Inhalation Drug Delivery Videos

  1. What's In A Combination Product Development Lifecycle? 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, lays out the phases and key activities in the development of a combination product or combination therapy. She underscores the importance of integrated development when merging medicinal product development with delivery device development. 

  2. Management Responsibility and the New QMSR 7/11/2024

    What is management’s responsibility in the implementation of approaches to the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies underscores the criticality of management commitment to and engagement in the process.

  3. Integrating Regulatory Strategies For Advanced Therapy Development 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, discuses critical components of an integrated regulatory strategy for advanced therapy product development. 

  4. Pathways For Pulmonary Delivery

    As orally inhaled drug delivery grows to encompass novel therapies and diverse molecule sizes, CDMOs are rising to meet the demand for specialized knowledge and scalable manufacturing capabilities.

  5. 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.

  6. 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.

  7. 3 Key 'Look Forwards' In Drug Delivery 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 invites panelists Fran DeGrazio, Barr Weiner, and Rumi Young to identify and comment on their most important takeaways from their panel conversation. They point to platform thinking, post-market manufacturing, and the representation of combination products in regulatory guidances.

  8. Trends And Advances In Inhalation Delivery With Kindeva's Stephen Stein 6/16/2025

    Stephen Stein, scientific director of inhalation products at Kindeva, joins Supplier Horizons host Tom von Gunden in a discussion of opportunities and challenges for inhalation product development. The topics discussed include ensuring bioequivalence in generics, reducing environmental impact from propellants, and advancing inhalation-based delivery of vaccines and combination therapies.

  9. Drug Delivery Market Success: Lessons From A Discontinued Product 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, host Fran DeGrazio and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, ponder the discontinuation of Repatha® Pushtronex®. They comment on how its withdrawal may illustrate key market drivers and factors that bolster a product’s success or, alternatively, lead to its demise.

  10. 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.