James Cai is Vice President of Global Regulatory Affairs of Amgen since May 2014. Under Dr Cai’s leadership, Amgen JAPAC has successfully filed more than 100 marketing authorization approvals in 3-year. The first PCSKi 9 product is approved in Australia, Japan, South Korea, Taiwan etc…

Prior to Amgen, Dr. Cai worked for Roche / Genentech as head of Asia Early Phase Clinical Development strategy, Vice President of Medical Affairs Roche China. He worked with AstraZeneca as R&D head China, and with other MNCs including Pfizer and MSD as Medical Director and External Affairs Director respectively. He is the first Medical Director with NMCs to initiate the MRCT in China and led biomarker guided MRCT including INTEREST and IPASS trials of Iressa with leading Oncologists from mainland China, Hong Kong, Japan and other markets worldwide. IPASS is the first Asia initiated global MRCT.

Dr. Cai is trained as Medical Doctor and Clinical Scientist from Shanghai Jiao Tao University Medical School, New York University Medical School, MBA from Columbia University.