Activity Report 2015

A New Age of Bio-BusinessToward the Creation of New Industry Clusters

Create the future
via bio-innovation

Japan Bioindustry Association

Mission

JBA contributes to bioindustry andrelated industries in the fields of health,environment and food

About JBA
History ■JBA’s roots date back to Shusei Kyokai (theDistilled Spirits Institute) established in 1942.
Its name, after being changed to the Japanese
Association of Industrial Fermentation, wasrenamed as Japan Bioindustry Association(JBA) in 1987.

Our mission at JBA is to address the imminent problems facing mankind
such as those concerning climate change and biodiversity and to facilitate
implementation of appropriate measures as necessary, particularly byutilizing the latest developments in biosciences in an effective manner.
To that goal, one of the most important priorities of JBA is to formulate
and advance specific public policies through science-based reviewsof regulations as well as to craft strategies to strengthen collaboration
between industry, academia and government. Furthermore, to encourage
the exchange of vital data and information, we realize that cooperationand communication with like-minded organizations throughout the world isof paramount importance. We are keenly aware of the value of providing
free and open access to information regarding new technologies andproducts to all those who are interested in opportunities for innovation. On
a more local level, our mission will also be expanded to help organize anddevelop regional associations for bioindustries in Japan. As an example
of such endeavors, we hold an annual fair called BioJapan that comprises
exhibitions, seminars for academia and industry, and business to businessmatching.

Members ■Corporate members: 214 companies(pharmaceutical, food, chemical, cosmetic
and machinery companies)
Public members: 103 organizations
Individual members: approx. 700(university and corporate researchers)
Budget ■ 540 million yen (2015)

Board of Directors
Chairman

Sakayu Shimizu

Professor Emeritus,
Kyoto University
Professor,
Kyoto Gakuen University

President,
Representative Director

Osamu Nagayama

Three - year plan (2014 - 2017)

Chairman & CEO,
Chugai PharmaceuticalCo., Ltd.

Attainment target
JBA will enhance the development base andplatform functions of bioindustry, to contributeto the international competitivenessof the bioindustry in Japan.

Executive Director

Yoshiaki Tsukamoto

Ex-Professor,
Tokyo Institute of Technology,
Ex-Director-Generalof Shikoku Bureau of METIJBA Activity Report 2015
Missioncontents

Recent Topics

1

2

5
1 Policy Proposal and Dialog
2 Science Agora for the Information 6
on Advanced Biotechnology

3 Open Innovation throughNetworking

1

©2015

Policy Proposal
and Dialog

42

Science Agora
for Information
on Advanced
Biotechnology

International
Network

5

3

Open Innovation
through
Networking

Establishing
the Infrastructureof Bioindustry

911
4 International Network
5 Establishing the Infrastructure 12of Bioindustry

1

5 Actions ofRecent

TopicsNew Study Groups
Launched Out

Activity Report 2015

JBA has established new study groups to meet theneeds of corporate members. Going beyond collection
and dissemination of information, we propose policies
and projects, clarify objectives for the establishment ofconsortia, and take action with a sense of urgency.

Establishment of New Health Care
Study Group

Energizing the Research & Development
Team on Functional Foods

Social demands of human health

Proactive proposals and communication regarding
the new functional labeling system for foods

Having a background of a declining birthrate and an increase inlifestyle-related diseases, health care initiatives to address predisease conditions and to support health are increasingly importantfrom the perspective of societal demands for quality of life (QOL)
improvement and medical cost constraint.
With a large number of companies engaged in or oriented toward
the health care business, JBA established this study group in fiscal
2014 to share information among members and respond to common
issues.
Members of the study group enriched its lectures and discussion
sessions, conducting short presentations on topics close to businessand exchanging information. Mr. Takeo Niga and Dr. Susumu
Kajiwara presented talks titled “Concerning Health Care Industry
Policy” and “Overview of the Organization for Life Design andEngineering, Tokyo Institute of Technology,” respectively. The study
group also exhibited within the Open Innovation Zone at BioJapan
2014 and promoted business matching among companies.

Noboru Yumoto
Vice President
AIST

Takeo Niga

Senior Analyst
METI

Susumu Kajiwara

Professor
Tokyo Institute of Technology

Future JBA conducts lectures and information collection
Activities on specific health care topics including nursing

care robots, “medical towns” that reorganize urban areas aroundhospitals, and medical treatment and nursing care services offeredthrough collaboration between regions and universities. We arealso exploring collaboration among JBA members in these fields.

