Articles by Tom von Gunden

51. 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.

52. Considering Human Factors In Combination Product Design And Use 3/7/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 7 on human factors engineering (HFE) from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press) with the chapter’s co-authors.

53. 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.

54. Scaling Platform Delivery Of Gene Therapies With NewBiologix's Igor Fisch 2/25/2025

    Gene therapies aim to treat the root causes of disease rather than merely the symptoms. In this episode of Supplier Horizons, host Tom von Gunden talks with CEO Igor Fisch of NewBiologix, a developer of AAV-based gene therapy platform technologies.

55. Managing Risk When Developing Combination Products 2/20/2025

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 6 on risk management from 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 Edwin Bills.

56. Bolstering Bowel And Bladder Control With Dignify Therapeutics' Karl Thor 2/6/2025

    In this episode of Sit and Deliver, host Tom von Gunden talks with Chief Scientific Officer Karl Thor of Dignify Therapeutics about providing relief for patients suffering from neurogenic bowel and bladder dysfunction.

57. Developing A Combination Product: Early-Stage Formulation And Device Considerations At GSK 2/5/2025

    Successful development of a safe and effective combination product depends on careful consideration of factors impacting the alignment between drug formulation and delivery device. In this episode of In Combination, host Tom von Gunden combines the perspectives of three functional area leads who work collaboratively during early-stage product development and device selection at GSK.

58. Accelerating Antibody Delivery With Surf Bio's Bryan Mazlish 1/29/2025

    In this episode of Sit and Deliver, Surf Bio CEO Bryan Mazlish talks with host Tom von Gunden about subcutaneous delivery of monoclonal antibodies (mAbs) and other biologics via autoinjectors. Bryan shares with Tom the benefits of polymer-enabled administration of high-dose antibody treatments outside of infusion centers.

59. Integrating Development Processes For Combination Products 1/27/2025

    The discussion highlights key aspects of a biopharma organization’s business and operations that must be effectively integrated when developing drugs and devices in tandem. These include imperatives such as establishing common terminology, applying QbD (Quaility by Design) principles, and managing supplier controls for providers of constituent parts.

60. Broadening The Range Of Self-Administered Biologics With Stevanato Group's Riccardo Butta 1/20/2025

    Along with the goal of moving a wider range of biologics-based therapies into self-administered, in-home scenarios comes the challenge of delivering increased dosage volumes and higher viscosities via subcutaneous and transdermal methods. In this episode of Supplier Horizons, host Tom von Gunden talks with Stevanato Group’s President, Americas, Riccardo Butta about the convergence of human factors and device design during platform development for injectable and on-body delivery systems.