Abstract
Sustainability transitions are often hindered by institutional lock-in, regulatory inertia, and historically contingent technological choices that persist long after their limitations become apparent. These dynamics have been widely examined across energy systems, transportation, agriculture, and environmental governance, yet remain comparatively underexplored in biomedical research systems. While animal-based biomedical research serves here as an illustrative case study, the framework of path dependency has broad relevance across sustainability transitions, where historical institutional choices continue to shape present-day technological and policy trajectories.
This presentation applies the framework of path dependency to examine how animal-based research became institutionally entrenched within modern drug development, toxicology, and biomedical science despite longstanding concerns regarding translational reliability, efficiency, and human predictivity. Using historical and policy analysis, the presentation traces a series of critical regulatory junctures—including the 1938 Federal Food, Drug, and Cosmetic Act, the 1962 Kefauver–Harris Amendments, postwar expansion of federally funded biomedical infrastructure, and international regulatory harmonization efforts—that collectively reinforced animal-centric research paradigms across academia, industry, and government.
The analysis further explores how these institutional arrangements generated self-reinforcing feedback mechanisms involving funding systems, scientific training pipelines, publication incentives, industrial standardization, and regulatory expectations. These dynamics contributed to the persistence of animal-dependent models despite the high attrition rates observed in clinical drug development and increasing availability of human-relevant alternatives. The analysis additionally connects biomedical animal dependence to wider sustainability and planetary health concerns, including resource-intensive animal production systems, land-use pressures associated with feed agriculture, and increasing attention to zoonotic disease risks arising from intensive human-animal interactions.
Particular attention is given to the evolving policy landscape between 2022 and 2025, including the FDA Modernization Act 2.0, subsequent FDA Modernization Act 3.0 discussions aimed at accelerating implementation pathways for human-relevant methods, and broader initiatives undertaken by the FDA, NIH, EPA, CDC, Department of Veterans Affairs, and Department of the Navy to expand the use of New Approach Methodologies (NAMs), including advanced in vitro, organ-on-chip, and computational platforms. These developments may represent an important transition point in biomedical governance and scientific innovation policy.
By situating biomedical reform within broader sustainability transition theory, this presentation argues that the movement toward human-relevant science should be understood not solely as a technical evolution, but as a systems-level transformation involving governance, institutional redesign, scientific culture, and regulatory modernization. The presentation concludes by discussing the opportunities and risks associated with transition periods, including the possibility that alternative methods remain merely supplementary rather than structurally transformative.