In order for the functional foods-related industry to prosper, JBA
organized relevant issues, held discussions on resolution of theissues, and in 2013 launched a new research and development
team aimed at proposing solutions to the government. In order toenhance information communication functions related to foods andhealth foods, we are undertaking actions centered on (1) proposal ofsolutions regarding functional labeling, regulations, etc.; (2) draftingof projects aimed at scientific evaluation of the 3 functions of foods,
rational demonstration of safety, etc.; and (3) cooperation among
business, academia, regional clusters, etc. for the development
and overseas expansion of the functional foods-related industry (27member companies and organizations).

■ Communication of Opinions and Proposals to SocietyWith an eye toward the content of guidelines released in March
2015 regarding the new functional labeling of foods, we focused on
the sharing of issues and aggregation of opinions by conducting
seminars on the functional food labeling system that started on April
1, 2015, along with workshops and idea exchanges among members,
and further communicated opinions and proposals (see box below).
■ Communication of opinions in response to public comments:“Food Labeling Standards Concerning the New Functional Labeling
System for Foods (Draft)” (2014-09-26)■ Cooperation with Japan Association of Bioindustry Executives(JABEX) in submitting the proposal paper “Proposal for the
Functional Labeling System for Foods: Aiming for the Extensionof Citizens’ Healthy Longevity and Industrial Revitalization” to the
Cabinet Office Deputy Director-General, Cabinet Secretariat Healthand Medicine Strategy Office, Ministry of Agriculture, Forestry and
Fisheries, and Consumer Affairs Agency (Until Apr., 2015)

Exhibition in the Open Innovation Zone

(Health Care Study Group, Research & Development Teamon Functional Foods)
JBA took part in a joint exhibition (12 exhibits) in the Open
Innovation Zone at BioJapan 2014, where Zone exhibitors
and related bio-clusters conducted 44 presentations on
the food and health care sectors and engaged in active
business discussions. At BioJapan 2015 (2015-10-14~16), we
will further expand the event to cover health care, functional
foods, diagnostics, regenerative medicine, biochemicals,
plant biotechnology, the environment, and more.

2Recent

TopicsOver several meetings of the study group, Mr.Takeshi Takeda
discussed recent information on the new system and the necessityof an organization like the ODS (the U.S. NIH Office of Dietary
Supplements), while Dr. Mari Maeda-Yamamoto spoke on theevidence-based development of processed products and functional
agricultural, forestry, and fisheries products.

Keiko Abe

Professor Emeritus
The University of Tokyo

Takeshi Takeda

Mari Maeda Yamamoto

Managing Director
Director of Food Function
Global Nutrition Group, Inc. Division Natl. Food ResearchInstitute, NARO

Future With specific products coming to market under the
Activities new functional labeling system, the study groupwill debate and issue opinions on issues and problems with
the new system, including policy matters. It will also engage inconsideration of topics including rational methods (i.e. standards)
for verifying safety, assurance of first-mover benefits, andfunctional label patent claims. The study group will also cooperate
closely with the “Development of Next-Generation Agriculture,
Forestry, and Fisheries Products and Foods” strategic innovation
program (SIP), which seeks to create technology in the industry
and for which Ms. Abe serves as Sub-Program Director, and willfurther ramp up activity aimed at the prosperity of the functional
foods-related industry.

Launch of the Plant Biotechnology
Study Group
Reassessing the potential of plants and promoting
industrial usage
JBA has established a new study group with the aim of conducting
discussions across departments and specialties, selecting basic andmediating technologies that should be developed, and engaging incollaboration among industry, government, and academia to breakthrough problems. The group welcomes participation.
Special members,sponsoring members,
general members,
venture members,
public members,
and representativesof academia(including independentadministrative institutions)are all invited to inquire.

Daisuke Shibata

Department Director, Kazusa DNA
Research Institute

Activities about the Nagoya Protocol
At the 10th meeting of the Conference of the Parties to theConvention on Biological Diversity (COP10) held in Nagoya in
October 2010, the Nagoya Protocol on Access to Genetic Resources
and the Fair and Equitable Sharing of Benefits Arising from their
Utilization (hereinafter, the Nagoya Protocol) was adopted. This is aninternational agreement which aims at sharing the benefits arisingfrom the utilization of genetic resources in a fair and equitable way.
Although the Nagoya Protocol was adopted as a result of difficultinternational negotiations for many years, there are a numberof ambiguous points in its major provisions with regard to theirinterpretation. While the Nagoya Protocol entered into force in
October 2014, the government of Japan has been discussing theformulation of Japan’s domestic measures for the ratification of the
Nagoya Protocol and its implementation in Japan.
Under these circumstances, JBA, Japan Association of Bioindustries
Executives (JABEX) and four other industry groups submitted an
opinion paper on the Nagoya Protocol to the Ministry of Foreign
Affairs, the Ministry of Health, Labour and Welfare, the Ministry of
Economy, Trade and Industry, and the Ministry of the Environment in
October 2014. The opinion paper notes that, while the protocol bears
the name of the Japanese city Nagoya, the government should not
act too hastily but must carefully consider every issue in the Protocol
through dialogues with the bioindustry sectors.

