Page 84 - Binder2

2.7 – A System Built for Launch, Not

Longevity

If you step back and look at the biologics pipeline—from
bench to bedside—it becomes clear that the system isn’t
broken.

It’s working exactly as it was built to - The problem is, it
was never built to last.

From academic discovery through clinical trials, regulatory
review, commercial launch, and post-marketing
surveillance, the machinery of biologic drug development
is optimized for one primary goal: getting to approval.
Once a biologic shows statistically significant efficacy and
an acceptable safety profile—usually within a 12- to 24-
week trial window—it’s cleared for market. And from that
point forward, the incentives shift. Revenue starts.
Milestones trigger. Stock prices rise.

Everything after that? It’s maintenance.

There is no formal checkpoint for long-term immune
compatibility. No mandated reassessment at year two or
three. No requirement that a biologic demonstrate
durability before being considered a standard of care. If
patients lose response, the system handles it through
existing protocols: dose escalation, therapeutic switching,
immunosuppressant layering. The burden of adaptation is
placed squarely on the clinic—not on the product.

This launch-first mentality isn’t the result of negligence.

It’s the result of deep structural design.

82