Tai Yu

VP, Regulatory Affairs at Bolt Biotherapeutics

Tai Yu, Vice President, Regulatory Affairs, joined Bolt Biotherapeutics in 2022 with more than 18 years of clinical research and regulatory affairs experience across multiple therapeutic areas. Prior to joining Bolt, Mr. Yu worked at Amgen for more than 16 years with increasing regulatory strategy and oversight responsibilities for clinical programs and marketed products. Most recently, Mr. Yu served as the Global Regulatory Leader for bemarituzumab. During his tenure at Amgen, Mr. Yu was responsible for regulatory strategy for multiple T cell engager programs in early clinical development, participated in meetings with the FDA Oncologic Drug Advisory Committee, EMA Scientific Advisory Group, and other regulatory agencies. He also led global marketing application filings and approvals of BLINCYTO (blinatumomab) worldwide, including in the U.S., EU, Japan, China, and other countries. Prior to Amgen, Mr. Yu worked in clinical research at the City of Hope National Medical Center and The Parkinson’s Disease and Movement Disorder Institute. Mr. Yu holds a master’s degree in biological sciences, with an emphasis in molecular biology and a bachelor’s degree in microbiology and medical technology from California State Polytechnic University, Pomona.

Timeline

  • VP, Regulatory Affairs

    Current role

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