Transdermal Drug Delivery Videos

  1. 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.

  2. Regulating Drug Delivery Platform And System Development 1/12/2026

    In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks panelist Fran DeGrazio to comment on her front-of-mind topic of systems thinking and platform approaches to combination product development.

  3. Linking Quality To Controls In Biologics Product Development 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 linkage between the QTPP (Quality Target Product Profile) and the Control Strategy to panelist Rubi Burlage. She identifies three fundamental aspects of the quality and control relationship: raw materials, process controls, and batch consistency. 

  4. 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.

  5. Leveraging Combination Products For Biologics Delivery 7/22/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 12 on biologics delivery with chapter author Manfred Maeder and the book’s editor, Susan Neadle. Manfred and Susan comment on the challenges of moving large molecule formulations into combination products while considering product stability, usability, and supply chain.

  6. Integrating Development Processes For Combination Products 1/27/2025

    The discussion highlights key aspects of a biopharma organization’s business and operations that must be effectively integrated when developing drugs and devices in tandem. These include imperatives such as establishing common terminology, applying QbD (Quaility by Design) principles, and managing supplier controls for providers of constituent parts.

  7. 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.

  8. 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.

  9. Becoming A Combination Product Development Organization 1/12/2026

    In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks the panel to comment on regulatory challenges and considerations for traditional drug product pharma companies moving into combination product development. Patient centricity, device expertise, and supplier relationships are among the topics identified.

  10. 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.