Canada’s Approach to COVID-19 Vaccine Development and ApprovalThe vaccine development, regulatory review and public health response to COVID-19 have been unprecedented. The innovation and regulatory life cycle frames all aspects of the introduction and revision of therapeutics in Canada. The COVID-19 epidemic has required many innovations to meet Canadian and worldwide needs. This has included a nimble approach to vaccine development and regulatory activities. This presentation provides an in depth perspective on these innovations. Discussion will include success, lessons learned and impact on regulations post pandemic. Using case studies we will explore both the MAH and regulatory authority perspectives.
The vaccine development, regulatory review and public health response to COVID-19 have been unprecedented. The innovation and regulatory life cycle frames all aspects of the introduction and revision of therapeutics in Canada. The COVID-19 epidemic has required many innovations to meet Canadian and worldwide needs. This has included a nimble approach to vaccine development and regulatory activities. This presentation provides an in depth perspective on these innovations. Discussion will include success, lessons learned and impact on regulations post pandemic. Using case studies we will explore both the MAH and regulatory authority perspectives.
Deborah Danoff, MD, FRCPC
Health Canada, Canada
Dr. Danoff is a medical officer in the Marketed Health Products Directorate at Health Canada. Her current focus is post marketing surveillance for biologics including vaccines. She received her medical degree from McGill University Faculty of Medicine and completed specialty training in Internal Medicine and Clinical Immunology and Allergy at McGill. Her clinical practice focused on patients with complex allergy problems or autoimmune diseases. Her research focus included autoimmune diseases and issues related to medical education.
Fiona M Frappier, PhD
Senior Policy Analyst
Health Canada, Canada
Fiona Frappier is a Manager in the Office of Policy and International Collaboration at the Biologics and Radiopharmaceutical Drugs Directorate of the Health Products Food Branch at Health Canada. She has a PhD in HIV Immunology and 10 years of experience on multi-jurisdictional policy issues including COVID-19, rare diseases, genomics and antimicrobial resistance.
Celia Lourenco, PhD
Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB
Health Canada, Canada
Celia Lourenco, PhD has been the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada since November 2018. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia has contributed to international initiatives such as ICH and IPRP, she co-chairs the ICMRA COVID-19 working group and participates on DIA's Council of Regulators.
Associate Director Regulatory Affairs
Pfizer Canada, Inc., Canada
Aline Silahian joined Pfizer Canada in 2003 and currently leads the Regulatory Strategy team responsible for Inflammation & Immunology, Rare Disease and Vaccines. In her years at Pfizer she has led teams responsible for a diverse portfolio including Anti-infectives/HIV, Men & Women’s Health, Endocrinology, Ophthalmology, Respiratory, and several established brands. She began her career in the Pharmaceutical Industry at Abbott Laboratories Canada where she established internal Safety processes & systems and took on roles with increasing responsibility in Pharmacovigilance/Safety and Regulatory. Aline graduated from University of Montreal’s School of Pharmacy and worked for several years as a Community Pharmacist prior to joining Industry.
Leslie D Madden, LLM, MBA
Head of Regulatory Affairs, Canada
Moderna, United States
Leslie Madden is the Head of Regulatory Affairs (Canada) at Moderna, responsible for leadership & strategic oversight of the registration of Moderna’s mRNA-based therapies, including the COVID-19 vaccine program. She has more than 15 years of experience with roles extending across the disciplines of RA, marketing, sales, QA, PV and BD. Prior to joining Moderna she was the Director of Regulatory at Elvium, Global Regulatory Lead at Biogen (US), and held positions at Galderma and GSK. Leslie earned a BSc from York University, an MBA from Rotman School of Management and a Global Professional LLM from the Faculty of Law at University of Toronto. She also serves as an Advisor for the Life Sciences Career Development Society (LSCDS).
Ron Boch, PhD
Vice President, Biotechnology and Industry Affairs
Dr. Ron Boch is the Vice President, Biotechnology and Industry Affairs with lead responsibility for BIOTECanada’s policy development reflecting the diverse nature of Canada’s health, industrial and agricultural biotechnology sectors. He brings a wide range of scientific, research and commercialization expertise in his work with emerging companies, vaccine manufacturers and global pharmaceutical companies, having worked for over 25 years with industry particularly regarding biotechnology products, vaccines and formulation. Dr. Boch serves advisory Boards including the Industry Advisory Committee of the Drug Development and Innovation Centre at the University of Alberta. He received the 2021 CSPS award of leadership in pharmaceutical Sciences