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!By biologicsconsulting

Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Pierre Stanislawski, our IDMP expert, and Josh Keliher, who’s leading the charge on AI at Ennov. Together, we dive into two major questions: what does AI really mean for regulatory a…

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager. We discuss the latest eCTD 4.0 news and a recent MHRA consultation on Medical Devices. Know what’s comin…

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

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

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…

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

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

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

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

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

How well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.By biologicsconsulting

HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.By kkraihanzel

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

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

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

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

A little bit about the show.By kkraihanzel