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.
6 May 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!
21 May 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.
16 Apr 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.
14 Nov 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 (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 (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 (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 (https://www.mitre.org/publications/technical-papers/playbook-threat-modeling-medical-devices)
18 Jul 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.
20 Jun 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.
16 May 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.
18 Apr 2023
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.
21 Mar 2023
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.
21 Feb 2023
6. Potency Assays, with Diana Colleluori
How well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.
31 Jan 2023
5. When you should hire a consultant, with HeeSun Smaldore
HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.
10 Jan 2023
4. Assembling Your Non-Clinical IND, with Emily Noonan Place
The regulatory agency doesn't get a lot of time with your IND submission. To figure out how to make the most of that time, we talk with Emily Noonan Place.
13 Dec 2022
3. Gap analysis, with David Pepperl
You may not have everything that you need when it comes to making a drug or device submission. How do you know? With a gap analysis. David Pepperl explains it in our conversation.
22 Nov 2022
2. In vivo cell therapy, with Robert Kutner
Using your own cells to help you heal isn't science fiction anymore. Robert Kutner takes us into the world of in vivo cell therapy.
1 Nov 2022
1. What a consultant can do for you, with Debra Barngrover
Bringing a drug or device to market can be arduous. In this interview with Debra Barngrover of Biologics Consulting, we learn how a consultant can help bring your picture into focus.
Guest: Debra Barngrover
Host: James C. Taylor
24 Oct 2022
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