Health Canada Cell Therapy Stakeholder Group (CTSG)
Background and Creation of the CTSG
The Canadian regenerative medicine and cellular therapy (RMCT) ecosystem is rapidly evolving. Newly approved cellular therapies and innovative treatments are actively being pursued as frontline treatments for difficult to manage conditions and rare diseases. Their development and influence on the regulatory landscape requires open, detailed dialogue between stakeholders developing those therapies and the regulatory agencies drafting guidelines accordingly. CellCAN, in conjunction with Health Canada, the International Society for Cellular Therapy (ISCT) and the Centre for Commercialization of Regenerative Medicine (CCRM), created a mutual and open discussion between the key stakeholders in the cell therapy community through a series of face-to-face meetings at Health Canada headquarters in Otttawa, ON.
Creation of this Cell Therapy Stakeholder Group (CTSG) with key international, national and regional stakeholders from the RMCT community has facilitated discussions on critical regulatory, quality and policy issues surrounding the field of cell-based therapies as well as provide an opportunity for mutual education on novel topics.
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.
Key Founding Members
- A pan-Canadian network of Cells, Tissue and Viral Vector Manufacturing Facilities (CMF) in Canada.
- Affiliated scientists and clinicians interested in advancing cell-based therapies.
- Mandated to harmonize quality and cGMP across its Canadian sites.
- Enabling innovative cell-based therapies for various disease indications.
- Consolidates feedback from the scientific community on various manufacturing, quality, regulatory and policy issues surrounding cell therapy in Canada.
- Committed to disseminating the knowledge gained under this program to critical user groups across Canada.
International Society of Cellular Therapy (ISCT)
- Represented by the North America Legal and Regulatory Affairs (NA LRA) Committee.
- Serves members and non-members in the cellular therapy field by providing up-to-date and relevant information regarding U.S., Canadian and international regulations, standards, and guidance.
- NA LRA Committee also acts as a conduit to train and provide information on relevant quality and manufacturing technical issues, publishes best practices, and represents regulatory concerns back to Regulatory Agencies.
- A Canadian, not-for-profit organization supporting the development of foundational technologies that accelerate the commercialization of cell and gene therapies, and regenerative medicine-based products and technologies.
- Leverages funding, infrastructure and their network of academics and industry partners to mobilize business and scientific expertise, enabling the translation of technologies into commercial products and therapies to meet the needs of patients in the future.
- Over 10 years of regulatory experience navigating both Canadian and international regulatory policies for transplant material, cell therapies, and gene therapies.
Dr. Sowmya Viswanathan, University Health Network, Toronto, ON (Co-chair, Cellular Manufacturing and Clinical Trials)
Dr. Olive Sturtevant, Administrative Director of Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana Farber Cancer Institute (Co-chair, ISCT Representative)
Catherine Parker, Director General of the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch, Health Canada
Minutes of the Meetings
A summary of frequently asked questions (FAQ) is currently in production and will be available shortly. Stay tuned!