文部科学省橋渡し研究加速ネットワークプログラム海外TRセンター

Translational Research Network Program
Ministry of Education, Culture,
Sports, Science and Technology
February 27, 2014, 9:30-11:50
Translational Research Informatics Center
Foundation for Biomedical Research and Innovation
1-5-4 Minatojima-minamimachi,Chuo-ku
Kobe,Hyogo 650-0047 Japan
MINISTRY OF EDUCATION, CULTURE, SPORTS, SCIENCE AND TECHNOLOGY
Translational Research Network Program
Translational Research Center Workshop
Time & Date：9:30-11:50, Thursday, February 27, 2014
Venue：Office Building of the Ministry of Education, Culture, Sports, Science and Technology
(MEXT), Tokyo, Japan
Theme：Management & Acceleration Strategies of Translational Researches
PROGRAM
9:30-9:40 １. Opening Remarks：Welcome to this Workshop
Takao Saruta
Program Director, Translational Research Network Program
9:40-9:55 ２. National Strategies to Promote Translational Researches in Japan
Takahiro Inoue
Ministry of Education, Culture, Sports, Science and Technology
9:55-10:15 ３. Reports on Visits to Translational Research Centers Abroad
Yoji Nagai
Foundation for Biomedical Research and Innovation
４. Translational Research Initiatives in Respective Countries : Current Achievements
and Future Directions (20 minutes presentation and 5 minutes discussion)
Chairman　Shigeru Kageyama, Osamu Inagaki
Program Officer, Translational Research Network Program
10:15-10:40　1) S huwen Koh (Biomedical Sciences Industry Partnership Office , Singapore)
“Translational Research Initiatives in Singapore” : Singapore's Biomedical Initiative”
10:40-11:05　2) Gerno Schmiedeknecht (Fraunhofer IZI, Germany) “Translational Research Initiatives in
Germany : Experiences on Cell Processing Services”
11:05-11:30　3) Augustin Godard (INSERM TRANSFERT, France) “Translational Research Initiatives in
France : Experiences on Technology Licensing Organization ”
11:30-11:50５. General Discussion and Closing Remarks
Masanori Fukushima
Foundation for Biomedical Research and Innovation
－1－
MINISTRY OF EDUCATION, CULTURE, SPORTS, SCIENCE AND TECHNOLOGY
Translational Research Network Program
文部科学省　橋渡し研究加速ネットワークプログラム
海外 TR センターワークショップ
日　時：平成 26 年 2 月 27 日（木）9：30 ～ 11：50
場　所：文部科学省東館 3 階第一講堂
テーマ：トランスレーショナルリサーチの管理・加速化戦略
プログラム
１．開会の辞（9:30 － 9:40）
猿田享男（文部科学省橋渡し研究加速ネットワークプログラム　プログラムディレクター）
２．TR 促進のための日本の戦略（9:40 － 9:55）
井上　隆弘（文部科学省）　３．海外の TR センター視察報告（9:55 － 10:15）
永井　洋士（公益財団法人先端医療振興財団）
４．各国における TR 推進戦略－これまでの実績と今後の方向性－（発表 20 分、質疑応答５分）
座長　景山　茂、稲垣　治
（文部科学省橋渡し研究加速ネットワークプログラム　プログラムオフィサー）
1）Shuwen Koh (Biomedical Sciences Industry Partnership Office , Singapore)　「シンガポールにおける TR 推進戦略」（10:15 － 10:40）
２）Gerno Schmiedeknecht (Fraunhofer IZI, Germany)
「ドイツにおける TR 推進戦略－細胞調製サービスの経験」（10:40 － 11:05）
３）Augustin Godard (INSERM TRANSFERT, France)
「フランスにおける TR 推進戦略－技術移転機関としての経験」（11:05 － 11:30）
５．総合討論・閉会の辞
福島　雅典（公益財団法人先端医療振興財団）（11:30 － 11:50）
当初ご案内しております内容に変更が生じております、ご了承ください。
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Contents
1．Welcome to this Workshop（Opening Remarks）�� p6
Takao Saruta
Program Director, Translational Research Network Program
2．National Strategies to Promote Translational Researches in Japan��p10
Takahiro Inoue
Ministry of Education, Culture, Sports, Science and Technology
