CVG 2021 Seminar-3:Pre-Clinical Toxicology in the Pharmaceutical Industry
October 27 @ 5:30 pm to 6:30 pm
Speaker: Dr Robin Walker
Seminar will be conducted online via Zoom @ 5:30 pm EDT and 3:30 MDT
Non-clinical safety assessment is an essential and important component of the drug development process. It is highly regulated with the main sets of compliance requirements being Good Laboratory Practice (GLP) regulations (OECD and individual country) that stipulate how the data should be collected from a quality perspective and International Conference on Harmonization (ICH), OECD, and individual country regulatory guidelines that specify what types, designs, and durations of studies should be conducted.
Speaker: Dr Robin Walker
Dr. Robin Walker is an American Board of Toxicology certified toxicologist with over 35 years of experience in nonclinical aspects of drug development.
After obtaining a PhD from the Department of Pathology in collaboration with the Department of Pharmacology and Toxicology at Queen’s University, Dr. Walker worked for large pharmaceutical companies (Parke-Davis/Warner Lambert and Pfizer) for over 20 years and subsequently as a consultant to private companies and regulatory agencies.
Dr. Walker has extensive experience on international drug development teams with responsibilities for the design, overall direction, summarization, and issue resolution of nonclinical toxicology. He has been a member of highly successful development teams responsible for the development of marketed drugs (Neurontin and Cerebyx) and was responsible for the direction of exploratory and GLP-compliant laboratory operations that supported many other drug development programs. Dr. Walker has been active in the Society of Toxicology of Canada (STC) serving as a councillor on the Board of Directors, member and chair of the Program Committee, and member of the Organizing Committee and co-chair of the Program Committee for the International Congress of Toxicology when it was held in Montreal. He also has extensive experience as a study director and monitor of contracted GLP-compliant toxicology studies and has an extensive record of scientific publication. Consulting experience has been with respect to due diligence evaluations, development of preclinical development plans for small and medium sized pharmaceutical / biotechnology companies, preparation of CTA/IND/NDS/NDA/MAA and other regulatory documents for new chemical entities and medical devices, monitoring of toxicology studies at contract laboratories, and provision of toxicology advice to industry and Health Canada. Dr. Walker has also taught in the Regulatory Affairs Program at Humber College in Toronto and is an adjunct faculty member in the Department of Biomedical and Molecular Sciences at Queen’s University.