07.03.26 -- Drug Delivery Leader Best Of June

In this article, Chief Editor Tom von Gunden explores the need for and existence of cross-functional communication during drug product development and delivery device selection. He consults industry veterans with experience in various formulation or delivery roles at GSK and Merck. They identify the Target Product Profile (TPP) as the core concept guiding collaboration. 

In this segment of the Drug Delivery Leader Live online event, Large Molecule Biologics Delivery: Aligning Formulations, Doses, And Devices, Chief Editor Tom von Gunden directs an audience question about the delivery device selection process to panelist Dominick DeGrazio. In outlining key considerations, DeGrazio emphasizes technical requirements and adds others, including compatibility, regulatory, quality, sterility, and supply chain. 

In this article, combination product consultant Doug Mead demonstrates the practice and results of using GenAI search tools to conduct precedent research on Human Factors (HF) regulatory considerations. He illuminates query responses related to Complete Response Letters (CRLs), HF study waivers, use errors, critical tasks, and other aspects of FDA approvals for combination products and other delivery devices.

Developing new delivery routes is essential for creating more effective treatments. Nanoforming enables new routes to simplify dosing, enhance patient comfort, and reduce healthcare costs.

Skin delivery platforms expand therapies by boosting convenience, stability, and adherence. Integrated formulation, device, and manufacturing development is key to confidently scale.

Early engagement with an expert packaging partner supports safe, cost-effective drug development and logistical success from precommercial stages through full market launch.