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Eventually, tolerization will no longer be a background
issue. It will be the issue that defines the next era of
biologic development.
The question is not whether pharma can afford to talk about
it.
It’s how much longer the system can afford not to.
Too Disruptive for Regulators
Regulators like the FDA in the United States and the EMA
in Europe are tasked with a mandate that’s both vital and
constrained: ensure that drugs entering the market are safe
and effective. But what counts as "effective" is often
defined narrowly measured in weeks or months, not years.
Most biologics are approved based on short-term
endpoints: symptom relief, biomarker reduction, tumor
shrinkage. These are important, but they offer only a
snapshot of the therapy’s interaction with the immune
system.
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