Expedited Drug Development with James Mencel

CMC Live
Introduction to CMC Live
July 27, 2020
Establishing Regulatory Starting Materials & Understanding the ICH with James Mencel
August 7, 2020

Expedited Drug Development with James Mencel

Episode Summary

DS InPharmatics' Senior Drug Substance Consultant, James Mencel, joins the show to share his background with CMC management. In this episode, Ed, Meranda and James discuss the impact that expedited drug development programs have had on the pharma industry. They break down regulations, breakthrough designations and best practices when it comes to these programs.

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… Click To Tweet 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… Click To Tweet 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. Click To Tweet

Links Mentioned

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

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