Commercialization of regenerative-medicine therapies

The clinical translation of regenerative-medicine products, including cell therapies, therapeutic tissue engineering products, and human cell and tissue products, remains limited because of the so-called ‘valley of death’, that is, the lack of resources necessary to move a product from early preclinical to clinical development. To advance more regenerative-medicine products into the clinic, academic researchers may benefit greatly from insights into the commercialization process, in particular, through academic startups. In this Review, we discuss key commercialization aspects, that is, protecting intellectual property, navigating regulatory pathways and obtaining funding, and highlight case studies of academic startups that have successfully developed US Food and Drug Administration-approved regenerative-medicine products and companies that have received Regenerative Medicine Advanced Therapy designations for their regenerative-medicine products in development. Academic researchers interested in the commercialization of regenerative-medicine therapies stand to benefit from an understanding of the overall commercialization process. This Review covers, with specific examples, the salient commercialization aspects of protecting intellectual property, navigating regulatory pathways and obtaining funding.