Oral Drug Delivery Videos
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The Landscape For Advanced Therapies And Combination 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, traces key conditions driving and impacting the development of advanced therapies and combination products. These include the demand for precision medicines, the complexity of regulatory frameworks, and pressures on healthcare systems.
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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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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.
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The History And Evolution Of Drug 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, Carolyn Dorgan, director of technical services at device design consultancy Suttons Creek, and James Wabby, head of global regulatory affairs for emerging device technologies and combination products at AbbVie, trace the evolution of drug delivery technologies over the last 100 or so years. The timeline illustrates the trajectory from the earliest prefilled syringes to the nanotechnologies and other advances of today.
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Organizational Readiness For Next-Gen Therapeutics
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, outlines key management considerations for biopharma companies developing combination therapies. These include suppliers, partnerships, quality, container closure, and regulatory.
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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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Leveraging The Target Product Profile For Oral Delivery Formulation
6/12/2026
In this segment of the Drug Delivery Leader Live online event, Advanced Oral Delivery: Maximizing Molecules, Targets, And Adherence, Chief Editor Tom von Gunden asks panelist Jing Ling about front-of-mind formulation drivers for lab scientists. Ling leads with the Target Product Profile (TPP), and panelist Eduardo Jule echoes its importance.
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Expanding Biologics Delivery Options Via Oral Devices With Biograil's Karsten Lindhardt
4/25/2025
Large, complex molecules present significant challenges in the formulation and absorption of biologics-based therapies administered orally. In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Karsten Lindhardt of oral platform technology developer Biograil about capsule-enclosed combination devices that offer patients convenience, safety, and effectiveness while bolstering patient compliance.
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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.
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Orally Administered Botanical Therapies Targeting ASD With DeFloria's Jared And Joel Stanley
5/19/2025
In this episode of Sit and Deliver, host Tom von Gunden talks with Jared Stanley, CEO, and Joel Stanley, board chairman, from DeFloria, a botanical therapeutics development company. Tom talks with the Stanley brothers about cannabinoid-based therapies targeting Autism Spectrum Disorder (ASD). The discussion covers aspects of drug development and delivery including molecule characterization, formulation, and dosing for oral administration, as well as key considerations for commercial-scale production and distribution of regulated botanicals.