CPHI Milan: Packaging and Delivery Decisions Must Reflect Real-World Care

In part 3 of an interview with PharmTech, Ron Scarboro, CEO, Azurity Pharmaceuticals, argues that a medicine's value depends as much on whether it reaches patients reliably and works in everyday use as on the science behind it. He treats formulation robustness and post-approval performance as design and measurement questions that development, quality, and supply teams share.

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

Access Part 2 of this interview in which Scarboro discusses how drug reformulation that removes patient barriers must preserve efficacy.

When discussing when increased robustness justifies the extra cost and complexity, Scarboro says teams should start with the real conditions of supply and use: where the product is stored, who administers it, and what the supply chain and care setting can reasonably deliver. A therapy intended for a specialist center may face very different conditions than one used in a community clinic or a patient's home. Transport, storage infrastructure, training, and regulatory requirements also vary by market, and he says those differences should inform formulation, packaging, and delivery decisions early. "Robustness does not mean claiming a product will perform outside its validated storage or handling conditions. It means understanding the intended environment, identifying where the system may be vulnerable, and designing and testing accordingly." In some cases, that supports a different package or delivery approach; in others, the conventional format is appropriate.

Scarboro also questions success metrics built on discoveries, patents, and approvals. "What they do not tell us by themselves is whether a medicine reaches patients reliably or if it fits in the realities of their care." For regulatory and quality teams, he recommends tracking product complaints, packaging and administration issues, and whether a product continues to meet quality standards through distribution and use, paired with supply measures such as availability in intended markets. Where reliable data exist, medical and commercial teams can add adherence and persistence. "The real measure of success is whether the medicine can actually make a difference for the patient who depends on it every day."