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. Going Deep On Delivery With The Subcutaneous Consortium 11/13/2025

    In this episode of In Combination, officers from industry association The Subcutaneous Drug Development and Delivery Consortium join host Tom von Gunden to introduce the structure and work of the group. The discussion of sub-team activities and outputs illuminates key challenges and innovation opportunities around bioavailability, immunogenicity, high dose formulations, sustainability, clinical development, regulatory strategy, and patient preference.

  3. 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. 

  4. 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. 

  5. Crossing The Blood-Brain Barrier To Target Tumors With CNS Pharmaceuticals 7/31/2025

    Targeting glioblastoma (GBM) and other malignant brain tumors brings with it the long-standing challenge of crossing the blood-brain barrier, or BBB. In this episode of Sit and Deliver, host Tom von Gunden talks with CEO John Climaco and Chief Medical Officer Dr. Sandra Silberman from CNS Pharmaceuticals about intravenously crossing the BBB to deliver classes of drugs, such as taxanes, proven in treating solid tumors in other locations. 

  6. Drug Delivery And Digital Health: It's A Case Of Connectivity 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, uses the example of a connected pen cap to discuss technology, patient, and market considerations at the intersection of drugs, devices, and data.

  7. 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.

  8. 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.

  9. Partnership And Clinical Trial Strategies For Digitally Connected Devices 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.

  10. An EDDO Identification Tutorial For An On-Body Injector (OBI) 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 an on-body injector (OBI) to demonstrate a template for identifying EDDOs.