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regulators will trust to deliver durable, immune-
compatible therapy.

This is more than science—it’s strategy.

What founders and CEOs must champion:

• Trust as a design principle. Make patient access,
tolerability, and immune harmony part of your pitch
deck—not just efficacy rates or target market size.
• Durability as a moat. Highlight not only the effect
size, but the time horizon. Demonstrate why your
therapy avoids immune rejection and how that
lowers switching, infusion burden, and payer churn.
• Regulatory courage. Seek designations for novel
delivery or tolerogenic platforms. Push for inclusion
in post-marketing immune tracking programs. Be
first—not last—to meet rising standards.
• Transparency as branding. Be the company that
publishes full ADA profiles. That commits to open-
source tolerogenic design tools. That earns trust by
sharing what others hide.

Startups have always been where rebellion begins. But
now, they’re where lasting change is codified—in
platforms, pipelines, and immune-informed playbooks.

Patients and Advocates: Demand More Than
Temporary Relief

Biologic patients have been taught to expect failure. To
switch drugs every year or two. To be grateful for a few
symptom-free months before rejection sets in. That story is
outdated—and damaging.

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