Rushing vs. Readiness — The High Cost of a Clinical Hold on a Biologics IND

Welcome to Chasing Compliance, the GLOBAL regulatory podcast, where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy – from bench to bedside. 

Today we are chatting with Julie Matison and Scott Michaels. 

Julie Matison holds a Bachelor’s degree in Chemical Engineering and a Master’s degree in Mechanical Engineering, and recently earned the RAC-Drugs certification through RAPS. She has over 21 years of experience in the pharmaceutical industry, with a strong background in manufacturing, validation and quality.  

Scott Michaels earned his Master’s in Pharmaceutical Chemistry from the University of Kansas and his Bachelor’s in Chemistry from McGill University.  He has held a variety of regulatory and CMC product development roles over the past 20 years, working with both small molecules and biologics. 

Thank you both for being here! On this episode, we are discussing CMC strategy around biologics IND submissions. I am sure our audience is looking forward to your insights, so let’s dive in.