Inhalation Drug Delivery Videos

  1. An EDDO Identification Tutorial For An On-Body Injector (OBI) 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, and Alan Stevens, regulatory head of complex devices and drug delivery systems at AbbVie, use a hypothetical case study for an on-body injector (OBI) to demonstrate a template for identifying EDDOs.

  2. Nanoforming Biologics, GLP-1s: From I.V. To Sub Q And Inhaled Delivery 9/9/2025

    Developing new delivery routes is essential for creating more effective treatments. Nanoforming enables new routes to simplify dosing, enhance patient comfort, and reduce healthcare costs.

  3. 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.

  4. 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.

  5. 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.

  6. PBPK Modeling: Mitigating Absorption Risks In Early Drug Development

    Discover how PBPK models combined with in vitro tools and solubility enhancement expertise can be used to identify and mitigate absorption risks in early drug development.

  7. 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.

  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. 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. 

  10. Treating Gastroparesis: From Nose To Stomach With Evoke Pharma's Matt D'Onofrio 12/4/2024

    In this episode of Sit and Deliver, Matt D’Onofrio, CEO of Evoke Pharma, talks with host Tom von Gunden about using nasal delivery to alleviate the discomfort of gastroparesis while smoothing the path for oral drug delivery to patients suffering from it.