We had our bi-annual Cell Therapy Stakeholder Group (CTSG) meeting with Health Canada on December 4, 2018. 6 Agenda items were presented and discussed at this meeting. Approved meeting minutes are available at the following address: www.cellcan.com/ctsg.

1. The first agenda item included a welcome, roundtable and announcements of retirements and new appointments. Cathy Parker co-chair of the CTSG group and Director General of BGTD announced her retirement effective December 24, 2018 and introduced her replacement, Dr. Celia Lourenco. Dr. Lourenco was the Senior Executive Director in the Therapeutic Products Directorate and has worked in radiopharmaceuticals at BGTD in the past. Georgette Roy, Director, Office of Regulatory Affairs also announced her retirement and introduced Marianne Tang as her replacement.
   
   
2. The second agenda item led by Dr. Courtman from CellCAN was about Early Engagement mechanisms between Health Canada, clinical trial applicants and novel device developers. The discussion centered on various cell manufacturing devices, and how these are regulated by Health Canada as medical devices or not. Early engagement with regulators to understand what regulatory pathways are needed to get these devices approved for use in cell manufacturing practices would be useful. Health Canada responded by providing a quick overview of the classes for medical devices. It further clarified that that there were three main scenarios in which a device may be used in cell manufacturing processes including i) use of an approved medical device that is used for its intended purpose, ii) use of an approved medical device that is used for a different purpose, and iii) use of a medical device that is not approved. In the latter two cases, Health Canada would need additional information to evaluate the equipment and associated manufacturing steps. Health Canada recommended early engagement with them to clarify the requirements.
   
   
3. Olive Sturtevant from ISCT presented on the Use of Banked HCT/P’s and Samples from Biorepositories for Future Clinical use. This discussion centered on issues that arise when cells are cells collected and stored for one purpose, but are repurposed for a different clinical application. Health Canada responded it has similar expectations to the US, and all cells/tissue that are used as source materials for clinical investigations must meet regulatory requirements set out in guidance documents including “Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans.” Health Canada also clarified that a draft position paper on future use of bio-banked material was being prepared. Generally, cells/tissues may be sourced from public banks which are compliant with Cells, Tissues and Organs Regulations, private banks, which may not be compliant or biobanks, which may conduct their own tests. Regardless of the type of banks, all cells/tissues must conform with current regulatory requirements.
   
   
4. Dr. Viswanathan presented on Comparability study requirements for process change as sponsors move from early to later phase clinical trials. This discussion focused on the types of comparability studies needed as sponsors transitioned from early phase to late phase clinical trials. Were in vitro studies sufficient or were in vivo studies required or was clinical testing needed? Health Canada responded that depending on the product and risk analyses, small non-clinical and/or clinical bridging studies could be used to show comparability. Health Canada performs this review on a case-by-case basis and emphasized the importance of characterizing not only the critical attributes but other aspects, using qualified or validated methods.
   
   
5. Dr. Craig Hasilo from CellCAN presented on Development of frequently asked questions from Cell Therapy Stakeholder Group bilateral meetings and BGTD. The discussion focused on the need for a reliable and user-friendly webpage for dissemination of regulatory guidelines and issues. CellCAN working with Health Canada would develop an FAQ function to assist sponsors/users who may find the official website difficult to navigate. The intent was not to misdirect or replace the original website, but to provide easy-to-use information that had been vetted through Health Canada and was therefore reliable.
   
   
6. Gayle Piat from CellCAN presented on Health Canada’s GMP Requirements for Cell Therapy. The discussion focused on the apparent disconnect regarding facility requirements during clinical trials vs. Regulatory Office and Region’s Branch (RORB)’s requirements at the time of product licensure. In response, RORB provided an overview of their GMP inspection program and it’s focus on marketed drugs. Typically, an inspection is scheduled following receipt of an application for a drug establishment license (DEL). RORB also discussed the requirements for importers for drugs manufactured outside of Canada, and the requirements of manufacturers located in Canada vs. US to be GMP compliant. RORB is using this discussion and questions supplied to augment its draft guidance on GMP compliance.

The meeting concluded with a round-table discussion and proposal for a spring 2019 meeting. The next meeting date is to be determined.