Development of cell therapy medicinal products by academic institutes.

ABSTRACT

In the rapidly evolving fields of cellular immunotherapy, gene therapy and regenerative medicine, a wide range of promising cell therapy medicinal products are in clinical development. Most products originate from academic research and are explored in early exploratory clinical trials. However, the success rate toward approval for regular patient care is disappointingly low. In this paper, we define strengths and hurdles applying to the development of cell therapy medicinal products in academic institutes, and analyze why only a few promising cell therapies have reached late-stage clinical development. Subsequently, we provide recommendations to stakeholders involved in development of cell therapies to exploit their potential clinical benefit.