3．Reports on Visits to Translational Research Centers Abroad ��p16
Yoji Nagai
Foundation for Biomedical Research and Innovation
4．Translational Research Initiatives in Respective Countries :
Current Achievements and Future Directions
1）“Translational Research Initiatives in Singapore :
Singapore 's Biomedical Initiative” ��p22
Shuwen Koh
Biomedical Sciences Industry Partnership Office
2）“Translational Research Initiatives in Germany :
Experiences on Cell Processing Services”��p28
Gerno Schmiedeknecht
Fraunhofer IZI
3）“Translational Research Initiatives in France :
Experiences on Technology Licensing Organization”��p36
Augustin Godard
INSERM TRANSFERT
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Memo
－4－
Opening Remarks
－5－
開会にあたって
文部科学省橋渡し研究加速ネットワークプログラム
プログラムディレクター
猿　田　享　男
本日は、文部科学省による橋渡し支援事業の一環として企画させていただきました、海外トラ
ンスレーショナルリサーチ（TR）ワークショップ「トランスレーショナルの管理・加速化戦略」
に御参加下さいまして誠に有難うございます。
日本では、2006 年 3 月に総合科学技術会議が策定したライフサイエンス分野の分野別推進戦略
として、TR が揚げられ、それを受けて 2007 年、文部科学省では「橋渡し研究支援推進プログラム」
を開始されました。第１期の 5 年間のプログラム（2007 － 2011 年）では、全国 7 拠点が選出され、
先端医療振興財団臨床研究情報センターのサポートにより、シーズの発掘、知財戦略、製剤、臨
床研究、治験を実施する体制が築かれてきました。各拠点に 5 年間の事業期間の終了までに求め
られた目標である、薬事法に基づく治験届の 2 件以上の受理も達成されました。その成果が評価
され、2012 年より第 2 期プログラムが開始されました。
第 2 期プログラムでは、すでに拠点整備や開発能力が充実したことから、シーズの実用化の一
層の促進のため、拠点間および全国の主要病院とのネットワークの強化と国際発展に力を入れて
いただくため、プログラムの名称が「橋渡し研究加速ネットワークプログラム」とされました。
すでに 2 年間が経過し、着実に効果が上がってきていると思います。
これからは、国際的発展が一層求められることから、サポート機関の方々は、これまでに主要
な国々の TR 事業の視察を行ってきました。その視察報告を先端医療振興財団　臨床研究情報セ
ンターの永井洋士先生にお話しいただくとともに、今後の日本の TR 事業推進に役立つことを願っ
て、海外で活躍されている TR 事業の関係の方々を招待して、ワークショップを開催させていた
だくことになりました。
シンガポールからは Biomedical Sciences Industry Partnership Office の Dr. S. Koh、ドイツか
らは Fraunhofer IZI の Dr. G． Schmiedeknecht、フランスから INSERM TRANSFERT の Dr. A.
Godard の計 3 名の方が参加され、各国の TR 推進戦略について講演していただくとともに、意見
交換ができればと考えております。
日本で TR 事業に関係されている方々、また、この方面に関心をお持ちの方々にとって、少し
でも役立つワークショップになればと考えております。
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Welcome to this Workshop
MEXT Translational Research Network
Program Director
Takao Saruta
Thank you all very much for attending this Overseas Translational Research (TR) Workshop, "Strategy
for Management and Acceleration of TR,” which is a MEXT's program designed to support translational
research.
In March 2006, TR was raised as a subject in the life science area considered pertinent to the promotional
strategy set forth by the General Council on Science and Technology in Japan, and upon which, MEXT
commenced with the "Coordination, Support and Training Program for Translational Research" in 2007.
During the first five-year program (2007 to 2011), seven core centers were selected nationwide; with the
assistance of the Translational Research Informatics Center, Foundation for Biomedical Research and
Innovation, have engaged in development of strategies to support seeds discovery, intellectual properties,
formulation studies, clinical research, and framework to conduct clinical trials. Further, the goal set for
each core center in the five-year period, which was to win acceptance from a minimum of two clinical trial
notifications, was also achieved. The results were considered successful and in 2012, the program entered its
second term.
