INTERVIEWThe Future of Advanced Medical Development at Nagoya University Hospital

05 Eﬀorts of the “Center for Advanced Medicine and Clinical Research,”

MIZUNO, Masaaki

One of the Creative Centers for Novel Medical Technology

At the same time, the development of pharmaceuticals and medical
devices requires not only physicians but also professionals in various
other fields. This Center already possesses exceptional humanresources, but in order to strengthen its organization further, we would
like to devote even more energies to nurturing human resources.

Center for Advanced Medicine and Clinical Research,
Nagoya University Hospital
Clinical Professor

The key word is“bridge-building”–
For the future ofmedical carein Japan

Organization Outline

Chubu Regional Consortium for Advanced Medicine,accelerating the practical application of medicine

Japan’s basic technology in drug discovery and medical device
creation is world class, but we lack the coordinating power toskillfully channel basic technology into final products, and for thisreason Japan’s health care industry lags behind other medicallydeveloped countries. In order to break through this situation, Japan’snational government has deployed the “Translational Research
Network Program”*1 under the Ministry of Education, Culture, Sports,
Science and Technology (MEXT) and the “Clinical Trials Core
Hospital Development Projects”* 2 under the Ministry of Health,Labour and Welfare (MHLW). The “Innovation of Creative Center for
Novel Medical Technology,”* 3 a collaboration between these twoministries, was also initiated to implement the programs in anintegrated manner.
But even before Japan’s national government instituted theseprograms, Nagoya University Hospital ’s Center for Advanced
Medicine and Clinical Research (later adopted as one of thegovernment’s “Creative Centers”) was already taking measures thatwere consistent with the policies of both the MEXT and the MHLW
programs. The Center for Advanced Medicine and Clinical Research
is a support organization that unifies the phases of research into an
integrated process leading all the way from the discovery of seeds tothe establishment of new forms of treatment in actual medical
practice. In doing so, it bridges the Department of Advanced Medical
Support, which is responsible for phases from basic research to “firstin human,” where pharmaceuticals are first administered to people,and the Department of Clinical Research Support, which is responsible for the subsequent clinical research and clinical trials. Clinicaltrials are now being conducted constantly, and they are beginning tobear fruit steadily.

The Center for Advanced Medicine and Clinical Research also
supports the activities of the “Chubu Regional Consortium for
Advanced Medicine” to promote advanced medical development on
the part of the entire region. The Chubu Regional Consortium is anorganization that links 12 Chubu Region universities and medical
facilities around the hub of our own university in an effort to rapidly
develop new medical technologies and medical devices, and it isactive in conducting multicenter clinical studies and otherinvestigations. By utilizing the scale of the consortium, we canfacilitate the smooth progress of clinical trials, which will further thedevelopment of medicine in the Chubu Region and contribute to
global medical care.

Striving to solve problems by drawing close to“people”
Advanced medical development is conducted with an eye to thefuture, in an effort to build human health and happiness. An
example of the problems it tackles is the rise of the super-agedsociety in Japan. Hints to new medical science that could solve thisproblem will most likely be found at the scene of actual medical
practice, not in research laboratories.
I myself am proactive about going to the front lines of medicine tolend an ear to various people and collect information. The seeds
found in grassroots activities eventually grow into major efforts thatwill lead to the cultivation of new medical treatments. That is why
my approach to problem solving is to adopt a broad view and broad
strategies in a spirit of challenge. Today, once again, I will searchfor solutions to medical issues while drawing close to “people” as I
walk through actual treatment facilities.

*1 MEXTTranslational Research Network
Program*2 MHLW
Clinical Trials Core Hospital
Development Projects*3 MEXT / MHLW
Innovation of Creative Center for Novel
Medical Technology

A program that aims to streng then seeddevelopment capacity and establish permanentbases while creating a network of translational
research support bases to connect promising
fruits of basic research to clinical applications.
Nagoya University was adopted into the programin 2012.

A project that promotes clinical research at
the global level and investigator-led clinical
trials on intractable diseases, etc. as a core
hospital in a network endeavoring to producenovel Japan-born pharmaceuticals and medicaldevices. Nagoya University was adopted into
the project in 2012.

