This project analyses two distinctive approaches of commercialisation in regenerative medicine; the centralised global approach, and a distributed localised approach. It will involve a comparison of these approaches, together with multiple hybrids of these models that foster local industrial growth. Conceptualisation of these models will be examined through behavioural economics/entrepreneurship analysis from the perspectives of scientists, suppliers, patients, clinicians and payers, resulting in new business models for global/localised commercialisation. An understanding of the decision-making processes surrounding how a therapy is regulated will allow this project to contribute towards the improvement of regulatory pathways, e.g. early definition of product/therapy/device classifications, approval processes, pharmacovigilance and governance mechanisms.