Transdermal Drug Delivery Videos

  1. 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.

  2. 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. 

  3. 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.

  4. Understanding Oral Administration Challenges 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, panelists John Higgins and Rubi Burlage respond to an audience question about oral delivery of biologic products. In commenting on efforts to deliver peptides, proteins, antibodies and other large molecules orally, Higgins and Burlage summarize key challenges to stability and bioavailability presented by the GI tract. 

  5. Knowing When To Lock Down A Biologics TPP 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 Rubi Burlage an audience question about timetable for finalizing a TPP (Target Product Profile) during product development. While acknowledging the iterative nature of a TPP, Burlage recommends Phase III as the ideal stage for a lockdown and advises against late changes at validation. 

  6. 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.

  7. Knowing How Injection Volumes Impact Delivery Options 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 relays an audience question about how to decide if injection volumes dictate delivery via prefilled syringe versus autoinjector.

  8. 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.

  9. Rare Disease Targeting and Novel Therapy Delivery with Kymanox' Evan Edwards 8/29/2024

    Commenting on a wide range of therapeutic targets, Kymanox president Evan Edwards joins Supplier Horizons host Tom von Gunden in highlighting opportunities for drug delivery innovation. Front of mind for Evan as he considers areas of advancement are human factors engineering for increased self-administration, targeting rare diseases with novel therapies, and, in general, addressing the challenges of delivering large molecule biologics. 

  10. Combination Products Regulatory Considerations with FDA's Barr Weiner 10/1/2024

    From his roles and experiences in the combination products and combined use systems arena, John “Barr” Weiner offers perspectives on how to approach pre- and post-market activities with regulatory requirements and guidance in mind. Cross-functional coordination, integrated development, and primary mode of action (PMOA) designations are among the considerations Barr reminds organizations to implement thoughtfully as they work to advance combination products within a regulatory landscape.