Infusion Drug Delivery Videos
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Comprehensive Prefillable Syringe Systems For Safe And Effective Drug Delivery
5/14/2025
Stevanato Group offers advanced glass and polymer EZ-fill® syringes, tailored for complex drugs, with customizable options and innovations like thin-wall needles for patient comfort.
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Confirming Study Approaches For Clinical Bridging
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 Beate Bittner to highlight patient-centric considerations as drug and delivery product development moves into the clinic. Bittner points to the role of platforms and previous studies in approaches to clinical bridging.
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Partnership And Clinical Trial Strategies For Digitally Connected Devices
5/23/2025
In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, and Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, discuss key product development considerations when bringing digital connectivity solutions to drug delivery devices. These aspects include product and health authority partnerships, clinical studies, and regulatory approvals.
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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.
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Developing Regulatory Strategies For Combination Products
12/16/2024
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 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. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.
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Balancing User-Related Risk Assessments With Use-Enabling Device Enhancements
12/11/2024
Can a diligent focus on patient safety during combination product development inadvertently lead to missed opportunities for device use enhancements? 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, discusses ways to keep the organization focused on developing quality products that enhance user adoptability while also mitigating user-related harm.
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Linking Quality To Controls In 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 directs an audience question about the linkage between the QTPP (Quality Target Product Profile) and the Control Strategy to panelist Rubi Burlage. She identifies three fundamental aspects of the quality and control relationship: raw materials, process controls, and batch consistency.
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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.
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Combining Nanocrystals With Microneedles For Long-Acting Delivery With Alejandro Paredes
10/22/2025
For treatment of chronic diseases, microneedle patches hold great promise for bolstering patient adherence and therapeutic efficacy over time. In this episode of Sit and Deliver, videocast host Tom von Gunden talks with Alejandro Paredes, senior lecturer in pharmaceutical sciences at Queen’s University Belfast, about getting long-acting formulations into combination products leveraging nanocrystals and microneedles as delivery platforms.
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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.