002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel

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 Miranda 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 package is, the more likely you are to be successful in your proposal.”

“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 the FDA and say, ‘Look, here’s what we have based upon the guidance. What do you think?’ I think you’re better off than waiting until you face them now and when you have to do it because you’ve run out of time and you’re really not prepared.”

“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.”

“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.”

“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 rid of. How do you deal with an impurity that does not go away?”

Relevant Links

International Council fo Harmonisation

Leadership

Project Management

Analytical

Drug Substance

Drug Product

Regulatory

Quality Assurance

Biologics & Microbiology

Formulation & Clinical Ops

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