021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola

What We Covered00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3  11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) and the different starting points for drug process development  19:45 – Ed and Meranda talk about characterization, the process of manufacturing drug substances/products and the importance of excipients  37:44 – Ed expounds on the analytical aspect of API and regulatory drug development  46:55 – Ed and Meranda share their thoughts on the process of packaging drug substances  49:09 – Ed and Meranda discuss the role that stability plays in development methods  53:42 – P2 Pharmaceutical Development  Tweetable Quotes“If anyone’s listening and not familiar with the drug development process, the one area that’s most important is the FDA guidance.” “Characterization is, in my mind, one of the fundamentals of a product and a process and a program. If you don’t know what you’re dealing with to start, it’s hard to catalog it, make it consistently and answer questions about it.”“This is probably, in some folks’ minds, the most important. It’s the manufacturing of the drug substance and the drug product. If you don’t have a process, you don’t have a product.” “There are a few caveats to excipients. One of the things you’ll want to recognize and a question that might come up is ‘are they of human or animal origin?’ And the other big thing is ‘are they novel?’” “Any changes to anything in the program – process-wise or control-wise – late in the game could be a problem because you’re gonna have to generate additional data. There’s an unknown there. What does that change mean?” Relevant LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedInOdd Couple Series