Will regulation be the death of cell therapy in the United States?

Advanced cell-based therapies are rapidly evolving and there is apparent increasing tension between regulation and introduction of new scientific advances. The model and concept of product development has introduced new challenges for laboratories developing cell-based therapies. The scale-up of experimental processes to production processes is an expensive but poorly compensated activity. The regulatory issues including personnel and facility requirements for manufacturing creates significant economic barriers to academic centers entering the field. As yet the model of product development envisioned by regulatory agencies is a patented commercial product to be manufactured by a company or its licensed manufacturers. The alternative model of advanced blood banks producing products may provide wider dissemination of products to patients. Although regulations have sometimes been perceived to be delaying advances, the regulatory agencies are evolving into a cooperative, supportive position that will ultimately speed the introduction of safe and effective cell-based therapies to broad clinical use. The vision for cell-based therapies needs scientific breadth and regulatory understanding to benefit the greatest number of patients.