Insight at Biologics

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Helping you navigate through the maze of drug and device development.

  1. 27. Jan.

    16. Bridging Drug Development: Advancing Analytical Methods from Preclinical to Commercialization

    We talk with Neha Chitre and Vineeta Sharma about analytical method progression during drug development and commercialization.

  2. 06.05.2025

    15. Navigating CMC and Nonclinical Challenges with Novel Cell and Gene Therapy Products

    Bringing novel cell and gene therapy products to market can be challenging for both nonclinical and CMC. David Pepperl, Diana Colleluori, and Robert Kutner return to talk with James C Taylor about it!

  3. 21.05.2024

    14. When to take an early FDA meeting, with Aleese Hopkins and Samira Shirwa

    For smoother sailing with an IND, it can help to have a meeting with the FDA before the IND. But how do you do that and what do you need? Find out from Aleese Hopkins and Samira Shirwa.

  4. 16.04.2024

    13. Getting Out of Trouble, with Chris Vessely

    When you have an anomalous lab result, you just might be in trouble. However, Chris Vessely can help you close the case of what went wrong, help you find a way to save the day, and help keep you from getting in trouble in the first place.

  5. 14.11.2023

    12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman

    Security from cyberattack for medical devices is paramount. And the FDA wants you to have a plan for it. Becky Ditty and Donna-Bea Tillman tell you how to be prepared. Guidance documents: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff (related to the requirements per the Consolidated Appropriations Act, 2023) https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-refuse-accept-policy-cyber-devices-and-related-systems-under-section Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-networked-medical-devices-containing-shelf-ots-software Playbook for Threat Modeling devices https://www.mitre.org/publications/technical-papers/playbook-threat-modeling-medical-devices

  6. 18.07.2023

    11. eCTD 4.0 and standardized data, with Ben Wimmer

    Changes are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.

  7. 20.06.2023

    10. Commercial Readiness, with Vince Narbut

    How prepared is your facility? Being prepared is crucial and in this episode Vince Narbut takes you through commercial readiness.

  8. 16.05.2023

    9. Weight of Evidence vs Carcinogenicity Testing Part 2, with Bruce Pearce

    The ICH has released a guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument. We conclude our two-part discussion of why to do that and how to do that with Bruce Pearce.

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Helping you navigate through the maze of drug and device development.

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