Articles by Tom von Gunden

  1. 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.

  2. Defining and Regulating Combination Products: An Evolutionary Journey 10/15/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 1 of The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023) with the book’s editor, Susan Neadle. Given that the initial chapter was penned by the FDA’s John “Barr” Weiner, the discussion focuses on reasons for establishing the historical and regulatory context for combination products early in the handbook’s topic coverage.

  3. What Is There to Learn from a Combination Products Handbook? Plenty! 10/15/2024

    In this initial episode of The Combination Products Handbook: The Series, a chapter-by chapter videocast series introducing topics from The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems (CRC Press, 2023), host Tom von Gunden discusses the book’s intent with its editor, Susan Neadle. The discussion focuses on the rationale for each chapter and the expert contributions of various chapter authors and co-authors.

  4. Combination Products Regulatory Considerations with FDA's Barr Weiner 10/1/2024

    From his roles and experiences in the combination products and combined use systems arena, John “Barr” Weiner offers perspectives on how to approach pre- and post-market activities with regulatory requirements and guidance in mind. Cross-functional coordination, integrated development, and primary mode of action (PMOA) designations are among the considerations Barr reminds organizations to implement thoughtfully as they work to advance combination products within a regulatory landscape.

  5. Drug Device Availability, Sustainability, and Integrity with Windgap Medical's Aaron Mann 9/25/2024

    CEO Aaron Mann of multi-platform drug delivery company Windgap Medical joins Supplier Horizons host Tom von Gunden to discuss drivers of innovation in injectable delivery. Expanding patient access to new and emerging therapies, reducing costs, and bolstering sustainability are among the topics covered in a conversation focused on benefits to patients.

  6. LNP-Delivered mRNA via Inhalation with Ethris' Carsten Rudolph and Thomas Langenickel 9/18/2024

    How can genetic information be carried into lung tissue for the treatment of asthma and potentially other conditions? In this inaugural episode of In Combination, host Tom von Gunden combines the perspectives of two executives from LNP/mRNA (lipidoid nanoparticle / messenger RNA) formulation and delivery platform developer Ethris: CEO Carsten Rudolph and Chief Medical Officer Thomas Langenickel. The conversation illuminates the value to patients of platform approaches to inhalation-delivered treatments.

  7. Oral Small Molecule Targeting of Cancer with Cantex' Stephen Marcus 9/17/2024

    Dr. Stephen Marcus boasts drug development experience across various routes of administration targeting varied therapeutic areas. Now as Cantex CEO, he leans on his background as an oncologist to drive his passion for effectively treating cancer while easing the patient experience. In this episode of Sit and Deliver, host Tom von Gunden asks Dr. Marcus about innovations in small molecule delivery for complex, life-threatening conditions.

  8. Rare Disease Targeting and Novel Therapy Delivery with Kymanox' Evan Edwards 8/29/2024

    Commenting on a wide range of therapeutic targets, Kymanox president Evan Edwards joins Supplier Horizons host Tom von Gunden in highlighting opportunities for drug delivery innovation. Front of mind for Evan as he considers areas of advancement are human factors engineering for increased self-administration, targeting rare diseases with novel therapies, and, in general, addressing the challenges of delivering large molecule biologics. 

  9. 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.