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.
Run time: 42:24mins
CMC011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos
Video Credit: DSI, a PLG Company
Takeaways:
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
About CMC Live
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.