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

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

FromCMC Live - Chemistry, Manufacturing & Controls


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

FromCMC Live - Chemistry, Manufacturing & Controls

ratings:
Length:
35 minutes
Released:
Dec 4, 2020
Format:
Podcast episode

Description

What We Covered01:03 – 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 showTweetable 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 LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInDaniel Torok on LinkedInDavid Adams on LinkedInJim Mencel on LinkedInDavid Blasingame on LinkedIn
Released:
Dec 4, 2020
Format:
Podcast episode

Titles in the series (27)

FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.