Over the course of my career, I've participated in and advised development programs across pharmaceuticals, biologics, regenerative medicine, diagnostics, neuroscience and many other therapeutic areas. One pattern keeps showing up regardless of the therapeutic area. The programs that struggled were rarely the ones with the weakest science. More often, they generated evidence that didn't quite match what regulators, clinicians, and payers needed to make a decision. The programs that succeeded had usually done something harder: they'd stayed aligned with those stakeholders the whole way through. Approval, in my experience, isn't the result of one breakthrough decision.
