Transdermal Drug Delivery Videos

1. URRA And UFMEA: Together Or Separate For Combination Products? 12/11/2024

   Both uFMEA (Use Failure Mode Effects Analysis) and URRA (Use-Related Risk Analysis) tools are available during combination product development for conducting risk assessments related to human factors. In this segment of the Drug Deliver 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 scenarios in which a uFMEA might be used to inform a URRA regulatory submission.

2. Enabling In-Home Drug Delivery With SMC's Asmita Khanolkar 12/10/2024

   Methods for enabling self-administered, in-home delivery of drugs and biologics must accommodate increasingly larger volumes and more complex formulations. In this episode of Supplier Horizons, host Tom von Gunden talks with Asmita Khanolkar, Senior Director of Pharma Services at contract manufacturer SMC Ltd., about patient-centric considerations such as ergonomics and tolerability in the development of combination products, autoinjectors, and other delivery systems.

3. What Types Of Products Are Assessed With A URRA? 12/11/2024

   What types of products in development may need to be assessed in accordance with the FDA’s URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Deliver Leader Live! event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Natalie, Abts, head of human factors engineering at Genentech, describes several common scenarios that illustrate when a URRA approach may or may not be needed.

4. The Regulatory Intent Of A URRA For Combination Products 12/11/2024

   To what extent are approaches to conducting risk assessments specified in the FDA URRA (Use-Related Risk Analysis) guidance? In this segment of the Drug Deliver Leader Live! event Human Factors Risk Analysis: Leveraging URRA And UFMEA Tools, Shannon Hoste, chief scientific officer at Pathway for Patient Health, offers context-setting perspective on what FDA is looking for when reviewing URRA compliance.

5. Management Responsibility and the New QMSR 7/11/2024

   What is management’s responsibility in the implementation of approaches to the new QMSR? In this segment of the Drug Deliver Leader Live! event New FDA QMSR: Its Role in Part 4 Compliance for Combination Products, consultant Laurie Auerbach of Compliance Prodigies underscores the criticality of management commitment to and engagement in the process.

6. 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.

7. Identifying EDDOs During Drug Delivery Device Design 10/9/2024

   How are EDDOs (Essential Drug Delivery Outputs) determined during the design of a drug-led or biologic-led combination product? In this segment of the Drug Deliver Leader Live! event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC lays out the foundational considerations.

8. Applying Control Strategies to EDDOs 10/9/2024

   After Essential Drug Delivery Outputs (EDDOs) have been identified, each will need to be controlled during the development of a drug delivery device.  In this segment of the Drug Deliver Leader Live! event The FDA Guidance on EDDO: What to Know, What to Do, consultant Susan Neadle of Combination Products Consulting Services, LLC provides the rationale for a risk-based approach to EDDO control strategies.

9. 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.

10. Developing Regulatory Strategies For Combination Products 12/16/2024

    In this episode of The Combination Products Handbook: The Series, host Tom von Gunden discusses Chapter 3 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. The conversation focuses on building into product development a regulatory strategy that incorporates key enablers of market success from early clinical studies, through the marketing application, to post-market changes.