Kyriakos Michailaros is Head of Drug Products Services at Design Space InPharmatics. With over twenty years of experience in exploratory, clinical phase and commercial projects within the pharmaceutical industry, Kyriakos brings a wealth of knowledge to today’s show. In this episode, Kyriakos, Ed, Meranda and Brian discuss product development reports, the important role that timing plays in these reports and trends in drug product manufacturing. Kyriakos shares specific examples from his career that showcase how influential these development reports have become with reviewers in the industry.
“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.”
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Link to Hey Google, Tell Me About the Importance of Living Development Reports