Institutional and infrastructure challenges for hospitals producing advanced therapies in the UK: the concept of 'point-of-care manufacturing readiness'.

Aim: To propose the concept of point-of-care manufacturing readiness for analyzing the capacity that a country, a health system or an institution has developed to manufacture therapies in clinical settings (point-of-care manufacture). The focus is on advanced therapies (cell, gene and tissue engineering therapies) in the UK. Materials & methods: Literature review, analysis of quantitative data, and qualitative interviews with professionals and practitioners developing and administering advanced therapies. Results: Three components of point-of-care manufacturing readiness are analyzed staff and institutional procedures, infrastructure, and relations between hospitals and service providers. Conclusion: The technical and regulatory experience that has been gained through manufacturing advanced therapies at small scale in hospitals qualifies the UK for more complex and larger-scale production of therapies in the future.

Point-of-care manufacture is the production of therapies in hospitals, carried out when there is no time for storing the medicine, which is delivered to the patient with no delays. Such procedures can be useful for advanced therapies derived from techniques such as gene editing, cell manipulation and tissue engineering. Over the last decades, UK hospitals have produced advanced therapies in small quantities. In the future, this production will likely be more thoroughly integrated into clinical routines. In this way, the technical and regulatory experience that hospitals have accumulated so far underpins the more frequent and larger-scale work expected for the future. This accumulation of expertise, infrastructure and institutional contacts provides the foundation for what we call 'point-of-care manufacturing readiness'.

Biomodifying the 'natural': from Adaptive Regulation to Adaptive Societal Governance.

Biomodifying technologies-such as gene editing, induced pluripotent stem cells, and bioprinting-are being developed for a wide range of applications, from pest control to lab-grown meat. In medicine, regulators have responded to the challenge of evaluating modified 'natural' material as a therapeutic 'product' by introducing more flexible assessment schemes. Attempts have also been made to engage stakeholders across the globe on the acceptable parameters for these technologies, particularly in the case of gene editing. Regulatory flexibility and stakeholder engagement are important, but a broader perspective is also needed to respond to the potential disruption of biomodification. Our case-study technologies problematize basic ideas-such as 'nature', 'product', and 'donation'-that underpin the legal categories used to regulate biotechnology. Where such foundational concepts are rendered uncertain, a socially responsive and sustainable solution would involve exploring evolutions in these concepts across different societies. We suggest that the global observatory model is a good starting point for this 'Adaptive Societal Governance' approach, in which a self-organizing network of scholars and interested parties could carry out the multi-modal (meta)analyses needed to understand societal constructions of ideas inherent to our understanding of 'life'.

Digital readiness in 3D bioprinting: software, governance and hospitals' proto-clinical interfaces.

Aim: To understand the process through which some hospitals have become ready to assimilate the digital technologies required for 3D bioprinting. By enhancing their digital readiness, hospitals will be able to develop the current proto-clinical potentialities of bioprinting. Materials & methods: We conducted interviews with bioprinting researchers, entrepreneurs and regulators in three countries (United Kingdom, Italy and Brazil). We analyzed bioprinting papers in which hospital-based researchers participated. We also analyzed the international bioprinting market. Results: Digital readiness is more advanced in some hospitals and countries, which have noticed the strategic relevance of bioprinting. Furthermore, it is strengthened by the reformulation of the relations between hospitals and other institutions, a phenomenon that is here interpreted with the concept of interfaces.

Genomics Politics through Space and Time: The Case of Bioinformatics in Brazil.

The emergence of scientific disciplines, as well as the policies aimed to steer them, have geographical implications. This becomes visible in areas such as genomics and related fields. In this paper, the relation between scientific evolution, political decisions and geographical configuration is studied. The recent formation of bioinformatics in Brazil is focused on. The study involves an analysis of data collected on the website of CNPq, a funding agency attached to the Ministry of Science and Technology. Furthermore, I conducted fieldwork in four cities, interviewing 15 bioinformaticians. In the history of Brazilian bioinformatics, three periods can be identified. In the first period (1900-1996), bioinformatics was actually absent, but biology research groups were formed which would subsequently explore bioinformatics. The second period (1997-2006) was marked by the emergence of the discipline and geographical concentration of major research groups in the southern part of Brazil. A third period can be pointed to (2007-2014), in which political choices have turned geographical diffusion and institutional equality into a national target. As a consequence of the recent shifts, genomics and bioinformatics researchers have been involved in a debate, some defending the existence of few specialized research and sequencing platforms, whereas others welcoming the constitution of a scientific scenario based on decentralized platforms. I defend an intermediate solution, whereby some places would be selected to be genomics hubs. This would fit the regional diversity of this vast country, in addition to tackling the scientific weaknesses of the northern area.

"Geographical randomization" and "social exploitation" in clinical research: world trials in Santiago, Chile.

In the discussion of global clinical trials, two ideas are frequently advanced. Firstly, it is sometimes articulated that companies can displace clinical protocols between countries quite easily (what I propose to call "geographical randomization"). The second idea conveys that global trials lead to the exploitation of poor regions and poor people ("social exploitation"). By analyzing the context of Santiago, the capital city of Chile, I argue that, although these ideas are not myths, they cannot capture the whole complexity of global trials. On the one hand, geographical factors restrain the mobility of the clinical trials industry. On the other, studies tend to be concentrated in wealthier areas with more affluent people.