Since the core centers and their R&D capabilities had been well established, this program was named
"Translational Research Network Program" for the second term. The objectives of this program were to
further promote the application of seeds for practical use, thereby strengthening the network between core
centers and with major hospitals all around Japan, and to contribute to international development. Now, two
years into this program term, there has been significant progress with concrete results.
As an effort to further contribute to future international development, staff from our support organizations
traveled overseas to visit TR projects in some major countries, the report on which will be presented here
by Dr. Yoji Nagai of the Translational Research Informatics Center (Foundation for Biomedical Research
and Innovation). Also invited to this workshop are four friends from overseas who are actively involved in
TR projects abroad, and from whom we hope to gain knowledge that will ensure our future success in TR
projects in Japan.
Attending this workshop are Dr. S. Koh of Biomedical Sciences Industry Partnership Office, Singapore; Dr. G.
Schmiedeknecht of Fraunhofer IZI, Germany; and Dr. A. Godard of INSERM TRANSFERT, France. They
will present on the promotional strategy for TR implementations in each country, and share and exchange
information with us.
I hope this workshop will be beneficial and of value to those who are involved in or interested in TR projects
in Japan.
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Memo
－8－
National Strategies to Promote
Translational Researches in Japan
－9－
National Strategies to Promote Translational Researches in Japan
Takahiro Inoue
Senior Specialist, Division of Life Science, Ministry of Education, Culture, Sports,
Science and Technology
Abstract
The importance and necessity of promoting translational research (TR) in Japan have been well recognized,
however, filling the gap between basic science and clinical application has not progressed. This issue is
called the "Valley of Death." In order to bridge the “Valley of Death,” MEXT (Japanese government,
Ministry of Education, Culture, Sports, Science and Technology) launched a five year national project
called “Coordination, Support and Training Program for Translational Research” in FY2007. The aim of
this program was to form a research and development (R&D) pipeline within major universities in Japan.
We selected six universities and one institution, and intensively supported them in establishing TR centers.
After the project was successfully completed, we initiated the “Translational Research Network Program”
in FY2012. In this program, we aim to form sustainable R&D pipelines within major universities through
networking. The goal of the program is to ensure that various kinds of seeds are nurtured in each TR center,
without financial dependence on governmental aid, and that the TR center network generates the synergistic
effects. The speaker talks about the Japanese government's current strategies for promoting TR.
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Reports on Visits to Translational
Research Centers Abroad
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Reports on Visits to Translational Research Centers Abroad
Yoji Nagai
Vice-director, Translational Research Informatics Center
/ Foundation of Biomedical Research & Innovation
Profile
Nagai studied both pharmaceutical sciences at Univ. of Tokyo (1982
-1987) and medicine at Osaka Univ. Medical School (1987-1991). After
completing residency, he worked as a stroke neurologist at Hoshigaokakouseinenkin Hospital (1992-1996) and later at Osaka Univ. Hospital
(1998-2003). Also, he received the training on clinical studies (Visiting
Fellow) at National Institutes of Health in US (1996-1998). Since 2003,
he has been working at the current institute (Translational Research
Informatics Center), with the primary commitment to facilitate translational
and clinical researches performed in the academic sector.
SCHOOL EDUCATION
1982 - 1984 Faculty of General Education, Univ. of Tokyo
1984 - 1986 Faculty of Pharmaceutical Sciences, Univ. of Tokyo
1986 - 1987Graduate School, Division of Chemical Toxicology & Immunochemistry, Faculty of
Pharmaceutical Sciences, Univ. of Tokyo
1987 - 1991 Osaka Univ. Medical School
POSITION HELD SINCE GRADUATION
1991 - 1992 Resident, First Department of Internal Medicine, Osaka Univ.
