011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

• 00:53 – Kyriakos Michailaros joins the show to share his background and expertise in the subject matter of drug product services
• 02:59 – Kyriakos shares his thoughts on appropriate timing for a development report, the validation process and the importance of having your development report be a living document
• 08:53 – Addressing risks and concerns as it pertains to drug development programs and what Kyriakos looks for in a comprehensive development report
• 14:56 – Kyriakos speaks to the standards he looks for in development programs when determining dosage form and the value of efficient documentation
• 21:49 – The importance Kyriakos places on stability data and proper documentation
• 30:03 – Kyriakos explains tablet friability, pan coating, the Ishikawa fishbone diagram and elaborates on the strangest dosage form he’s ever come across
• 40:02 – Ed, Brian and Meranda thank Kyriakos for joining the show

Tweetable Quotes

“I think it’s never too early. Ideally you want to have the story of the development program pretty much summarized by the time you’re making an NDA submission.”

“A good development program is gonna do risk assessments at certain points along the way and assess what are the major concerns associated with developing this drug product.”

“Particles tend to de-mix and segregate based on size.”

“Some reviewers, it seems, can be primarily box checking, take less of a holistic risk based approach, which has been the trend for some time now. I try to focus on what is actually important for this particular product and has that been explored appropriately.”

“If you’re not gonna have a working development report, what you need to have is a working document repository with a file structure that can be easily followed so that you can go back and know what you have and piece together a report or a submission from that.”

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Kyriakos Michailaros on LinkedIn

Link to Hey Google, Tell Me About the Importance of Living Development Reports