With over 15 years of FDA CDER review experience and 12+ years in pharmaceutical industry and CRO management, Dr. Dou has a comprehensive background in drug evaluation and development. While serving as a Pharmacology Reviewer and Team Lead for Botanical Drug Review at the U.S. FDA, they led safety assessments of new drugs and played a pivotal role in the approval of Veregen and Fulyzaq, the only two botanical drugs approved in FDA history. They also contributed to the development of FDA guidance documents and provided regulatory consulting across FDA centers including CBER and CVM. Professor Dou has comprehensive, end-to-end expertise in pharmaceutical R&D and product development.