Page 110 - Binder2

something very different than a sharp bolus delivered into
the arm.

It means extending clinical trial timelines to track not just
how fast a biologic works, but how long it lasts. It means
measuring immunogenicity across months and years,
monitoring for creeping ADA levels, subtle
pharmacokinetic changes, and early clinical signs of
rejection—not waiting until patients cycle off the drug and
post-market surveillance raises red flags.

And it means changing who’s in the room.
Immunologists at year one, not year five.
Not brought in to solve a tolerization crisis, but to prevent
it.
To shape the molecule, the delivery, and the study design
with immune education in mind—not just immune evasion.

All of this is expensive.
It’s slower. It’s harder to model. It’s riskier from a
regulatory standpoint. And most importantly—it’s invisible
on a balance sheet until something goes wrong.

And that’s the problem.

The current system doesn’t reward long-term thinking.
It rewards speed.
It rewards launch.
It rewards differentiation in crowded markets based on
binding affinity, dosing convenience, or clever
branding—not immune resilience.

Durability isn’t built into most commercial forecasts.
It’s not reflected in the trial endpoints that lead to approval.
And it’s rarely priced into the market—because payers
don’t yet demand it, and regulators don’t yet require it.

108