Infusion Drug Delivery Videos

  1. Preparing For Combination Product Regulatory Inspections 4/11/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 9 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, and chapter co-author Kim Trautman.

  2. Defining and Regulating Combination Products: An Evolutionary Journey 10/15/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.

  3. Monitoring Patient Preferences And Post-Market Safety 2/17/2026

    In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden asks panelist Shannon Hoste to comment on patient considerations related to commercialized products. She discusses post-market surveillance related to patient preferences and patient safety. 

  4. Confirming Study Approaches For Clinical Bridging 2/17/2026

    In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden asks panelist Beate Bittner to highlight patient-centric considerations as drug and delivery product development moves into the clinic. Bittner points to the role of platforms and previous studies in approaches to clinical bridging. 

  5. Confirming EDDOs Based on "Device Dependence" 10/9/2024

    Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” 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 explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.

  6. Scaling Platform Delivery Of Gene Therapies With NewBiologix's Igor Fisch 2/25/2025

    Gene therapies aim to treat the root causes of disease rather than merely the symptoms. In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Igor Fisch of NewBiologix, a developer of AAV-based gene therapy platform technologies.

  7. Patient Adoption Of On-Body Delivery Systems 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, panelists Carolyn Dorgan and Courtney Evans from delivery device consultancy Suttons Creek talk with host Fran DeGrazio about factors creating challenges and opportunities in moving patients to on-body injectors (OBIs) and other wearable drug delivery systems.

  8. 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.

  9. 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.

  10. Preparing Early For Regulatory Marketing Submissions 2/17/2026

    In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden asks panelist Jonathan Amaya-Hodges to comment on weaving patient-centric product considerations into regulatory approaches. Amaya-Hodges points to early preparation for marketing submissions as key.