Building for Biology: A Gene Therapy Trial Infrastructure

Engaging Science, Technology, and Society

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Field Value
Title Building for Biology: A Gene Therapy Trial Infrastructure
Creator Taylor-Alexander, Samuel
Addison, Courtney
Subject Science and Technology Studies; Medical Anthropology; Regulatory Studies;
infrastructure; clinical trials; gene therapy; cystic fibrosis; regulation; rare diseases
Description In this article, we examine the construction of the infrastructure for a Phase II gene therapy trial for Cystic Fibrosis (CF). Tracing the development of the material technologies and physical spaces used in the trial, we show how the trial infrastructure took form at the uncertain intersection of scientific norms, built environments, regulatory negotiations, patienthood, and the biologies of both disease and therapy. We define infrastructures as material and immaterial (including symbols and affect) composites that serve a selective distributive purpose and facilitate projects of making and doing. There is a politics to this distributive action, which is itself twofold, because whilst infrastructures enable and delimit the movement of matter, they also mediate the very activity for which they provide the grounds. An infrastructural focus allows us to show how purposeful connections are made in a context of epistemic and regulatory uncertainty. The gene therapy researchers were working in a context of multiple uncertainties, regarding not only how to do gene therapy, but also how to anticipate and enact ambiguous regulatory requirements in a context of limited resources (technical, spatial, and financial). At the same time, the trial infrastructure had to accommodate Cystic Fibrosis biology by bridging the gap between pathology and therapy. The consortium’s approach to treating CF required that they address concerns about contamination and safety while finding a way of getting a modified gene product into the lungs of the trial participants.
Publisher The Society for Social Studies of Science
Contributor S.T.-A's research is funded by Wellcome Trust Award No: WT103360MA, PI: Graeme Laurie
C.A. is a member of the Consortium for Designer Organisms, which is funded by the University of Copenhagen’s Excellence Program for Interdisciplinary Research
Date 2017-06-29
Type info:eu-repo/semantics/article
Peer-reviewed Article
anthropology; science and technology studies (STS)
Format application/pdf
Source Engaging Science, Technology, and Society; Vol 3 (2017); 332-350
Language eng
Coverage United Kingdom; Europe

Rights Copyright (c) 2017 Samuel Taylor-Alexander, Courtney Addison

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