Infusion Drug Delivery Videos

  1. Drug Delivery For Various Molecules And Modalities 6/24/2025

    In this episode of Sit and Deliver, host Tom von Gunden talks with Merck VP of Pharmaceutical Sciences and Clinical Supply Allen Templeton about formulation and device considerations for combination products and other delivery systems deployed across a range of molecule types and sizes. The conversation takes them from small molecules, through peptides and mAbs, to large molecule biologics, across various routes of administration including oral, injectable, and inhalation.

  2. 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.

  3. Understanding the Difference Between EDDOs and Primary Functions 10/9/2024

    How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? 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, describes the differences between the two concepts, including how they differently relate to considerations of risk.

  4. 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. 

  5. 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.

  6. 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.

  7. An EDDO Identification Tutorial For A Metered Dose Inhaler (MDI) 4/23/2025

    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 uses a hypothetical case study for a meter dose inhaler (MDI) to demonstrate a template for identifying EDDOs.

  8. Regulatory Evolution In Drug Delivery 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Courtney Evans, principal consultant at delivery device consultancy Suttons Creek and formerly at FDA, provides an overview of the evolution of regulations and standards that have been developed for and/or applied to drug delivery technologies over the years.

  9. When And How To Use A UFMEA During Device Design 12/11/2024

    When and how might using a uFMEA (Use Failure Mode Effects Analysis) tool benefit biopharma companies addressing regulatory expectations for analyses of risk and/or human factors? 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, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss potential differences in the contexts, purposes, and degrees of detail in information presented for review.

  10. Understanding The Change From EPR To EDDO 10/9/2024

    Why does the FDA’s new guidance on drug-led or biologic-led device design include a change in terminology from Essential Performance Requirements (EPRs) to Essential Drug Delivery Outputs (EDDOs)?  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, offers his perspective on how the change in terminology clarifies key concepts related to design controls.