Articles by Tom von Gunden

  1. Understanding CGMPs For Combination Products 1/15/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 4 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems with the book’s editor, Susan Neadle, and chapter co-author Mike Wallenstein. In the exchange, Susan and Mike share their perspectives on combination product CGMP’s, including regulatory definitions and differences in the U.S. and Europe, supplier controls, design controls, and manufacturer responsibilities.

  2. Defying Dysphagia Via Gel-Based Delivery With Gelteq's Nathan Givoni 1/6/2025

    Patients suffering from dysphagia, or difficulty swallowing, have historically faced limited options for how they receive medications and what kinds can be effectively delivered to them. In this episode of Sit and Deliver, host Tom von Gunden speaks with Gelteq CEO Nathan Givoni about advances in gel-based oral delivery that would allow patients to overcome the challenges dysphagia presents. 

  3. Developing Regulatory Strategies For Combination Products 12/16/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.

  4. Enabling In-Home Drug Delivery With SMC's Asmita Khanolkar 12/10/2024

    Methods for enabling self-administered, in-home delivery of drugs and biologics must accommodate increasingly larger volumes and more complex formulations. In this episode of Supplier Horizons, host Tom von Gunden talks with Asmita Khanolkar, Senior Director of Pharma Services at contract manufacturer SMC Ltd., about patient-centric considerations such as ergonomics and tolerability in the development of combination products, autoinjectors, and other delivery systems.

  5. Treating Gastroparesis: From Nose To Stomach With Evoke Pharma's Matt D'Onofrio 12/4/2024

    In this episode of Sit and Deliver, Matt D’Onofrio, CEO of Evoke Pharma, talks with host Tom von Gunden about using nasal delivery to alleviate the discomfort of gastroparesis while smoothing the path for oral drug delivery to patients suffering from it.

  6. Gene Therapy Delivery With Battelle's Gabe Meister And Tony Duong 11/25/2024

    A significant challenge in gene therapy delivery – particularly for in vivo approaches – has been limitations in cargo capacity of the gene payload carrier. In this episode of Supplier Horizons, host Tom von Gunden talks with technical director Gabe Meister and scientist Tony Duong from biopharmaceutical research and development company Battelle about the promise of polymer nanoparticles as delivery vehicles for treating rare diseases with in vivo gene therapies.

  7. How To Identify And Differentiate Combination Products 11/18/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 2 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor and Chapter 2 author, Susan Neadle. Considering both product development and the global regulatory landscape, the discussion focuses on answers to the question posed by the chapter title, “What Is a Combination Product?”

  8. Patient Safety Through Overdose Protection With Elysium Therapeutics' Greg Sturmer 11/18/2024

    Drug overdoses can result both from knowingly risky behavior, such as opioid use disorder, and from unwitting patient acts of over-consumption. In this episode of Sit and Deliver, Greg Sturmer, co-founder and CEO of biopharmaceutical company Elysium Therapeutics, talks with Sit and Deliver host Tom von Gunden about ways to add overdose inhibitors to oral medications prone to abuse or misuse.

  9. Needle-Free Rescue Therapies With Crossject's Patrick Alexandre And Dan Chiche 11/12/2024

    Just how quickly might the emergency treatment of an epileptic seizure or other sudden, chronic attack be enabled? With advances in needle-free autoinjectors, the promise of near immediacy is near. In this episode of In Combination, host Tom von Gunden combines perspectives from two different executive roles at emergency medicines company Crossject. CEO Patrick Alexandre and Chief Medical Officer Dan Chiche discuss common rescue scenarios, rapid self-administration of treatments, and collaborative development efforts across drug formulation and device engineering.

  10. Intranasal Delivery for Post-Viral Smell Loss with Cyrano Therapeutics' Rick Geoffrion 10/29/2024

    COVID-19 and other viruses have drawn increased attention to the debilitating effects and potentially consequential underlying causes of hyposmia or anosmia (reduced or complete inability to smell). In this episode of Sit and Deliver, Rick Geoffrion, founder and CEO of regenerative medicine company Cyrano Therapeutics, talks with Sit and Deliver host Tom von Gunden about why an effective therapeutic response may well involve – you guessed it – a payload through the nose.