Infusion Drug Delivery Videos

1. 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. 

2. Organizational Readiness For Next-Gen Therapeutics 10/8/2025

   In this segment of the Drug Delivery Leader Live online event, Next-Gen Drug Delivery: Rethinking Routes For New Therapies, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, outlines key management considerations for biopharma companies developing combination therapies. These include suppliers, partnerships, quality, container closure, and regulatory. 

3. Confirming EDDOs Based on "Device Dependence" 10/9/2024

   Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” 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 explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.

4. Effective Supplier Management In Drug Delivery Development With Suttons Creek 9/25/2025

   In this episode of In Combination, Albana Thorpe and Max Lerman from the technical director team at drug delivery product development consultancy Suttons Creek discuss with host Tom von Gunden, chief editor at Drug Delivery Leader, considerations around supplier relationships in product development for combination products and other delivery devices. Albana and Max share perspectives on quality management, documentation, usability testing, regulatory pathways, post-market design changes, and other aspects of supplier controls. 

5. Formulations, Devices, Regulations, and Patients: Two Takes On Drug Delivery Trends 3/14/2025

   In this unique episode of In Combination, series host Tom von Gunden, Chief Editor at Drug Delivery Leader, puts himself in combination with DDL Executive Editor Fran DeGrazio as the two share perspectives on drug delivery trends.

6. Who Is Responsible For Design Controls? 7/11/2024

   In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process are responsible for design controls – the sponsor company, the contracted component provider, or both.

7. Defining and Regulating Combination Products: An Evolutionary Journey 10/15/2024

   In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.

8. Vector Approaches To Reaching CNS Targets With Vect-Horus' Jean-Manuel Péan 5/23/2025

   A long-standing challenge in delivering therapeutic treatments for CNS (central nervous system) disorders is how to overcome drug permeability constraints imposed by the blood-brain barrier (BBB). In this episode of Supplier Horizons, host Tom von Gunden talks with Chief Scientific Officer Jean-Manuel Péan from Vect-Horus, a developer of vector-based, platform delivery technologies, about addressing that challenge in targeting disorders such as autism, dementia, Alzheimer’s, epilepsy, Parkinson’s, Huntington’s, sclerosis, and CNS tumors.

9. Understanding How EDDOs Relate To CGMPs 4/23/2025

   How are EDDOs (Essential Drug Delivery Outputs) related to CGMPs (Current Good Manufacturing Practices) during the design of a drug-led or biologic-led combination product? 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 establishes the connection between the two regulatory concepts.

10. 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.