From Clinical to Commercial: Introducing Devices Earlier to Streamline the Drug-Device Combination Journey

Achieving scalability, flexibility, and integration from Phase I to Commercial Launch

As parenteral therapies become increasingly patient-centric, drug developers are recognizing the importance of introducing delivery devices such as prefilled syringes, cartridges, autoinjectors, and pens earlier in clinical development. Making informed device choices in the early phases can have a profound impact on scalability, manufacturability, and speed to market later on.

In this expertXchange session, experts from PCI Pharma Services will discuss how early device integration can de-risk development, streamline scale-up, and bridge the gap between clinical and commercial manufacturing. The session will explore key decision points around device selection, design-for-manufacture considerations, and the value of an integrated approach to sterile filling, assembly, packaging, and testing.

Whether adapting a platform device or developing a custom solution, attendees will gain a practical understanding of how to align early-phase clinical planning with long-term commercial objectives creating a flexible, efficient pathway from first-in-human studies to global launch.

Learning Objectives

By the end of this session, attendees will:

• Understand the benefits of introducing device strategy and selection earlier in clinical development.
• Learn how early alignment between clinical and commercial manufacturing can reduce cost, risk, and time to market.
• Explore how integrated solutions can support seamless scale-up from pilot to full-scale production.
• Identify key considerations for device assembly, packaging, and testing that enable regulatory and commercial readiness.
• Review emerging trends in early device adoption and combination product development.

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