Thelansis

For many biopharma teams, Phase III is treated as the final mountain to climb. Once efficacy and safety are proven, commercial readiness is assumed to follow naturally. In reality, that assumption is one of the most costly missteps in drug development. More assets than ever are reaching regulatory approval on time, yet facing slower-than-expected uptake, prolonged access negotiations, or restrictive reimbursement decisions. The issue isn’t clinical failure. It’s evidence of misalignment. Approval is Not the Same as Readiness Phase III trials are designed to answer a specific question: Does the therapy work, and is it safe? Regulators care deeply about this, and rightly so. But payers, HTA bodies, and health systems are solving a different problem altogether. They are deciding who should receive the therapy, when, and at what cost to the system, rather than what. When evidence is optimized only for approval, commercial teams are often left trying to retrofit value stories after ...