Title:
Acceleration of Translational Research – Bridge over Tomorrow

Toshihiko Okazaki Associate Professor
Incubation Center for Advanced Medical Science(ICAMS), Kyushu University Hospital

Abstract:
　Recently, the developmental strategy of new therapeutic methods has been activated. The related venture companies are flooded around the United States as well as Japan , and increasing number of clinical research protocols have been proposed with accelerating speed. It is now in the state that several gene therapy medicines are waiting for approval of clinical application in the world, and recently dendritic cell vaccine as the first cellular-medicine in the world has been authorized by Food and Drug Administration (FDA) in the United States . In Japan , the peptide vaccine was recently authorized as an advanced medical treatment, in addition, the new device for gene therapy as “Made in Japan ” would be approved on the market soon. Thus in the field of gene therapy and the regenerative medicine and cell therapy, the movement of the development of new drugs as “Made in Japan ” is vigorously activated.
　Kyushu University has endeavored on the development of advanced Medical Technology especially around pure domestic biotechnology medicine based on the viral genetically modified technology and the informative advanced treatment system based on our world renowned engineering technology. Under the supportive national program of Ministry of Education, Culture, Sports, Science and Technology ” Coordination, support and training program for translational research ” since 2008, we have been working on the formation of the Translational Research (TR) base center in which it aimed at prompt practical use and the industrialization of original, epoch-making domestic Medical Technology. Good Manufacturing Practice ( GMP) controlled molecular and cell processing center (MCPC) has been newly established in Kyushu University hospital, which work as basic facility where the TR projects are promoted, and to accept external seeds widely as an open centre in the future.
　In this seminar, first, I would like to introduce the overview of MCPC facility, following, to present the outline of under going phase I clinical trial as the example of the “Made in Japan ” medical technology development track of TR which is one of the supporting seeds of ” Coordination, support and training program for translational research “.
　In addition, I would like to propose the underlying issues of Japanese approval system of new drugs expressed as drug lag and device lag through our experience and the comparison with American system, to help promotion of clinical trials.