Page 83 - Binder2
P. 83

velocity—or immune compatibility over brute force—
               simply couldn’t compete. Not on timeline. Not on trial
               design. Not on reimbursement.


               So instead of investing in those long-term solutions, the
               industry doubled down on its existing approach: build,
               launch, escalate, switch.

               And with that, some of the most promising tools for
               preventing tolerization were quietly left on the shelf—not
               because they didn’t work, but because they didn’t fit the
               formula.


               Part of the problem is structural. In many pharma
               organizations, drug development is siloed. Immunologists
               don’t always sit at the same table as formulation chemists
               or clinical program leads. Tolerance isn’t modeled early in
               preclinical work—it’s often an afterthought, studied only
               when ADA rates start rising in Phase III or post-launch.


               In other words, we engineered these molecules without a
               full conversation with the immune system.


               And now we’re paying the price. In lost response. In patient
               churn. In mounting costs from switching, re-dosing, and
               layering drugs that were never meant to be stacked. We
               built the scaffolding for a biologic future—without laying
               the foundation of immune cooperation.

               This is not a failure of science.
               It’s a failure to ask the right questions soon enough.

               And in the next chapter of drug development, those
               questions can no longer be optional.




                                           81
   78   79   80   81   82   83   84   85   86   87   88