1992 - 1996 Clinical Fellow, Department of Internal Medicine,
Hoshigaoka-kouseinenkin Hospital, Osaka
1996 - 1998 NIH/NIA, Lab of Clinical Science (Visiting Fellow)
1998 - 2003 Clinical Fellow, First Department of Internal Medicine,
Osaka Univ. Hospital (Stroke Neurology)
2003 - 2010Chief Researcher, Translational Research Informatics Center / Foundation of Biomedical
Research & Innovation
2010 - Vice-director, Translational Research Informatics Center / Foundation
present
of Biomedical Research & Innovation
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Abstract
To potentiate the function of major TR centers in the Japanese academia, and to generate synergistic effects
by networking such centers, "Translational Research Network Program" is being implemented by the
government. The aim is to form sustainable R&D pipelines in the TR centers, thus leading to the revolution of
current treatments for intractable diseases. Also, the tangible goal is the condition, in which seeds of various
kinds and stages are nurtured in each TR center, and the centers are financially independent of governmental
supports. Particularly, the government is requesting each TR center to start at least 3 investigator-initiated
IND trials during the program period.
Under such conditions, to allow for the acceleration of program, we visited outstanding TR centers in Europe
last year, and learned how they are managed and operated. Also, based on the obtained information, we have
made proposals to the governmental program, to intensify national infrastructure of TR.
Thus, to learn more on the TR center function on the globe and to allow for the benchmarking, we visited
TR centers in US in January 2014, where centers with established ARO function were surveyed and selected.
Results of the current visits will be reported at this workshop.
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TR Acceleration NW Program
Since 2012, 40 million dollars/year
Aim
– Formation of sustainable R&D pipeline in Academia
Goal
– Seeds of various kinds and stages are nurtured in each TR center
– TR centers are financially independent, with synergistic effects generated by the network TR centers
Sapporo, Sendai, Tokyo, Nagoya, Kyoto, Osaka, Fukuoka
TR center support
Kobe TRI
1
Outline of TR Center Visits
• Last year, we visited outstanding TR centers in Europe, and learned how they are managed and operated. • To learn more about the function and to allow for benchmarking, we have visited TR centers in US, where centers with established ARO function were selected from CTSA program by NCATS/NIH. – Harvard Clinical and Translational Science Center (Catalyst)
– Stanford Center for Clinical and Translational Education and Research (Spectrum)
– South Carolina Clinical and Translational Research Institute CTSA：Clinical and Translational Science Awards
NCATS: National Center for Advancing Translational Science
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2
Points of Interest
1. System of ARO Position in corporation, Running cost, Income source, Efforts to increase income, Management of R&D pipeline
2. Function of ARO
Recruitment of R&D seeds/clinical studies, Management of IP, Phase I unit, CPC, Data center, Methods of monitoring/auditing, Facilitation of patients’ recruitment, Education system, Project management
3. R&D support services by ARO Service items, Fee structure, Business partners, Relationships with pharmaceutical companies
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Memo
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Translational Research Initiatives in
Respective Countries :
Current Achievements and Future
Directions
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Translational Research Initiatives in Singapore :
Singapore’s Biomedical Initiative
Shuwen Koh
Industry Alliance Manager,
Biomedical Sciences Industry Partnership Office ,Singapore
Profile
Dr. Koh Shuwen was a researcher and laboratory manager at the
Nayang Technological University before pursuing her Ph.D. She obtained
her Ph.D. from the University of California, Los Angeles (UCLA) in
Biomedical Engineering under a USA Department of Defense fellowship.
At UCLA, she participated in multi-disciplinary projects that built on the
university’s strong business, science and engineering departments as well
as medical school. Upon returning to Singapore in 2010, she joined the
Biomedical Sciences group at the Economic Development Board (EDB)
managing investment promotion and industry development for the pharma
and biotech sector. While at EDB, she worked with MNCs on R&D,
manufacturing and business engagements. She joined the Biomedical Sciences Industry Partnership Office
(BMS IPO) in Jan 2012.
The Biomedical Sciences Industry Partnership Office (BMS IPO) is a new joint initiative by the Singapore
Economic Development Board (EDB), Agency for Science, Technology and Research (A*STAR) and the
Ministry of Health (MOH). BMS IPO aims to provide dedicated support to companies that have made
significant funding commitments for R&D collaborations with Singapore-based investigators across multiple
research institutions. It is the single Singapore point of contact for such companies, to introduce them to the
local research landscape and to accelerate the establishing of research partnerships.
