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

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. Literature review, analysis of quantitative data, and qualitative interviews with professionals and practitioners developing and administering advanced therapies.

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.

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

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. We conducted interviews with bioprinting researchers, entrepreneurs and regulators in three countries (United Kingdom, Italy and Brazil).

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.

"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").