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Adjunct Professor, Department of Biopharmaceutical Sciences at UIC College of Pharmacy
Sarfaraz K. Niazi, Ph.D., SI, FPAMS, FACB, FRSB, is the founder of Adello Biologicsi, a pure play biosimilar products company with manufacturing facilities in Chicago, Cashel (Ireland) and development laboratories in Chicago and Piscataway (NJ). Adello is a fully integrated facility from the creation of cell lines to fill and finish and commercialization. Dr. Niazi created the entire structure of the company, recruited and developed all teams, intensely interacted with FDA and achieved many first-time milestones, including the first waiver given by FDA from conducting phase 3 trials for two biosimilar products. Part of the waiver was based on his patented inventions relating to analytical testing methods to demonstrate 3D and 4D structural similarity of protein drugs that were highly applauded by regulatory agencies. As the founder of Adello Biologics, LLC, Dr. Niazi has raised over $500 Million, the largest such investment raise by a US startup biotech company. He is an inductee into the Chicago Entrepreneur Hall of Fame for his entrepreneurial leadership.ii He is widely written about for his technical expertise and passion in the world press; the Forbes Magazineiii lists him as the most interesting man in the world for his efforts in making high-cost drugs affordable across the globe; other include The Chicago Tribune,iv Crain's Business,v The Express,vi and Diagnostico Brazil.viiBefore founding Adello, Dr. Niazi coordinated global development of several biosimilar products including erythropoietin, interferon alpha, interferon beta, insulin (third largest manufacturing in the world), etanercept, insulin glargine, bevacizumab, and several other products taking them to EMA, and other regulatory agencies. He has managed projects costing several hundred million dollars in the past. He has hands on experience in US, EU, India, Brazil, Pakistan, Iran, Indonesia and many other countries.