Shows
Insight at Biologics14. When to take an early FDA meeting, with Aleese Hopkins and Samira ShirwaFor 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.
2024-05-2116 minInsight at Biologics13. Getting Out of Trouble, with Chris VesselyWhen 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.
2024-04-1618 minInsight at Biologics12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea TillmanSecurity 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...2023-11-1427 minInsight at Biologics11. eCTD 4.0 and standardized data, with Ben WimmerChanges are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.
2023-07-1818 minInsight at Biologics10. Commercial Readiness, with Vince NarbutHow prepared is your facility? Being prepared is crucial and in this episode Vince Narbut takes you through commercial readiness.
2023-06-2015 minInsight at Biologics9. Weight of Evidence vs Carcinogenicity Testing Part 2, with Bruce PearceThe 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.
2023-05-1627 minInsight at Biologics8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce PearceThe 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.
2023-04-1818 minInsight at Biologics7. Institutional Memory, with Kerin AblashiHow can your organization continue to know what it's doing after people move on? Institutional memory. We talk about it with Kerin Ablashi.
2023-03-2118 minInsight at Biologics6. Potency Assays, with Diana ColleluoriHow well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.
2023-02-2124 minInsight at Biologics5. When you should hire a consultant, with HeeSun SmaldoreHeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.
2023-01-3115 min
Insight at Biologics4. Assembling Your Non-Clinical IND, with Emily Noonan PlaceThe 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.
2023-01-1015 min
Insight at Biologics3. Gap analysis, with David PepperlYou 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.
2022-12-1321 min
Insight at Biologics2. In vivo cell therapy, with Robert KutnerUsing your own cells to help you heal isn't science fiction anymore. Robert Kutner takes us into the world of in vivo cell therapy.
2022-11-2220 minInsight at Biologics1. What a consultant can do for you, with Debra BarngroverBringing 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
2022-11-0113 minInsight at BiologicsInsight at Biologics - TrailerA little bit about the show.
2022-10-2400 min
COVID19 Road to a vaccineCOVID-19 vaccine candidates regulatory process update with Professor Norman BaylorIn episode 16 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford speaks once again with Professor Norman Baylor. Professor Baylor is the former Director of the Office of Vaccines Research and Review Center at the U.S. Food and Drug Administration (FDA) and is the President and CEO of Biologics Consulting and current advisor to the WHO.In this episode they discuss:•The recent FDA Vaccines and related biological products advisory committee meeting which was, as is customary, open to the public•The huge amount countries like Australia can learn from the...2020-11-0127 minCOVID19 Road to a vaccineThe importance of regulatory bodies in the development of vaccines with Professor Norman BaylorIn episode 7 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford speaks with Professor Norman Baylor. Professor Baylor is the former Director of the Office of Vaccines Research and Review Center at the U.S. Food and Drug Administration (FDA) and is the President and CEO of Biologics Consulting and current advisor to the WHO. In this episode they discuss:•The important role of regulatory authorities in the development and release of new vaccines•Emergency Use Authorisations (EUA) and their use•Compressed timelines in the development of SARS-CoV-2 vaccines•Requirem...2020-07-0629 min