Despite the success of tissue engineered medical products (TEMPs) in preclinical translational research, very few have had success in the clinical market place. This gap, referred to as the “valley of death” is due to the large number of ventures that failed to attract or retain investor funding, promotion, and clinical acceptance of their products. This loss can be attributed to a focus on a bench to bedside flow of ideas and technology, which does not account for the multitude of adoption, commercial, and regulatory constraints. The implementation of an alternative bedside to bench and back again approach permits investigators to focus on a specific unmet clinical need, defining crucial translation related questions early in the research process.
Regenerative medicine therapies aim to rebuild and restore health to patients challenged by chronic conditions and degenerative diseases. Despite advances in the field, much of the science is still in early research phases, meaning that many treatments haven’t been proven safe and effective for humans as standard-of-care therapies yet. Because the scientific process is long, and there is great hope for regenerative therapies as treatments for a wide variety of diseases, the FDA has created streamlined pathways to help get regenerative options to patients more quickly. In fact, the FDA recently announced that it will greatly expand its regenerative therapies review process.