Edmund Mickunas

Vice President Regulatory Affairs and Quality Assurance

Ed has over 40 years of experience in various areas of drug and biologic development, including the last 15 years focusing on gene therapy and regenerative medicine. He has also served as Chief Operating Officer, NewStem Biotechnology, COO of Seeing Medicines, Inc. and Regulatory Affairs and Quality Consultant for Semma Therapeutics, Asterias, InVivo, Vigeo Therapeutics and ImStem Biotechnology. He was the Vice President of Regulatory Affairs, QA and Clinical at Advanced Cell Technology/Ocata Therapeutics, who was the principal strategist for two of the first human ESC-derivative cell clinical trials approved by FDA in the US and the first human ESC-derivative cell clinical trial approved in EU.


Ed has over 40 years of experience in various areas of drug and biologic development, including the last 15 years focusing on gene therapy and regenerative medicine. He has also served as Chief Operating Officer, NewStem Biotechnology, COO of Seeing Medicines, Inc. and Regulatory Affairs and Quality Consultant for Semma Therapeutics, Asterias, InVivo, Vigeo Therapeutics  and  ImStem Biotechnology. He was the Vice President of Regulatory Affairs, QA and Clinical at Advanced Cell Technology/Ocata Therapeutics, who was the principal strategist for  two of the first human ESC-derivative cell clinical trials approved by FDA in the US and the first human ESC-derivative cell clinical trial approved in EU.