Examining Health Canada’s agile new approach to regulating Advanced Therapeutic Products

Elizabeth Toller is an experienced policy specialist and public sector leader with over eleven years’ experience working in the Government of Canada. Her passion for health issues and social policy has seen Elizabeth split her time in government between Health Canada, Immigration, Refugees, and Citizenship Canada, and the Privy Council Office. Elizabeth currently serves as the Executive Director for Regulatory Innovation in Health Canada’s Health Products and Food Branch, driving the modernisation of Canada’s food and drug regulations in support of innovation. Outside of work, Elizabeth is a mother of two and garden enthusiast.

Liz Anne Gillham-Eisen is the Director of the Office of Policy and International Collaboration. As Director, Liz Anne oversees regulatory policy development and stakeholder engagement for Biologics and Radiopharmaceutical Drugs Directorate. She is also responsible for the coordination of international collaboration and capacity building activities. Liz Anne led the policy development for: the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (2007); the Blood Regulations (2014); the regulations under the Assisted Human Reproduction Act (2019); and the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (2020). Liz Anne has published several articles on the organ and tissue donation process as well as on safe donor screening and has co-authored book chapters on the regulation of cells, tissues and organs and advanced cellular therapies.

Nadine Kolas is a senior policy analyst and former researcher with expertise in reproductive biology and early mechanisms of cancer development using mouse models and human cell genomics approaches. After completing her PhD in molecular genetics from Albert Einstein College of Medicine in New York City, she conducted post-doctoral work at the Lunenfeld-Tanenbaum Research Institute in Toronto where she discovered novel genes that modulate DNA repair. Her work has been published in journals including Science and Cell, she has held fellowships from CIHR and the Terry Fox Research Institute, and won the 2008 Polanyi Award for medicine/physiology from the Ontario government. Shifting her focus from research to knowledge translation, she turned down an offer to start her own lab in favour of policy with Health Canada and has been the senior policy analyst for advanced cell therapies in Health Canada’s Health Products and Foods Branch since the beginning of January 2017. Prior to joining the Branch she worked with an expert panel, led by David Naylor, to review the federal ecosystem supporting fundamental research in Canada; and developed policy for knowledge translation and research governance for management of Health Canada’s regulatory research programs including chemicals, nanomaterials, Northern contaminants and air pollution.

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