A presentation by Lauralyn McIntyre, MD and Josee Champagne (Ottawa Hospital Research Institute) at the Bench to Bedside for Biotherapeutics (B3) Workshop held in Toronto on October 5, 2017.
In this seminar Dr. McIntyre provides an overview of the clinical trial pipeline, highlighting the goals and rational of each stage. Through a series of examples from the CISS Trial, Dr. McIntyre discusses the basic design principles of starting a Phase 1 Clinical Trial. Josee Champagne next examines the regulatory challenges for Investigator-led Clinical Trials and provides an overview of the Clinical Trial Application Process and considerations when preparing for Health Canada approval.
This video is presented by the Clinical Translation Education Group: BioCanRx, CCRM, CellCAN, Foundation Fighting Blindness, Ontario Institute for Cancer Research, Ontario Institute for Regenerative Medicine and Stem Cell Network.