3

Future JBA will continue its activities to ensure that the
Activities implementation of the Nagoya Protocol facilitates

the utilization of genetic resources in a fair and equitable way
and contributes to the conservation of biological diversity andthe sustainable use of its components.

The Nagoya Protocol published by CBD
Secretariat (left) and its Japanese translation
by JBA (right)

Activity Report 2015

Launch of the Bio-Business Seminar
JBA has assumed the Pharmaceutical and Other Companies Top
Management Seminar that had been conducted as an activityof the Metropolitan Bio Network Japan until fiscal 2013. In 2014,
we launched the Bio-Business Seminar as a venue at which
executives and key persons from member companies can present
information on research and development, business strategy, coretechnologies, case studies of external resource usage, and othertopics, sharing this information with JBA members.

Strategy: Sustainable, Seniors, and Global” (2014-12-26)
Session 8: “Sumitomo Chemicals’ Life Sciences Business: Toward
the Rollout of Business on the Themes of Foodstuffs, Health, and theEnvironment” (2015-01-19)

Future In fiscal 2015, too, we will make the seminars an
Activities opportunity for open innovation that crosses industries

and sectors, and a valuable venue for more member companies.

■ Seminar Content (8 sessions)

Session 1: “FUJIFILM’s New Business Challenge”(2014-02-06)

Session 2: “Mitsubishi Chemical Holdings’
Health Care and Green Agribusiness Strategy”(2014-02-24)

Session 3: “TORAY’s Advanced Film Technology
Creation and Innovation Strategy” (2014-05-20)
Session 4: “TEIJIN’s Technological Innovation
and Green Chemistry & Health Care Business
Strategy” (2014-08-07)
Session 5: “Daiichi Sankyo’s Biologics Strategy”(2014-09-16)

Seminar by

Session 6: “Ajinomoto’s R&D: Focusing on theWorld of Amino Acids” (2014-11-19)
Session 7: “Kao Corporation’s Daily Goods Bio

Yasuhiro Yoshioka,
FUJIFILM Corporation

Launch of International
Partnership Seminars
In 2014, JBA launched the International Partnership Seminar forforeign embassies, regional and state government organizations,and overseas biotechnology organizations. The seminar is avenue to communicate the latest bio-related topics and selected
information from overseas, and to provide up-to-date information
to corporate members and opportunities for interaction among
members.

of Technology (Australia) and the Potential for International IndustryAcademia Partnerships” (2015-03-27)

Future JBA has 31 embassies and regional and state offices
Activities in Japan as public members. We will continue to planand offer seminars in partnership with these members.

■ Seminar Content (6 sessions)

Session 1: “From San Diego: Mobile Health and the Recent
Widening of the Bio Industry” (2014-04-14)
Session 2: “The Current State of Life
Sciences in Medicon Valley” (2014-0630)

Session 3: “Europe’s Advance into theLife Sciences Sector: Why Scotland is
an Option –Tips and Points for Making
Use of Scotland–” (2014-07-14)
Session 4: “Life Sciences in Canada”(2015-02-09)

Session 5: “Overview of the Pharmaceutical and Bio Industries of Catalonia,
Spain” (2015-02-23)
Session 6: “Overview of Biomass
Research Led by Queensland University

Stephen Dibert

Global Practice Lead Foreign
Affairs, Trade and Development
CanadaQueensland state seminar4

1

ActionPolicy Proposal
and Dialog

JBA carries out policy proposals and dialogs with government bodies on biotechnology
and industrial issues in cooperation with member companies, universities.
In cooperation with the Japan Association of Bioindustry Executives (JABEX; Chairman
Kouichirou Aramaki), JBA has been offering a variety of policy proposals and retains opportunities
for dialog for the sound development of biotechnology and bioindustry.

