Dr. Michael Yao

Medical Doctor Global Biopharma Policy Leader

Key Roles

  • Former Senior Medical Officer, U.S. FDA (15 years): Led policy design and approvals for cell/gene therapies, awarded US FDA Outstanding Achievement
    (2006) and Lifetime Achievement (2017).
  • U.S.-EU Policy Coordinator : Co-Chaired FDA-EUA Biopharma Policy Harmonization Committee.
  • Advisor : Macau SAR Chief Executive, Chinese Academy of Engineering (Immunology), and biopharma investment funds.
  • Academic Roles : Guest Professor at Tsinghua University, Peking Union Medical College, CKGSB, and Macau University of Science and Technology.

Career Highlights

  • Regulatory Architect : Drafted U.S. Congressional/FDA biopharma regulations, shaping global cell/gene therapy frameworks.
  • Global Bridge builder : Pioneered alignment of U.S.-EU regulatory standards for advanced therapies.
  • Strategic Investor : Advisor/shareholder in multiple biotech firms, driving innovation in Asia and beyond.

Legacy

  • Merged regulatory expertise with academic and commercial leadership to advance translational medicine.
  • Recognized as a pivotal figure in global biopharma policy and investment.