CMC Live - Chemistry, Manufacturing & Controls

017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know

Episode Summary

The market for the manufactured and supplied APIs is changing continuously, and there are many factors influencing these changes. Being aware of these changing trends is important. Perhaps what’s even more important is how you leverage the opportunities they bring and how to react to them. In this episode, Ed, Meranda and Brian talk with a group of drug substance services experts about the major trends you should know and be aware of, and how you can use them to your advantage. This panel includes experts who have appeared on the podcast before: David Blasingame, Jim Mencel, Dave Adams and Daniel Torok.

Episode Notes

What We Covered

Tweetable Quotes

“We’re certainly seeing a very rapid change in the API/CMO world. I think if you went out with an RFP maybe two years ago and you threw this RFP out to eight vendors, you’d have eight proposals back fairly rapidly.” 

“I don’t know how many of you guys have been involved in plant build outs and plant qualifications. It is not a slam dunk, especially when you’re trying to retrofit an existing site.” 

“The number of people in the U.S. who have manufacturing backgrounds in small molecules is just small and diminishing rapidly because all the jobs have been offshored.” 

“Good operators are worth their weight in gold.” 

“I think what has to happen [in the future of API manufacturing in the U.S.] is that the industry has to know that the demand is there.”

Relevant Links

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn

Daniel Torok on LinkedIn

David Adams on LinkedIn

Jim Mencel on LinkedIn

David Blasingame on LinkedIn