Policy Proposal

JBA visited LDP Executive Acting Secretary-General Hiroyuki Hosoda(Chairman of the Diet Members’ Promotion Alliance for Life Sciences),
Minister for Foreign Affairs Fumio Kishida (Secretary-General of theaforementioned Alliance), and Minister of the Environment Yoshio
Mochizuki to present the industrial position on the Nagoya Protocol.
We made suggestions to the Cabinet Secretariat, the Cabinet Office,and other relevant parties concerning the 5th Term of the Scienceand Technology Basic Plan, bio-ventures, functional foods labeling,
and other topics.
LDP Executive Acting Secretary-General Hosoda (left)
and Representative Aramaki (right)

Minister for Foreign Affairs Kishida (left)

Policy Dialog

An opinion on “Human derived biological sample usage promotion
for drug discovery” was suggested at “Council for Genomic Medicine
Promotion” of the Cabinet Secretariat Health and Medicine Strategy
Office by our steering committee member Dr. Toshinori Agatsuma.

Expression of Qualified
Opinions

JBA expressed opinions on National Strategic Economic Growth
Areas, food labeling standards, the new functional labeling system forfoods, and other topics. We supported the members’ activities on socalled the System to Removing Gray Zone Areas and the System ofSpecial Arrangements for Corporate Field Tests.

Minister of the Environment Mochizuki (second from right)

Business” (Ministry of Economy, Trade and Industry) (2014-06-12)■“Overview of 2014 General Strategy for Science and Technology
Innovation” (Cabinet Office) (2014-09-02)■“Overview of the Leading Package Strategy: Toward the Realizationof Innovative Pharmaceuticals, etc. Ahead of the World” (Ministry of
Health, Labour and Welfare) (2014-09-26)■“ Toward the Strengthening of Social Security Policy and theDevelopment of the Pharmaceutical Industry” (Ministry of Economy,
Trade and Industry) (2015-01-09)■“Overview of Overseas Pharmaceutical Market Trends: Current
State and Issues as Seen from the Relationship with Policy
Measures” (Ministry of Health, Labour and Welfare) (2015-03-12)

Government policy seminars

JBA holds ongoing policy information seminars with presentations
by ministry and agency officials in charge of drafting and promoting
policy measures.
■“Overview of the Center of Innovation S&T Radical Innovation and
Entrepreneurship Program (COI STREAM)” (Ministry of Education,
Culture, Sports, Science and Technology) (2014-06-11)■“Overview of Policy Measures Concerning the Genetic Testing5

Government policy seminar

2

ActionScience Agora for
the Information
on Frontier Biotechnology

Activity Report 2015

JBA provides recent issues on biotechnology and new technical information for the industry,along with the discovery of seeds and industrialization,in cooperation with member companies, universities, and government bodies.
JBA gathers information on advanced biotechnology in Japan and overseas, conducts surveys on the latest development
trends, discovers technological seeds that will lead to new industries, shares information with members and communicates
information externally through lectures and seminars. Furthermore, JBA proposes project concepts that should be
conducted in cooperation with industry, government, and academia.

Expanding Lectures and Seminars

Increase in seminars & audience (2014)

In fiscal 2014, JBA hosted a total of 71 workshops, seminars, lectures, symposiums, andstudy tours drawing 5,737 participants. Along with lectures and seminars on drugs, medicalcare, the environment and manufacturing, and the health care sector, JBA took up the topic
of the plant biotechnology sector. In addition to targeting niche and compound domains, thiscombines biotechnology with basic technology that supports cutting-edge science, and willlead to the creation of new businesses. JBA’s lecture covered technological information fromoverseas, and plans that propose solutions for new industrial technologies.

Key words from advanced information seminars

Advanced Themes and Leading Lecturers

Drawing on the results of questionnaires aimed at members, weselected themes appropriate to JBA lectures. We also proactively
held seminars that are planned and proposed by corporate members,
taking up themes that included brain science, space drug discovery,
and plasma, with the aim of fusing different sectors and industries
and creating new businesses.

Expanding Potential for New Businessat Networking Events

With the formation of networks among participants a key objective,
JBA strives holds seminars with the goal that these will lead tothe creation of businesses and markets, proposals for policy,

and business matching. Networking meetings and business cardexchanges have taken root as activities following our lectures, withparticipants forming long lines to meet speakers every time.

Enhancement of member privileges

After the conclusion of events, JBA promptly posted reports on its
website and made presentation slides available as PDF documents,
limited to JBA members. JBA also enhanced its video streaming service
for corporate members, with a total of 36 seminars and 85 presentations
available. In total, viewing requests have come from 182 persons, for 461
seminar videos and 1,110 presentation videos. (fiscal 2014)
JBA is enhancing its seminars for corporate members in order to deliver
fresh information. Seminars proposed by corporate members have also
taken root at JBA.

