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must last, that immune rejection is not acceptable collateral,
and that biologics can—and must—be built to stay.

8.2 – What Needs to Change

For all the promising signs of movement—startups
innovating, academics testing new delivery systems,
regulators drafting new guidance—the biologic industry
remains structurally entrenched in a model that tolerates
tolerization. The shift from resistance to revolution will not
come from science alone. It will require rewiring how we
define value, how we reward durability, and how we
measure success.

Here’s what must change across three critical dimensions:
policy, mindset, and investment.

Policy: Redefining Success in Biologic Approval
and Access

For most of modern biotech history, biologic success has
been measured with a stopwatch.
Does it reduce symptoms in 8 weeks? Do inflammatory
markers drop at Week 12? Can it show statistical
significance in a double-blind study before the immune
system starts to notice?

These were convenient benchmarks—not because they
captured long-term outcomes, but because they fit the
structure of clinical trials, regulatory cycles, and investor
timelines.

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