CMC Live - Chemistry, Manufacturing & Controls25 Sep 2020

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

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.” (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.”

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Brian Lihou on LinkedIn

Meranda Parascandola on LinkedIn

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Episoder(27)

025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll

What We Covered00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development 04:28 – Mike talks about his involvement in the ...

12 Mar 202131min

024 - Quality Management Systems Explained!

What We Covered00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS) Explained! 07:53 – The panel expounds on the timing necess...

5 Mar 202138min

023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel

What We Covered00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation07:46 – The importance of Proven Acceptable Range (PAR) and Critical Pro...

26 Feb 202143min

022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

What We Covered00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation 05:41 – Shelli talks about ...

19 Feb 202132min

021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola

What We Covered00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) ...

12 Feb 20211h

020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

What We Covered00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest01:56 – Ed speaks to his extensive background in CMC and the importance he places on build...

29 Jan 202148min

019 - Complexity of Project Management in Drug Development with Paul Long

What We Covered00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management consultant and speaks to some of the benefits and challenges o...

22 Jan 202143min

018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

What We Covered00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok10:11 – Ed, Brian and Meranda reflect bac...

8 Jan 202152min