Infusion Drug Delivery Videos
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Monitoring Patient Preferences And Post-Market Safety
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 Shannon Hoste to comment on patient considerations related to commercialized products. She discusses post-market surveillance related to patient preferences and patient safety.
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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).
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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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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.
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Exosome-Based Gene Therapy Delivery With OmniSpirant's Gerry McCauley
2/25/2026
In this episode of Sit and Deliver, host Tom von Gunden talks with OmniSpirant Therapeutics CEO Gerry McCauley about leveraging stem cell-derived exosomes for platform delivery of gene therapies targeting cancers, respiratory diseases, and other indications. They consider patient safety along the way of transforming life-threatening diseases into manageable, treatable conditions.
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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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The Role of ISO 13485 in the New QMSR
7/11/2024
What does the addition of ISO 13485 as reference in the new QMSR mean for those working to comply with 21 CFR 820? 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 explains the relationship between the two guidance documents.
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Integrating Regulatory Strategies For Advanced Therapy Development
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, discuses critical components of an integrated regulatory strategy for advanced therapy product development.
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Formulations, Devices, Regulations, and Patients: Two Takes On Drug Delivery Trends
3/14/2025
In this unique episode of In Combination, series host Tom von Gunden, Chief Editor at Drug Delivery Leader, puts himself in combination with DDL Executive Editor Fran DeGrazio as the two share perspectives on drug delivery trends.
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Effective Supplier Management In Drug Delivery Development With Suttons Creek
9/25/2025
In this episode of In Combination, Albana Thorpe and Max Lerman from the technical director team at drug delivery product development consultancy Suttons Creek discuss with host Tom von Gunden, chief editor at Drug Delivery Leader, considerations around supplier relationships in product development for combination products and other delivery devices. Albana and Max share perspectives on quality management, documentation, usability testing, regulatory pathways, post-market design changes, and other aspects of supplier controls.