Areas of Expertise:
Denis Roy, PhD
Denis has more than 30 years of experience in nonclinical research and drug development in pharmaceutical, biotechnology, consulting, and contract research organizations. As a Vice President of SciLucent, he provides senior management and leadership oversight of the Nonclinical Safety and Development services and manages a professional team comprised of pharmacologists and toxicologists. Denis develops and oversees the implementation of international regulatory strategies and nonclinical testing programs for pharmaceuticals, biologics, medical devices, and combination products for diverse therapeutic areas including endocrine/metabolism, oncology, pulmonary, central nervous system, cardio-renal, gastrointestinal, ophthalmic, vaccine, anti-infective/allergy, dermal, ocular, and reproductive health products. He has extensive experience interacting with regulatory agencies and attending meetings with the American and international authorities. Denis has authored and/or provided integrated scientific oversight of regulatory submissions including pre-meeting packages, Investigational New Drug (IND), Clinical Trial Application (CTA), and premarketing and marketing submissions in multiple countries. He has significant experience in different work environments and has effectively directed national and multinational Alliance projects. As a former Study Director, Denis has designed and conducted numerous nonclinical safety studies, in a wide variety of laboratory species, using all routes of administration, including inhalation, ocular, intrathecal, and special delivery devices. In addition, Denis has performed animal surgeries, interpreted clinical pathology datasets, assessed Good Laboratory Practice (GLP) compliance, and directed laboratory operations. He also managed a 70,000 square-feet non-GLP vivarium facility and staff. His technical expertise enables him to provide real-time and hands-on support for the design, outsourcing, conduct and reporting of a wide variety of nonclinical studies including specialty in developmental and reproductive and inhalation toxicology. Prior to joining SciLucent, Denis worked for pharmaceutical, biotechnology, consulting, and contract research organizations. He managed and led the Nonclinical Drug Safety departments in large pharmaceutical and small biotechnology environments and served as the scientific and technical expert in nonclinical regulatory and general drug development for many investigational products, including leptin, amylinomimetics, insulin, glucagon, and GLP1 receptor agonists. Denis has a Ph.D. in Physiology-Endocrinology, an M.Sc. in Experimental Medicine, and a B.Sc. in Biology from Laval University, Quebec, Canada.