Articles by Tom von Gunden

  1. 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.  

  2. 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.

  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. 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. 

  5. 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. 

  6. 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. 

  7. 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. 

  8. Exosome-Based Gene Therapy Delivery With OmniSpirant's Gerry McCauley 2/25/2026

    In this episode of Sit and Deliver, host Tom von Gunden talks with OmniSpirant Therapeutics CEO Gerry McCauley about leveraging stem cell-derived exosomes for platform delivery of gene therapies targeting cancers, respiratory diseases, and other indications. They consider patient safety along the way of transforming life-threatening diseases into manageable, treatable conditions. 

  9. Advancing Nanomedicine Formulation And Delivery At Duquesne University 2/10/2026

    In a special episode of In Combination, host Tom von Gunden visits the Graduate School of Pharmaceutical Sciences and the Nanomedicine Manufacturing Laboratory at Duquesne University. There, a professor and some graduate students share insights into the program’s focus on innovating nanoparticle formulation, manufacturing, and delivery. The coverage illuminates the role of academic, industry, and government partnerships in advancing the science and technology of nanomedicines toward clinical translation. 

  10. Localized Treatments Via Precision Injections With RheoTek's Dan Mazzaferro 1/27/2026

    Dr. Daniel Mazzaferro, founder and president at precision drug delivery technology company RheoTek Medical, joins Supplier Horizons host Tom von Gunden in a discussion of using needle-based and needle-free injection systems for precision targeting of skin cancers and other dermatological indications. The conversation includes coverage of the goals and benefits of localized rather than systemic approaches to therapeutic administration and mechanisms of action.