• No results found

Development of Advanced Medicine at Nagoya University. Center for Advanced Medicine and Clinical Research. Nagoya University Hospital

N/A
N/A
Protected

Academic year: 2021

Share "Development of Advanced Medicine at Nagoya University. Center for Advanced Medicine and Clinical Research. Nagoya University Hospital"

Copied!
8
0
0

Loading.... (view fulltext now)

Full text

(1)

Contact Us

State of Advanced Medical Development

in Japan in 2012

Japan’s position in advanced medicine

Establishment of a System for Development of

Advanced Medicine at Nagoya University

Center for Advanced Medicine and

Clinical Research

Faculty and Staff

Development of Advanced Medicine at

Nagoya University

2013

Center for Advanced Medicine and Clinical Research.

Nagoya University Hospital

Website

http://www.nu-camcr.org

Administration Division

For Research Sponsors

Located in Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya

TEL: 052-744-2942 / FAX: 052-744-1303

E-mail: camcr@med.nagoya-u.ac.jp

In 2007, Japan became the first country in which the elderly (those older than 65 y) comprised more than 21% of the total population. This circumstance has sparked dynamic changes in numerous facets of society, including politics, the economy, and daily life. In a medical context, Japan’s rapidly growing aging population has trans-lated into more cases of disorders secondary to stroke and myocardial infarction as well as of chronic diseases such as diabetes and nephrotic disorders. Currently, the elderly segment of the population garners more than 50% of the national medical expenditure. To support an active and healthy aging society, a new system that is better equipped to provide care to these patients and personnel that are well trained to serve them are needed urgently.

The number of investigational drugs under development in Japan remained almost the same from 2002 to 2007, with only a 1% decrease compared to 2002. In contrast, the United States, United Kingdom, France, and Germany all saw increases of 22% to 38%. In addition, 2009 saw an import excess of 2,600 billion yen in medici-nal products and medical devices. Among major countries, only Japan has experienced a relative decrease in the ratio of profit from medical products and devices to the GDP. However, these figures do not necessarily indicate a lack of competence in the development of advanced medicine. Japan is third in the world (behind the United States and United Kingdom) in the number of new drugs developed annually. In addition, about 80% of the mechanical parts for the da Vinci robotic surgical device are made by Japanese companies. However Japan’s ability to compete in the worldwide medical marketplace is hampered by a poorly structured system for commercializing new medical treatments, products, and technologies.

To strengthen Japan’s economy and enrich its social structure, the Japanese government created the New Growth Strategy. Accordingly, the Five-Year Strategy for Medical Innovation began in June 2012 and the Strat-egy to Revitalize Japan was initiated in July 2012—these two initiatives reclaim the importance of developing advanced medical products, treatments, procedures, and equipment. Nagoya University was selected to partici-pate in two key projects of these initiatives: the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science and Technology of Japan and the Establishment of a Core Medical Facility for Clinical Research of the Ministry of Health, Labour and Welfare.

As a partner in the Translational Research Network Program and Establishment of a Core Medical Facility for Clinical Research initiatives, Nagoya University has created the Center for Advanced Medicine and Clinical Re-search. The Center is based at Nagoya University Hospital, which is being expanded as a core facility.

[Clinical Trial Administration Office]

Located on the 4th floor of the Out-patient Building TEL: 052-744-2946 or 2947 / FAX: 052-744-2428 E-mail: center-j@med.nagoya-u.ac.jp

[IRB Administration Office and

Investigational Drug Management Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1958 / FAX: 052-744-2948 E-mail: center@med.nagoya-u.ac.jp

[CRC Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1956 or 1962 / FAX: 052-744-2948

18 clinical research coordinators, 6 data managers, 6 technical members,

5 clinical trial administrators, 5 IRB and drug administration members,

2 members for intellectual property management and 7 administrative staff

Seiichi MATSUO

Director, Professor

Toshihiko WAKABAYASHI

Associate Director, Professor Advanced Medicine Support Department

Yoshinori HASEGAWA

Associate Director, Professor Clinical Research Support Department

Masaaki MIZUNO

Associate Director, Professor General Project Manager

Masahiko ANDO

Associate Professor, Clinical Epidemiologist

Katsuyoshi KATO

Lecturer

Area of Oversight, Clinical Research

Akihiro HAYAKAWA Lecturer, Biostatistician Shinobu SHIMIZU Lecturer Area of Oversight, Pharmaceutical Affairs Akira OOBA Area of Oversight, Hospital Policies and

Procedures

Tomoki NAOE

Director, Professor General Project Director

General Project Director (GPD)

External Project 1 Researcher

A Researcher B Researcher C

Core Support Facility for Translational and Clinical Research Nagoya University Hospital

Center for Advanced Medicine and Clinical Research

General Project Manager (GPM)

Support from Progress Management

Administrative Resources

Clinical Trial

Administration Office Project Manager Investigational Drug

Administrator Project Coordinator Biostatistician Research Plan Developer Monitoring Associates Data Manager

Audit Associates Progress Management Support Resources Progress Management Conference Facility Operations Conference Progress Report Meeting

Progress Report

Ethics Review Committee

Director

Risk–Benefit Assessment Committee Committee

Research Resources Preparation Facility Biomaterial Preparation Unit gene medicine, cell medicine,

and regenerative medicine ISO9001:2008/13485:2003

Support from Research Resources Preparation

Administrative Division

Chubu Regional Consortium for Advanced Medicine (Interinstitutional network with 7 university hospitals in the Chubu area)

Chubu Network for Industrialization of Medical Care (Network between healthcare companies in Chubu and Nagoya University)

Nagoya University Affiliate Network

Network with 34 large-scale hospitals with more than 500 beds, over 20,000 beds in total

Collaboration

other

internal projects otherexternal projects

Pharmaceutical Division Nursing Division

Complete information disclosure to

Project Manager Complete information disclosure to Project Manager

Data Center

Nagoya University

Headquarters for

Industry–Academia–Government Cooperation (Control and Evaluation of Intellectual Property)

Continual exploration and development of innovative ideas External collaborative network for effective

research advancement

Support from Human Resources

Complete information disclosure to Project Manager Research Representative 1 Internal Project 1 Researcher A Researcher B Researcher C Research Representative 2 Internal Project 2 Researcher A Researcher B Researcher C External Research Representative 1 Strategy Development Board

for Advanced Medicine

Contact Us

State of Advanced Medical Development

in Japan in 2012

Japan’s position in advanced medicine

Establishment of a System for Development of

Advanced Medicine at Nagoya University

Center for Advanced Medicine and

Clinical Research

Faculty and Staff

Development of Advanced Medicine at

Nagoya University

2013

Center for Advanced Medicine and Clinical Research.

