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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When And How To Use A UFMEA During Device Design
12/11/2024
When and how might using a uFMEA (Use Failure Mode Effects Analysis) tool benefit biopharma companies addressing regulatory expectations for analyses of risk and/or human factors? 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, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss potential differences in the contexts, purposes, and degrees of detail in information presented for review.
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Platform Approaches To Personalized Medicines With NanoVation's Dominik Witzigmann
3/20/2025
In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Dominik Witzigmann of LNP (lipid nanoparticle) platform developer NanoVation Therapeutics about addressing a wide range of patient needs while partnering with biopharma and navigating the regulatory landscape to do so.
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URRA And UFMEA: Together Or Separate For Combination Products?
12/11/2024
Both uFMEA (Use Failure Mode Effects Analysis) and URRA (Use-Related Risk Analysis) tools are available during combination product development for conducting risk assessments related to human factors. 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, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss scenarios in which a uFMEA might be used to inform a URRA regulatory submission.
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What Is the Impact of the New QMSR on 21 CFR Part 4?
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 enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.
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Confirming EDDOs Based on "Device Dependence"
10/9/2024
Among the characteristics of a device design feature that helps identify it as an Essential Drug Delivery Output (EDDO) is “device dependent.” 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 explains the differences between the concepts of device-dependent versus device-independent and illustrates why only the former is applicable to an EDDO.
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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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Partnering On Patient Needs With DSM-Firmenich's George Mihov And Lukasz Koroniak
10/23/2024
Principal Scientist George Mihov and Global Biomaterials Director Lukasz Koroniak from DSM-Firmenich join Supplier Horizons host Tom von Gunden to discuss partnering with pharma on formulation development. Among the topics covered are translational research, materials development, and complex molecules required for biologic-based therapies.
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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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Deploying Immunologic Viral Agents To Target Cancers With Oncolytics Biotech's Thomas Heineman
2/27/2025
In this episode of Sit and Deliver, host Tom von Gunden talks with Oncolytics Biotech’s Chief Medical Officer Thomas Heineman about deploying oncolytic viral agents to ensure successful arrival at lymph nodes and at primary and metastatic tumor sites.