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.

Learning Objectives:
  • 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

 Sheldon Morris M.D., M.P.H.
   
 Eric Ahrens, PhD
   
 Michael Caligiuri, PhD
   
 Michael Choi, MD
   
 Joe Ciacci, MD
 
 
 Catriona Jamieson, MD, PhD
   
 Dan Kaufman, MD, PhD
   
 Vickie Sheckler
   
 Robert Signer, PhD