Packaging As Strategy: Enabling Clinical-To-Commercial Success For Complex Therapies

This interview explores how pharmaceutical packaging has evolved into a strategic enabler of clinical-to-commercial success, particularly as pipelines shift toward complex biologics, targeted therapies, and drug-device combination products. Paul Smallman explains that packaging now plays a critical role in usability, manufacturability, regulatory readiness, and global scalability. For oral solid dose products, agility is replacing traditional efficiency models, with late-stage customization helping to reduce waste and manage SKU complexity.

In clinical development, flexible labeling and on-demand configurations support rapid protocol changes and smoother transitions to commercial supply. The discussion also highlights how high-potency and targeted therapies require advanced containment and engineered packaging environments, while injectables depend on precision assembly, human-factors-driven design, and scalable automation. Sustainability, he notes, can be achieved through incremental, validated improvements that preserve safety and compliance. Ultimately, tight integration between clinical and commercial packaging is essential to avoid delays and rework, with packaging increasingly shaping early development decisions and enabling more patient-centric, globally resilient drug delivery.