Nagoya University Hospital

Website

http://www.nu-camcr.org

Administration Division

For Research Sponsors

Located in Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya

TEL: 052-744-2942 / FAX: 052-744-1303

E-mail: camcr@med.nagoya-u.ac.jp

In 2007, Japan became the first country in which the elderly (those older than 65 y) comprised more than 21% of the total population. This circumstance has sparked dynamic changes in numerous facets of society, including politics, the economy, and daily life. In a medical context, Japan’s rapidly growing aging population has trans-lated into more cases of disorders secondary to stroke and myocardial infarction as well as of chronic diseases such as diabetes and nephrotic disorders. Currently, the elderly segment of the population garners more than 50% of the national medical expenditure. To support an active and healthy aging society, a new system that is better equipped to provide care to these patients and personnel that are well trained to serve them are needed urgently.

The number of investigational drugs under development in Japan remained almost the same from 2002 to 2007, with only a 1% decrease compared to 2002. In contrast, the United States, United Kingdom, France, and Germany all saw increases of 22% to 38%. In addition, 2009 saw an import excess of 2,600 billion yen in medici-nal products and medical devices. Among major countries, only Japan has experienced a relative decrease in the ratio of profit from medical products and devices to the GDP. However, these figures do not necessarily indicate a lack of competence in the development of advanced medicine. Japan is third in the world (behind the United States and United Kingdom) in the number of new drugs developed annually. In addition, about 80% of the mechanical parts for the da Vinci robotic surgical device are made by Japanese companies. However Japan’s ability to compete in the worldwide medical marketplace is hampered by a poorly structured system for commercializing new medical treatments, products, and technologies.

To strengthen Japan’s economy and enrich its social structure, the Japanese government created the New Growth Strategy. Accordingly, the Five-Year Strategy for Medical Innovation began in June 2012 and the Strat-egy to Revitalize Japan was initiated in July 2012—these two initiatives reclaim the importance of developing advanced medical products, treatments, procedures, and equipment. Nagoya University was selected to partici-pate in two key projects of these initiatives: the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science and Technology of Japan and the Establishment of a Core Medical Facility for Clinical Research of the Ministry of Health, Labour and Welfare.

As a partner in the Translational Research Network Program and Establishment of a Core Medical Facility for Clinical Research initiatives, Nagoya University has created the Center for Advanced Medicine and Clinical Re-search. The Center is based at Nagoya University Hospital, which is being expanded as a core facility.

[Clinical Trial Administration Office]

Located on the 4th floor of the Out-patient Building TEL: 052-744-2946 or 2947 / FAX: 052-744-2428 E-mail: center-j@med.nagoya-u.ac.jp

[IRB Administration Office and

Investigational Drug Management Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1958 / FAX: 052-744-2948 E-mail: center@med.nagoya-u.ac.jp

[CRC Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1956 or 1962 / FAX: 052-744-2948

18 clinical research coordinators, 6 data managers, 6 technical members,

5 clinical trial administrators, 5 IRB and drug administration members,

2 members for intellectual property management and 7 administrative staff

Seiichi MATSUO

Director, Professor

Toshihiko WAKABAYASHI

Associate Director, Professor Advanced Medicine Support Department

Yoshinori HASEGAWA

Associate Director, Professor Clinical Research Support Department

Masaaki MIZUNO

Associate Director, Professor General Project Manager

Masahiko ANDO

Associate Professor, Clinical Epidemiologist

Katsuyoshi KATO

Lecturer

Area of Oversight, Clinical Research

Akihiro HAYAKAWA Lecturer, Biostatistician Shinobu SHIMIZU Lecturer Area of Oversight, Pharmaceutical Affairs Akira OOBA Area of Oversight, Hospital Policies and

Procedures

Tomoki NAOE

Director, Professor General Project Director

General Project Director (GPD)

External Project 1 Researcher

A Researcher B Researcher C

Core Support Facility for Translational and Clinical Research Nagoya University Hospital

Center for Advanced Medicine and Clinical Research

General Project Manager (GPM)

Support from Progress Management

Administrative Resources

Clinical Trial

Administration Office Project Manager Investigational Drug

Administrator Project Coordinator Biostatistician Research Plan Developer Monitoring Associates Data Manager

Audit Associates Progress Management Support Resources Progress Management Conference Facility Operations Conference Progress Report Meeting

Progress Report

Ethics Review Committee

Director

Risk–Benefit Assessment Committee Committee

Research Resources Preparation Facility Biomaterial Preparation Unit gene medicine, cell medicine,

and regenerative medicine ISO9001:2008/13485:2003

Support from Research Resources Preparation

Administrative Division

Chubu Regional Consortium for Advanced Medicine (Interinstitutional network with 7 university hospitals in the Chubu area)

Chubu Network for Industrialization of Medical Care (Network between healthcare companies in Chubu and Nagoya University)

Nagoya University Affiliate Network

Network with 34 large-scale hospitals with more than 500 beds, over 20,000 beds in total

Collaboration

other

internal projects otherexternal projects

Pharmaceutical Division Nursing Division

Complete information disclosure to

Project Manager Complete information disclosure to Project Manager

Data Center

Nagoya University

Headquarters for

Industry–Academia–Government Cooperation (Control and Evaluation of Intellectual Property)

Continual exploration and development of innovative ideas

External collaborative network for effective research advancement

Support from Human Resources

Complete information disclosure to Project Manager Research Representative 1 Internal Project 1 Researcher A Researcher B Researcher C Research Representative 2 Internal Project 2 Researcher A Researcher B Researcher C External Research Representative 1 Strategy Development Board

(2)

Contact Us

State of Advanced Medical Development

in Japan in 2012

Japan’s position in advanced medicine

Establishment of a System for Development of

Advanced Medicine at Nagoya University

Center for Advanced Medicine and

Clinical Research

Faculty and Staff

Development of Advanced Medicine at

Nagoya University

2013

Center for Advanced Medicine and Clinical Research.

