CMC Live - Chemistry, Manufacturing & Controls31 Jul 2020

001 Expedited Drug Development - James Mencel

What We Covered

00:23 – James discusses regulations and the importance of starting with big ideas when it comes to expedited drug development programs
05:44 – Breakthrough designations that occur as a result of expedited drug development programs
08:20 – When a sponsor should consider applying for expedited drug development
11:14 – James speaks to his unique background and experiences with CMC including obstacles and challenges that CMC faces
15:02 – What companies can do to get ahead of the curve when it comes to drug development
18:10 – Ed and Miranda thank James for joining the show

Tweetable Quotes

“When you are in a program that gets expedited, the attention is for the program to move quickly. And there are several ways in which it can move quickly. But almost all of them lead to a very shortened timeframe for CMC. So what it gets you is the FDA’s aware that there is stress on CMC.”

“If you know you’ve got a receptor site – a validated model – some sponsors know from the outset they’re going to approach the FDA even before they go into Phase One because they have a receptor site model. And if they get a model that hits then they’re going to request some sort of expedited status.”

“The first question to ask yourself is, ‘Can this process do the job?’ Because, if this program goes expedited, this process that I’m running right now may be the commercial process whether I like it or not.”

Relevant Links

Leadership - https://dsinpharmatics.com/leadership/#leadership

Project Management - https://dsinpharmatics.com/leadership#projectmanagement

Analytical - https://dsinpharmatics.com/leadership#analytical

Drug Substance - https://dsinpharmatics.com/leadership#drugsubstance

Drug Product - https://dsinpharmatics.com/leadership#drugproduct

Regulatory - https://dsinpharmatics.com/leadership#regulatory

Quality Assurance - https://dsinpharmatics.com/leadership#qualityassurance

Biologics & Microbiology - https://dsinpharmatics.com/leadership#biologics

Formulation & Clinical Ops - https://dsinpharmatics.com/leadership#formulation

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

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Episoder(27)

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

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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

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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