The Clinical Trials Initiative Workshop will focus on the practical issues of cell-based clinical trials. Patrick Bedford, Manager of Clinical Translation and Regulatory Affairs at CCRM will speak to the regulatory environment involving the use of IPSC in clinical trials and potential hurdles as these cells move towards the clinic.
Emily Titus, Director of Technology Development with CCRM will address considerations for cell manufacturing and scale-up production of GMP grade IPSC.
Lastly, David Courtman, Senior Investigator at OHRI and Director of the Biotherapeutics Core Facility will provide insights from lessons learned during the process of regulatory approval and implementation of a cell-manufacturing platform to support MSC production for use in cell and gene therapies.
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