Recipes to Build Towards Your NDA/BLA with Ed Narke, Brian Lihou and Meranda Parascandola

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Recipes to Build Towards Your NDA/BLA with Ed Narke, Brian Lihou and Meranda Parascandola

Episode Summary

Edward Narke is a Principal and Regulatory Managing Director, Brian Lihou is the Head of Operations and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed, Brian and Meranda join the show to share their collective experiences in the field of CMC. They dissect the process of filing for an Investigational New Drug (IND) and a New Drug Application (NDA), the concept of ‘rest-of-world awareness,’ and the importance of storyboards and timelines for document submission.

What We Covered

  • 00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry
  • 5:12 – The process of filing an Investigational New Drug (IND) and a New Drug Application (NDA)
  • 18:54 – What it means to have ‘rest-of-world awareness’ as you author an NDA
  • 22:37 – Ed, Brian and Meranda speak to the importance of storyboards and telling a story from the right perspective
  • 28:55 – Ed, Brian and Meranda break down the detailed development process, including the work that Design Space InPharmatics does
  • 39:28 – The document review process, timelines for submissions and tracking projects
  • 49:00 – Ed, Brian and Meranda conclude the podcast and thank the audience for listening

Tweetable Quotes

Filing an IND is important to get a trial started. And folks start clinical trials for a variety of reasons. Click To Tweet Out of academia we see a lot of this very little information filed into an IND, and then very little information generated up to the point where you get to a Phase Two or Three where you see efficacy data and then suddenly you have… Click To Tweet It’s hard to become an expert. There’s no real training. I think a lot of it is just experience. It’s going into meetings with FDA when you don’t have all the data. Click To Tweet Make sure it looks good, because it does reflect on the actual data and content in there, just like anything in life. Click To Tweet As the author goes through the process with the client, there’s still another piece. And that’s the publishing group. Click To Tweet One way to alleviate that (stress) is to be able to give an update on any given subject or any given section at any given time. Click To Tweet

Links Mentioned

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn

Brian Lihou on LinkedIn

Meranda Parascandola on LinkedIn