Infusion Drug Delivery Videos

1. Crossing The Blood-Brain Barrier To Target Tumors With CNS Pharmaceuticals 7/31/2025

   Targeting glioblastoma (GBM) and other malignant brain tumors brings with it the long-standing challenge of crossing the blood-brain barrier, or BBB. In this episode of Sit and Deliver, host Tom von Gunden talks with CEO John Climaco and Chief Medical Officer Dr. Sandra Silberman from CNS Pharmaceuticals about intravenously crossing the BBB to deliver classes of drugs, such as taxanes, proven in treating solid tumors in other locations. 

2. What Is the Impact of the New QMSR on 21 CFR Part 4? 7/11/2024

   In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, DDL Executive Editor Fran DeGrazio enlists consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to summarize where Part 4 is documented in the new guidance.

3. Managing Combination Products Post-Market 3/25/2025

   In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 8 on post-market lifecycle 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 Khaudeja Bano.

4. Understanding How EDDOs Relate To CGMPs 4/23/2025

   How are EDDOs (Essential Drug Delivery Outputs) related to CGMPs (Current Good Manufacturing Practices) during the design of a drug-led or biologic-led combination product? In this segment of the Drug Delivery Leader Live event EDDOs Revisited: Putting Essential Drug Delivery Outputs Into Practice, consultant Susan Neadle of Combination Products Consulting Services, LLC establishes the connection between the two regulatory concepts.

5. Drug Delivery For Various Molecules And Modalities 6/24/2025

   In this episode of Sit and Deliver, host Tom von Gunden talks with Merck VP of Pharmaceutical Sciences and Clinical Supply Allen Templeton about formulation and device considerations for combination products and other delivery systems deployed across a range of molecule types and sizes. The conversation takes them from small molecules, through peptides and mAbs, to large molecule biologics, across various routes of administration including oral, injectable, and inhalation.

6. Drug Delivery Self-Administration: The Rise Of The Epinephrine Autoinjector 5/23/2025

   In this segment of the Drug Delivery Leader Live online event, Innovations In Drug Delivery: Opportunities For Enhancing Familiar, Mature Approaches, Courtney Evans, principal consultant at Suttons Creek, comments on drug delivery technology advancements, particularly around the challenge of greater reliability. Her commentary begins with the market introduction of epinephrine autoinjectors and moves to more recent advances in nasal spray alternatives.

7. What Happened to CAPA (Corrective and Preventive Actions) Requirements? 7/11/2024

   Is CAPA still part of the requirements picture for the new QMSR? In this segment of the Drug Delivery Leader Live event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Ed Bills of Edwin Bills Consultant discusses changes in the treatment of corrective and preventive actions.

8. DARPin-Delivered Radiotherapy With Molecular Partners And Orano Med 8/20/2025

   In this episode of In Combination, CEO Patrick Amstutz of Molecular Partners and CEO Arnaud Lesegretain of Orano Med join host Tom von Gunden in a discussion of using DARPins (Designed Ankyrin Repeat Proteins) as vector delivery platforms for high-affinity binding of radioisotopes to treat cancer. Using the example of small cell lung cancer. Patrick and Arnaud describe how DARPin-delivered radiotherapy can attack metastatic cancers while overcoming the targeting limitations of external beam radiation and of antibodies. 

9. Clarifying The EDDO Focus On Design Outputs, Not Design Inputs 10/9/2024

   In what ways are Essential Drug Delivery Outputs (EDDOs) different from design inputs for combination products? In this segment of the Drug Delivery Leader Live event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC explains the difference.

10. 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.