The Personalisation Challenge: Designing Medicines That Perform Beyond the Primary Market

Pharmaceutical packaging has long been engineered for a single, well-defined market and adapted outward. Personalised medicine breaks that model entirely. When every patient represents their own manufacturing batch, with their own care setting, access condition, and delivery requirement, the economics of standardised, scale-driven packaging no longer hold.

This keynote argues that the shift to personalised medicine is not primarily a patient engagement challenge. It is a design and manufacturing challenge. What does it mean to engineer packaging and delivery systems that are reliable, compliant, and scalable across the highly variable real-world conditions that personalised therapies must navigate, from care setting differences and supply constraints to regulatory variability across geographies?

The answer demands a fundamentally different starting point: one that builds delivery, formulation, and packaging decisions around the conditions that actually exist across markets, rather than the conditions of a single primary one. The result is not simply improved patient access, but a more resilient and operationally grounded approach to medicines design, and a direct challenge to the legacy systems built for volume, not customisation.