Abstract

As the implementer of translational research / clinical research core center program for Japan Agency for Medical Research and Development, Osaka University Hospital has established an organization “Department of Medical Innovation (DMI)” that promotes clinical translation of basic research findings to bedside and evaluation of latest medical technologies.

Medical Center for Translational Research (MTR) is a division of DMI that comprehensively manages translational research projects of a number of promising seeds for development by providing a variety of support such as consultation from the basic research stage, research funding, non-clinical research, securing intellectual property, business matching, license agreement, regulatory affairs, clinical trial management, cell therapy product preparation, and investigational drug manufacturing through cooperation with the hospital pharmaceutical department. Highly specialized staffs who have carrier working for pharmaceutical companies, CROs, or regulating authorities provide reliable support for difficult tasks. Our facility includes GCTP-compliant cell processing center with 8 cell processing units and quality control laboratory.

Using those facilities and human resources, we have assisted more than 100 novel biomedical seeds toward clinical application. Among them, more than 20 investigator-initiated clinical trials were filed to PMDA and already 4 products have been granted manufacturing and marketing approval until now. One of the most notable recent achievement is the regulatory approval of “Heart Sheet” that is the first-ever regenerative medicine product for heart failure in the World, in September, 2015. Other than this, 7 more regenerative medicine projects including iPS cell-derived products are currently in clinical stage.

To further accelerate medical innovation and global contribution, the Center for Global Health (CGH) was established in DMI. As the outbound services, CGH help exporting Japan’s state-of-the-art technologies especially of the treatment devices, regenerative medicine products and diagnostic systems such as PET system and also provide support for conducting multinational clinical research.

Bio

Akira Myoui, MD, PhD is clinical professor, director of the Medical Center for Translational Research (MTR), Department of Medical Innovation, Osaka University Hospital.

He graduated from Osaka University Medical School in 1986 and finished PhD course in 1993.

In 1994, he was appointed as an assistant professor in the Department of Orthopedics, Osaka University and started research work on musculoskeletal tumors, bone cell biology, bone substitute materials and bone tissue engineering.

He was promoted to associate professor and the vice director of MTR in 2006, awarded a title of clinical professor in 2008, and then appointed to the current position in 2017. After moving to MTR, he has been working on the promotion of clinical translation of excellent discovery from basic biomedical science. In 2015, he was awarded Economy, Trade and Industry Minister’s Prize for the contributors in IndustryAcademia-Public Collaboration through the development of functional artificial bone.

He is a board member of ARO council and Japanese Society for Biomaterials. He is a Managing Editor for Journal of Artificial Organs.

External Speaker – Professor Akira Myoui flyer (PDF)