Drug Development (CMC) and Regulatory Consultant ● U.S. FDA Senior CMC Reviewer (10 years) ● Fellow, American Association of Pharmaceutical Scientists, AAPS (since 2007) ● Full Professor in Pharmaceutics at Temple University ● Associate Professor in Pharmaceutics at University of Georgia ● Ph.D in Industrial and Physical Pharmacy from Purdue University Dr. Donghao (Robert) Lu is a chief consultant in Drug Development (CMC) and Regulatory. Currently Dr. Lu carries out his consulting work with China and US pharmaceutical companies, for their CMC development and regulatory submissions (Phase 1-2-3, NDA) on small molecules. Dr. Lu was Senior CMC Reviewer at U.S. FDA (10 years). Dr. Lu is Fellow of American Association of Pharmaceutical Scientists (AAPS) since 2007. Prior to joining FDA, Dr. Lu was Full Professor in Pharmaceutics at Temple University and Associate Professor in Pharmaceutics at University of Georgia. Donghao Lu received Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1990.