Infusion Drug Delivery Videos
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The Combination Therapy Regulatory Pathway For Antibody-Drug Conjugates
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, illustrates the regulatory pathway for a drug-biologic combination therapy with the example of an antibody-drug conjugate (ADC).
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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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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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Using Phase Gates To Confirm Biologics Delivery Method
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 Dominick DeGrazio about key inflection points in determining the deviceability of a large molecule biologic product and feasibility of a specific delivery format. DeGrazio identifies candidate selection, first-in-human (FIH), and commitments to clinical phases II and III.
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Understanding the Difference Between EDDOs and Primary Functions
10/9/2024
How do Essential Drug Delivery Outputs (EDDOs) differ from Primary Functions – for example, as described in ISO 11608 regarding needle-based injection systems? 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, describes the differences between the two concepts, including how they differently relate to considerations of risk.
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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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DARPin-Delivered Radiotherapy With Molecular Partners And Orano Med
8/20/2025
In this episode of In Combination, CEO Patrick Amstutz of Molecular Partners and CEO Arnaud Lesegretain of Orano Med join host Tom von Gunden in a discussion of using DARPins (Designed Ankyrin Repeat Proteins) as vector delivery platforms for high-affinity binding of radioisotopes to treat cancer. Using the example of small cell lung cancer. Patrick and Arnaud describe how DARPin-delivered radiotherapy can attack metastatic cancers while overcoming the targeting limitations of external beam radiation and of antibodies.
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The Role Of Combination Products In Combatting Chronic Diseases
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 the panel to comment on front-of-mind regulatory movements of note. From her role as Director of Regulatory Policy at Novo Nordisk, Rumi Young identifies the inclusion of combination products in FDA initiatives focused on combatting chronic diseases and improving patient accessibility. Panelists Barr Weiner and Fran DeGrazio weigh in.
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Charting The Waters Of Drug Delivery Innovation With Suttons Creek
7/11/2025
In this episode of In Combination, the technical leadership team from device consultancy Suttons Creek joins host Tom von Gunden to discuss trends in the patient landscape driving innovation in drug delivery, including combination products and therapies. The conversation covers patient self-administration, emerging modalities, and key considerations in product development, regulatory pathways, and the supply chain.
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Drug Delivery Market Success: Lessons From A Discontinued Product
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 and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, ponder the discontinuation of Repatha® Pushtronex®. They comment on how its withdrawal may illustrate key market drivers and factors that bolster a product’s success or, alternatively, lead to its demise.