Infusion Drug Delivery Videos

31. 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.

32. The Role of ISO 13485 in the New QMSR 7/11/2024

    What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? 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 explains the relationship between the two guidance documents.

33. Combining Nanocrystals With Microneedles For Long-Acting Delivery With Alejandro Paredes 10/22/2025

    For treatment of chronic diseases, microneedle patches hold great promise for bolstering patient adherence and therapeutic efficacy over time. In this episode of Sit and Deliver, videocast host Tom von Gunden talks with Alejandro Paredes, senior lecturer in pharmaceutical sciences at Queen’s University Belfast, about getting long-acting formulations into combination products leveraging nanocrystals and microneedles as delivery platforms.  

34. Linking Quality To Controls In 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 directs an audience question about the linkage between the QTPP (Quality Target Product Profile) and the Control Strategy to panelist Rubi Burlage. She identifies three fundamental aspects of the quality and control relationship: raw materials, process controls, and batch consistency. 

35. Integrating Regulatory Strategies For Advanced Therapy Development 10/8/2025

    In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, discuses critical components of an integrated regulatory strategy for advanced therapy product development. 

36. Applying Control Strategies to EDDOs 10/9/2024

    After Essential Drug Delivery Outputs (EDDOs) have been identified, each will need to be controlled during the development of a drug delivery device.  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 provides the rationale for a risk-based approach to EDDO control strategies.

37. Charting The Waters Of Drug Delivery Innovation With Suttons Creek 7/11/2025

    In this episode of In Combination, the technical leadership team from device consultancy Suttons Creek joins host Tom von Gunden to discuss trends in the patient landscape driving innovation in drug delivery, including combination products and therapies. The conversation covers patient self-administration, emerging modalities, and key considerations in product development, regulatory pathways, and the supply chain.

38. Selecting Injection Devices And Platforms 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 Fran DeGrazio to explain how dosing influences delivery device or platform selection. She illustrates key considerations with examples including prefilled syringes and autoinjectors. 

39. 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.

40. 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.