Inhalation Drug Delivery Videos

  1. 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.

  2. The Future Portfolio Of Innovative Therapy Delivery 10/8/2025

    In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, provides a landscape overview of emerging and advancing therapeutic methodologies. These include antibody-drug conjugates, CRISPR-edited gene therapies, companion diagnostics, complex generics, and AI-enabled biomarker identification. 

  3. Balancing User-Related Risk Assessments With Use-Enabling Device Enhancements 12/11/2024

    Can a diligent focus on patient safety during combination product development inadvertently lead to missed opportunities for device use enhancements? 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, discusses ways to keep the organization focused on developing quality products that enhance user adoptability while also mitigating user-related harm.

  4. Why Start A URRA Early In Combination Product Design? 12/11/2024

    Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.

  5. Global Harmonization Of Combination Products Regulatory 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 movements of note. From his combination products and global operations leadership roles at FDA and now as regulatory consultant, panelist Barr Weiner points to global harmonization of regulatory definitions and requirements. Panelists Rumi Young and Fran DeGrazio weigh in on stability testing and specific ICH, ISO, and AAMI standards.

  6. 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.

  7. Organizational Readiness For Next-Gen Therapeutics 10/8/2025

    In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, outlines key management considerations for biopharma companies developing combination therapies. These include suppliers, partnerships, quality, container closure, and regulatory. 

  8. Public Health Drivers Of Delivery Enablers: An Emergency Use Case 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, traces the evolution of delivery technologies for the opioid overdose drug Naloxone to illustrate enablers of emergency use not requiring trained professionals to administer.

  9. The Regulatory Intent Of A URRA For Combination Products 12/11/2024

    To what extent are approaches to conducting risk assessments specified in the FDA URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers context-setting perspective on what FDA is looking for when reviewing URRA compliance.

  10. 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.