Translation and commercialization of regenerative medicines.

Historically, human healthcare has evolved within two main disciplines—medicine and surgery. Medicine has primarily focused on the use of chemistry to attempt to restore, correct or modify physiology in order to achieve alleviation of symptoms and in some instances (e.g. bacterial infections) cures. By the end of the last century, biological medicinal products had also become increasingly important comprising maybe 10 per cent of all marketed medicines. Surgery, in contrast, is by and large a physical science and employs engineering and material technology to address anatomical defects, abnormalities and trauma by physical repair. These very different modes of treatment have resulted in distinct funding structures, business models, regulatory pathways and reimbursement routes, which have evolved to allow the commercial success of medicines and medical devices. Regenerative medicine brings together these and other disciplines to create hybrid products for which neither commercial pathways are applicable and brings also additional unique challenges, for example, the logistics of delivering autologous cell products. Regenerative medicine products, unlike most medicines or medical devices, promise cures in many cases; such high expectations of product performance bring similarly high expectations from investors, regulators and healthcare providers. This series of papers explores the various issues that face regenerative medicine as a new multi-disciplinary field. Various scientific obstacles stand in the way of the successful translation of regenerative medicine: within this Theme Supplement there is good evidence that progress is being made with a number of these. The source