Dr. K. Pucaj has over 33 years of extensive experience in veterinary medicine, experimental pathology and nonclinical toxicology, out of which about 26 years has been spent in a contract research organization, conducting and directing nonclinical toxicity studies. He has in-depth knowledge of various ICH/FDA guidelines related to preclinical pre-IND (pre-CTA) drug development. He was preparing protocols, directing studies and writing preclinical study reports to meet standards of ICH/FDA/TPD/OECD and EU guidelines. He was also consulting clients on product development strategies to meet international regulatory request and preparation and management of nonclinical drug development programs (IND Enabling to Phase III). Dr. Pucaj received his DVM and Diploma in Small Animal Medicine from the University of Zagreb (Croatia), he is licensed veterinarian in the Province of Ontario, received a MSc in pathology from the University of Toronto, and is a Diplomate of the American Board of Toxicology. K. Pucaj is included in the external Scientific Experts Database for the Therapeutic Products Directorate of Health Canada, for the expert advice or review and recommendation on nonclinical and toxicology data.
Dr. D. Vaughan has over 25 years of broad pharmaceutical development experience. Since 2001, he has acted as an independent consultant to the pharmaceutical industry with significant clinical/ preclinical development and regulatory expertise in the GI, infectious disease, pain and CNS areas. More broadly, Dr. Vaughan has led or participated in numerous pre-clinical and NDA submission activities across virtually all therapeutic areas for numerous well known large pharmaceutical and venture-stage biotechnology companies. His past employers or clients include: BMS, Bayer, Pfizer, Affinium, NeurAxon, Intermune, Oscient, and Replidyne and he has also been an Entrepreneur-in-Residence at the University of Toronto. Prior to entering industry, Dr. Vaughan conducted oncology research at The Princess Margaret Hospital in Toronto. He received his PhD in Clinical Pathology and Biochemistry from the University of Toronto.
Dr. M.A. (Tony) Hayes is an internationally recognized veterinary pathologist with over 25 years experience as a toxicologic pathology consultant in environmental toxicology research and preclinical pharmaceutical development. He obtained a veterinary degree from the University of Melbourne in 1971 and after several years in clinical practice, he emigrated to Canada in 1975. In 1980, after graduate studies in veterinary pathology and toxicology at the University of Saskatchewan, he obtained a PhD and became a Diplomate of the American College of Veterinary Pathologists (ACVP). As an MRC postdoctoral fellow and then adjunct professor, he worked for 5 years on mechanisms of chemical carcinogenesis in the Department of Pathology at the University of Toronto. In 1983, he joined the faculty in the Department of Pathology (now Pathobiology) at Ontario Veterinary College at the University of Guelph. During his 30-year academic career, he developed specialized expertise in toxicological pathology and in the diagnosis of liver diseases, and also taught diagnostic pathology, neoplasia and mechanisms of disease in the DVM and graduate programs. His research laboratory has focused on carcinogenesis, toxic liver injury and innate immunity, utilizing various biochemical, molecular genetic, proteomic, immunodiagnostic and microscopic approaches. He supervised the research of more than 30 graduate students and postdoctoral fellows, authored or co-authored over 300 scientific articles and presentations, and obtained over $5m in research grant funding. He has received several awards for teaching and research, and received the University Professor Emeritus award from the University of Guelph in 2013. He is a member of the ACVP, the Society of Toxicologic Pathology, the American Society for Investigative Pathology, and the College of Veterinarians of Ontario.
