Infusion Drug Delivery Videos

1. Understanding the Difference Between EDDOs and Primary Functions 10/9/2024

   How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? 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, describes the differences between the two concepts, including how they differently relate to considerations of risk.

2. Gene Therapy Delivery With Battelle's Gabe Meister And Tony Duong 11/25/2024

   A significant challenge in gene therapy delivery – particularly for in vivo approaches – has been limitations in cargo capacity of the gene payload carrier. In this episode of Supplier Horizons, host Tom von Gunden talks with technical director Gabe Meister and scientist Tony Duong from biopharmaceutical research and development company Battelle about the promise of polymer nanoparticles as delivery vehicles for treating rare diseases with in vivo gene therapies.

3. 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.

4. The Best CDMO Fit For Small Molecule, Sterile Injectable Fill/Finish 7/19/2023

   "One stop” sterile injectable fill/finish capabilities can accelerate timelines and reduce costs. Explore August Bio’s operational flexibility and available capacity to support small-, mid-size, and large-scale batches.

5. An EDDO Identification Tutorial For A Metered Dose Inhaler (MDI) 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 uses a hypothetical case study for a meter dose inhaler (MDI) to demonstrate a template for identifying EDDOs.

6. An EDDO Identification Tutorial For A Prefilled Syringe (PFS) 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 a prefilled syringe (PFS) to demonstrate a template for identifying EDDOs.

7. 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.

8. 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.

9. 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.

10. Partnering On Patient Needs With DSM-Firmenich's George Mihov And Lukasz Koroniak 10/23/2024

    Principal Scientist George Mihov and Global Biomaterials Director Lukasz Koroniak from DSM-Firmenich join Supplier Horizons host Tom von Gunden to discuss partnering with pharma on formulation development. Among the topics covered are translational research, materials development, and complex molecules required for biologic-based therapies.