Registration for OIRM's Clinical Trials Initiative Workshop: April 11, 2017
Clinical Trials Initiative Workshop
As research programs move closer to the clinic, fundamental questions surrounding the regulatory approval and scale-up manufacturing remain. Our April 11th 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 sounding 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.