Building for Biology: A Gene Therapy Trial Infrastructure

Keywords: infrastructure, clinical trials, gene therapy, cystic fibrosis, regulation, rare diseases


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.

Author Biographies

Samuel Taylor-Alexander, Monash University

Samuel Taylor-Alexander is Research Fellow in Anthropology at Monash University. He has held academic posts at the University of Auckland and the University of Edinburgh as well as visiting positions at Harvard University (STS) and the University of Copenhagen (Anthropology). His work is published in Medical Anthropology Quarterly, Current Anthropology, New Genetics and Society, Molecular Therapy and Science. Samuel is the author of On Face Transplantation: Life and Ethics in Experimental Biomedicine (Palgrave Macmillan).

Courtney Addison, Monash University

Courtney Addison is an anthropologist of science and medicine, and Research Assistant at Monash University. Her doctoral research examined the politics of ethics and knowledge-production in the context of gene therapy through London-based hospital ethnography. Her work is published in Biosocieties, New Genetics and Society and Medical Anthropology.

29 Jun 2017
Research Articles