Governing the Genetic Age: Mechanism-Based Safety for Rapidly Expanding Technologies

Jun Ueda, Silvia Behrendt, David Bell, Jaspar Bovenberg, Alexandra Henrion-Caude, Robyn Cosford, Clare Craig, Paul Cullen, Gerald Dyker and Maarten Fornerod

No ags6u_v1, SocArXiv from Center for Open Science

Abstract: The 1975 Asilomar Conference established safety principles for synthetic DNA technologies. Today, lipid-nanoparticle-encapsulated nucleic acids globally circumvent those principles. This stems not from emergency measures, but from misapplying outdated vaccine classifications to gene-transfer technologies. Classifying infectious-disease-targeted gene-transfer technologies as vaccines exempts them from mandatory pharmacokinetic and genotoxicity studies. This unjustified exemption now standardizes routine use in healthy populations, relying on assumptions lacking mechanism-informed data on distribution, persistence, and genomic interactions. We propose “Asilomar 2027”—a global summit establishing: (i) regulatory classification based on biological mechanisms, not intended-use labels; (ii) preclinical verification aligned with biological reality; (iii) shifting the evidentiary burden to manufacturers to prospectively prove safety via auditable data before deployment; and (iv) independent international oversight. This framework couples innovation with biology, restoring the rigorous safety standards essential for sustainable medical progress.

Date: 2026-04-04
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Persistent link: https://EconPapers.repec.org/RePEc:osf:socarx:ags6u_v1

DOI: 10.31219/osf.io/ags6u_v1

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