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2

Science Agora for the Information
on Advanced Biotechnology

Seminarspeaker“New Development in Surgery:
Cardiac Regeneration Service”
Yoshiki Sawa
Professor, Osaka University“Science and Technology Policy
in Japan and Innovation Strategy
in the Chemical Industry”
Kazuhito Hashimoto
Professor, The University of Tokyo“Development of a Special
Peptide Drug Discovery Platform
and its Future Outlook”
Hiroaki Suga
Professor, The University of Tokyo“The Potential for Culturing
Technology Standardization andQuality Control Technology Using
Images of Cultured Cells
in Regenerative Medicine”
Ryuji Kato

Associate Professor, Nagoya University“Application of Textile Materials
to Biological Interfaces and the
Future Outlook: Wearing Functional
Material ‘hitoe’ Enables Continuous
Measurement of Biological
Information”
Keiji Takeda“Principles of Optical Topography
and Examples of Application in
Brain Science”
Atsushi Maki
Chief Researcher, Hitachi, Ltd.

“Substance Production/
Environmental Issues andNetwork Analysis: Assumptions
for Biodiesel Production Routes”
Sachiyo Aburatani
Leader, AISTManager, Toray Industries, Inc.

“PROESATM: breakthroughtechnology for production ofadvanced biofuel from cellulosic
biomass”
Mr. Pierluigi Picciotti
Business Development Director,
Beta Renewables S.p.A.

Hosting of comprehensive Symposium on Biopharmaceutical
Manufacturing
JBA’s Bioengineering Study Group hosted a comprehensive symposium
titled “New Developments in Biopharmaceutical Manufacturing.” Theevent discussed possibilities and issues related to manufacturing

process monitoring and the real-time shipping of biopharmaceuticals,
and further deepened understanding with an exhibition of manufacturing
equipment.

Hosting of Local Study Tours
JBA held study tours of locations
including the Shizuoka Cancer
Center and the Asahi Breweries
Kanagawa Brewery, collecting
on-site information during eachtour.

Rotating gantry irradiationchamber for proton beam
therapy (Shizuoka Cancer
Center Pharma Valley
Project site visit)

2,000 L single-use culture tank
(Nippon Zenyaku Kogyo(ZENOAQ))

The Asahi Breweries Kanagawa Brewery study
tour heard a lecture on “Contributions to theConstruction of a Low-Carbon Society,” observed
the beer brewing process and environmental
conservation initiatives, and engaged in networking.

Cooperation and Strengthening of Activities in the Green Sector

and raw materials recycling, we are creating scenarios for green
In three green biotechnology-related study groups (the study group on
biotechnology regeneration that leverage the strengths of each study
fermentation and metabolism, the study group on alcohol fermentation &group, and are undertaking activities with a view toward making
biomass utilization, and the study group on new resource bioconversion),
proposals for national projects.
JBA deepened cooperation aimed at strengthening structures andinitiatives in the sector. In fiscal
2014, we planned seminars, lecturesat BioJapan, and study tours that
addressed the shared theme ofalgae. On December 12, JBA held ajoint symposium by the three study
groups, titled “The Future of Growth
Strategies in Green Businesses with
Moderator
Fermentation andAlcohol Fermentation and
New Resources
Algae.” Perspectives of elements Metabolism Study Group
Biomass Utilization Study Group Bioconversion Study Group Shigeru Okada
Associate Professor,
Masahiro Samejima
Ogawa
Masaharu Ishii
spanning biomass raw materials Jun
The University of Tokyo
Group Leader,Group Leader,Group Leader,
to conversion, commercialization, Kyoto University
The University of Tokyo
The University of Tokyo

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Activity Report 2015

Research & development project

To strengthen the development base and platform functions of bioindustry and improve the international competitivenessof Japan’s bioindustry, JBA is currently undertaking four entrusted research and development projects.

■ Biomass Energy Technology Development and the Projectfor Research and Development of Valuablel Technology for
Biofuel Manufacturing: NEDO FY 2013-2016

JBA is engaged in research and development projects on thefollowing two themes adopted within the Project for Researchand Development of Useful Elements for Biofuel Manufacturing,
technological development of which is expected to reach commercialscale practical application in 2020.
(1) Manufacture of Innovative Saccharification Enzyme Industrial
Production Microorganisms and Development of Production
Technology for Saccharification Enzymes for the Creation of
Bio-Fuel BusinessThis project is conducting studies to strengthen the activationof component enzymes and overcome the decline in thesaccharification rate, in order to enhance the functionality ofsaccharification enzymes. With regard to optimal saccharification
enzyme composition, the project has identified correlations
among various substrate biomasses. The project also studied
various production criteria using a mini jar fermenter, calculated
the manufacturing cost and the scale and construction costs for
manufacturing facilities, and conducted analyses from economic
angles, with the aim of developing low-cost mass production
technology for saccharifying enzymes.
(2) Fermentation Production Technology Using Beneficial
Microorganisms
This project studied 1) development of microorganisms for
simultaneous fermentation of C5/C6 sugars, 2) development of asimultaneous saccharification and parallel multiple fermentation
process, and 3) process design packages, in order to achieve
an ethanol production concentration of 5%w/v or higher andan ethanol fermentation yield of 95% or higher at a pilot scaleof several m3 or higher. The project also established standard
evaluation systems for enzyme volume, inocula volume, ventilationlevel, etc. for the creation of standard substrate samples and foryeast efficiency, and selected optimal bred strains.

