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• Education campaigns to build public trust around
“medicine grown in plants”

Getting to Market: A Playbook for the First Movers

Companies developing edible biologics can accelerate path-
to-approval by:

1. Engaging early with regulators – especially on
manufacturing controls and immune endpoints
2. Investing in preclinical immune modeling, not
just efficacy
3. Designing for simplicity – using well-characterized
plant systems, standardized doses, and easy-to-
administer formats
4. Demonstrating health economic advantage – not
just through lower production cost, but through
improved adherence, fewer switches, and reduced
side effects
5. Building commercial alliances that reflect the
unique value proposition—cost, convenience, and
immune compatibility

Edible biologics won’t fit the old playbook.
But that’s not a weakness—it’s the point.

They don’t just require new thinking from regulators.
They offer a new model for what drug approval and access
can look like in a decentralized, durability-focused, patient-
driven world.

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