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Short abstract:

This paper tracks the regulatory lives of rVSV, a viral-vector vaccine platform that has played a central role in recent emergency outbreak response, as a prompt to examine the shifting sociotechnical norms attendant to an emerging paradigm of accelerated global health R&D.

Long abstract:

This presentation elaborates the social and political life of rVSV, a vector vaccine that uses the vesicular stomatitis virus, as a backbone technology upon which multiple target vaccines could be built. Viral vectors like rVSV have enabled a shift from bespoke vaccinology to assembly line—a ‘plug and play’ approach capable of achieving economies of scale through decentralized, tech-transfer driven, production. In addition to greasing the R&D pipeline, platform technologies have torqued our notions of equity, from pursuing justice through the widespread allocation of finished products, to engineering access into the production process—a model of just-in-time innovation that, through the material process of manufacture, could be fundamentally more just. Mapping the regulatory life of rVSV, this paper considers the novel epistemic and ethical imaginations the platform can provoke. To some extent, regulatory science always operates ‘in the wild’, its judgments inflected by explicitly ethical and value-laden concerns—a highly liminal and heterodox process of adjudication that gains considerable amplitude in the context of a public health emergency. Under the pressure of outbreak response, regulation becomes less a matter of fixing new medical products in law, than facilitating their movement across multiple sites and settings. Through plug-and-play design, platforms enable that circulation—an iterative open-endedness that incorporates a wide range of actors—humanitarian, industry, national, philanthropic, that render an emergency workable as a global health response. rVSV provides an opportunity to think through those pragmatics and raise new questions about the evidentiary magnitude of regulation as a means of R&D acceleration.

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Drawing on interviews with patients at a U.S. academic medical center, we present patient visions for shared governance of health data, challenging the dominant biomedical platform for health data sharing whose claim to openness obscures intertwined practices of data monetization and medical racism.

Long abstract:

Biomedical platforms for health data sharing often frame patient data as a “common good.” Patients’ electronic health records and bodily materials circulate between exam rooms, laboratories, and machine-learning applications and are aggregated and transformed into data that is “open” for research. However, while fostering knowledge creation, health data also becomes monetized or directed toward other kinds of value creation once it is “de-identified” and constituted as not “belonging” to individual patients or requiring consent for ongoing use. Moreover, data oversight prioritizes compliance with laws and regulations rather than public benefit, and rarely incorporates the perspectives of those who provide health data. Seeking to understand what role patients might play in the (re)formation of this platform, this paper reports on interviews with patients at a U.S. academic medical center and reflects on their perspectives on “open” health data sharing. Surprised to learn that de-identified data could be shared with for-profit entities without their explicit consent, patients highlighted contradictions of biomedical platforms that are “open,” yet opaque and profit-seeking."Open" sharing within a market-based system risks perpetuating inequities, particularly when oversight does not include those most affected by these harms. In considering a way forward, we expand on what one patient called an “alternative imaginary,” a model for shared governance of biomedical data by patients, community members, clinicians, and researchers. Shared governance would center perspectives of groups disproportionately harmed by health data expropriation and medical racism. By reforming biomedical platforms with patients, we seek a governance model that prioritizes equity and justice.

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Short abstract:

This paper investigates the new bioinformational paradigm in microbiomic precision medicine and examines how the push to globalize precision medicine corresponds to and is constitutive of international efforts to open science, a situation that might prove to increase rather than reduce inequality.

Long abstract:

In projecting innovations for global health, hope is gathered for research on the human microbiome to make a difference for people in the developing world. Presented as the next frontier in precision medicine, microbiomic science is mobilized as an ‘omic’ that can assist in major global health challenges, for instance child malnutrition, but also non-communicable diseases that have greatly affected people in industrialized urban centers. Furthermore, the link between human microbiomes and their ecological environments makes the science important for what has been termed planetary health.

Different to other global health innovations, however, therapeutics in the microbiomic translational space are dependent on computationable data from individuals and populations in situ (rather than from isolated pathogenic material). As Biagioli and Pottage argue, such postgenomic translational work depends on a cybernetic logic that understands nature as “diagnostic information that is used to fine-tune therapeutic procedures” (2021: 233). This logic presents novel understandings of the body and of medicine, namely as being processual (rather than mechanical), modelled by signals (rather than chemical compounds). Using the heuristic device of biomedical platforms, my paper investigates the new bioinformational paradigm in microbiomic precision medicine. It examines how the drive to globalize precision medicine—legitimated by humanitarian and democratic appeals—is correlated to an international effort to open science. How do such efforts impact the generative dimensions of bioinformational platforms? And in what ways do they assist or thwart the pursuits of global and planetary health?

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Long abstract:

The worker health system in Pakistan bases itself on the quantification and monitoring of accidents, injuries, disabilities as well as financial contributions from industrial owners that run the healthcare system. Health data and data management systems have played a unique role in linking the industrial system to the medical wellbeing of its workers. As a worker is injured at work, records of the workers monthly contribution from the industry determine if they will receive care. Further, differences in how visible and invisible injuries are quantified lay bare who gets to be counted and hence compensated. How different injuries are included within data determines how care will be provided, leaves given, fitness for future work determined and compensation provided. Data in the worker health system also sets medical precedence for compensation in legal cases fought between workers and their employing industries. Taking cue from the intertwining of data and bodies, this paper explains how technological systems of quantification count bodily injuries and what work they do to provide access to care, survey worker health, and compensate injuries. Through a lens of governance and social studies of health, this paper shows how technological data management, categorizations of workers, and worker health are formed together over time. Therefore this paper asks: what work does data do to align industrial and medical systems, how data reveals and obscurs material conditions of disablement and what is disability in relation to different injuries and bodily conditions within health data?

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Short abstract:

We present a multi-sited exploration of how new cellular technologies of organoids were mobilized as part of ‘emergency R&D’ during outbreaks of Zika and Covid-19. We discuss the significance of organoids for infectious disease research and the need for equity in addressing global health challenges.

Long abstract:

We present an empirical multi-sited exploration of how new cellular technologies are mobilized as part of ‘emergency R&D’ during infectious disease outbreaks of Zika and Covid-19, and of their growing significance for global health. Organoids are a new biotechnology, which involve constructing miniature like lungs and brains out of cells and infecting them with viruses. We explore how organoids were significant in the public health emergencies of Zika and Covid-19, when understanding how emerging pathogens behave and affect the human body was key to the rapid outbreak response. We address the implications of new organoid technologies within the context of emerging infectious disease research, shedding light on the largely unacknowledged but significant role of cell-based technologies in these contexts.

We draw on a range of collected data, reports and interviews related to these health emergencies. We demonstrate that organoid research has primarily been focused on common complex diseases (CCD) prevalent in the Global North. However, in times of public health emergencies, organoid research has been mobilized and rapidly developed in the area of infectious disease research to tackle Zika outbreak and the Covid-19 pandemic. We argue that this use of organoids has led to celebratory discourses which emphasize the collective effort in fighting outbreaks and the positive role biotechnologies can play in global health. Despite this success, however, such scientific mobilization underscore broader issues of inadequate preparedness and organized responses, revealing disparities in defining research priorities and a need for greater equity in addressing global health challenges.