Michel Mikhail
Senior VP
International Expert in Biosimilars
USA
Biography
Dr. Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Monoclonal antibodies Medicines. He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, ICH Guidelines and now in the US-FDA Biosimilars Guidelines. He is a Chartered Expert in Pharmacology-Toxicology, a chartered Clinical Expert as well as a chartered Analytical Expert. Dr. Mikhail is member of the Expert committee of the Government Federal Institute of Risk Assessment (BfR) Germany and served as member of the Expert Committee for Toxicology of the United States Pharmacopoeia (USP)..
Research Interest
Biosimilars, Monoclonal antibodies Medicines, Pharmacology-Toxicology