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

Author

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

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 This stems not from emergency measures, but from misapplying outdated vaccine classifications to gene-transfer technologies.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.

Suggested Citation

  • Ueda, Jun & Behrendt, Silvia & Bell, David & Bovenberg, Jaspar & Henrion-Caude, Alexandra & Cosford, Robyn & Craig, Clare & Cullen, Paul & Dyker, Gerald & Fornerod, Maarten, 2026. "Governing the Genetic Age: Mechanism-Based Safety for Rapidly Expanding Technologies," SocArXiv ags6u_v1, Center for Open Science.
    • Handle: RePEc:osf:socarx:ags6u_v1
    DOI: 10.31219/osf.io/ags6u_v1
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