Nagoya University Hospital

Website

http://www.nu-camcr.org

Administration Division

For Research Sponsors

Located in Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya

TEL: 052-744-2942 / FAX: 052-744-1303

E-mail: camcr@med.nagoya-u.ac.jp

In 2007, Japan became the first country in which the elderly (those older than 65 y) comprised more than 21% of the total population. This circumstance has sparked dynamic changes in numerous facets of society, including politics, the economy, and daily life. In a medical context, Japan’s rapidly growing aging population has trans-lated into more cases of disorders secondary to stroke and myocardial infarction as well as of chronic diseases such as diabetes and nephrotic disorders. Currently, the elderly segment of the population garners more than 50% of the national medical expenditure. To support an active and healthy aging society, a new system that is better equipped to provide care to these patients and personnel that are well trained to serve them are needed urgently.

The number of investigational drugs under development in Japan remained almost the same from 2002 to 2007, with only a 1% decrease compared to 2002. In contrast, the United States, United Kingdom, France, and Germany all saw increases of 22% to 38%. In addition, 2009 saw an import excess of 2,600 billion yen in medici-nal products and medical devices. Among major countries, only Japan has experienced a relative decrease in the ratio of profit from medical products and devices to the GDP. However, these figures do not necessarily indicate a lack of competence in the development of advanced medicine. Japan is third in the world (behind the United States and United Kingdom) in the number of new drugs developed annually. In addition, about 80% of the mechanical parts for the da Vinci robotic surgical device are made by Japanese companies. However Japan’s ability to compete in the worldwide medical marketplace is hampered by a poorly structured system for commercializing new medical treatments, products, and technologies.

To strengthen Japan’s economy and enrich its social structure, the Japanese government created the New Growth Strategy. Accordingly, the Five-Year Strategy for Medical Innovation began in June 2012 and the Strat-egy to Revitalize Japan was initiated in July 2012—these two initiatives reclaim the importance of developing advanced medical products, treatments, procedures, and equipment. Nagoya University was selected to partici-pate in two key projects of these initiatives: the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science and Technology of Japan and the Establishment of a Core Medical Facility for Clinical Research of the Ministry of Health, Labour and Welfare.

As a partner in the Translational Research Network Program and Establishment of a Core Medical Facility for Clinical Research initiatives, Nagoya University has created the Center for Advanced Medicine and Clinical Re-search. The Center is based at Nagoya University Hospital, which is being expanded as a core facility.

[Clinical Trial Administration Office]

Located on the 4th floor of the Out-patient Building TEL: 052-744-2946 or 2947 / FAX: 052-744-2428 E-mail: center-j@med.nagoya-u.ac.jp

[IRB Administration Office and

Investigational Drug Management Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1958 / FAX: 052-744-2948 E-mail: center@med.nagoya-u.ac.jp

[CRC Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1956 or 1962 / FAX: 052-744-2948

18 clinical research coordinators, 6 data managers, 6 technical members,

5 clinical trial administrators, 5 IRB and drug administration members,

2 members for intellectual property management and 7 administrative staff

Seiichi MATSUO

Director, Professor

Toshihiko WAKABAYASHI

Associate Director, Professor Advanced Medicine Support Department

Yoshinori HASEGAWA

Associate Director, Professor Clinical Research Support Department

Masaaki MIZUNO

Associate Director, Professor General Project Manager

Masahiko ANDO

Associate Professor, Clinical Epidemiologist

Katsuyoshi KATO

Lecturer

Area of Oversight, Clinical Research

Akihiro HAYAKAWA Lecturer, Biostatistician Shinobu SHIMIZU Lecturer Area of Oversight, Pharmaceutical Affairs Akira OOBA Area of Oversight, Hospital Policies and

Procedures

Tomoki NAOE

Director, Professor General Project Director

General Project Director (GPD)

External Project 1 Researcher

A Researcher B Researcher C

Core Support Facility for Translational and Clinical Research Nagoya University Hospital

Center for Advanced Medicine and Clinical Research

General Project Manager (GPM)

Support from Progress Management

Administrative Resources

Clinical Trial

Administration Office Project Manager Investigational Drug

Administrator Project Coordinator Biostatistician Research Plan Developer Monitoring Associates Data Manager

Audit Associates Progress Management Support Resources Progress Management Conference Facility Operations Conference Progress Report Meeting

Progress Report

Ethics Review Committee

Director

Risk–Benefit Assessment Committee Committee

Research Resources Preparation Facility Biomaterial Preparation Unit gene medicine, cell medicine,

and regenerative medicine ISO9001:2008/13485:2003

Support from Research Resources Preparation

Administrative Division

Chubu Regional Consortium for Advanced Medicine (Interinstitutional network with 7 university hospitals in the Chubu area)

Chubu Network for Industrialization of Medical Care (Network between healthcare companies in Chubu and Nagoya University)

Nagoya University Affiliate Network

Network with 34 large-scale hospitals with more than 500 beds, over 20,000 beds in total

Collaboration

other

internal projects otherexternal projects

Pharmaceutical Division Nursing Division

Complete information disclosure to

Project Manager Complete information disclosure to Project Manager

Data Center

Nagoya University

Headquarters for

Industry–Academia–Government Cooperation (Control and Evaluation of Intellectual Property)

Continual exploration and development of innovative ideas

External collaborative network for effective research advancement

Support from Human Resources

Complete information disclosure to Project Manager Research Representative 1 Internal Project 1 Researcher A Researcher B Researcher C Research Representative 2 Internal Project 2 Researcher A Researcher B Researcher C External Research Representative 1 Strategy Development Board

(3)

Contact Us

State of Advanced Medical Development

in Japan in 2012

Japan’s position in advanced medicine

Establishment of a System for Development of

Advanced Medicine at Nagoya University

Center for Advanced Medicine and

Clinical Research

Faculty and Staff

Development of Advanced Medicine at

Nagoya University

2013

Center for Advanced Medicine and Clinical Research.

