Page 59 - Binder2

• From industry demanding ROI on billion-dollar
development cycles.
• From policymakers seeking faster access to
innovative therapies.

To respond to these pressures, agencies have developed
accelerated pathways—fast track, priority review,
conditional approval—that streamline the process for high-
need areas like cancer, autoimmune disease, and rare
conditions.

The COVID-19 pandemic intensified this trend. In the
name of urgency, regulatory bodies embraced
unprecedented speed—issuing Emergency Use
Authorizations, condensing trial timelines, and accepting
surrogate endpoints for approval. What began as crisis
response has since reshaped expectations: speed became
not just possible, but preferred.

The success of rapid vaccine and therapeutic approvals
created a precedent that now echoes into other disease
areas, reinforcing a development culture that prioritizes
launch velocity over long-term resilience—including for
biologics.

These programs are well-intentioned, even lifesaving. But
they also incentivize developers to optimize for early
wins, not immune harmony. The unspoken rule: prove the
drug works now, and we’ll worry about the long-term later.

That “later” is supposed to be handled by post-marketing
surveillance—pharmacovigilance. But in the case of
tolerization, this is a fiction. There is no centralized system
that systematically collects and analyzes ADA data from
real-world use. There is no shared repository of tolerization
rates across patient populations. What exists is a patchwork

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