Tom’s Articles

1. Need A Drug Delivery Conversation Starter? Try Target Product Profile 5/18/2026

   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. 

2. Regulatory Attention To Human Factors: How Much Is There? 5/5/2026

   In this article, Chief Editor Tom von Gunden considers trends in drug delivery likely to drive increased scrutiny around Human Factors {HF) in regulatory submissions and approvals. In an embedded video and transcript from Tom’s conversation with combination products consultant Doug Mead, the two discuss findings from GenAI queries that surfaced FDA precedents on HF-related matters including critical tasks, use errors, and risk mitigation.  

3. Patient-Centric Drug Delivery: Do Possible And Preferable Always Align? 4/22/2026

   In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.

4. Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions 3/2/2026

   In this article, Chief Editor Tom von Gunden considers the need for and benefit of conducting AI-based research into regulatory precedents for drug delivery submissions and approvals. He consults combination products consultant Doug Mead on best practices in bolstering regulatory intelligence and regulatory approval success by way of advanced search methods. 

5. Combination: The Drug Delivery Word Of The Year For 2026 12/30/2025

   In this article, Chief Editor Tom von Gunden explains why he sees 2026 as the year combination products and therapies become fully central to drug and biologics product development, delivery, and regulatory. He points to personalized medicine and patient self-administration as key factors shaping his view of the drug delivery landscape.

6. Regulating For Patient Safety And Success With Combination Products 12/16/2025

   At the AFDO/RAPS Combination Products Summit 2025, a notable focus emerged around approaches to risk assessment and human factors studies. In this article, Chief Editor Tom von Gunden offers his appreciation for the biopharma industry’s consideration of patient usability and safety in the development and regulation of combination products and other drug delivery devices. 

7. What Do Patients Appreciate? Therapeutic Innovation And Accessibility 11/11/2025

   At the PODD 2025 conference, patient advocates telling their own treatment stories focused on innovations in therapies and delivery methods for targeting chronic and rare diseases, leveraging technologies such as gene editing and subcutaneous delivery of complex biologics. In this article, Chief Editor Tom von Gunden carries forward the patient-centric themes of convenience and accessibility.