Gregory Hileman

Dr. Hileman has more than 25 years of pharmaceutical regulatory affairs experience, specializing in strategic global regulatory affairs, Food and Drug Administration (FDA) and European Medicines Agency (EMA) meeting management, project team leadership, and pharmaceutical sciences. His areas of therapeutic experience include neurology (sleep disturbances, pain, Alzheimer's disease, migraine, epilepsy, seizure disorders, stroke), psychiatry (depression, anxiety, schizophrenia), drug addiction, antibiotics, oncology, reproductive health, osteoarthritis, and osteoporosis. Before joining Cato Research, Dr. Hileman served 19 years at GlaxoSmithKline, most recently as executive director of Global Discovery Regulatory Affairs. At Cato Research, Dr. Hileman is a senior director of regulatory affairs and a principal regulatory scientist in the Regulatory Strategy department, working with project teams guiding biologics, drugs, and medical devices through the regulatory process. He has authored multiple Investigational New Drug applications (INDs), Clinical Trial Applications, New Drug Applications (NDAs), Biologics License Applications, orphan drug designations, fast track designations, and breakthrough therapy applications in traditional and common technical document format, as well as final study reports, clinical protocols, annual reports (Development Safety Update Reports), United States (U.S.) pediatric study plans, European Union pediatric investigational plans, gap analyses, and other sponsor-specific reports, including submissions to European Union regulatory agencies. Dr. Hileman earned a B.S. in pharmacy from the St. Louis College of Pharmacy and a Ph.D. in pharmaceutical sciences and physical chemistry from the University of Missouri-Kansas City.