Helping you navigate through the maze of drug and device development.
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14. When to take an early FDA meeting, with Aleese Hopkins and Samira Shirwa
16:07
16:07
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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.By biologicsconsulting
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13. Getting Out of Trouble, with Chris Vessely
18:10
18:10
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18:10
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.By biologicsconsulting
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12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman
27:28
27:28
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27:28
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…
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11. eCTD 4.0 and standardized data, with Ben Wimmer
18:55
18:55
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Changes are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.By biologicsconsulting
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10. Commercial Readiness, with Vince Narbut
15:35
15:35
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How prepared is your facility? Being prepared is crucial and in this episode Vince Narbut takes you through commercial readiness.By biologicsconsulting
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9. Weight of Evidence vs Carcinogenicity Testing Part 2, with Bruce Pearce
27:36
27:36
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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.By biologicsconsulting
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8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce
18:14
18:14
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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.By biologicsconsulting
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7. Institutional Memory, with Kerin Ablashi
18:12
18:12
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How can your organization continue to know what it's doing after people move on? Institutional memory. We talk about it with Kerin Ablashi.By biologicsconsulting
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How well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.By biologicsconsulting
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5. When you should hire a consultant, with HeeSun Smaldore
15:53
15:53
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HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.By kkraihanzel
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4. Assembling Your Non-Clinical IND, with Emily Noonan Place
15:22
15:22
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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.By kkraihanzel
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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.By kkraihanzel
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2. In vivo cell therapy, with Robert Kutner
20:44
20:44
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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.By kkraihanzel
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1. What a consultant can do for you, with Debra Barngrover
13:20
13:20
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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. TaylorBy kkraihanzel
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A little bit about the show.By kkraihanzel
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