Infusion Drug Delivery Videos

  1. 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.

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

    What changes in approaches to risk management will the addition of ISO 14385 trigger? 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 when and how organizations will now need to address risk management within the context of design development and controls.

  3. Why Start A URRA Early In Combination Product Design? 12/11/2024

    Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.

  4. Preparing Early For Regulatory Marketing Submissions 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 asks panelist Jonathan Amaya-Hodges to comment on weaving patient-centric product considerations into regulatory approaches. Amaya-Hodges points to early preparation for marketing submissions as key. 

  5. Understanding Delivery Device Selection For Biologics 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 directs an audience question about the delivery device selection process to panelist Dominick DeGrazio. In outlining key considerations, DeGrazio emphasizes technical requirements and adds others, including compatibility, regulatory, quality, sterility, and supply chain. 

  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. Confirming Study Approaches For Clinical Bridging 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 asks panelist Beate Bittner to highlight patient-centric considerations as drug and delivery product development moves into the clinic. Bittner points to the role of platforms and previous studies in approaches to clinical bridging. 

  8. Comprehensive Prefillable Syringe Systems For Safe And Effective Drug Delivery 5/14/2025

    Stevanato Group offers advanced glass and polymer EZ-fill® syringes, tailored for complex drugs, with customizable options and innovations like thin-wall needles for patient comfort.

  9. Protecting And Sustaining Biologics Via Microencapsulated Delivery With Likarda's Stella Vnook 9/30/2025

    A common challenge in administering cell therapies and other biologics-based treatments is sustaining delivery and bioavailability while protecting against degradation and off-target toxicities. In this episode of Supplier Horizons, host Tom von Gunden discusses with CEO Stella Vnook from platform technology developer Likarda methods for deploying hydrogel microencapsulation to safely route cells, proteins, and other biologic agents to therapeutic targets. These include long-acting formulations in oncology, immunology, and other chronic or rare diseases. 

  10. Delivering Large Genetic Payloads With SonoThera's Ken Greenberg 7/28/2026

     

    Videocast host Tom von Gunden talks with CEO Ken Greenberg of SonoThera about delivering large payload gene therapies to targeted indications, particularly those requiring redosing. Using Duchenne Muscular Dystrophy {DMD] as primary example, Greenberg describes how ultrasound-mediated, in vivo infusion of naked, or non-encapsulated, DNA to organ targets allows for larger cargo sizes than do vector-based approaches.