Denis Roy, PhD
Denis leads SciLucent’s Nonclinical Safety & Development practice, which provides strategic scientific, outsourcing, and regulatory expertise to support international development of a wide variety of healthcare products. In addition to internal management and oversight responsibilities, he provides senior strategic consulting services in nonclinical pharmaceutical development and regulatory toxicology testing strategies for pharmaceuticals, biologics, medical devices, and specialized/combination products for a broad range of therapeutic areas. He has a track record for successfully assisting clients in the development and implementation of integrated international regulatory strategies and addressing issues encountered during product development plans including clinical holds, with both national and international agencies. He has participated in the preparation of numerous pre-meeting packages, INDs, CTAs, and premarketing and marketing submissions in multiple countries. Denis has designed and/or conducted several hundreds of nonclinical safety studies, in a wide variety of laboratory species, using common and specialized routes of administration, including inhalation, intravitreal, intrathecal, and special delivery devices/product combinations. In addition, Denis has direct experience in animal surgeries, clinical pathology, GLP compliance, and GLP laboratory management. His broad technical and scientific 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. He has published book chapters on carcinogenicity testing, nonclinical development of oncology drugs, and biologics development strategies. Denis has a Ph.D. in Physiology-Endocrinology, an M.Sc. in Experimental Medicine, and a B.Sc. in Biology from Laval University, Québec, Canada.