United States of America
Greg is currently President of CTM Solutions, LLC, a CMC and clinical trial materials consultancy. He has over 20 years’ experience in GLP, GMP and GCP regulated drug product development, and is a subject matter expert in drug substance synthesis, scale up, process development, and analytical characterization. He also provides regulatory CMC guidance. Greg completed his PhD in Biological Chemistry, at the University of Guelph, Ontario, Canada and postdoctoral training at University of Denver. He has held positions of increasing responsibility at Synthetech, Cell Therapeutics, and SNBL USA. Most recently Dr. Coulter has worked on development teams leading to the FDA approval of the weight loss drug Contrave and the PI3K delta inhibitor Zydelig.