Challenges Identified in the Project for the Development of Human Cell Therapy Products in Hokkaido University: Mid-term Review

Abstract

Background: The Hokkaido University Graduate School of Medicine has been carrying out a project to create cell therapy products for stroke. The aim of this project includes establishing guidelines and initiating personal exchanges between academia and Pharmaceuticals and Medical Devices Agency (PMDA). It is worthwhile for the future development of medicinal products by academia to widely share among academics the knowledge and experiences gained during a project. Objectives: The objective of mid-term review is to elucidate the challenges facing human cell therapy product development in academia and identify potential improvement measures. Methods: The track records of the project, including meeting minutes, were reviewed. Challenges and improvement measures were identified through group discussion from the viewpoints of both the regulatory authority and academia. Results: As a result of our review of the project, we identified periodic review by program officers and consultation with PMDA as good points, insufficient understanding of regulation and obscure roll assignment in the development team as project delaying factors, defining roles and making appropriate assignments as improvement measures to be implemented, and the utilization of information and experience from other clinical trials as a recommendation for the future. Conclusions: In order to accelerate the development of medicinal products, it is important for academia to take full advantage of both information from their clinical trial experience and knowledge concerning project management accumulated in the organization.