Tai Yu
About Tai Yu
Tai Yu Vice President Regulatory Affairs at Bolt Biotherapeutics
Tai Yu is the Vice President of Regulatory Affairs at Bolt Biotherapeutics, having joined the company in 2022. His role involves overseeing regulatory strategies and ensuring compliance with industry regulations. With his extensive experience, he plays a crucial part in guiding the company through the complex regulatory landscape, aimed at bringing innovative therapies to market.
Tai Yu's Extensive Experience in Clinical Research and Regulatory Affairs
Tai Yu has over 18 years of experience in clinical research and regulatory affairs across diverse therapeutic areas. His career spans various significant responsibilities, including managing regulatory strategies and overseeing clinical programs and marketed products. His extensive experience ensures comprehensive understanding and execution of regulatory requirements.
Tai Yu's Tenure at Amgen
Tai Yu spent more than 16 years at Amgen, where he handled increasing regulatory strategy and oversight responsibilities. At Amgen, he served as the Global Regulatory Leader for bemarituzumab and led global marketing application filings and approvals for BLINCYTO (blinatumomab). His work enabled successful submissions in regions including the U.S., EU, Japan, China, and others, thereby facilitating the global availability of these therapies.
Educational Background of Tai Yu
Tai Yu holds a master's degree in biological sciences, with an emphasis in molecular biology. Additionally, he has a bachelor's degree in microbiology and medical technology from California State Polytechnic University, Pomona. This academic background provides him with a solid foundation in scientific principles essential for his role in regulatory affairs.
Early Clinical Research Roles of Tai Yu
Prior to his role at Amgen, Tai Yu gained valuable clinical research experience at institutions such as the City of Hope National Medical Center and The Parkinson’s Disease and Movement Disorder Institute. These roles helped him develop the skills and knowledge that would later be instrumental in his regulatory and clinical research career.