Nagoya University Hospital

Website

http://www.nu-camcr.org

Administration Division

For Research Sponsors

Located in Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya

TEL: 052-744-2942 / FAX: 052-744-1303

E-mail: camcr@med.nagoya-u.ac.jp

In 2007, Japan became the first country in which the elderly (those older than 65 y) comprised more than 21% of the total population. This circumstance has sparked dynamic changes in numerous facets of society, including politics, the economy, and daily life. In a medical context, Japan’s rapidly growing aging population has trans-lated into more cases of disorders secondary to stroke and myocardial infarction as well as of chronic diseases such as diabetes and nephrotic disorders. Currently, the elderly segment of the population garners more than 50% of the national medical expenditure. To support an active and healthy aging society, a new system that is better equipped to provide care to these patients and personnel that are well trained to serve them are needed urgently.

The number of investigational drugs under development in Japan remained almost the same from 2002 to 2007, with only a 1% decrease compared to 2002. In contrast, the United States, United Kingdom, France, and Germany all saw increases of 22% to 38%. In addition, 2009 saw an import excess of 2,600 billion yen in medici-nal products and medical devices. Among major countries, only Japan has experienced a relative decrease in the ratio of profit from medical products and devices to the GDP. However, these figures do not necessarily indicate a lack of competence in the development of advanced medicine. Japan is third in the world (behind the United States and United Kingdom) in the number of new drugs developed annually. In addition, about 80% of the mechanical parts for the da Vinci robotic surgical device are made by Japanese companies. However Japan’s ability to compete in the worldwide medical marketplace is hampered by a poorly structured system for commercializing new medical treatments, products, and technologies.

To strengthen Japan’s economy and enrich its social structure, the Japanese government created the New Growth Strategy. Accordingly, the Five-Year Strategy for Medical Innovation began in June 2012 and the Strat-egy to Revitalize Japan was initiated in July 2012—these two initiatives reclaim the importance of developing advanced medical products, treatments, procedures, and equipment. Nagoya University was selected to partici-pate in two key projects of these initiatives: the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science and Technology of Japan and the Establishment of a Core Medical Facility for Clinical Research of the Ministry of Health, Labour and Welfare.

As a partner in the Translational Research Network Program and Establishment of a Core Medical Facility for Clinical Research initiatives, Nagoya University has created the Center for Advanced Medicine and Clinical Re-search. The Center is based at Nagoya University Hospital, which is being expanded as a core facility.

[Clinical Trial Administration Office]

Located on the 4th floor of the Out-patient Building TEL: 052-744-2946 or 2947 / FAX: 052-744-2428 E-mail: center-j@med.nagoya-u.ac.jp

[IRB Administration Office and

Investigational Drug Management Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1958 / FAX: 052-744-2948 E-mail: center@med.nagoya-u.ac.jp

[CRC Office]

Located on floor B1 of the Clinical Laboratory and Examination Center

TEL: 052-744-1956 or 1962 / FAX: 052-744-2948

18 clinical research coordinators, 6 data managers, 6 technical members,

5 clinical trial administrators, 5 IRB and drug administration members,

2 members for intellectual property management and 7 administrative staff

Seiichi MATSUO

Director, Professor

Toshihiko WAKABAYASHI

Associate Director, Professor Advanced Medicine Support Department

Yoshinori HASEGAWA

Associate Director, Professor Clinical Research Support Department

Masaaki MIZUNO

Associate Director, Professor General Project Manager

Masahiko ANDO

Associate Professor, Clinical Epidemiologist

Katsuyoshi KATO

Lecturer

Area of Oversight, Clinical Research

Akihiro HAYAKAWA Lecturer, Biostatistician Shinobu SHIMIZU Lecturer Area of Oversight, Pharmaceutical Affairs Akira OOBA Area of Oversight, Hospital Policies and

Procedures

Tomoki NAOE

Director, Professor General Project Director

General Project Director (GPD)

External Project 1 Researcher

A Researcher B Researcher C

Core Support Facility for Translational and Clinical Research Nagoya University Hospital

Center for Advanced Medicine and Clinical Research

General Project Manager (GPM)

Support from Progress Management

Administrative Resources

Clinical Trial

Administration Office Project Manager Investigational Drug

Administrator Project Coordinator Biostatistician Research Plan Developer Monitoring Associates Data Manager

Audit Associates Progress Management Support Resources Progress Management Conference Facility Operations Conference Progress Report Meeting

Progress Report

Ethics Review Committee

Director

Risk–Benefit Assessment Committee Committee

Research Resources Preparation Facility Biomaterial Preparation Unit gene medicine, cell medicine,

and regenerative medicine ISO9001:2008/13485:2003

Support from Research Resources Preparation

Administrative Division

Chubu Regional Consortium for Advanced Medicine (Interinstitutional network with 7 university hospitals in the Chubu area)

Chubu Network for Industrialization of Medical Care (Network between healthcare companies in Chubu and Nagoya University)

Nagoya University Affiliate Network

Network with 34 large-scale hospitals with more than 500 beds, over 20,000 beds in total

Collaboration

other

internal projects otherexternal projects

Pharmaceutical Division Nursing Division

Complete information disclosure to

Project Manager Complete information disclosure to Project Manager

Data Center

Nagoya University

Headquarters for

Industry–Academia–Government Cooperation (Control and Evaluation of Intellectual Property)

Continual exploration and development of innovative ideas External collaborative network for effective

research advancement

Support from Human Resources

Complete information disclosure to Project Manager Research Representative 1 Internal Project 1 Researcher A Researcher B Researcher C Research Representative 2 Internal Project 2 Researcher A Researcher B Researcher C External Research Representative 1 Strategy Development Board

