Page 131 - Binder2
P. 131

Durability is not an afterthought.
               It is the difference between a drug that works for six
               months and one that transforms the long-term course of a
               disease.


               If we keep defining success by short-term response, we will
               continue to launch expensive biologics that are built to fail.
               But if we redefine success as immune persistence, we can
               finally start designing biologics that last—not just on the
               market, but in the body.

               This shift requires trials to run longer, and to design
               endpoints that reflect staying power, not just first-past-the-
               post improvement. That’s not something investors want to
               hear. Time is money. However, in this instance time is
               lucrative investment.

               It pays in time saved from developing another drug when
               the initial one rushed through trials eventually fails. It pays
               in longer periods of adherence when a drug is prescribed
               and continues to work. It pays in trust and confidence from
               clinicians and patients alike.


               Biologics that work for 90 days are not equivalent to
               biologics that work for 5 years. But under the current
               system, they’re approved the same way.


               That’s not precision medicine. That’s expiration-dated
               medicine.










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