Page 108 - Binder2

regulators is short-term efficacy and safety.
Immunogenicity, as long as it isn’t catastrophic, is treated
as an unfortunate artifact—not a structural failure.

Long-term drug survival?
That’s someone else’s problem. It shows up in payer
dashboards, in prescribing trends, in real-world data that
emerges only years after the initial approval. And by then,
the development team has moved on. The marketing cycle
has shifted to the next product. The company has filed new
patents, launched new indications, or positioned a “next-
generation” version of the molecule. Meanwhile, the
patient is back in their doctor’s office asking why the drug
that once worked no longer does.

This is the quiet handoff that happens throughout the
biologics industry:
Responsibility for durability is passed downstream.

It’s not part of the design mandate. It’s not part of the
launch KPI. And so, most companies don’t optimize for
immune resilience.

Why would they?

Doing so would require more time. More complexity. More
cost. It would mean slowing down the development
timeline to integrate immunology teams early, to rethink
delivery platforms, to test alternative formulations or
tolerance-inducing strategies. And in a competitive market,
speed to approval is king.

There’s no line item for "long-term immune harmony" on a
quarterly earnings report.
No credit on the stock price for a drug that lasts five years
instead of two—unless the market forces it.

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