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. Identifying EDDOs During Drug Delivery Device Design 10/9/2024

    How are EDDOs (Essential Drug Delivery Outputs) determined during the design of a drug-led or biologic-led combination product? 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 lays out the foundational considerations.

  3. Understanding CGMPs For Combination Products 1/15/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 4 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems with the book’s editor, Susan Neadle, and chapter co-author Mike Wallenstein. In the exchange, Susan and Mike share their perspectives on combination product CGMP’s, including regulatory definitions and differences in the U.S. and Europe, supplier controls, design controls, and manufacturer responsibilities.

  4. Scaling Platform Delivery Of Gene Therapies With NewBiologix's Igor Fisch 2/25/2025

    Gene therapies aim to treat the root causes of disease rather than merely the symptoms. In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Igor Fisch of NewBiologix, a developer of AAV-based gene therapy platform technologies.

  5. 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.

  6. An EDDO Identification Tutorial For A Metered Dose Inhaler (MDI) 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 uses a hypothetical case study for a meter dose inhaler (MDI) to demonstrate a template for identifying EDDOs.

  7. Drug Delivery Market Success: Lessons From A Discontinued Product 5/23/2025

    In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, host Fran DeGrazio and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, ponder the discontinuation of Repatha® Pushtronex®. They comment on how its withdrawal may illustrate key market drivers and factors that bolster a product’s success or, alternatively, lead to its demise.

  8. Preconditioning Devices under EDDO Guidance 10/9/2024

    What does the FDA’s guidance on Essential Drug Delivery Outputs (EDDOs) mean for activities involved in preconditioning the device delivery components of combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, Alan Stevens,  regulatory head of complex devices and drug delivery systems at AbbVie and formerly at FDA, discusses the likely intent and impact of EDDOs on preconditioning for both manufacturers and sponsor companies.

  9. 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. 

  10. Setting The Strategic Direction For Advanced Therapy Products 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, underscores the importance of cascading business and regulatory strategies for advanced therapies and delivery products throughout the organization’s quality management systems.