Infusion Drug Delivery Videos

  1. Partnership And Clinical Trial Strategies For Digitally Connected Devices 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.

  2. Combination Platform Delivery In Immuno-Oncology 5/2/2025

    Fundamental goals of immuno-oncology therapies are to generate T-cell responses and overcome immunosuppression. In this episode of Sit and Deliver, host Tom von Gunden talks with Syncromune CEO Eamonn Hobbs about using injection- and infusion-based drug-device combination therapies in targeting solid tumor cancers.

  3. Applying Control Strategies to EDDOs 10/9/2024

    After Essential Drug Delivery Outputs (EDDOs) have been identified, each will need to be controlled during the development of a drug delivery device.  In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC provides the rationale for a risk-based approach to EDDO control strategies.

  4. 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?”

  5. 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.

  6. Understanding How EDDOs Relate To Design Controls 4/23/2025

    How are EDDOs (Essential Drug Delivery Outputs) related to Design Controls during the design and development of a combination product? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC illustrates how the concept of Design Outputs fits within the broader context of Design Controls.

  7. Preconditioning Devices under EDDO Guidance 10/9/2024

    What does the FDA’s guidance on Essential Drug Delivery Outputs (EDDOs) mean for activities involved in preconditioning the device delivery components of combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, discusses the likely intent and impact of EDDOs on preconditioning for both manufacturers and sponsor companies.

  8. 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.

  9. What Happened to CAPA (Corrective and Preventive Actions) Requirements? 7/11/2024

    Is CAPA still part of the requirements picture for the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.