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 discuss CMC marketing application strategies and submissions. Specifically, they speak to the important role regulatory reviewers play in deciphering data and ensuring all authors are following one cohesive story. They break down other CMC issues they’ve encountered with projects they’ve worked on and provide insights and protocols clients can follow to yield a successful program.
“I think the experience level of that regulatory point person during the submission is really critical.”
“Oftentimes we find that clients are also looking for a submission to be a learning opportunity for their own people.”
“When you’re preparing to undertake this preparation to write this, the first and probably the most critical step is to engage across disciplinary teams.”
“One of the things that I think is often a recipe for anxiety and stress is not understanding roles and responsibilities.”
“One of the areas that’s really essential when you’re putting together your authoring team is to have somebody at the client that truly understands where the skeletons are.”
“Over the years we’ve worked to build in efficiencies that take a lot of the guess work out of compiling the submissions.”
“I think respecting the experience of the people that brought the project to this point is critical.”
“Planning is probably a better option than chance.”
“Typically what I would do if I was moving on from an IND and starting to develop an NDA, I would start from ground zero, making sure I at least have an outline chart with all of the ECTB sections outlined in that manner.”
“I think it’s important to note that the cost of doing an incomplete filing is monumental.”
“Regulatory authorities are part of the team. They’re your friends. Seek advice, ask for their advice and also educate them.”
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