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Dr. Oortgiesen is managing director of the Durham office of Cato Research and has more than 20 years of research and drug development experience in academia and the biotechnology and pharmaceutical industries. She oversees all facets of the company’s projects and has expertise in most aspects of drug development and clinical research, including regulatory strategy, clinical trial management, and pharmacovigilance. In her global position as director of Integrated Drug Development, Dr. Oortgiesen is responsible for overseeing activities within the group of Integrated Drug Development scientists to ensure the continuity of services and deliverables provided across all Cato Research locations. She also facilitates the activities of the pharmacovigilance group to confirm compliance with all applicable safety regulations. Dr. Oortgiesen has managed various international clinical programs as project manager and program director, overseeing clinical trials (Phases 1 through 4), pharmacovigilance, as well as the preparation of clinical protocols, Investigator’s Brochures, and clinical study reports. In addition, she has experience in a broad range of regulatory and clinical development activities, working on strategic development plans, multiple successful Investigational New Drug applications, marketing applications, Orphan Drug Applications, and fast track applications. Dr. Oortgiesen’s academic background started in neuropharmacology and neuroimmunology with collaborative projects in the United States and the Netherlands with various health and environmental agencies and other governmental and corporate institutions. Subsequent biotechnology and pharmaceutical projects involved drugs and biologics in a range of therapeutic areas with a focus on oncology, but also including immunology, neurology, and infectious diseases. Dr. Oortgiesen is Regulatory Affairs Certified by the Regulatory Affairs Professionals Society and is a Certified Clinical Research Professional by the Society of Clinical Research Associates. | 