013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

• 01:16 – Ed, Brian and Meranda take a deep dive into analyzing CMC strategy and submissions
• 11:26 – Ed, Brian and Meranda discuss resources required for compiling CMC dossiers and the importance of understanding roles and responsibilities within this process
• 20:09 – Essential aspects of putting together an effective authoring team
• 25:25 – Brian speaks to the importance of respecting the experience of those that have been working on projects from the jump
• 28:28 – Ed, Brian and Meranda discuss what sponsors should know about CMC regulations to prepare for a marketing application

Tweetable Quotes

“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.”

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Brian Lihou on LinkedIn

Meranda Parascandola on LinkedIn