Health Canada Cell Therapy Stakeholder Group (CTSG)

Background and Creation of the CTSG

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.

CellCAN, 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 with an aim to create a unified group to meet with BGTD in the bilateral meeting program to discuss topics relating to cell and cell-based gene therapies. Thereafter, BGTD can hold meetings with Cell Therapy Stakeholders, including CellCAN, ISCT, CCRM, and RMAC 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.

Key Founding Members

CellCAN 

  • 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.

CCRM

  • 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.

Current Chairs

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)

Celia Lourenco, Director General of the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch, Health Canada

Documentation

Minutes of the Meetings

FAQ

A summary of frequently asked questions (FAQ) is currently in production and will be available shortly. Stay tuned! 

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