George Chen
Daiichi Sankyo Inc.
My current position is Executive Director and Distinguished Regulatory Scientist at Daiichi Sankyo Inc. Responsible for the RA CMC group and the recent approvals in the oncology portfolio of both small molecules, Turalio (pexidartinib) Capsules, 200 mg, and the biologicals, Enhertu (trastuzumab deruxtecan) for Injection 100 mg.
My twenty-nine years of regulatory affairs CMC experience starts with my FDA experience as a review chemist in the Division of Gastrointestinal and Coagulation Drug Products, followed by my industrial experience at Boehringer Ingelheim, Altana Pharma, Biovail Technologies Ltd and Daiichi Sankyo Inc.
During the course of my career I have been responsible of the approval of seven (7) NDA, two (2) BLA, three (3) API DMFs, and five (5) device DMFs.
My twenty-nine years of regulatory affairs CMC experience starts with my FDA experience as a review chemist in the Division of Gastrointestinal and Coagulation Drug Products, followed by my industrial experience at Boehringer Ingelheim, Altana Pharma, Biovail Technologies Ltd and Daiichi Sankyo Inc.
During the course of my career I have been responsible of the approval of seven (7) NDA, two (2) BLA, three (3) API DMFs, and five (5) device DMFs.