Infusion Drug Delivery Videos

  1. 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.

  2. 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.

  3. 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.

  4. Drug Delivery Technology Adoption: A Case Of Too Many Options? 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, uses the case of Enbrel® and the multiple delivery options for it to illustrate patient considerations and market factors that can impact product success.

  5. Relying On Human Factors Clinical Data For Regulatory Approvals 2/17/2026

    In this segment of the Drug Delivery Leader Live online event, Injected, Infused, or Implanted: A Penetrating Look At Patient Centricity, Chief Editor Tom von Gunden relays an audience question about increased FDA regulatory scrutiny around human factors. Panelists Jonathan Amaya-Hodes and Shannon Hoste comment on the importance of clinical data in regulatory submissions and in approval pathways. 

  6. How To Identify And Differentiate Combination Products 11/18/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 2 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the book’s editor and Chapter 2 author, Susan Neadle. Considering both product development and the global regulatory landscape, the discussion focuses on answers to the question posed by the chapter title, “What Is a Combination Product?”

  7. Regulating Drug Delivery Platform And System Development 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 asks panelist Fran DeGrazio to comment on her front-of-mind topic of systems thinking and platform approaches to combination product development.

  8. Advancing Nanomedicine Formulation And Delivery At Duquesne University 2/10/2026

    In a special episode of In Combination, host Tom von Gunden visits the Graduate School of Pharmaceutical Sciences and the Nanomedicine Manufacturing Laboratory at Duquesne University. There, a professor and some graduate students share insights into the program’s focus on innovating nanoparticle formulation, manufacturing, and delivery. The coverage illuminates the role of academic, industry, and government partnerships in advancing the science and technology of nanomedicines toward clinical translation. 

  9. Surveying Analytical Tools For Combination Product Testing 6/10/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 11 on analytical testing with the book’s editor, Susan Neadle, and chapter coauthor Jennifer Riter. Susan and Jennifer discuss various analytical methods for testing compatibility, performance, stability, and safety when combining drugs or biologics with delivery devices and device constituent parts.

  10. Selecting The Molecule For Biologics Product Development 4/13/2026

    In this segment of the Drug Delivery Leader Live online event, Large Molecule Biologics Delivery: Aligning Formulations, Doses, And Devices, Chief Editor Tom von Gunden asks panelist John Higgins to describe early-stage molecule selection and formulation considerations for determining drugability for biologics. Higgins introduces the guiding importance of the Target Product Profile (TPP).