Edward Narke is a Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at Design Space InPharmatics. Today, Ed and Meranda discuss topics they’ve covered on DSI’s ongoing blog series, The Regulatory Odd Couple. They dive deep into the process of regulatory drug development, including the importance of having regulatory starting materials, building the quality overall summary and the role that excipients play in that process. Ed and Meranda share their thoughts on the analytical framework of API and other stages of pharmaceutical development.
“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?”
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