Health Canada Cell Therapy Stakeholder Group (CTSG)
About the CTSG
The CTSG bilateral meeting was initiated for the manufacturers of GMP cell and gene therapy products to interact directly with the Canadian regulatory authorities. Since 2014, the Biologics and Radiopharmaceutical Drugs Directorate (BRDD; formerly the Biologics and Genetic Therapies Directorate (BGTD)) hosts regular bilateral meetings with a number of national stakeholder organizations to discuss and consult on regulatory issues of mutual interest, exchange information, share expertise and, when appropriate, responsibilities. These organizations include those whose business is directly impacted by the regulation of biologics, cell and gene therapies, blood and blood products, and radiopharmaceuticals, e.g. industry and other associations.
Key stakeholders in the cell therapy community, currently representing more than 2000 people across Canada, created a mutual and open discussion with an aim to create a unified group to meet with BRDD in the bilateral meeting program to discuss topics relating to cell and cell-based gene therapies. Thereafter, BRDD can hold meetings with Cell Therapy Stakeholders, with a view to improving interactions between the regulator and the cell therapy community, improving capacity to navigate cell therapy regulations, and to discuss challenges as they relate to cell therapy submissions.
Objectives of the CTSG
The Cell Therapy Stakeholder Group will engage in a bilateral dialogue with Health Canada in order to:
Identify and address regulatory policy gaps for cell therapy in Canada,
Identify enabling guidelines,
Identify quality and regulatory challenges,
Identify pre-clinical and clinical regulatory bottlenecks and assist in proposing mutually acceptable solutions,
Gather the most important questions from the RMCT community for dialogue with HC and disseminate the responses back to the RMCT community at large.
The purpose of the group is to increase transparency of the regulations and guidelines and which in turn can facilitate easier translation of cell therapy and regenerative medicine innovations in Canada.
Dr. Olive Sturtevant, Administrative Director of Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana Farber Cancer Institute (Co-chair, ISCT Representative)
Dr. Celia Lourenco, Director General of the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch, Health Canada
Dr. Sowmya Viswanathan, University Health Network, Toronto, ON (Co-chair, Cellular Manufacturing and Clinical Trials)
Minutes of the Meetings