Abstract
2013 marked the 10th anniversary of Biopolis, which was born out of a vision in 2000 to establish
the Biomedical Sciences (BMS) as a key pillar of Singapore’s economy. The BMS focus was planned to
diversify Singapore’s economy from manufacturing and propel Singapore up the value chain.
Phase 1 of Singapore’s BMS initiative was launched with a funding of ~US$1 billion in June 2000. This
included the systematic development of research capabilities and talent spanning basic to translational
research as well as the establishment of Biopolis in 2003. International scientists were recruited to head up
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the research institutes under the Agency for Science, Technology and Research (A*STAR) as well as train
and nurture local talent who would be the next generation of movers and shakers in biomedical research.
The key focus of Phase 2 (2006 to 2010) was to strengthen Translational and Clinical Research (TCR)
capabilities with an investment of ~US$2.6 billion. TCR institutes and consortia were established to bring
more scientific discoveries from the laboratories to the patients in hospitals, particularly in therapeutic areas
of regional strategic importance such as gastric cancer and dengue. In addition, emerging research areas such
as neuroscience and immunology were developed.
Currently, Phase 3 is focused on leveraging Singapore’s strong scientific and clinical foundation to foster
public-private partnerships. Companies are attracted by the opportunities for collaboration with Singapore
scientists and clinicians. Synergistic industry-academia collaborations have catalysed new ideas, some which
will mature and translate into medical discoveries and innovations. Besides pharmaceuticals and biologics,
which are the traditional industry, clusters, there are increasing opportunities in the medical technology,
nutrition and personal care industry clusters that are fast growing in the Asia-Pacific. Reflecting the new
opportunities, pharmaceutical companies such as Novartis and GSK in the early years have been joined by
biotech and medical technology companies such as Arkray, Fluidigm, Illumina and Thermo Fisher, as well
as nutrition companies such as Abbott and Danone, and personal care companies like L’Oreal and Procter &
Gamble.
In the last decade, A*STAR, Ministry of Health (MOH) and the National Research Foundation (NRF)
put in place strategic collaborative programmes and grant mechanisms to achieve greater coordination and
integration among the whole BMS ecosystem made up of the A*STAR research institutes, universities,
hospitals, specialty centres, regulators and companies. With the strong and sustained government support
to the BMS sector, we expect more local research efforts to be able to take advantage of Singapore’s strong
track record in early phase clinical trials when they reach the commercialisation and clinical trial stages in
the coming years.
As a result of the vision that started in 2000, the number of BMS R&D jobs in the public and private
sectors have doubled from 2,150 in 2002 to 5,427 in 2012 and the R&D expenditure grew 6-fold from
~US$200 million to US$1.2 billion during the same period.
In the words of Prime Minister Lee Hsien Loong, “Singapore’s long-term aim is to be one of the most
research-intensive, innovative and entrepreneurial economies in the world in order to create high-value jobs
and prosperity for Singaporeans. Research and innovation underpin the competitiveness of our industries,
catalyse new growth areas, and transform our economy. Increasingly, intellectual capital will be critical for
our next phase of economic development.”
