Robert Niecestro Ph.D. — Executive Vice President of Clinical and Regulatory at TG Therapeutics

Dr. Robert Niecestro, Ph.D. has been Head of Regulatory Affairs of Axsome Therapeutics, Inc since October 2012 and has been its Vice President of Clinical and Regulatory since September 15, 2016. Dr. Niecestro served as Vice President of Axsome Therapeutics, Inc since October 2012 until September 15, 2016. Dr. Niecestro is an Experienced Professional in the pharmaceutical industry with approximately 26 years of experience in regulatory affairs and project management. Dr. Niecestro served as the Executive Vice President of Clinical & Regulatory at TG Therapeutics, Inc. since December 2011. Dr. Niecestro served as the Vice President of Clinical & Regulatory Affairs of Keryx Biopharmaceuticals, Inc., where among other things he successfully negotiated six SPA agreements with the FDA. He served numerous senior management positions including serving as Vice President of Clinical Development for Andrx Laboratories, Senior Director, Clinical Development and Therapeutic Head for Gastrointestinal, Oncology and Stroke at Eisai Inc. and as Director, Clinical Operations and NDA Planning for Organon Inc. While at Andrx, he was part of the team that developed the following approved drugs: extended-release metformin, extended-release lovastatin and valproic acid. At Eisai, he played a pivotal role in the development and commercialization of Aciphex??? (rabeprazole sodium), the post-NDA program for Aricept??? (donepezil sodium), and started both the oncology and neurology franchises in the United States and while at Organon was part of the team that developed and commercialized the following drugs: Zemuron??? (rocuronium bromide), Orgaran??? (danaparoid sodium), Humegon??? (FSH/LH), Follistim??? (recombinant FSH beta), and one birth control pill (Mircette???). He is involved in the filing of over 45 Investigational New Drug (IND) applications. He has over 60 peer-reviewed publications and holds three patents. He completed his graduate and post-graduate work at the University of Illinois at Chicago.