(4)

New standards in medicine from Nagoya and Chubu to the world

Collaborative research on ideas from academia Fostering of practical use of ideas from industry Nagoya University Affiliate Network

(The largest medical facility network in Japan)

34 hospitals, each having more than 500 beds: more than 20,000 beds in total

New Healthcare Industry Promotion Forum Chubu Network for Industrialization of Medical Care

(Network of healthcare companies in Chubu) Promotion Council for Medical Device Industry (Nagoya Chamber of Commerce and Industry) Chubu Regional Consortium for Advanced Medicine

(7 university hospitals in and around Chubu and 1 interinstitutional network)

Nagoya University Hospital

Center for Advanced Medicine and Clinical Research Abundant sites for clinical research

Services at the Center for Advanced Medicine and Clinical Research

Selected Projects at the Center for Advanced Medicine and Clinical Research

Chubu Regional Consortium for Advanced Medicine

Nagoya University Hospital

Center for Advanced Medicine and Clinical Research

Translational Research Network Program

Clinical Research Core Hospital Program

About the Consortium

Activities of the Consortium

About the Center

Structure

In response to nationally recognized medical challenges such as the growing elderly population, the decline of community healthcare, changes in the conceptual framework regarding chronic disorders, and medical globalization, the Center has created a system that fosters clinical research within the hospital as a whole. At the same time, timely execution and industrialization of research objectives is expected as a leading country in global standards.

To this end, each annual action plan addresses four areas: (1)Exploration of promising new ideas and their sustainable development, (2)Education of personnel involved in clinical research, (3)Compliance with inter-national standards regarding clinical research (ICH-GCP standards), and (4)Practical application and indus-trialization of outstanding innovations.

1) Exploration of promising new ideas and their sustainable development

The Center incorporates an information network that focuses on the exploration of promising ideas and promotes the matching of these research interests with those of healthcare companies for the develop-ment of those ideas. This effort is in cooperation with the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science and Technology of Japan.

2) Education of personnel involved in clinical research

The Center’s educational and training events produce physicians and scientists who can generate new research ideas and pursue their exploration as well as experts who can envision the outcomes of aca-demic research in terms of their socioeconomic value. These efforts involve interoccupational collabora-tions and postgraduate education programs.

3) Compliance with international standards regarding clinical research (ICH-GCP standards)

The Center encourages clinical studies that follow ICH-GCP standards by initiating projects that comply with the ICH-GCP guidelines for advanced medicine. Focal areas include the installation of 24-hour ser-vice sites, management of serious adverse events, and broad-based support for patients and their fami-lies.

4) Practical application and industrialization of outstanding innovations

The Nagoya University Hospital and the Chubu Regional Consortium for Advanced Medicine are superior resources for patient enrollment for clini-cal trials and the strategic translation of cliniclini-cal research into cliniclini-cal practice. In addition, the Center’s Information and Communication Tech-nology (ICT) system achieves effective and appropriate communication with various regulatory agencies.

The purpose of the Consortium is to rapidly deliver new medical technology and devices that fulfill societal needs through mutual participation among all Chubu-area universities and to improve human health and pro-mote peace worldwide. The consortium comprises 8 members: Aichi Medical University, Kanazawa University, Gifu University, Nagoya City University, Nagoya University, Fujita Health University, Mie University, and the National Center for Geriatrics and Gerontology.

As an affiliate of the Translational Research Network Program, the Center established a sustainable network-based environment for the development of advanced medicine that is network-based at Nagoya University Hospital and promotes the creation and dissemination of new standards in medicine from the Nagoya–Chubu area by (1)offering an environment that fosters translational research, (2)consolidating opportunities and tools that enable the pursuit of promising new ideas, and (3)establishing mechanisms that provide consistent and continuous su-pport for translational research.

1) Offering an environment that fosters translational research

Each project at the Center is assigned a Project Manager and a Design Buildup Team that consists of biostatis-ticians, lawyers, data managers, monitoring and audit associates, and clinical research coordinators. This strat-egy ensures effective communication with regulatory agencies. In addition, the Center’s collaboration with the Headquarters for Industry–Academia–Government Cooperation, Research Administration Bureau, and external experts maximizes the identification and processing of intellectual property concerns.

In-depth lectures, meetings, and seminars at the Center create opportunities for discussion among people involved in translational research. These events likely will accelerate the education of the general population as well as those involved in translational research. Also, the Center gathers and develops the human resources needed for the accurate monitoring and auditing of clinical trials.

2) Consolidating opportunities and tools that enable the pursuit of promising new ideas

The Center’s Information Collection and Administration System ensures rapid evaluation and development of innovative ideas. This system collects all the information related to those ideas from throughout the Chubu area and centralizes their management at Nagoya University Hospital. In addition, the employment of basic research associates facilitates the generation of fundamental data for conclusive preclinical studies.

3) Establishing mechanisms that provide consistent and continuous support for translational research

Establishing a system that functions as a Site Management Organization whose expertise is available to both Nagoya University and other institutions is a potentially profitable initiative, eventually earning revenues that the hospital can reinvest into translational research. In turn, these revenues ensure a balanced budget regarding our services, enabling the Center to remain an independent institution.

The Center for Advanced Medicine and Clinical Research was founded in 2010 to undergird the entire devel-opment process—from the exploration of innovative ideas and their practical develdevel-opment to their ultimate ap-plication in insurance-covered medical care. Consistent with the mission of Nagoya University, the Center is committed to providing improved medical services for future generations while contributing to current society through healthcare, education, and research. Through its commitment to its mission, the Center has trained numerous physicians, nurses, clinical epidemiologists, and biostatisticians that continue to focus on clinical research. Currently, the Center is broadening its intra- and inter-institutional support of medical research and clinical applications by funding the genesis and development of innovative concepts and reagents. A key to the Center’ s success is the ability to integrate, coordinate, oversee, and facilitate the entire scope of advanced medicine, from the fostering of novel ideas to their realization as clinically useful products and treatments.