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Translational Research Initiatives in Germany :
Experiences on Cell Processing Services
Gerno Schmiedeknecht
Head of Department Cell Engineering,
Fraunhofer Institute for Cell Therapy and Immunology (IZI), Germany
Profile
October 01, 2009 to now
Department leader “Cell Engineering” at the Fraunhofer Institute for Cell
Therapy and Immunology (IZI) in Leipzig / Germany; responsibility for the
“Cell Engineering/GMP Unit” (certified GMP-manufacturing facility for
so called “Advanced Therapy Medicinal Products” according to regulation
(EC) no 1394/2007) and the “Cell Engineering/GLP Unit” (certified GLP
testing facility for preclinical testing in the field of immune toxicology and
immunogenicity)
September 01, 2005 to now
Head of the “Cell Engineering/GMP Unit” at Fraunhofer IZI; establishment and leadership of one of the
biggest GMP-facilities for the manufacturing of cell-based therapeutics in Germany; Head of Manufacturing
according to §12 German Ordinance on the Production of Pharmaceuticals and Active Substances (AMWHV)
and Qualified Person (QP) according to §15, section 3a, point 2 AMG
October 01, 2013 to now
Regulatory consultant Northwest Biotherapeutics GmbH in Leipzig
November 01, 2009 to June 2013
Consultant for the German-Italian private stem cell bank InnovaStem GmbH in Leipzig with regard
to the establishment of the company as well as technical and regulatory support for the application for
manufacturing authorization according to §13 German Drug Act (AMG) for the isolation and storage of adult
stem cells from cord blood
April 01, 2004 to August 31, 2005
Head of the GMP facility for cell-based therapeutics and gene therapeutics at MOLOGEN AG, a listed
biotech company in Berlin / Germany; Head of Manufacturing (according to §15 AMG, special regulation
according to section 3a of the AMG revision at that time); main focus was the manufacturing and quality
control of autologous and allogeneic cell-based immunotherapies / gene therapies for treatment of renal cell
carcinoma
April 01, 2002 to March 31, 2004
Head of Manufacturing for cell-based therapeutics and gene therapeutics (according to §15 AMG, special
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regulation according to section 3a of the AMG revision at that time) at Geniotronic AG, a privately held
biotech company in Berlin; main focus was process development, manufacturing, and quality control of
autologous and allogeneic cell-based immunotherapies / gene therapies for treatment of renal cell carcinoma
July 01, 2001 to December 31, 2001
Project head within the department “Biochip-Development” at ARCENSUS AG, a privately held biotech
company in Berlin; main focus was the development of new diagnostic tools for rapid detection / typing of
pathogens from clinical specimens
January 01, 2001 to June 30, 2001
Head of the profit-center “Molecular Diagnostics” at Invitek GmbH, a privately held biotech company in
Berlin; main focus was the development of new diagnostic tools for cancer prediction
January 01, 1999 to December 31, 2000
Scientist in the profit centers “Recombinant Protein Expression” and “Nucleic Acid Extraction” at Invitek
GmbH, a privately held biotech company in Berlin; main focus was the recombinant expression and
purification of proteins in insect cells and E. coli bacteria and the development of nucleic acid extraction kits
(e.g. total RNA extraction from blood, tissues etc.)
August/1994 to August/1998
Doctoral Thesis (Dr. rer. nat.)
Performed at the Institute for Clinical Chemistry and Laboratory Medicine of the University Hospital
Regensburg, University of Regensburg, Bavaria / Germany
Degree with grade 1.0 (magna cum laude)
Scientific field: “Cloning and characterization of candidate genes with a potential atherosclerosis association”
September/1989 toJuly/1994
University Education
Study of biochemistry at the Faculty of Biosciences, Pharmacy and Psychology of the University of Leipzig /
Germany
Degree with grade “very good” (1.5)
Scientific topic diploma thesis: “Crotonobetainreduktase from Escherichia coli”
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Abstract
Translational Research Initiatives in Germany: Experiences on Cell
Processing Services
The Fraunhofer Institute for Cell Therapy and Immunology IZI is part of the Fraunhofer-Gesellschaft
(FhG). FhG was founded in 1949 and is one of the “big four” German non-University research organizations,
and is the largest society for applied research in Europe. Fraunhofer-Gesellschaft operates 66 institutes and
independent research centres in Germany. It has more than 22,000 employees and an annual budget above
1.9 billion Euro. The Fraunhofer Institute for Cell Therapy and Immunology was founded in April 2005
and is located in Leipzig (headquarters), Halle and Rostock in the eastern part of Germany. Fraunhofer
IZI’s objective is to find solutions to specific problems at the interfaces between medicine, life sciences
and engineering for partners active in medicine-related industries and businesses. Currently it has more
than 230 highly qualified staff members and is divided in five independent scientific departments: a.)
