Dr. Daniel Peng is currently a Senior Principal Scientist/Director of Drug Product Manufacturing Science and Technology at Shire. His main responsibility is to support new product and technology introductions, transfers, and technical oversight of commercial products.
Prior to joining Shire, Daniel served as primary and secondary CMC reviewer for various types of regulatory submissions in the Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ) in CDER/FDA from 2010 to 2016. Daniel has also been involved in numerous OGD, OPQ and CDER committees and working groups for guidance and new initiatives development.
Previously, Daniel worked at AstraZeneca (Wilmington, DE) for four years as a Senior Formulation Scientist & Project Lead for Late Stage Product Development. Prior to this, he spent six years as a faculty member at College of Pharmacy, University of Tennessee Health Science Center (Memphis, TN). Daniel obtained his Ph.D. in Pharmaceutics in 1998 from West China University of Medical Sciences (Chengdu, China). He has published 4 book chapters, 21 peer reviewed papers and 4 US patents. Daniel has extensive experience in formulation and process development for solid oral dosage forms and novel drug delivery systems. Daniel has been invited to give presentations on various evolving regulatory topics such as QbD, DOE, process capability, quality risk management, regulatory commitment and lifecycle approach for process validation in domestic and international conferences.