■ Development of Highly Functional Genome Design
Technology for the Realization of Innovative Biomaterials:
Survey of Innovative Biomaterial Marketability and Global
Trends in Competing Technologies
Ministry of Economy, Trade and Industry (FY2013-2016) Highly
Functional Gene Design Technology Research Association(contracted project)
In addition to ongoing surveys of synthetic biology researchand innovative biomaterials, this project conducted a detailed
survey of the U.S. Department of Defense’s Living Foundries:
1000 Molecules Program, with the aim of creating breakthroughbiomaterial manufacturing technology. The project also led asurvey of marketability of analytical equipment born from theaforementioned Project’s long-chain DNA synthesis technology.
Destinations for overseas survey visits(1) U.S. Synthetic biology research facilities: Zymergen, Inc.,
Joint BioEnergy Institute (JBEI), J. Craig Venter Institute(JCVI), Synthetic Genomics Inc.(SGI), Broad Institute of MIT
and Harvard, Harvard University, Illinois University(2) 11th Annual World Congress on Biotechnology/Philadelphia(3) International Conference on Natural Products /SanDiego■ Development of Cell Manufacturing and Processing System
for the Industrialization of Regenerative Medicine, forRegenerative Medicine Products Derived from Human

Pluripotent Stem Cells (Cardiac, Nerve, Retinal Pigment
Epithelium, Liver Cells) and for Regenerative Medicine
Products Derived from Human Mesenchymal Stem Cells

NEDO (FY 2014-2018)/Stem Cell Evaluation Technology Research
Association (allotted research)
This project conducted limited SWOT analysis and cross-SWOT
analysis of equipment and basic technologies for regenerative
medicine product manufacturing systems. Further, in combination
with cross-SWOT analysis based on the Ministry of Economy,
Trade and Industry’s SWOT analysis of industrialization trends inJapan and the current state of industries surrounding regenerative
medicine, it determined strategic options (business opportunities)
for new acquisition of regenerative medicine business markets. In
addition, the project conducted a survey of recent trends in Japan andoverseas involving the foundations for clinical application, the practicalrealization, and the industrialization of regenerative medicine andhuman stem cell technologies, and formulated an outline of a global
market acquisition strategy for a regenerative medicine productmanufacturing system. The project also proposed the catch phrase“KotoDukuri (Industrialization)” for regenerative medicine.

■ “Development of Basic Technology for the Creation of
Next-Generation Pharmaceuticals for Individualized
Medicine (Technology for the Manufacture of NextGeneration Therapeutic Antibodies Meeting International
Standards)” Project: Survey of Trends Concerning NextGeneration Biopharmaceutical Production Technologies
and Intellectual Property

METI (FY 2013-2017)/Manufacturing Technology Association of
Biologics (MAB) (allotted research)
Europe and the U.S. have taken a significant lead in biopharmaceutical manufacturing technology. JBA surveyed intellectual
property that likely to become an obstacle in the development of
manufacturing technology in this project, and continued analysis ofthreats in the area, such as the impacts of prior intellectual property.
In existing biopharmaceutical manufacturing lines, the normalizationand standardization of manufacturing lines through single-use
technology is moving forward, and there are fears that the multiple
guidelines and regulations that have been established may become
obstacles. This project is collecting information on leading actionsin Japan and overseas through intellectual property and academic
information, corporate data available on the Internet, information fromacademic papers, and other sources, and is undertaking surveys
for the purpose of providing information to strategic initiatives under
this project in the future. In terms of intellectual property, the project
has analyzed and summarized materials surveyed and collectedfrom the previous fiscal year. It has also carried out organization of
information focused on genetic modification technology aimed at
genetic modification to improve conditions for cell culture, vectors,
high expression of proteins, and productive cell screening systems,
and has further performed analysis of production and culturingmethods. It collected information centered on academic papers,
and sorted findings into information related to antibodies overall,
the drug efficacy of new structurally modified antibodies, side effectmechanisms, antibody screening, and genome editing.
The project took part in international academic meetings andexhibitions rich in information related to antibodies, collected up-to-date
information, and summarized the information with the chief purposeof manufacturing methods and technological development concerning
cells, culturing methods, purification techniques, single-use, and more.