To accomplish the goals above, the Consortium

1) Plans, organizes, conducts, and evaluates multi-institutional clinical research, 2) Convenes a multi-institutional Ethics Review Board,

3) Educates and trains physicians, researchers, and technicians that are engaged in the development of advanced medicine, and

4) Fosters cooperative agreements with private companies and appropriately manages resulting intellectual property.

Structure for development of advanced medicine as proposed by the Chubu Regional Consortium for Advanced Medicine Strategic process to the Application and Industrialization of Medical Ideas proposed by Nagoya University Hospital

Center for Advanced Medicine and Clinical Research is a nexus for cooperation between industry, academia, and government Organization chart of Center for Advanced Medicine and Clinical Research

Department of Advanced Medicine Support - Discovery and development of genes, cells, and regenerative medicine for advanced use

- Preparation and quality-control of research resources

- Performance of supported research

- Support for clinical research

Department of Clinical Research Support

Intellectual Property Department

Medical Research Department Ethics Review Committee

Center for Advanced Medicine and Clinical Research

Integrated process from the discovery of new ideas to their advancement into clinical applications

Collaboration

Facility Operations Conference Director

Administration Division

(within and between institutions)

Goals of the Center for Advanced Medicine and Clinical Research

Idea Development

Translational Research (TR) Clinical Research

Non-clinical

Research ResearchClinical

Company-initiated clinical research Investigator-initiated

clinical research

Matching of research interests with those of private companies Goal-setting regarding the preparation of

medicines and medical devices Consultation with regulatory agencies

Strategic research

Idea Exploration

Project Manager

Formation of a

Design Buildup Team(DBT)

Academicians (physicians, researchers) Collaborators from private companies Lawyers Healthcare providers

Development Build-up Teams (DBT)

Administration Division

Information sharing regarding - clinical research

- patient information - research sites

- laboratories, companies Council

Regional Consortium engaging with community and facilities

Project Summary Medical Project Large number of cases Small number of cases More profitable Less profitable Unapproved drugs and medical devices

Screening-level clinical research

Advanced Medicine

Investigator-initiated research Rapidly introduced into

practice after development

Institutional configuration criteria

Company-initiated research

Healthcare Project

(Wellness, Prevention, Welfare)

DBT

A DBTB DBTC DBTD

Engaged area

Hospitals Private

Companies ResearchCenters

Medical Products

Field Project Title

Development of tau aggregation inhibitor

Development of Amyloid β protein polymerization inhibitor

Research into efficacy of locally injectable nucleic acids in patients with pancreatic cancer who cannot undergo radical excision Advanced multimodal strategies for malignant glioma by means of nano-medicine encapsulated with nucleic acidic medicine Development of a new quick diagnostic method of acute kidney injury

Development of simulation technology for computer-directed operative site analysis during corrective skeletal surgery Development of novel therapy using microenvironmental factors produced by adipose tissue-derived stem cells Drug screening for promoting osteoblastic differentiation and bone formation through activating Runx2 expression

Project Title

Limb lengthening using culture-expanded bone marrow cells

Optimization of regenerative medicine of the resected jaw bone for improvement of the quality of life

Research into the efficacy of using non-cultured autologous human adipose-derived mesenchymal cells in treatment for stress urinary incontinence Development of immunocyte therapy with antigen-specific cytotoxic T lymphocytes

Development of virus specific cytotoxic T lymphocyte therapy after allogeneic hematopoietic stem cell transplantation Human bone marrow derived mesenchymal stem cell therapy for steroid refractory Graft versus Host disease after stem cell transplantation Research into the safety and efficacy of infusing natural killer cells that are alloreactive against relapsed leukemia cells after hematopoietic stem cell transplantation Development of regenerative and immunosuppressive therapy by using adipose-derived pluripotential cells – application in renal disease and refractory autoimmune disease Medical Devices Regenerative Medicine Field Regenerative Medicine Functional Regeneration

Administration for Institutional Review Board Coordination of clinical research

Data management Monitoring and auditing

Design and development of clinical trials Statistical analysis

Medical writing and others

Other Japanese and international universities and

hospitals

Other Japanese and international

companies Other Japanese and

international research

organizations Medical Device AgencyPharmaceuticals and Ministry of Health, Labour and Welfare of

Japan

Ministry of Educa-tion, Culture, Sports, Science and

Technol-ogy of Japan

Ministry of Health, Labour and Welfare

of Japan

Discoveries fall into the “Valley of Death”

Effective financial management Advance communication with

regulatory agencies

Practical application in nsurance-covered

medical care (industrialization)

Application for approval of medicinal product or device is submitted with data showing satisfactory results in patients

Promotion of connections between these steps leads to rapid practical application of research findings

Areas in regenerative medicine that require special equipment or utility (such as the Cell Processing Center) are evaluated by Pharmaceutical Affairs Department in regard to establishing facility standards in addition to addressing issues of safety and efficacy.

Use in insured medical care at

limited number of facilities Special Medical Consortium(tokku)

Data collection at data center

Pharmaceutical Approval Review by

related ministry

Widespread use in insured medical care

- Aichi Medical University - Kanazawa University - Gifu University - Nagoya City University - Nagoya University - Fujita Health University - Mie University

- National Center for Geriatrics and Gerontology

- Chubu Bureau of Economy, Trade, and Industry - Chubu Economic Federation - Nagoya Chamber of Commerce and Industry

- Chubu Medical Device Manufacturers Association - Governmental Organizations and others

(5)

New standards in medicine from Nagoya and Chubu to the world

Collaborative research on ideas from academia Fostering of practical use of ideas from industry Nagoya University Affiliate Network

(The largest medical facility network in Japan)

34 hospitals, each having more than 500 beds: more than 20,000 beds in total

New Healthcare Industry Promotion Forum Chubu Network for Industrialization of Medical Care

(Network of healthcare companies in Chubu) Promotion Council for Medical Device Industry (Nagoya Chamber of Commerce and Industry) Chubu Regional Consortium for Advanced Medicine

