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

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

• 01:03 – Ed, Brian and Meranda welcome to the show a panel of drug substance services experts, Daniel Torok, Dave Adams, Jim Mencel and David Blasingame who speak to trends they’ve observed in the landscape of API manufacturing
• 07:04 – The panel speaks to the types of drug manufacturing requests they’ve been seeing
• 14:42 – The panel expresses their shared concerns over the diminishing number of API manufacturing professionals in the United States
• 23:53 – The panel provides their thoughts on the immediate future of API manufacturing
• 30:04 – The panel discusses the current state of regulation
• 33:15 – Ed, Brian and Meranda thank the panel for joining the show

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