Improved Organoid Movement and Moral Responsibility for Clinical Trial Deaths

Maschler, Jack, School of Engineering and Applied Science, University of Virginia
Highley, Chris, EN-Biomed Engr Dept, University of Virginia
Laugelli, Benjamin, University of Virginia

Socio-technical Synthesis: Improved Organoid Movement and Moral Responsibility for Clinical Trial Deaths
My technical work and my STS research are connected primarily through the idea of improved disease treatment, and exploring how new social and technical developments may achieve that. My technical work revolves around the development of a novel device to automatically move organoids free from human intervention. Organoids are clusters of stem cells that are differentiated into different tissues and can be used to study disease, create drug models, and more, thus improving the organoid movement method dramatically increases the scalability of organoid studies to improve disease treatment. My research investigates the moral responsibility of the deaths involved in the Audentes Therapeutics gene therapy trial to gain insight into which actors may hold moral responsibility. Although my technical work approaches improved disease treatment from an upstream manner and my STS research from a downstream manner, the concept of improved disease treatment is central across both projects.
My technical work aims to help overcome the time barrier in organoid research. In any study involving organoids, at some point, a researcher will have to move organoids between different well-plates or centrifuge tubes completely by hand. This dramatically decreases the scale at which organoid studies can be conducted purely due to the increased time required and decreased precision due to human manual dexterity limitations. My capstone team developed a device utilizing commercially available and CAD-created components and a machine-learning algorithm to identify, pick up, and place organoids in user-specified locations. The goal of our project is to allow researchers to improve their organoid study design and throughput by utilizing our device in hopes of eventually improving disease treatment.
My STS research aims to identify different actors that may hold moral responsibility for the deaths in the Audentes Therapeutics gene therapy trials. Michel Callon’s actor-network theory and Van de Poel and Royakkers’ moral fairness requirement are employed sequentially to first identify the key actors involved in the trial deaths and then which may be considered morally responsible due to their foreseeability and freedom of action. My claim is that Audentes Therapeutics and the FDA can be held morally responsible for the trial deaths through their violations of the moral fairness requirement. My paper explores their violations in hopes of developing a more comprehensive understanding of the root cause of the Audentes Therapeutics trial deaths and other gene therapy deaths alike. Through understanding the causes of gene therapy deaths, future severe adverse events can be mitigated, improving the treatment of disease.
Simultaneously approaching improved disease treatment from an upstream approach with my technical project and a downstream approach with my STS research helped me develop a more comprehensive understanding of how each step in the process is equally important. Working on my technical project gave me a better understanding of how important study trial design is on trial outcomes, which helped me identify clinical trial protocol shortcomings that contributed to the fatalities. Similarly, the research I conducted for my STS paper helped me understand future obstacles the applications of my technical project will have to overcome, such as FDA approval, which helped design device testing protocols. In summary, working on the STS research paper and my technical project in tandem has allowed me to explore improved disease treatment from multiple angles while also improving the quality of each project.

BS (Bachelor of Science)
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