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.
“Filing an IND is important to get a trial started. And folks start clinical trials for a variety of reasons.” (05:43) (Ed)
“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 to file an NDA.”
“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.”
“Make sure it looks good, because it does reflect on the actual data and content in there, just like anything in life.”
“As the author goes through the process with the client, there’s still another piece. And that’s the publishing group.”
“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.”
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