Articles by Tom von Gunden

31. 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.

32. Treating Chronic Conditions Via Long-Acting Implants With Vivani's Adam Mendelsohn 6/3/2025

    The popular GLP-1 agonists employed in treating obesity and Type 2 diabetes are commonly administered via weekly injections. In this episode of Sit and Deliver, host Tom von Gunden talks with CEO Adam Mendelsohn of Vivani Medical about enhancing patient adherence and convenience via long-acting, controlled release implants delivering medications for chronic conditions.

33. Vector Approaches To Reaching CNS Targets With Vect-Horus' Jean-Manuel Péan 5/23/2025

    A long-standing challenge in delivering therapeutic treatments for CNS (central nervous system) disorders is how to overcome drug permeability constraints imposed by the blood-brain barrier (BBB). In this episode of Supplier Horizons, host Tom von Gunden talks with Chief Scientific Officer Jean-Manuel Péan from Vect-Horus, a developer of vector-based, platform delivery technologies, about addressing that challenge in targeting disorders such as autism, dementia, Alzheimer’s, epilepsy, Parkinson’s, Huntington’s, sclerosis, and CNS tumors.

34. 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.

35. 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.

36. Combination Platform Delivery In Immuno-Oncology 5/2/2025

    Fundamental goals of immuno-oncology therapies are to generate T-cell responses and overcome immunosuppression. In this episode of Sit and Deliver, host Tom von Gunden talks with Syncromune CEO Eamonn Hobbs about using injection- and infusion-based drug-device combination therapies in targeting solid tumor cancers.

37. 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.

38. Developing Therapy Delivery Options For Autoimmune And Allergic Diseases At Revolo Biotherapeutics 4/22/2025

    In this episode of In Combination, host Tom von Gunden combines the perspectives of three executives at Revolo Biotherapeutics – CEO Woody Bryan, Chief Scientific Officer Roly Foulkes, and Chief Medical Officer Kari Brown – in a discussion about developing and delivering peptide-based alternatives to steroids for allergic and autoimmune diseases.

39. Preparing For Combination Product Regulatory Inspections 4/11/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 9 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 Kim Trautman.

40. Oral Drug Delivery For Breast Cancer Prevention With Atossa Therapeutics' Steven Quay 4/7/2025

    In this episode of Sit and Deliver, host Tom von Gunden talks with Atossa Therapeutics CEO Steven Quay about oral drug delivery for early intervention in patients at high risk of breast cancer. The discussion covers formulations, coatings, and dosing for orally administered, cancer-preventative approaches to reducing breast density.