CPHI Milan: Why End-to-End Pathway Ownership Matters

In part 2, of a 3-part interview, Ron Scarboro, CEO, Azurity Pharmaceuticals, examines the technical and organizational demands of re-engineering proven therapies for patients who need a different way to take them. Scarboro describes the central formulation challenge as a balance between usability and performance. "The hardest part is changing the condition of use while preserving the confidence in how the medicine's actually performing," he says.

Access Part 1 of this interview in which Scarboro explains why real-world usability belongs at product definition.

He uses a fasting requirement as an example. Such instructions are often tied to how a drug is absorbed, so any reformulation that removes the barrier must still meet the same standards for exposure, safety, and efficacy. "Convenience matters, but only if the medication continues to do its job," Scarboro says. The work requires iterative formulation, careful testing, and regulatory, clinical, and manufacturing input throughout development. He adds that each product must stand on its own evidence: "If data does not support the change, you have to change course."

For companies without an integrated development-to-commercial model, Scarboro recommends starting with a specific patient use problem. Development, medical, regulatory, quality, manufacturing, supply, and commercial teams should then assess together whether an improvement can be made, produced reliably, delivered to patients, and supported commercially. "So if those issues are examined one department at a time, the difficult decisions come late and become expensive," he says.

Scarboro notes that smaller companies do not need to own every capability and can work through partners or licensing arrangements. CDMOs increasingly fill that role, aligning formulation science with manufacturing so that patient-centric therapies stay scalable and compliant. "What matters is that someone owns the entire pathway for that product from identifying the unmet need through development, approval, supply, and use."