclude that establishing an essential techno-scientific difference between pre-existing and novel technologies does not in itself require new regulatory structures, and that the regulatory strategy that is followed will be determined by a combination of different forms of knowledge

A living biobank of canine mammary tumor organoids as a comparative model for human breast cancer.

Mammary tumors in dogs hold great potential as naturally occurring breast cancer models in translational oncology, as they share the same environmental risk factors, key histological features, hormone receptor expression patterns, prognostic factors, and genetic characteristics as their human counterparts. We aimed to develop in vitro tools that allow functional analysis of canine mammary tumors (CMT), as we have a poor understanding of the underlying biology that drives the growth of these heterogeneous tumors. We established the long-term culture of 24 organoid lines from 16 dogs, including organoids derived from normal mammary epithelium or benign lesions. CMT organoids recapitulated key morphological and immunohistological features of the primary tissue from which they were derived, including hormone receptor status. Furthermore, genetic characteristics (driver gene mutations, DNA copy number variations, and single-nucleotide variants) were conserved within tumor-organoid pairs. We show how CMT organoids are a suitable model for in vitro drug assays and can be used to investigate whether specific mutations predict therapy outcomes. Specifically, certain CMT subtypes, such as PIK3CA mutated, estrogen receptor-positive simple carcinomas, can be valuable in setting up a preclinical model highly relevant to human breast cancer research. In addition, we could genetically modify the CMT organoids and use them to perform pooled CRISPR/Cas9 screening, where library representation was accurately maintained. In summary, we present a robust 3D in vitro preclinical model that can be used in translational research, where organoids from normal, benign as well as malignant mammary tissues can be propagated from the same animal to study tumorigenesis

Contested Futures: Envisioning “Personalized,” “Stratified,” and “Precision” Medicine

In recent years, discourses around “personalized,” “stratified,” and “precision” medicine have proliferated. These concepts broadly refer to the translational potential carried by new data-intensive biomedical research modes. Each describes expectations about the future of medicine and healthcare that data-intensive innovation promises to bring forth. The definitions and uses of the concepts are, however, plural, contested and characterized by diverse ideas about the kinds of futures that are desired and desirable. In this paper, we unpack key disputes around the “personalized,” “stratified,” and “precision” terms, and map the epistemic, political and economic contexts that structure them as well as the different roles attributed to patients and citizens in competing future imaginaries. We show the ethical and value baggage embedded within the promises that are manufactured through terminological choices and argue that the context and future-oriented nature of these choices helps to understanding how data-intensive biomedical innovations are made socially meaningful

Opening up the participation laboratory: the co-creation of publics and futures in upstream participation.

How to embed reflexivity in public participation in techno-science and to open it up to the agency of publics are key concerns in current debates. There is a risk that engagements become limited to “laboratory experiments,” highly controlled and foreclosed by participation experts, particularly in upstream techno-sciences. In this paper, we propose a way to open up the “participation laboratory” by engaging localized, self-assembling publics in ways that respect and mobilize their ecologies of participation. Our innovative reflexive methodology introduced participatory methods to public engagement with upstream techno-science, with the public contributing to both the content and format of the project. Reflecting on the project, we draw attention to the largely overlooked issue of temporalities of participation, and the co-production of futures and publics in participation methodologies. We argue that many public participation methodologies are underpinned by the open futures model, which imagines the future as a space of unrestrained creativity. We contrast that model with the lived futures model typical of localized publics, which respects latency of materials and processes but imposes limits on creativity. We argue that to continue being societally relevant and scientifically important, public participation methods should reconcile the open future of research with the lived futures of localized publics