CTEG: Bench to Bedside: Designing pre-clinical studies to support in-human trials. (Part 2 of 2)

A presentation by Julia Pomoransky, PhD (Turnstone Biologics) at the Bench to Bedside for Biotherapeutics (B3) Workshop held in Toronto on October 5, 2017.

In this seminar, Dr. Pomoransky discusses the translational continuum of moving pre-clinical studies towards in-human trials. Through a series of examples, Dr. Pomoransky discusses the considerations of pre-clinical development including; pre-clinical POC, GLP toxicology, process and assay development, GMP manufacturing and testing, stability testing and regulatory interactions.

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.

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We wish to acknowledge this land on which CCRM operates. For thousands of years, it has been the traditional land of the Huron-Wendat, the Seneca, and the Mississaugas of the Credit. Today, this meeting place is still the home to many Indigenous people from across Turtle Island and we are grateful to have the opportunity to work on this land.