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Once a first-in-class drug is approved, the remaining patients eligible for the second entrant's trial are different. Enrollment-era bias means placebo arms in sequential trials are not comparable — and cross-trial superiority claims built on that foundation are weaker than they appear.

Conventional pharma wisdom assumes oral beats injectable. But Part B buy-and-bill economics create financial incentives for community oncologists to maintain infusion-based prescribing — and the patient cost math can actually favor the needle.

In rare disease, the standard launch playbook assumes the market exists. But when class penetration is below 30%, the majority of eligible patients are undiagnosed. The real competitor isn't the incumbent drug — it's diagnostic inertia.

The gap between clinical expertise and technical execution is the single biggest bottleneck in oncology commercialization. Here's how to close it.