8

3

ActionOpen Innovation
through Networking

JBA provides opportunities to help the development of biotechnology and industry.
JBA holds the partnering bio event BioJapan as an effective mean for creation of opportunities,
promotion of alliances, and construction of business platforms. Moreover, functioning as a hub of All
Japanese Bio Regions Committee, JBA aims to form networks among bio-related parties, and support
development of bio-ventures through mutual cooperation.

BioJapanFoods

A variety of companies and academic institutes focused on biotechnology participate
in BioJapan to make open innovation a reality.

Environment/ Diagnosis/
EnergyMedical devices

Medicine/
MecicalHealthcare

Research
tools

Opportunities for creating open innovation● Collaborative research ● Licensing in and out of the technology● Business collaboration ● Business Partnerships● Creating innovation in fusional areas

Support for bio-venture companies and bio-clusters
Through networking with nationwide bio groups and clusters,
JBA actively promotes interaction among industry, academia, andgovernment to support and foster bio-venture companies and form
bio-clusters.
Functioning as the hub for bioclusters through the Japanese
Regional Clusters Forum, JBA seeks to form networks of cooperating
industrial, academic, and government bodies, and to invigorate bioventures through collaboration on a nationwide scale. In recent years,
we have strengthened our mutual communication activities withleading biotechnology organizations overseas, and are cooperatingwith corporate members, universities, and government to foster
partnerships that will contribute to the development of biotechnology
and industry.
Shikoku Industry& Technology
Promotion Center

Hokkaido Bio-Industry
Association
Northern Advancement
Center for Science &Technology
Hokkaido Associationfor Bio-Business
Senri Life Science
Foundation

Foundation for
Biomedical Researchand Innovation

Kihara Memorial
Yokohama Foundation for
The Advancement of Life
Sciences

Kurume Research Park
Okinawa Industry
Promotion Public
Corporation

9

Kumamoto Industrial
Support Foundation

Kinki Bio-Industry
Development Organization
Osaka Bio Headquarters

The Shizuoka Organization
for Creation of Industries
Pharma Valley Center(Shizuoka)

Activity Report 2015

All Japanese Bio Regions
Committee

All Japanese Bio Regions Committee has constructed a system by which major regional industrial,academic, and government bio organizations can strengthen networking, share information, consider
future policy, and cooperate mutually.

Biocluster Summit: Strengthening
International Partnerships
in BioJapan 2014

Committee Meeting: Partnerships in Japanand Overseas(2015-01-14)

Biotechnology organizations from Japan, Thailand, New
Zealand, the U.S., France, Germany, Scotland, and Spain came
together to deepen discussions on the current state of humanresource development and case studies of cluster policy that
leads to business creation.

JBA engages in exchanges of ideas with other parties on many
topics, including issues faced by regions and future solutions,the current state of industrial, academic, and government
partnerships, the state of partnerships and cooperative activities
with overseas clusters, and proposals to the national government.

………………………………………………………………………………

………………………………………………………………………………

Support for the Formation of Bio-venture Alliances

JBA engages in activities to support the formation of bio-venture alliances. At BioJapan 2014 weoperated the JBA BIOTECH SQUARE pavilion for bio-ventures, where we supported partnering
activities. The coordinators of the pavilion stepped into business development on behalf of thebio-ventures by working to promote business matching with major medium-sized enterprises.

Preparation of a Bio-venture Directory

In conjunction with open innovation, JBA is collaborating with bio organizations nationwide toaggregate and release basic information online concerning the nation's increasingly-watchedbio-ventures, with the aim of accelerating alliances among clusters and companies in Japanand overseas.

Implementation of Open Innovation by using Bio-venture Directory
Image of Venture
directoryJBA BIOTECH SQUARE

Commercialization/
Implementation(Please click “Bio Venture Directory” at the JBA website)

Preparation of statistical dataon bio-venture businessIn fiscal 2014, JBA conducted a questionnaire survey of bioventures across Japan and statistical analysis. In addition tostatistical surveys, we conducted an ongoing original surveyof topics including trends in joint research and licensing
agreements between bio-ventures and large and medium-sizedcompanies. The results were gathered in the 2014 Survey ofBioventure Statistics and Trends (with an overview available
on the JBA website). Our look at the trends surrounding bioventures, joint research, licenses, and agreements between
bio-ventures and medium-sized companies reveals thatthese remain stable, with an upward trend in results such as
acceptance of milestones. A portion of the survey (“New Public
Offerings and Fundraising by Bio Startups”) was posted on thewebsite of the Hitotsubashi University Institute of Innovation
Research as a result of the joint research.

