Inhalation Drug Delivery Videos

1. When And How To Use A UFMEA During Device Design 12/11/2024

   When and how might using a uFMEA (Use Failure Mode Effects Analysis) tool benefit biopharma companies addressing regulatory expectations for analyses of risk and/or human factors? 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, and Shannon Hoste, chief scientific officer at Pathway for Patient Health, discuss potential differences in the contexts, purposes, and degrees of detail in information presented for review.

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. Identify And Mitigate Absorption Risks With PBPK Modeling 3/12/2024

   See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies.

4. Why Start A URRA Early In Combination Product Design? 12/11/2024

   Both a URRA (Use-Related Risk Analysis) and IFU (Instructions for Use) can help to mitigate the risk of user misuse of a combination product. In this segment of the Drug Delivery Leader Live event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers rationale for starting and conducting the URRA ahead of developing or finalizing IFU.

5. 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.

6. 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.

7. 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.

8. Formulating Better ASDs And mAbs: Advances In Applied Nanotechnology 5/1/2024

   Learn about new data on nanotechnology formulations for multiple dose forms and routes of delivery, including oral, long-acting injectables, inhalation, and ophthalmic.

9. Who Is Responsible For Design Controls? 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 asks consultants Laurie Auerbach of Compliance Prodigies and Ed Bills of Edwin Bills Consultant to identify which organization in a combination product manufacturing process are responsible for design controls – the sponsor company, the contracted component provider, or both.

10. Intranasal Delivery for Post-Viral Smell Loss with Cyrano Therapeutics' Rick Geoffrion 10/29/2024

    COVID-19 and other viruses have drawn increased attention to the debilitating effects and potentially consequential underlying causes of hyposmia or anosmia (reduced or complete inability to smell). In this episode of Sit and Deliver, Rick Geoffrion, founder and CEO of regenerative medicine company Cyrano Therapeutics, talks with Sit and Deliver host Tom von Gunden about why an effective therapeutic response may well involve – you guessed it – a payload through the nose.