Articles by Tom von Gunden

  1. 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. 

  2. 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. 

  3. 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. 

  4. 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. 

  5. Ensuring Medication Adherence Via Smart Patches With Ategenos' Don DeGolyer 1/27/2026

    An unfortunately common occurrence, especially with oral administration, is patients missing doses of their medications. In this episode of Sit and Deliver, Founder and CEO Don DeGolyer of Ategenos Phamaceuticals talks with host Tom von Gunden about ways to counter medication non-adherence by using smart transdermal delivery devices for monitoring and administering medicines. 

  6. 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.

  7. 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. 

  8. Deploying Viruses To Counter Antibiotics Resistance With Paldara's William Colton 11/26/2025

    An increasingly common obstacle to treating patients with infections is resistance to antibiotics. In this episode of Sit and Deliver, CEO William Colton of biologics platform delivery developer Paldara Pharmaceuticals talks with videocast host Tom von Gunden about infection-combatting alternatives using hydrogel-based systems to deliver bacteriophage viral therapeutics directly to infection sites.

  9. Going Deep On Delivery With The Subcutaneous Consortium 11/13/2025

    In this episode of In Combination, officers from industry association The Subcutaneous Drug Development and Delivery Consortium join host Tom von Gunden to introduce the structure and work of the group. The discussion of sub-team activities and outputs illuminates key challenges and innovation opportunities around bioavailability, immunogenicity, high dose formulations, sustainability, clinical development, regulatory strategy, and patient preference.

  10. 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.