(7 university hospitals in and around Chubu and 1 interinstitutional network)

Nagoya University Hospital

Center for Advanced Medicine and Clinical Research Abundant sites for clinical research

Services at the Center for Advanced Medicine and Clinical Research

Selected Projects at the Center for Advanced Medicine and Clinical Research

Chubu Regional Consortium for Advanced Medicine

Nagoya University Hospital

Center for Advanced Medicine and Clinical Research

Translational Research Network Program

Clinical Research Core Hospital Program

About the Consortium

Activities of the Consortium

About the Center

Structure

In response to nationally recognized medical challenges such as the growing elderly population, the decline of community healthcare, changes in the conceptual framework regarding chronic disorders, and medical globalization, the Center has created a system that fosters clinical research within the hospital as a whole. At the same time, timely execution and industrialization of research objectives is expected as a leading country in global standards.

To this end, each annual action plan addresses four areas: (1)Exploration of promising new ideas and their sustainable development, (2)Education of personnel involved in clinical research, (3)Compliance with inter-national standards regarding clinical research (ICH-GCP standards), and (4)Practical application and indus-trialization of outstanding innovations.

1) Exploration of promising new ideas and their sustainable development

The Center incorporates an information network that focuses on the exploration of promising ideas and promotes the matching of these research interests with those of healthcare companies for the develop-ment of those ideas. This effort is in cooperation with the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science and Technology of Japan.

2) Education of personnel involved in clinical research

The Center’s educational and training events produce physicians and scientists who can generate new research ideas and pursue their exploration as well as experts who can envision the outcomes of aca-demic research in terms of their socioeconomic value. These efforts involve interoccupational collabora-tions and postgraduate education programs.

3) Compliance with international standards regarding clinical research (ICH-GCP standards)

The Center encourages clinical studies that follow ICH-GCP standards by initiating projects that comply with the ICH-GCP guidelines for advanced medicine. Focal areas include the installation of 24-hour ser-vice sites, management of serious adverse events, and broad-based support for patients and their fami-lies.

4) Practical application and industrialization of outstanding innovations

The Nagoya University Hospital and the Chubu Regional Consortium for Advanced Medicine are superior resources for patient enrollment for clini-cal trials and the strategic translation of cliniclini-cal research into cliniclini-cal practice. In addition, the Center’s Information and Communication Tech-nology (ICT) system achieves effective and appropriate communication with various regulatory agencies.

The purpose of the Consortium is to rapidly deliver new medical technology and devices that fulfill societal needs through mutual participation among all Chubu-area universities and to improve human health and pro-mote peace worldwide. The consortium comprises 8 members: Aichi Medical University, Kanazawa University, Gifu University, Nagoya City University, Nagoya University, Fujita Health University, Mie University, and the National Center for Geriatrics and Gerontology.

As an affiliate of the Translational Research Network Program, the Center established a sustainable network-based environment for the development of advanced medicine that is network-based at Nagoya University Hospital and promotes the creation and dissemination of new standards in medicine from the Nagoya–Chubu area by (1)offering an environment that fosters translational research, (2)consolidating opportunities and tools that enable the pursuit of promising new ideas, and (3)establishing mechanisms that provide consistent and continuous su-pport for translational research.

1) Offering an environment that fosters translational research

Each project at the Center is assigned a Project Manager and a Design Buildup Team that consists of biostatis-ticians, lawyers, data managers, monitoring and audit associates, and clinical research coordinators. This strat-egy ensures effective communication with regulatory agencies. In addition, the Center’s collaboration with the Headquarters for Industry–Academia–Government Cooperation, Research Administration Bureau, and external experts maximizes the identification and processing of intellectual property concerns.

In-depth lectures, meetings, and seminars at the Center create opportunities for discussion among people involved in translational research. These events likely will accelerate the education of the general population as well as those involved in translational research. Also, the Center gathers and develops the human resources needed for the accurate monitoring and auditing of clinical trials.

2) Consolidating opportunities and tools that enable the pursuit of promising new ideas

The Center’s Information Collection and Administration System ensures rapid evaluation and development of innovative ideas. This system collects all the information related to those ideas from throughout the Chubu area and centralizes their management at Nagoya University Hospital. In addition, the employment of basic research associates facilitates the generation of fundamental data for conclusive preclinical studies.

3) Establishing mechanisms that provide consistent and continuous support for translational research

Establishing a system that functions as a Site Management Organization whose expertise is available to both Nagoya University and other institutions is a potentially profitable initiative, eventually earning revenues that the hospital can reinvest into translational research. In turn, these revenues ensure a balanced budget regarding our services, enabling the Center to remain an independent institution.

The Center for Advanced Medicine and Clinical Research was founded in 2010 to undergird the entire devel-opment process—from the exploration of innovative ideas and their practical develdevel-opment to their ultimate ap-plication in insurance-covered medical care. Consistent with the mission of Nagoya University, the Center is committed to providing improved medical services for future generations while contributing to current society through healthcare, education, and research. Through its commitment to its mission, the Center has trained numerous physicians, nurses, clinical epidemiologists, and biostatisticians that continue to focus on clinical research. Currently, the Center is broadening its intra- and inter-institutional support of medical research and clinical applications by funding the genesis and development of innovative concepts and reagents. A key to the Center’ s success is the ability to integrate, coordinate, oversee, and facilitate the entire scope of advanced medicine, from the fostering of novel ideas to their realization as clinically useful products and treatments.

To accomplish the goals above, the Consortium

1) Plans, organizes, conducts, and evaluates multi-institutional clinical research, 2) Convenes a multi-institutional Ethics Review Board,

3) Educates and trains physicians, researchers, and technicians that are engaged in the development of advanced medicine, and

4) Fosters cooperative agreements with private companies and appropriately manages resulting intellectual property.

