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Regulatory fast tracks for tolerogenic innovation:
Agencies like the FDA and EMA need new designations—
akin to “Breakthrough Therapy” or “Orphan Drug”
status—for biologics that prioritize immune compatibility.
Candidates using:

o Oral delivery
o Mucosal targeting
o Tolerogenic adjuvants
should qualify for accelerated review,
dedicated regulatory support, and outcome-
based flexibility.

Post-marketing surveillance reform:
Today, long-term immune rejection data is often a
voluntary afterthought. That must change.
Every approved biologic should be subject to:

o Standardized ADA monitoring across
populations
o Centralized SLOR tracking databases
o Public transparency around immune
durability in real-world settings

The policy paradigm must shift. Biologics can no longer
be approved and priced on speed alone. If they don’t last,
they don’t work. And if they don’t work long-term, the
system should stop pretending they do.

Mindset: From Molecule to System

The most entrenched obstacle to change isn’t scientific. It’s
cultural. For too long, the biologic development model has
been built on adversarial immunology: suppress the

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