Articles by Tom von Gunden

  1. Delivery Device Functional Scrutiny: Can You Pass (Without) The Test? 7/13/2026

    In this article, Chief Editor Tom von Gunden considers the relationship between regulatory testing and the biopharma industry’s interest in leveraging drug delivery platform technologies to reduce regulatory burden in product development. Tom includes a conversation with guest columnist Doug Mead about waivers on testing in the context of FDA’s guidance on Essential Drug Delivery Outputs (EDDOs).  

  2. 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. 

  3. Increasing Oral Delivery Precision For CNS Targets With Tris Pharma's Ketan Mehta 5/13/2026

    Videocast host Tom von Gunden talks with CEO Ketan Mehta of Tris Pharma about innovations in oral delivery approaches to CNS disorders, such as ADHD, pain, and addiction. They discuss dosage form options, including liquid, solid, and powder, for leveraging polymer-based particle science to deliver stable, long-acting formulations. Among the advances discussed is precision targeting of payload release locations in the GI tract for optimal absorption.

  4. 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.  

  5. Decreasing Nebulizer Size, Increasing Therapeutic Targets With Nebu-Flow's Andrea Cusack 5/4/2026

    In this episode of Sit and Deliver, host Tom von Gunden talks with Nebu-Flow CEO Andrea Cusack about advances in nebulization science and technology targeting respiratory conditions, as well as systemic conditions reached through the lungs. The discussion focuses on using conveniently sized nebulizers to deliver vaccines, nanomedicines, and other complex biologics that address unmet patient needs with increased bioavailability. 

  6. An Orally Delivered Alternative Approach To Obesity With Aphaia's Steffen-Sebastian Bolz 4/23/2026

    Offering an alternative to injectable peptides, Chief Scientific Officer Steffen-Sebastian Bolz from Aphaia Pharma describes for videocast host Tom von Gunden an obesity treatment that leverages the body’s natural mechanisms for processing food and engaging the brain’s intake-management functions. The approach loads glucose into orally consumed beads that travel to the lower intestine and trigger combinations of brain-signaling hormones, including GLP-1s.

  7. 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.

  8. Enabling Adherence Via Multidose Injectors With SHL Medical's Courtney Nicholas Sutton 4/13/2026

    Courtney Nicholas Sutton, Head of Product Strategy at drug delivery systems developer and manufacturer SHL Medical, joins Supplier Horizons host Tom von Gunden to discuss opportunities for multidose pen injection technologies to advance patient adherence and therapeutic benefits. With the primary treatment scenario being chronic, cardiometabolic diseases, the discussion covers topics including dosing accuracy, human factors, and device reusability. 

  9. Enabling Oral Delivery Of Biologics With Vivtex's Thomas von Erlach 4/7/2026

    The rapidly expanding demand for biologics-based treatments for chronic, metabolic diseases has spurred a desire for oral administration. Videocast host Tom von Gunden talks with CEO Thomas von Erlach from delivery platform developer Vivtex about using high-throughput screening, advanced computational tools, and formulation technologies to drive higher absorption and bioavailability of peptides and other macromolecules delivered via gastrointestinal routes. 

  10. From IV To Subcutaneous: Easing Administration, Advancing Efficacy 4/1/2026

    In this episode of In Combination, patients Todd Kennedy and Cathleen Bergin describe for videocast host Tom von Gunden the significant life and health transformations brought about when their treatment regimens shifted from IV to subcutaneous administration. Adding perspective on the technology enablers is Chief Medical Officer Charles Theuer from drug delivery systems provider Halozyme.