Establishing Regulatory Starting Materials & Understanding the ICH with James Mencel

Expedited Drug Development with James Mencel
July 31, 2020
Effective Strategies for Early Stage Drug Development with Judy Magruder
August 14, 2020

Establishing Regulatory Starting Materials & Understanding the ICH with James Mencel

Episode Summary

DS InPharmatics' Senior Drug Substance Consultant, James Mencel continues his discussion on expedited drug development programs, specifically the importance of establishing regulatory starting materials. In this episode, Ed, Meranda, Brian and James discuss how the FDA and sponsors deal with the challenges of establishing starting materials, the role of the International Council for Harmonisation (ICH) and striking the balance between appropriate regulatory control and sustainable manufacturability.

What We Covered

  • 00:54 – James continues his discussion of expedited drug development programs, focusing on the importance of establishing regulatory starting materials
  • 07:34 – James provides best practices for working with clients who don’t want to approach the FDA proactively and curating fallback plans
  • 11:45 – James speaks to strategies for establishing ideal regulatory starting materials
  • 16:44 – James shares his thoughts on ICH Q11
  • 20:39 – James expounds on the idea behind Quality by Design (QBD)
  • 28:53 – James provides some final thoughts on the process of establishing regulatory starting materials
  • 34:10 – Ed and Meranda thank James for joining the show

Tweetable Quotes

It takes a fair bit of time to develop a package to support a regulatory starting material proposal to an agency. And the better packages are ones that are supported by data…The reason this is important is because the stronger your… Click To Tweet I see this as like being an advanced scout watching another team play ball. If you can stand at the field and watch how they approach and do things, you’re prepared when you face that team yourself. And I think if you can approach… Click To Tweet One of the crux issues with choosing a starting material is the whole case you can make about how you purge the impurities from that point forward. Click To Tweet I think it’s (the ICH Q11) is a great document. And I think that any process chemist should read it and understand what’s being looked for. Click To Tweet What it really comes down to is you want to try to understand what’s making your process tick. If you get some new impurity, the process is telling you something. Where is it coming from? Sometimes you get impurities you can’t get… Click To Tweet

Links Mentioned

International Council fo Harmonisation


Project Management


Drug Substance

Drug Product


Quality Assurance

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