Translational Regenerative Medicine (Stem Cell Translation): Sheldon Morris M.D., M.P.H. & Catriona Jamieson, M.D., Ph.D.

This course, focused on the practical application of the principles of translating Stem Cell based therapies that focuses on the early development and phase 1 studies required to translate these interventions from the bench to the bedside. This course will highlight the unique aspects of stem cell based therapies compared to drug development.

• Understanding to bench to bedside concept for Regenerative Medicine
• Understand the scope of Regenerative Medicine (e.g. what are stem cell versus cellular based therapies)
• Understanding the process of development of new stem cell based therapies
• Determining the preclinical work needed to support first-in-human studies
• Identify and describe the appropriate study design and methods
• Select a study population and methods for their recruitment and selection  of study subjects for a stem cell study
• Describe methods of stem cell delivery and monitoring
• Understand Human Subjects issues for Regenerative Medicine studies
• Describe approval process for Regenerative Medicine products
• understand the purpose and structure of a targeted product profile