Welcome to the Virtual Summit: Dose Delivery

The Virtual Summit is a one-day virtual program on different hot topics with four sessions of speaker presentations and panel discussions.

This Virtual Summit on "Harmonizing CMC and Device Strategies for Dose Delivery" will evaluate the CMC and device technical development and intersecting regulatory frameworks that govern the lifecycle of combination product presentations. The Summit will analyze the critical interfaces where CMC and device requirements intersect. View the full Summit abstract below. The full scientific program will be available soon.

Summit Abstract

Control of drug product content, uniformity, and deliverable dose accuracy is a continuous technical process that extends from formulation, drug product manufacturing, the delivery device, and ultimately to the patient's systemic exposure. Achieving the designated label claim requires aligning CMC specifications and filling parameters alongside device engineering tolerances and clinical exposure requirements. Technical variances introduced at any stage of this continuum can impact delivery at the point of care.

This Virtual Summit will evaluate the CMC and device technical development and intersecting regulatory frameworks that govern the lifecycle of combination product presentations, ranging from standard vials/syringes and pre-filled syringes to large volume on body injectors. Drawing on technical considerations for pharmaceutical development, DP manufacturing, and device development, coupled with recent regulatory intelligence and health authority inspection trends, this Summit will analyze the critical interfaces where CMC and device requirements intersect.

Key technical sessions will examine:

• The Journey to the Dose: Examining the technical and clinical interfaces encountered during development of a combination product—specifically how formulation attributes (e.g. viscosity), DP filling line capability, primary container closure/delivery device interactions (e.g. break-loose/glide forces, spring rates, holdup volumes), and clinical dosing context (narrow vs. wide therapeutic windows) cumulatively impact deliverable dose consistency.
• Navigating Regulatory Framework: Balancing CMC, device, and clinical requirements within a dossier, and the resultant label claim.

Through data-driven case studies and strategic discussions, this Summit will provide a pragmatic framework to align on an integrated control strategy which supports dose label claims across varying product configurations.