Oral Drug Delivery Videos
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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.
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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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Surveying Analytical Tools For Combination Product Testing
6/10/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 11 on analytical testing with the book’s editor, Susan Neadle, and chapter coauthor Jennifer Riter. Susan and Jennifer discuss various analytical methods for testing compatibility, performance, stability, and safety when combining drugs or biologics with delivery devices and device constituent parts.
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Becoming A Combination Product Development Organization
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 regulatory challenges and considerations for traditional drug product pharma companies moving into combination product development. Patient centricity, device expertise, and supplier relationships are among the topics identified.
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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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Oral Peptide Delivery with Protagonist Therapeutics' Dinesh Patel
8/22/2024
To stab or to swallow? For treating conditions in the I&I (immunology and inflammation) space – think psoriasis, as one common example – some see the holy grail of delivery as moving from injectable to oral administration. In this inaugural episode of Sit and Deliver, host Tom von Gunden invites Dinesh Patel, president and CEO at clinical stage biotech company Protagonist Therapeutics, to deliver the rationale for targeting I&I diseases and other therapeutic areas with oral peptides.
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Understanding Supplier Quality And Controls For Combination Products
5/12/2025
In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 10 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, and chapter co-author Fran DeGrazio. On the topic of supplier quality and controls, Susan and Fran discuss key considerations for using third-party suppliers of raw materials, constituent parts, and services in combination product development.
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Integrated Strategies For Poor Solubility, Modified Release & Pediatrics
6/8/2022
Through case studies on modified release, poor solubility, and pediatrics, discover how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines for even the most challenging of molecules.
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What Types Of Products Are Assessed With A URRA?
12/11/2024
What types of products in development may need to be assessed in accordance with the FDA’s URRA (Use-Related Risk Analysis) guidance? 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, describes several common scenarios that illustrate when a URRA approach may or may not be needed.
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Dramatic Reduction Of Solvent Usage In Pharmaceutical Spray Drying
Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs).