Regulatory Odd Couple with Ed Narke & Meranda Parascandola

Regulatory Odd Couple with Ed Narke & Meranda Parascandola

CMC021 Ed Meranda Square

Episode Summary

Edward Narke is the Principal and Regulatory Managing Director and Meranda Parascandola is the Head of Business Development & Marketing at DSI. In this episode, Ed and Meranda discuss topics they’ve covered previously 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 justification for regulatory starting materials, how to convey the sweet spots of your process, secrets to building the quality overall summary, and the role that excipients play. 

Ed and Meranda also share their thoughts on the considerable latitude for assimilating, discussing, comparing, and contrasting data that is allowed and even encouraged. 

There are opportunities to be creative, to tell a story, and to craft cohesive arguments to help regulatory bodies understand your product.

What We Covered

  • 00:51 – 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. Click To TweetCharacterization 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. Click To TweetThis 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. Click To TweetThere 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? Click To TweetAny 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? Click To Tweet

Links Mentioned

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn

Odd Couple Series