Infusion Drug Delivery Videos

  1. The Role of ISO 13485 in the New QMSR 7/11/2024

    What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies explains the relationship between the two guidance documents.

  2. Considering Injection Options For High Dose Biologics 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 directs to panelist Dominick DeGrazio an audience question about wearable devices versus autoinjectors for frequent dosing of biologics. DeGrazio describes key factors in the decision including dose volume, injection rate, and patient preference and compliance. 

  3. 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. 

  4. Next Generation Drug And Biologics 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, host Fran DeGrazio asks panelists James Wabby of biopharmaceutical company AbbVie and Carolyn Dorgan and Courtney Evans of device consultancy Suttons Creek to comment on trends and advances they anticipate in the next phase of delivery development. Those include combination therapies, nanotechnology, reconstitution, and microfluidics.

  5. Effective Supplier Management In Drug Delivery Development With Suttons Creek 9/25/2025

    In this episode of In Combination, Albana Thorpe and Max Lerman from the technical director team at drug delivery product development consultancy Suttons Creek discuss with host Tom von Gunden, chief editor at Drug Delivery Leader, considerations around supplier relationships in product development for combination products and other delivery devices. Albana and Max share perspectives on quality management, documentation, usability testing, regulatory pathways, post-market design changes, and other aspects of supplier controls. 

  6. 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.

  7. Understanding How EDDOs Relate To CGMPs 4/23/2025

    How are EDDOs (Essential Drug Delivery Outputs) related to CGMPs (Current Good Manufacturing Practices) during the design of a drug-led or biologic-led 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 establishes the connection between the two regulatory concepts.

  8. Understanding Delivery Device Selection For Biologics 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 directs an audience question about the delivery device selection process to panelist Dominick DeGrazio. In outlining key considerations, DeGrazio emphasizes technical requirements and adds others, including compatibility, regulatory, quality, sterility, and supply chain. 

  9. What Is the Impact of the New QMSR on 21 CFR Part 4? 7/11/2024

    In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.

  10. 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.