Infusion Drug Delivery Videos

1. 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.

2. Combination Platform Delivery In Immuno-Oncology 5/2/2025

   Fundamental goals of immuno-oncology therapies are to generate T-cell responses and overcome immunosuppression. In this episode of Sit and Deliver, host Tom von Gunden talks with Syncromune CEO Eamonn Hobbs about using injection- and infusion-based drug-device combination therapies in targeting solid tumor cancers.

3. Clarifying The EDDO Focus On Design Outputs, Not Design Inputs 10/9/2024

   In what ways are Essential Drug Delivery Outputs (EDDOs) different from design inputs for combination products? 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 difference.

4. What Is There to Learn from a Combination Products Handbook? Plenty! 10/15/2024

   In this initial episode of The Combination Products Handbook: The Series, a chapter-by chapter videocast series introducing topics from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023), host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors.

5. 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.

6. Managing Combination Products Post-Market 3/25/2025

   In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 8 on post-market lifecycle management from 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 Khaudeja Bano.

7. The History And Evolution Of Drug Delivery Technologies 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, and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, trace the evolution of drug delivery technologies over the last 100 or so years. The timeline illustrates the trajectory from the earliest prefilled syringes to the nanotechnologies and other advances of today.

8. 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.

9. 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.

10. What Happened to CAPA (Corrective and Preventive Actions) Requirements? 7/11/2024

    Is CAPA still part of the requirements picture for 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 Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.