Page 94 - Binder2

And yet, the consequences are not just molecular. They are
personal. When a biologic stops working, patients lose
more than symptom control. They lose faith—in the drug,
in the plan, in the promises made at the outset. They begin
to see therapy not as healing, but as trial and error. They
enter a cycle of hope, failure, and resignation. And they
begin to ask questions no one wants to answer:
Why didn’t this last? Why wasn’t I told this could happen?
What now?

The cost of what we overlooked isn’t just clinical. It’s
emotional. Financial. Structural.

It’s a cost paid silently—through abandoned therapies,
rising insurance claims, and patient frustration.

But there is power in naming what we missed.

Because when we recognize that tolerization isn’t rare—it’s
undermeasured—

When we accept that durability isn’t accidental—it’s
designable—

When we understand that immune rejection isn’t fate—it’s
feedback—

Then we can begin to build the next generation of biologics
not just as therapies, but as partners with the immune
system.

This chapter has laid bare the scaffolding of a system
optimized for speed, but not for sustainability. It has shown
how each stakeholder—industry, regulators, clinicians, and
payers—did their job, but not the whole job. The result is a

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