Why Now is the Most Important Time for Selecting a CMO

A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola
October 23, 2020
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Why Now is the Most Important Time for Selecting a CMO

Episode Summary

Rick Offerman is a Senior Project Management Consultant at Design Space InPharmatics. With over twenty years of experience as a process chemist, Rick brings a unique perspective to the drug manufacturing process. In this episode, Rick, Ed, Meranda and Brian discuss the challenges with scaling for process. There are several challenges involved as each scenario is different every time. They delve deep into the importance of carrying out evaluations and other necessary steps to manage these complexities as well as the value of taking an integrated approach.

What We Covered

  • 01:19 – Ed, Brian and Meranda welcome to the show Dr. Rick Offerman who speaks to his experience as a process chemist, the drug development process and what goes into selecting a solvent
  • 15:41 – The importance of selecting the right CMO partner
  • 19:05 – Questions that must be asked in the beginning of the drug manufacturing process
  • 23:14 – Dr. Rick breaks down best practices in cost-control
  • 30:16 – The importance of the project timeline
  • 40:13 – Dr. Rick takes a moment to recognize those who greatly influenced his career
  • 46:23 – Ed, Brian and Meranda thank Dr. Rick for joining the show

Tweetable Quotes

A lot of CMOs are now going to a ‘one-stop shop’ type model. So basically they’ll say, ‘Yeah we’ll take you all the way from gram quantities right through commercial. We can do your API and your drug substance.’ But there’s still a… Click To TweetCost is always a factor (in selecting a solvent) but it’s not the major one. Click To TweetYou’re gotta have an integrated approach all the way through the system to understand the API that you’re producing, the impurity profile, the crystal morphology, the polymorphs, that sort of thing. Click To TweetRealistically, when you look at the cost of an API as a percentage of a drug product, it’s usually fairly low. Click To TweetIf the analytical people aren’t up and ready to go, then when the chemists start running stuff in the hoods, how do they analyze it? We don’t have methods, so we’re kinda going on a wing and a prayer. Click To Tweet

Links Mentioned

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn

Rick Offerman on LinkedIn