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Speaker Short Biography

  • Simon Li

    Chief Medical Officer

    Evive Biotech

    Short Biography

    Dr. Li has extensive knowledge and experience in global drug development spanning over 25-years of work as CMO, VP and other senior roles in medical research and clinical development with several companies in the US and China including Lilly, Bayer, Pharmacia, Roche, Luye Pharma, CSPC, etc. He has led many clinical programs, obtained 3 NDA approvals in the US and China, and submitted 2 NDAs in the US. Dr. Li has hands-on experience in drug development strategy, clinical development plan, study design and protocol development, clinical project management, site monitoring, CRO management, KOL interactions, etc. He has reached agreements with the FDA and CDE on conditional approvals for several products and successfully convinced the CDE to follow the FDA regulation and US practice, which has resulted in faster marketing approvals. Dr. Li has also worked in pre-clinical area for several years and contributed to translational medicine research of several projects. He has evaluated many licensing candidates and participated in the negotiation and management of several BD deals. He has also participated in roadshows for 2 IPOs and routine interactions with investors. He has established few subsidiary companies or units in the US and China, led the teams to have successfully carried out several in-parallel clinical development programs in the US and China and raised $100 million. He has built the infrastructure for organization growth and SOPs and documentations systems for compliance.