Transdermal Drug Delivery Videos
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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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Managing Risk When Developing Combination Products
2/20/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 6 on risk management from 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 Edwin Bills.
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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.
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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.
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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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Rare Disease Targeting and Novel Therapy Delivery with Kymanox' Evan Edwards
8/29/2024
Commenting on a wide range of therapeutic targets, Kymanox president Evan Edwards joins Supplier Horizons host Tom von Gunden in highlighting opportunities for drug delivery innovation. Front of mind for Evan as he considers areas of advancement are human factors engineering for increased self-administration, targeting rare diseases with novel therapies, and, in general, addressing the challenges of delivering large molecule biologics.
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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.
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Broadening The Range Of Self-Administered Biologics With Stevanato Group's Riccardo Butta
1/20/2025
Along with the goal of moving a wider range of biologics-based therapies into self-administered, in-home scenarios comes the challenge of delivering increased dosage volumes and higher viscosities via subcutaneous and transdermal methods. In this episode of Supplier Horizons, host Tom von Gunden talks with Stevanato Group’s President, Americas, Riccardo Butta about the convergence of human factors and device design during platform development for injectable and on-body delivery systems.
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Management Responsibility and the New QMSR
7/11/2024
What is management’s responsibility in the implementation of approaches to the new QMSR? 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 underscores the criticality of management commitment to and engagement in the process.
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An EDDO Identification Tutorial For A Prefilled Syringe (PFS)
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 a prefilled syringe (PFS) to demonstrate a template for identifying EDDOs.