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Insight at Biologics episodes
- 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.
14 min - 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!
25 min - 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.
17 min - 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.
19 min - 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-softwarePlaybook for Threat Modeling devices
https://www.mitre.org/publications/technical-papers/playbook-threat-modeling-medical-devices28 min - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff.
- 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.
19 min - 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.
16 min - 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.
28 min - 8. Weight of Evidence vs Carcinogenicity Testing Part 1, 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 begin our two-part discussion of why to do that and how to do that with Bruce Pearce.
19 min - 7. Institutional Memory, with Kerin Ablashi
How can your organization continue to know what it's doing after people move on? Institutional memory. We talk about it with Kerin Ablashi.
19 min
About Insight at Biologics
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Helping you navigate through the maze of drug and device development.