Shaw T. Chen, MD, PhD, has been appointed Executive Vice-President of Regulatory Affairs at Polaris Pharmaceuticals, a subsidiary of Polaris Group. Dr. Chen had previously been with the U.S. Food & Drug Administration (FDA) for over 26 years in new drug development. Most recently he served as FDA’s Deputy Director in the Office of Drug Evaluation at the Center for Drug Evaluation and Research.
Unique Skill Set
“We are pleased to have Dr. Chen join us,” said Bor-Wen Wu, PhD, MBA, Chief Executive Officer of Polaris Pharmaceuticals, Inc. “His strong regulatory background coupled with his clinical and basic science expertise provide a unique skill set.”
Dr. Chen’s work at the FDA included management of new drug review divisions, drafting and implementing FDA guidance for new class drug products, and establishing modern drug review agency, as well as educating and training regulatory scientists in the Asian Pacific region.
Dr. Chen received his MD degree from the University of Miami, and his PhD from Johns Hopkins University. He undertook postgraduate training at Johns Hopkins, Yale University, the University of Minnesota, and the U.S. National Institutes of Health, where he was a medical staff fellow in clinical genetics in the Human Genetics Branch. ■