Past Event! Note: this event has already taken place.
You’re Invited! Dr. Dean Smith to speak at Carleton on the expedited authorization of COVID-19 vaccines
January 20, 2022 at 12:00 PM
The Department of Health Sciences is please to announce the next seminar in our 2021-2022 Health Sciences Seminar Series.
Key Scientific and Regulatory Principles That Support Expedited Authorization of COVID-19 Vaccines
January 20, 2022 12:00 PM Eastern Time (US and Canada) | Virtual event on Zoom
|It is essential for regulatory authorities to support innovation through appropriate and efficient risk/benefit driven review pathways and to come to timely evidence-based decisions. The current COVID-19 pandemic highlights the importance of Health Canada’s (HC) regulatory lessons learned over the past twenty years. These lessons have drawn from our regular vaccine review activities, preparedness efforts related to bioterrorist threat vaccines, and earlier pandemics (2003 SARS-CoV-1, 2009 H1N1, 2014/2016 large-scale Ebola outbreaks in West Africa). As of a result of the above experiences, and prior to the current pandemic, HC embarked on regulatory renewal to provide an agile regulatory framework to support ongoing regular, as well as emergency, review and authorization activities.
The importance of early phase 1 – 2 dose ranging studies with well-characterized immunogenicity studies to expedite authorization will be highlighted. How this approach also supports the urgently required manufacturing scale-up and related regulatory approvals will be described. Additionally, when combined with phase 3 efficacy and disease break-through data, dose ranging studies permit correlates of protection (CoP) analyses and new vaccine development. Current thinking on CoP and immunobridging options for new COVID-19 vaccine authorizations, evaluation of post-market vaccine effectiveness studies against variants of concern (VOC) and insights into COVID-19 vaccine pharmacovigilance will also be presented.
About the Speaker
|Dean Smith is an Associate Director in the Center for Biologics Evaluation (CBE) at Health Canada. Dr. Smith has over 20-years of experience in regulatory science in support of innovation in vaccine development, manufacturing and quality control. He has a wide range of biologics-based scientific and regulatory experience from his Senior Scientific Evaluator and management roles in CBE Divisions, including Bacterial and Viral Vaccines, as well Hemostatic Agents and Blood Substitutes. Representing Health Canada, Dr. Smith contributes to WHO’s vaccine and vaccine stability guidance development initiatives. He is Health Canada’s representative to the European Directorate of Quality of Medicines (EDQM) Group 15 (Vaccines) in support of the European Pharmacopeia, the Regulatory Advisory Committee with the Collation for Emergency Preparedness and Innovation (CEPI) and serves on the Science and Ethics Advisory Committee for VAC2VAC under the European Vaccines Initiative. Dr. Smith’s Ph.D. in Immunology is from the University of Alberta, Alberta, where his research dealt with vaccine antigen discovery, autoimmunity and viral vector-based gene therapy, and was a Research Associate at the NRC’s Institute of Biological Science, Vaccine Design Group prior to joining Health Canada.|