Dr. Li has extensive knowledge and experience in global drug development with a career spanning more than 27-years served in CEO, CMO, VP, and other senior roles with several global companies in the US and China including Lilly, Bayer, Pharmacia, Roche, Luye Pharma, and CSPC, as well as in start-up companies. He has led many clinical programs, obtained 3 NDA approvals in the US and China and 3 orphan drug designations in US, and submitted 3 applications for marketing approvals. Dr. Li has hands-on experience in drug development strategy, clinical development plan, study design and protocol development, clinical project management, site and CRO management, KOL interactions, etc. He has negotiated agreements with the FDA and CDE on approvals for several products and successfully persuaded the CDE to follow the FDA regulation, which has resulted in faster marketing approvals. Dr. Li has also participated in roadshows for 2 IPOs and raised $100 million. He has established several subsidiary companies or research centers in the US and China and led the teams to successfully carry out several clinical development programs in the US and China. He has built infrastructure for organization growth and established SOPs and documentation systems for compliance.