Articles by Tom von Gunden
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Inquiries In Inhalation, Part 1: The Breadth Of Breath
8/12/2026
In this article, Chief Editor Tom von Gunden considers the expanding range of addressable targets for inhalation drug and biologics delivery. He reports on innovations in oral and nasal inhalation technology that enhance approaches to traditional respiratory indications, as well enable delivery of inhaled therapies to systemic targets beyond the nose and lungs.
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Delivering Large Genetic Payloads With SonoThera's Ken Greenberg
7/28/2026
Videocast host Tom von Gunden talks with CEO Ken Greenberg of SonoThera about delivering large payload gene therapies to targeted indications, particularly those requiring redosing. Using Duchenne Muscular Dystrophy {DMD] as primary example, Greenberg describes how ultrasound-mediated, in vivo infusion of naked, or non-encapsulated, DNA to organ targets allows for larger cargo sizes than do vector-based approaches.
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Leveraging Platform Technologies In Drug Delivery With Suttons Creek
7/23/2026
In this episode of In Combination, Paul Chao and Carolyn Dorgan from combination product and delivery device consultancy Suttons Creek join host Tom von Gunden to discuss strategic considerations and best practices for employing technology platforms in device development for injection-based delivery. The conversation illuminates aspects such as the design space across product assets in development, component options within a platform offering, and regulatory pathways for platform-based submissions.
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Cross-Functional Decisions In Autoinjector Development with Windgap Medical's Aaron Mann
7/21/2026
On a return videocast appearance, CEO Aaron Mann of autoinjector provider Windgap Medical joins Supplier Horizons host Tom von Gunden to discuss product development decision points around delivering complex molecules via autoinjectors. These cross-functional considerations for drug teams and device teams include high viscosity formulations, device capabilities, product stability, patient safety, and human factors.
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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).
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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.
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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.
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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.
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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.
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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.