Cell Engineering; b.) Immunology; c.) Cell Therapy; d.) Diagnostics and e.) Drug Design and Target
Validation. The Department of Cell Engineering consists of the Cell Engineering GLP Unit and the Cell
Engineering GMP Unit. Preclinical Good Laboratory Practice (GLP) - studies for cell-based medicinal
products in small and large animal models are the main focus of the Cell Engineering GLP Unit. The Cell
Engineering GMP Unit operates with more than 60 employees two state of the art clean room facilities for
aseptic manufacturing according to Good Manufacturing Practice (GMP). The facilities are designed for
manufacturing and quality control of autologous or allogeneic cell-based therapeutics – so-called Advanced
Therapy Medicinal Products – ATMP’s (e.g. tissue engineering products, somatic cell therapeutics, gene
therapeutics) for clinical trials. A comprehensive quality assurance system covering the nine chapters of the
EU Guidelines to Good Manufacturing Practice is the framework for all manufacturing and quality control
activities. It consists of more than 750 documents and to date has been successfully inspected eight times
by the Germany pharmaceutical authorities. The Cell Engineering GMP unit offers the following services to
clients: a.) contract manufacturing and quality control; b.) support in set-up and validation of GMP-compliant
manufacturing processes and quality control assays (process development); c.) application for productspecific manufacturing authorizations according to section 13 German Drug Act; d.) application for tissue
procurement permissions according to section 20b German Drug Act; e.) application for import permissions
from countries outside of the European Union (e.g. for human derived materials used for manufacturing);
f.) support in regard to Investigational Medicinal Product Dossier (IMPD) writing and g.) regulatory
consultancy. The clients that perform their clinical trials together with Fraunhofer IZI’s Cell Engineering
GMP Unit are mainly biotechnology companies from all over the world, e.g. from USA or Australia.
Manufactured products range from Dendritic Cell based immunotherapies up to stem cell based products.
A wide variety of clinical trials up to phase III pivotal studies are within the current project spectrum. The
annual revenue of the Cell Engineering GMP Unit in 2013 was 2,850,000 Euro. This was sufficient to cover
all running costs and to generate a slight positive cash flow that is used as a backup if required. In addition
to the given information in regard to infrastructure, services, clients and budget this presentation will
provide specific information about methods to recruit talented human resources and to reach and maintain a
sustainable business model in the cell therapy manufacturing area.
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Memo
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Translational Research Initiatives in France :
Experiences on Technology Licensing Organization
Augustin Godard
Executive Vice President Open Innovation,
INSERM TRANSFERT, France
Profile
Augustin is Executive Vice President Open Innovation and Chief Business
Officer since 2013. He joined Inserm Transfert in 2008 as business
developer for licensing and strategic partnerships before becoming Director
of Industry Partnerships in 2012. He previously held marketing positions in
IT companies such as Nokia in Spain, Telia Research (Sweden) and startups in Silicon Valley. Augustin is a graduate of the Ecole Centrale of Paris
and the Royal Institute of Technology (KTH), where he participated in
several projects with Karolinska Institutet.
During his IT period, Augustin had the opportunity to work on several
cross-cutting research projects linked to the life sciences, which has given
him a particularly creative edge in his missions in Inserm Transfert. He has been keystone to the success of
current strategic partnerships between INSERM and significant Pharma companies (GSK, Astra Zeneca, …).
Abstract
INSERM - the French NIH- is home of over 13,000 staff in biomedical research, 80% of which are localized
in hospitals with direct access to patients and 1000+ patent families (3rd applicant in EU in pharmaceuticals).
Being the widest and the most diversified biological/preclinical platform globally, INSERM is by far a
partner of choice for strategic partnerships.
As Technology Transfer Office for INSERM, INSERM TRANSFERT SA has developed original approaches
in the Open Innovation space for providing privileged and customized access to INSERM’s inventions,
know-how and expertise (including new targets/pathways, research tools…) to meet specific needs of our
partners.
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Translational Research Network Program
Ministry of Education, Culture,
Sports, Science and Technology
February 27, 2014, 9:30-11:50
Translational Research Informatics Center
Foundation for Biomedical Research and Innovation
1-5-4 Minatojima-minamimachi,Chuo-ku
Kobe,Hyogo 650-0047 Japan

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