Managing the Chain of Custody and Identity for Regenerative Medicine Products.
By: Daniel R. Matlis, President
According to FDA Commissioner Scott Gottlieb, M.D. “We’re at the beginning of a paradigm change in medicine with the promise of being able to facilitate regeneration of parts of the human body, where cells and tissues can be engineered to grow healthy, functional organs to replace diseased ones; new genes can be introduced into the body to combat disease; and adult stem cells can generate replacements for cells that are lost to injury or disease. This is no longer the stuff of science fiction. This is the practical promise of modern applications of regenerative medicine.”
The promise of individualized therapies is why the FDA is encouraging and supporting innovation in this field. To this end, the Agency has released a framework outlining how it intends to apply existing laws and regulations to oversee these products. FDA’s stated goal is to ensure that it is nimble and creative to foster innovation, while taking steps to protect the safety of patients.
In individualized patient-derived cellular gene therapy products, the patient is the raw material, product, and the treatment. In gene therapy products, cells removed from the patient become the raw material. They are then genetically modified and returned to the patient as the “finished product”.