Impacts, Assimilations, and Adaptations within the Architectures of Regulatory Oversight, Capital Structures, Medicalization, and Governance of Precision Medical Technologies

This dissertation investigates and describes the concept of precision medicine from historical, conceptual, capital investment, industry strategic, regulatory oversight, and medicalization perspectives. The study examines the various current and ongoing challenges, impacts, assimilations, and actual adaptive measures occurring within each of these areas as a result of the emergence and continued evolution of precision medicine as a medical discipline, as well as the technosocial advancements characteristic of precision medical products, such as companion diagnostics and targeted therapeutics, seeking market entry in the United States. The dissertation argues that there is a disjunction between precision medicine and historical governance, oversight, and medical practice mechanisms. Through case studies of two case products, Foundation Medicine’s F1CDx companion diagnostic and Novartis’ Kymriah CAR-T Cell therapeutic, the dissertation illustrates the impacts, destabilization and destandardization effects, and re-standardization efforts around a precision medicine diagnostic and therapy. As a central contribution, this dissertation demonstrates and illustrates the impact(s) that precision medicinal technologies are having on the technoscientific network involved in the creation, development, evaluation, governance, and implementation of medical products in the United States. Results revealed an emerging precision medical innovation model between and among member components of a precision medical ecosystem comprised of the above-mentioned focal areas and that, to fully understand the emerging precision medical innovation model, it is critical to understand not only the impacts of precision medical technologies on the individual components of the precision medicine ecosystem, but also the impacts, adaptations, assimilations, and occlusions inherent to the ecological relations within and across the ecosystem itself. Findings include the destabilization of the traditional drug development process across all stakeholder areas, characterized by the development of non-linear adaptive processes at both the premarket and post-market phases. Although the findings from this study are significant, it is likely that they are temporary in nature and will continue to evolve in accordance with the further advancement of precision medicine, ultimately re-stabilizing the precision medical development ecosystem.