POLICY AND PRACTICE REVIEWS article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1581058
Harnessing the promises of cell therapy, gene therapy, and regenerative medicine in Québec, Canada
Provisionally accepted- 1Centre de recherche Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
- 2Institut d’hématologie, oncologie et thérapie cellulaire (iHOT), Hôpital Maisonneuve-Rosemont, Montreal, Canada
- 3Département de Médecine, Faculté de Médecine, Université de Montréal, Montreal, Quebec, Canada
- 4Québec Cell, Tissue, and Gene Therapy Network, Montreal, Canada
- 5Transfusion Medicine, Héma-Québec, Montreal, Canada
- 6Centre of Genomics and Policy, Department of Human Genetics, Faculty of Medicine and Health Sciences, McGill University, Montreal, Canada
- 7Héma-Québec, Montreal, Canada
- 8Borealis Medical Writing Inc, Montreal, Ontario, Canada
- 9Cancer Axis, Centre de recherche du Centre hospitalier de l'Université de Montréal, Montreal, Ontario, Canada
- 10Hepatopancreatobiliary Surgery & Liver Transplantation Service, Centre hospitalier de l'Université de Montréal, Montreal, Canada
- 11Axe santé des populations et pratiques optimales en santé, Centre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Québec, Canada
- 12Département de médecine sociale et préventive, Faculté de médecine, Université Laval, Québec, Canada
- 13Centre de recherche en organogénèse expérimentale de l'Université Laval/LOEX, Québec, Canada
- 14Department of Chemical and Biotechnological Engineering, Laboratoire de bio-ingénierie et de biophysique de l'Université de Sherbrooke, Université de Sherbrooke, Sherbrooke, Canada
- 15Faculté de médecine et des sciences de la santé, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Canada
- 16Centre de recherche du Centre hospitalier universitaire de Québec-Université Laval, Québec, Canada
- 17Département de médecine moléculaire, Université Laval, Québec, Canada
- 18adMare BioInnovations, Montreal, Canada
- 19Centre de Recherche, Centre Hospitalier Universitaire Sainte-Justine, Montréal, Canada
- 20Département de pharmacologie et physiologie, Faculté de médecine, Université de Montréal, Montréal, Canada
- 21Centre C3i, Montréal, Canada
- 22Division of Hematology, Department of Medicine, The Ottawa Hospital, Ottawa, Canada
- 23BioCanRx, Ottawa, Canada
- 24Medical Affairs and Innovation, Héma-Québec, Montréal, Canada
- 25Axe immunopathologie, Centre de recherche du Centre hospitalier de l'Université de Montréal, Montréal, Canada
- 26Département de microbiologie, infectiologie et immunologie, Faculté de médecine, Université de Montréal, Montréal, Canada
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The last decade has witnessed tremendous progress in the fields of cell and gene therapy and regenerative medicine (CGT/RM). However, these advances came with their own challenges and opportunities, which may vary among jurisdictions depending on infrastructures, laws, regulations, access to funding, and socioeconomic, political and cultural aspects.In September 2023, the Québec cell, tissue and gene therapy network (ThéCell) and Héma-Québec held a symposium on the opportunities and challenges of CGT/RM in Québec, Canada. We collected and synthetized the views of scientists, CGT/RM manufacturers, business representatives, and experts in ethics and law, pharmacoeconomics, and regulatory affairs expressed during and after this symposium.Comments were grouped into seven strategic orientations: (1) a framework should be built for the development of CGT/RM products based on principles that will enable fair and timely access for all;(2) governments should spur private and public research investments in CGT/RM; (3) the skillsets of developers should be mobilized to foster the development and production of CGT/RM products in the academic and industrial settings, and the training of Québec's workforce could be better aligned with industry and population needs to facilitate the industrialization of the sector, with the aim of reducing production costs and improving accessibility to patients; (4) Québec should ensure that the province's production and healthcare capacity is aligned with current and future needs in CGT/RM products, considering the rapidly evolving landscape of CGT/RM; (5) regulatory awareness may be improved among developers through outreach approaches and early consultations; (6) the regulations governing the development of CGT/RM could be streamlined and adapted to the needs of these emerging products; (7) ongoing efforts to reform the clinical reimbursement framework could be continued in Québec's public, single-payer healthcare system. This symposium provided guidance addressing current limitations and taking advantage of opportunities in CGT/RM in Québec. These considerations should help guide the development of new policies for CGT/RM products in Québec, keeping with principles of universal healthcare in Canada. We surmise that other jurisdictions face similar challenges, and the global CGT/RM community could benefit from these shared experiences to promote the optimal development and access to these promising therapies.
Keywords: Immune effector cell immunotherapy1, Research funding2, Economic evaluation3, Ethics4, Biological Drug approval5, Cell and tissue manufacturing6
Received: 05 Mar 2025; Accepted: 12 May 2025.
Copyright: © 2025 Delisle, Fournier, Santerre, Rochette, Zawati, Dumont-Lagacé, Turcotte, Guertin, Vermette, Tremblay, Parisotto, Beausejour, Petropoulos, Kekre, Michaud and Dieudé. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Jean-Sébastien Delisle, Centre de recherche Hopital Maisonneuve-Rosemont, Montreal, H1T 2M4, Quebec, Canada
Maude Dumont-Lagacé, Héma-Québec, Montreal, Canada
Mélanie Dieudé, Medical Affairs and Innovation, Héma-Québec, Montréal, Canada
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.