Infusion Drug Delivery Videos

  1. 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.

  2. Drug Delivery Market Success: Lessons From A Discontinued Product 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, host Fran DeGrazio and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, ponder the discontinuation of Repatha® Pushtronex®. They comment on how its withdrawal may illustrate key market drivers and factors that bolster a product’s success or, alternatively, lead to its demise.

  3. The History And Evolution Of Drug Delivery Technologies 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, trace the evolution of drug delivery technologies over the last 100 or so years. The timeline illustrates the trajectory from the earliest prefilled syringes to the nanotechnologies and other advances of today.

  4. Platform Approaches To Personalized Medicines With NanoVation's Dominik Witzigmann 3/20/2025

    In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Dominik Witzigmann of LNP (lipid nanoparticle) platform developer NanoVation Therapeutics about addressing a wide range of patient needs while partnering with biopharma and navigating the regulatory landscape to do so.

  5. Understanding The Global Regulatory Landscape For Combination Products 8/14/2025

    In this videocast episode, host Tom von Gunden discusses Chapter 14 of The Combination Products Handbook (CRC Press) with the book’s editor Susan Neadle, along with chapter coauthors Stephanie Goebel, Cherry Malonzo Marty, and Viky Verna. The group provides overviews of the commonalities and variances in regulatory definitions and guidances for combination products across global jurisdictions and agencies. 

  6. Balancing User-Related Risk Assessments With Use-Enabling Device Enhancements 12/11/2024

    Can a diligent focus on patient safety during combination product development inadvertently lead to missed opportunities for device use enhancements? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, discusses ways to keep the organization focused on developing quality products that enhance user adoptability while also mitigating user-related harm.

  7. 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.

  8. Using Phase Gates To Confirm Biologics Delivery Method 4/13/2026

    In this segment of the Drug Delivery Leader Live online event, Large Molecule Biologics Delivery: Aligning Formulations, Doses, And Devices, Chief Editor Tom von Gunden asks panelist Dominick DeGrazio about key inflection points in determining the deviceability of a large molecule biologic product and feasibility of a specific delivery format. DeGrazio identifies candidate selection, first-in-human (FIH), and commitments to clinical phases II and III. 

  9. Managing Risk When Developing Combination Products 2/20/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 6 on risk management from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor, Susan Neadle, and chapter co-author Edwin Bills.

  10. Drug Delivery Technology Adoption: A Case Of Too Many Options? 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, uses the case of Enbrel® and the multiple delivery options for it to illustrate patient considerations and market factors that can impact product success.