Working with various collaborators from Ottawa Hospital Research Institute and the Biotherapheutics Manufacturing Centre, coordinated activities for preparing the quality overview summary (QOS) of the clinical trial application, addressing all requirements set forth by Health Canada’s guidelines: For Clinical Trial Sponsors- Clinical Trial Applications and guidelines for Preparation of the Quality Information for Drug Submissions in the CTD Format- Biotechnological/ Biological (Biotech) Products. The submitted CTA contained over 1500 pages and was approved by HC within 30 days with no conditions.
Immunotherphy CAR-T clinical trial
Canada’s Michael Smith Genome Sciences Centre respectfully acknowledges that we operate on the traditional, ancestral and unceded territories of the xʷməθkwəy̓əm (Musqueam), Səl̓ílwətaʔ/Selilwitulh (Tsleil-Waututh), and Skwxwú7mesh (Squamish) nations who have cared and nurtured this land for all time. We give thanks, as uninvited guests, to be able to live and work on these lands.
