Dr. Zhigang Sun is a senior staff fellow in the Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration (FDA). Since joining FDA in 2006, he has been involved with the chemistry, manufacturing, and control (CMC) review function for Abbreviated new drug applications (ANDAs). Prior to the regulatory work at FDA, he was a senior development scientist at Malvern Instruments Inc and had been involved in pharmaceutical PAT applications as well as particle characterization for powders and dispersions. He received his Ph.D. in Chemical Engineering from Purdue University in 2001 and has authored or co-authored 17 journal articles and book chapter, 5 patents and provisional patent applications, and over 20 presentations.