Page 134 - Binder2

All of these tools already exist.
They’ve been published. Validated. Peer-reviewed.

What’s missing isn’t the science.
It’s the will—and the regulatory encouragement—to use
them early.

Because today’s pipeline decisions are still driven by
speed, simplicity, and legacy metrics. Binding strength gets
rewarded. Tolerogenicity? Ignored, unless it shows up in
Phase III. And by then, the sunk costs are too high to turn
back.

We wouldn’t build a bridge without modeling load-bearing
stress.
We wouldn’t launch a plane without testing long-term
fatigue.

So why are we building biologics without testing how the
immune system is likely to respond over time?

If we want to prevent tolerization, we have to stop hoping
for tolerance—and start designing for it.

That begins in the lab.
Not in the clinic.
And not after failure.

From Fast Trials to Smart Trials

The truth is simple: the immune system takes its time.
It learns. It adapts. It remembers.

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