Transdermal Drug Delivery Videos
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What Happened to CAPA (Corrective and Preventive Actions) Requirements?
7/11/2024
Is CAPA still part of the requirements picture for 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 Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.
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Knowing How Injection Volumes Impact Delivery Options
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 how to decide if injection volumes dictate delivery via prefilled syringe versus autoinjector.
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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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The Future Portfolio Of Innovative Therapy Delivery
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, provides a landscape overview of emerging and advancing therapeutic methodologies. These include antibody-drug conjugates, CRISPR-edited gene therapies, companion diagnostics, complex generics, and AI-enabled biomarker identification.
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Leveraging Combination Therapies For Precision Targeting
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, highlights the promise of using combination products and combination therapies to reach difficult targets with precision. Carolyn notes crossing the blood-brain barrier as an example of a key therapy delivery advance.
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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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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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Surveying Analytical Tools For Combination Product Testing
6/10/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 11 on analytical testing with the book’s editor, Susan Neadle, and chapter coauthor Jennifer Riter. Susan and Jennifer discuss various analytical methods for testing compatibility, performance, stability, and safety when combining drugs or biologics with delivery devices and device constituent parts.
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Deploying Viruses To Counter Antibiotics Resistance With Paldara's William Colton
11/26/2025
An increasingly common obstacle to treating patients with infections is resistance to antibiotics. In this episode of Sit and Deliver, CEO William Colton of biologics platform delivery developer Paldara Pharmaceuticals talks with videocast host Tom von Gunden about infection-combatting alternatives using hydrogel-based systems to deliver bacteriophage viral therapeutics directly to infection sites.
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Selecting The Molecule For Biologics Product Development
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 asks panelist John Higgins to describe early-stage molecule selection and formulation considerations for determining drugability for biologics. Higgins introduces the guiding importance of the Target Product Profile (TPP).