001 Expedited Drug Development - James Mencel

CMC Live - Chemistry, Manufacturing & Controls

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 gets you is the FDA’s aware that there is stress on CMC.”

“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 that hits then they’re going to request some sort of expedited status.”

“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.”

Relevant Links

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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