Infusion Drug Delivery Videos

31. Drug Delivery For Various Molecules And Modalities 6/24/2025

    In this episode of Sit and Deliver, host Tom von Gunden talks with Merck VP of Pharmaceutical Sciences and Clinical Supply Allen Templeton about formulation and device considerations for combination products and other delivery systems deployed across a range of molecule types and sizes. The conversation takes them from small molecules, through peptides and mAbs, to large molecule biologics, across various routes of administration including oral, injectable, and inhalation.

32. 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.

33. Developing Regulatory Strategies For Combination Products 12/16/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor Susan Neadle. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.

34. 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.

35. 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.

36. URRA And UFMEA: Together Or Separate For Combination Products? 12/11/2024

    Both uFMEA (Use Failure Mode Effects Analysis) and URRA (Use-Related Risk Analysis) tools are available during combination product development for conducting risk assessments related to 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 scenarios in which a uFMEA might be used to inform a URRA regulatory submission.

37. 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.

38. 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.

39. Managing Risk When Developing Combination Products 2/20/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 6 on risk 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 Edwin Bills.

40. 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.