Reinventing Biotechnology Regulations

摘要

Clayton Christensen's theory of disruptive innovation saw new technologies as mere enablers of transformative change. Making a splash requires two more things: business model innovation and new value networks to deliver the technologies in ways that are profitable, affordable, safe, and accessible to consumers. New business models require new regulatory models. Gene editing promises to cure rare forms of hereditary blindness but at prices above $500,000 per eye, if approved using FDA's last-century biologies regulations. Can the blind afford that?