This session will focus on the challenges involved in the development of cell therapy products for clinical applications. It follows the real-life development of a cell therapy product used in a clinical trial. Essential phases of product development and its many challenges are presented. Other topics include the timing for IND submissions, budgetary concerns, intellectual property concerns, specimen collections for laboratory endpoint studies and the considerations to move to a Phase I-II trial after the Phase I trail is complete. It is presented by a development team involved in the trial and includes the research scientist, the physician and cell therapy lab personnel. Their combined experience provides the framework for a working model of the process that moves from preclinical studies to completion of a Phase I clinical trial and beyond.