Structure for development of advanced medicine as proposed by the Chubu Regional Consortium for Advanced Medicine Strategic process to the Application and Industrialization of Medical Ideas proposed by Nagoya University Hospital

Center for Advanced Medicine and Clinical Research is a nexus for cooperation between industry, academia, and government Organization chart of Center for Advanced Medicine and Clinical Research

Department of Advanced Medicine Support - Discovery and development of genes, cells, and regenerative medicine for advanced use

- Preparation and quality-control of research resources

- Performance of supported research

- Support for clinical research

Department of Clinical Research Support

Intellectual Property Department

Medical Research Department Ethics Review Committee

Center for Advanced Medicine and Clinical Research

Integrated process from the discovery of new ideas to their advancement into clinical applications

Collaboration

Facility Operations Conference Director

Administration Division

(within and between institutions)

Goals of the Center for Advanced Medicine and Clinical Research

Idea Development

Translational Research (TR) Clinical Research

Non-clinical

Research ResearchClinical

Company-initiated clinical research Investigator-initiated

clinical research

Matching of research interests with those of private companies Goal-setting regarding the preparation of

medicines and medical devices Consultation with regulatory agencies

Strategic research

Idea Exploration

Project Manager

Formation of a

Design Buildup Team(DBT)

Academicians (physicians, researchers) Collaborators from private companies Lawyers Healthcare providers

Development Build-up Teams (DBT)

Administration Division

Information sharing regarding - clinical research

- patient information - research sites

- laboratories, companies Council

Regional Consortium engaging with community and facilities

Project Summary Medical Project Large number of cases Small number of cases More profitable Less profitable Unapproved drugs and medical devices

Screening-level clinical research

Advanced Medicine

Investigator-initiated research Rapidly introduced into

practice after development

Institutional configuration criteria

Company-initiated research

Healthcare Project

(Wellness, Prevention, Welfare)

DBT

A DBTB DBTC DBTD

Engaged area

Hospitals Private

Companies ResearchCenters

Medical Products

Field Project Title

Development of tau aggregation inhibitor

Development of Amyloid β protein polymerization inhibitor

Research into efficacy of locally injectable nucleic acids in patients with pancreatic cancer who cannot undergo radical excision Advanced multimodal strategies for malignant glioma by means of nano-medicine encapsulated with nucleic acidic medicine Development of a new quick diagnostic method of acute kidney injury

Development of simulation technology for computer-directed operative site analysis during corrective skeletal surgery Development of novel therapy using microenvironmental factors produced by adipose tissue-derived stem cells Drug screening for promoting osteoblastic differentiation and bone formation through activating Runx2 expression

Project Title

Limb lengthening using culture-expanded bone marrow cells

Optimization of regenerative medicine of the resected jaw bone for improvement of the quality of life

Research into the efficacy of using non-cultured autologous human adipose-derived mesenchymal cells in treatment for stress urinary incontinence Development of immunocyte therapy with antigen-specific cytotoxic T lymphocytes

Development of virus specific cytotoxic T lymphocyte therapy after allogeneic hematopoietic stem cell transplantation Human bone marrow derived mesenchymal stem cell therapy for steroid refractory Graft versus Host disease after stem cell transplantation Research into the safety and efficacy of infusing natural killer cells that are alloreactive against relapsed leukemia cells after hematopoietic stem cell transplantation Development of regenerative and immunosuppressive therapy by using adipose-derived pluripotential cells – application in renal disease and refractory autoimmune disease Medical Devices Regenerative Medicine Field Regenerative Medicine Functional Regeneration

Administration for Institutional Review Board Coordination of clinical research

Data management Monitoring and auditing

Design and development of clinical trials Statistical analysis

Medical writing and others

Other Japanese and international universities and

hospitals

Other Japanese and international

companies Other Japanese and

international research

organizations Medical Device AgencyPharmaceuticals and Ministry of Health, Labour and Welfare of

Japan

Ministry of Educa-tion, Culture, Sports, Science and

Technol-ogy of Japan

Ministry of Health, Labour and Welfare

of Japan

Discoveries fall into the “Valley of Death”

Effective financial management Advance communication with

regulatory agencies

Practical application in nsurance-covered

medical care (industrialization)

Application for approval of medicinal product or device is submitted with data showing satisfactory results in patients

Promotion of connections between these steps leads to rapid practical application of research findings

Areas in regenerative medicine that require special equipment or utility (such as the Cell Processing Center) are evaluated by Pharmaceutical Affairs Department in regard to establishing facility standards in addition to addressing issues of safety and efficacy.

Use in insured medical care at

limited number of facilities Special Medical Consortium(tokku)

Data collection at

data center Approval Review by Pharmaceutical related ministry

Widespread use in insured medical care

- Aichi Medical University - Kanazawa University - Gifu University - Nagoya City University - Nagoya University - Fujita Health University - Mie University

- National Center for Geriatrics and Gerontology

- Chubu Bureau of Economy, Trade, and Industry - Chubu Economic Federation - Nagoya Chamber of Commerce and Industry

- Chubu Medical Device Manufacturers Association - Governmental Organizations and others

References

Related documents

2. A good friend is one who to some extent shares our suffering when we ourselves are miserable. We would not want someone as a friend who.. The Big Picture: Divine

‹ Measure the ambient dose equivalent and ambient dose equivalent Measure the ambient dose equivalent and ambient dose equivalent rate in mixed radiation fields consisting in

Five symbols were sorted into the hypothesized categories by older children, but not younger children (i.e., Macedonian street sign, Macedonian football jersey,

Whether or not you believe that the New Apollo Project is on the mark, it is at the very least a sincere attempt to undermine the assumptions beneath special interest

ACCUPROBE UV está equipado con el indica- dor digital exclusivo SmartAlarm ™: el primer indicador visual de tamaño de fugas digital en un detector de fugas portátil con sensor

§  scenario should include concrete mechanisms for context awareness and adaptation. §  could be a stand-alone App on a mobile device or a distributed application with

Many researchers are working on how to minimize the number of power quality monitors on the power system network and to reduce the amount of redundant data generated by

Predictors: (Constant), Availability of sales personnel to respond to my request, mode of transport used for shopping, Convenience of approach, Warm relationships