B rings togeth er th e afo rem e ntio n e d M E X T a n d M H LW
measures under a single umbrella to construct a system forgiving practical application to the epoch - making basic
research that emerges from academia, while improving thesystem for implementing and supporting high-quality clinicalresearch and clinical trials at the global level. N agoya
University is one of 15 Creative Centers throughout Japan.

PROFILE

Chubu Regional Consortium for Advanced Medicine

Established in 2010. This organization provides support for all processes from the discoveryof seeds to the establishment of medical treatments covered by health insurance. TheDepartment of Advanced Medical Support and Department of Clinical Research Support work
together to discover and develop exceptional seeds at the same time that they bring to theworld the fruits of high-quality clinical research conducted in Nagoya and the Chubu Region.

Center for Advanced Medicine and Clinical Research
Academic Research &Industry-Academia-Government Collaboration(Intellectual Property & Technology Transfer Group)

Director

Graduate School of Medicine and Other Graduate Schools

Steering Council

Bioethics Review Committee

Department of Advanced Medical Support

Department of Clinical Research Support
Collaboration
Department of Management

Creative Centers for Novel Medical Technology
Bringing together all processes from the discovery of seeds to the establishment of medical treatments
Translational Research
Ministry of Project for the Improvement of the Clinical Research Quality
Ministry of Education, Network Program
Assurance System (Clinical Trials Core Hospital Development Projects)
Health,Culture, Sports,
Labourand Support for clinical research and clinical trials fromSupport
frombasic
researchtoScience and Technology
Welfare “ﬁrst in human”onward“ﬁrst in human”

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From basic to clinical, to industrial products ‒The Center for Advanced Medicine and Clinical Research

Aichi Medical University
Kanazawa University
Gifu University

Mie University
Kanazawa MedicalUniversity
Nagoya City University

National Hospital Organization
Nagoya Medical Center

Nagoya University

National Center for
Geriatrics and Gerontology

Hamamatsu University
School of Medicine

MIZUNO,
Masaaki

Board of Directors

12 participating organizations

Operation Committee
WG for Joint
Ethics Committee

WG for Multicenter
Study Management

MISSIONMISSION

Holding the Joint
Ethical Committee

Planning,
Implementing andEvaluating
Multi-centerstudies

WG for Industry,
Academia
Collaboration

WG for Information
Sharing

MISSIONMISSIONMISSIONMISSIONMISSION

Building expertisethrough seminars
and educational
exchange

Matching withIndustry, andsupport the IP
management

Development of theinformation sharing
systemManagement of the IP
regardingthe collaboration
Project

Development of thesystem to promoteclinical studies
under the ICH-GCP
in every University
participating theC-CAM

WG for Educationand Training

WG for IP

WG for Clinical
Data Science

Every WG works to achieve its own goal.

Major achievements in FY2014

Born in 1959. Completed doctoral course in Nagoya University Graduate School of Medicine. Doctor of Medicine. Clinical Professor at Nagoya University Hospital and Assistant
Director of the Center for Advanced Medicine and ClinicalResearch. Nagoya University
Presidential Assistant (for Industry-Academia-Government
Collaboration). His fields ofspecialization are molecular biology and neurosurgery.

● Establishment of the Joint Ethics Review Committee

University of Toyama

Fujita Health University● Development of a multi-center mutual monitoring system (multi-center SOP)
● Real-time distribution of clinical research seminars to the participating institutions → Establishment of a system of mandatory clinical study certification● Operation of a seeds-needs matching system and business negotiation with the Promotion Council for Medical Device Industry (Nagoya Chamber of Commerce & Industry)● Seeds information collection and management system → Initiation of a disease registry● Establishment of the Multi-Center Intellectual Property Liaison Council → Sharing of intellectual property information and standardization of evaluation criteria● WG of clinical study experts centered around biostatisticians → Registration, assignment, EDC; SOP / manual; seminar / OJT015
Profile M. 22015

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