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What’s missing isn’t the technology. It’s the alignment of
incentives.
A plant-based oral biologic delivered with a tolerogenic
adjuvant may not be the fastest to market. It may not fit the
classic antibody playbook. But if it can maintain immune
compatibility for years without rejection, escalation, or
switching, it may be the most valuable innovation in the
entire therapeutic category.
Because in a world of escalating costs and shrinking trust,
the biologics that endure will be those built not just for
the target—but for the immune system they must live
within.
And the companies that build them won’t just win market
share.
They’ll change the market itself.
3.5 – What Clinical Trials Would
Need to Change
If we want to build biologics that last, we need to start
testing them like they’re meant to last.
Right now, the clinical trial system for biologics is
optimized for speed, signal, and approval. The standard
model is straightforward: demonstrate statistically
significant symptom improvement—often at 8 or 12
weeks—and clear the regulatory bar. Get the drug to
market, get it on formularies, and let real-world evidence
sort out the rest.
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