Robert Niecestro

Robert Niecestro, Ph.D. is an experienced professional in the pharmaceutical industry with approximately 26 years of experience in regulatory affairs, and project management. Dr. Niecestro was the Vice President of Clinical and Regulatory Affairs for Keryx Biopharmaceuticals, Inc., where among other things he successfully negotiated six SPA agreements with the FDA. He has previously held 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, Dr. Niecestro was part of the team that developed the following approved drugs: extended-release metformin, extended-release lovastatin, and valproic acid. At Eisai, Dr. Niecestro 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). Dr. Niecestro has been involved in the filing of over 45 Investigational New Drug (IND) applications, has over 60 peer-reviewed publications, and holds three patents. Dr. Niecestro completed his graduate and post-graduate work at the University of Illinois at Chicago.