The Optispan Podcast with Matt Kaeberlein

Inside the Offshore Clinics Developing Gene Therapy to Fight Aging | 125

Aug 26, 2025
Ivan Morgunov, CEO of Unlimited Bio, and Anna Vakhrusheva, its CTO, share insights on their innovative gene therapies targeting aging. They discuss regulatory challenges that drove them to offshore clinics in special economic zones. The duo emphasizes the significance of the extracellular matrix in aging, their first VEGF therapy, and ethical debates around safety versus accessibility. They highlight exciting future therapies like follistatin and Klotho, while advocating for a balanced approach to regulation and innovation in longevity treatments.
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INSIGHT

Insurance As A De Facto Regulator

  • Prospera requires companies to buy liability insurance that functionally enforces safety standards.
  • The insurer acts as a commercial regulator by assessing and pricing perceived risk.
ADVICE

Bring Sandboxes Home Strategically

  • Consider exporting the sandbox model to home countries to reduce patient travel and increase oversight.
  • Use insurer competition and state-level sandboxes as mechanisms to create parallel regulatory options.
INSIGHT

Reusing Existing Approvals To Accelerate Access

  • Unlimited Bio leveraged a Russia-approved plasmid VEGF therapy to pilot offerings in Prospera.
  • Prior human use (10,000+ patients) made initial approval and safety assessment more practical in the sandbox.
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