Infusion Drug Delivery Videos
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The Role Of Terminology In Regulating Combination Products
1/12/2026
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden asks panelist Barr Weiner to describe the role of case study examples in defining and regulating combination products globally. Weiner makes the case for agreement about the science and technology being more important than commonality in terminology, Panelist Fran DeGrazio agrees.
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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.
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Public Health Drivers Of Delivery Enablers: An Emergency Use Case
5/23/2025
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, traces the evolution of delivery technologies for the opioid overdose drug Naloxone to illustrate enablers of emergency use not requiring trained professionals to administer.
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3 Key 'Look Forwards' In Drug Delivery Regulatory
1/12/2026
In this segment of the Drug Delivery Leader Live online event, Eying The Drug Delivery Regulatory Landscape: The 'Must See' Watch List For 2026, Chief Editor Tom von Gunden invites panelists Fran DeGrazio, Barr Weiner, and Rumi Young to identify and comment on their most important takeaways from their panel conversation. They point to platform thinking, post-market manufacturing, and the representation of combination products in regulatory guidances.
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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.
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Leveraging Janus Base Nanoparticles For Precision Therapeutic Delivery With Eascra's Mari Anne Snow
10/31/2025
A major challenge in delivering biologics-based therapies is penetrating cells for precision delivery to therapeutic targets. In this episode of Supplier Horizons, host Tom von Gunden and CEO Mari Anne Snow from platform technology developer Eascra Biotech discuss the use of Janus base nanoparticles to effectively and safely encapsulate therapeutic payloads, including CGTs and other large molecule biologics. The conversation also turns to the benefits of particle production conducted in space.
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Next Generation Drug And Biologics Delivery Technologies
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 asks panelists James Wabby of biopharmaceutical company AbbVie and Carolyn Dorgan and Courtney Evans of device consultancy Suttons Creek to comment on trends and advances they anticipate in the next phase of delivery development. Those include combination therapies, nanotechnology, reconstitution, and microfluidics.
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Preparing For Combination Product Regulatory Inspections
4/11/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 9 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, and chapter co-author Kim Trautman.
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Understanding How EDDOs Relate To Design Controls
4/23/2025
How are EDDOs (Essential Drug Delivery Outputs) related to Design Controls during the design and development of a 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 illustrates how the concept of Design Outputs fits within the broader context of Design Controls.
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Exosome-Based Gene Therapy Delivery With OmniSpirant's Gerry McCauley
2/25/2026
In this episode of Sit and Deliver, host Tom von Gunden talks with OmniSpirant Therapeutics CEO Gerry McCauley about leveraging stem cell-derived exosomes for platform delivery of gene therapies targeting cancers, respiratory diseases, and other indications. They consider patient safety along the way of transforming life-threatening diseases into manageable, treatable conditions.