Number of bio-venture companies

2014 Survey of Bioventure Statistics and Trends (JBA)

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ActionInternational Network

JBA provides international information on biotechnology and bioindustry
in cooperation with member companies, universities, and the government.
As one of our international activities, JBA offers overseas biotechnology information and related
events to members, and also provides information on Japan’s biotechnology industry andopinions on international issues to parties overseas, speaking as the Japanese biotechnology
organization.
We also cooperate with overseas biotechnology groups to promote interaction with JBA members
through their participation in BioJapan. Reflecting the situations of member companies, JBA builds
networks which are difficult to achieve as an individual or a single company.

Overseas bio-organizations having agreements with JBA★ … JBA members (31 organizations as of April 2015)★ … Overseas biotechnology organizations with which JBA has written agreements (as of April 2015)★ Ireland ★ UK ★ Estonia ★ the Netherlands★ Australia ★ Sweden ★ Spain ★ Catalonia (Spain)★ the Czech Republic ★ Denmark ★ Germany★ France ★ Lithuania ★ Scotland (UK)★ Flanders (Belgium) ★ Wallonia (Belgium)★ Medicon Valley Alliance (Denmark/Sweden)

Europe★ Russian Biotechnology Society (since 2009)★ CLIB2021 (Bioclusters of the Rhein Region)/

Cluster Bioindustrielle Biotechnologie (since 2009)★ DECHEMA (since 2010)★ SwedenBIO (since 2013)★ Medicon Valley Alliance (Denmark/Sweden) (since 2012)★ Life Science Austria (since 2013)★ Eurasante (France) (since 2014)★ Alsace Biovalley (France) (since 2014)★ Swiss Biotech Association (since 2005)

Canada★ Canada ★ Alberta★ Ontario ★ Quebec★ British Columbia

Asia★ Malaysia★ Shanghai Biopharmaceutics Industries
Association (since 2005)★ KoreaBIO (since 2012)★ Medical and Pharmaceutical Commercial
Association, All-China Federation ofIndustry and Commerce (since 2012)★ Taiwan Bio Industry Organization (Taiwan)(since 2012)

Oceania

United States★ Australia★ Queensland (Australia)★ Victoria (Australia)★ AusBiotech (since 2013)★ U.S. ★ Iowa ★ Georgia★ North Carolina ★ Pennsylvania★ BIO (since 2004) ★ Biocom (since 2014)

JBA events and activities for open innovation in 2014
■ Participation in BIO International Convention 2014 (San Diego, June)■ Participation in Japan-Taiwan Biotechnology business meeting/
BioTaiwan2014, Cooperation with interchange association(Taiwan, July)■ Participation in BIOPharm America 2014 (Boston, September)■ Participation in BIO-Europe2014 (Frankfurt, November)■ Participation in BIOTECH SHOWCASE 2015
(San Francisco, January)■ Participation in Biocom’s Global Life Science Partnering
Conference (San Diego, February)■ Participation in BIO-Europe Spring2015 (Paris, March)■ Participation in BIOAsia2015 (Tokyo, March)

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Meeting with overseas cluster(BioJapan 2014)

Exchange of MOU with BIOCOM(BIO SanDiego 2014)

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ActionActivity Report 2015

Establishing
the Infrastructureof Bioindustry

JBA is addressing the improvement of infrastructure for biotechnology
and industrial development in cooperation
with member companies, universities and government.
In the bioindustry field of food and environment, JBA gathers and shares information on relevant laws andregulation in enactment process and practical application to member organization and submit opinion as
the industry. At the same time, JBA coordinates improvement of bioindustry infrastructure by participatingin national research projects, fostering training of young scientists as well as awarding prizes.

Science/technology and laws/
regulations
Explanatory meeting on the utilizationof the Cartagena Act

Cartagena Act’s overall picture and application process were explained by Ministryof Education, Culture, Sports, Science and Technology (MEXT), Ministry of Health,Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI)
and National Institute of Technology and Evaluation (NITE) concerning simplifying
and expediting the application process for the conduct of wide range R&D andindustrialization. Following the explanatory sessions, individual consultations werearranged. (Tokyo 2015-01-21, Osaka 2015-01-27)

Explanatory meeting on the utilization of the Cartagena Act (Tokyo)

Activities Aimed at Operational Improvements
for the Cartagena Act

JBA summarizes the requests of our members and engages in opinion exchanges
and negotiations with supervising government bodies on simplified approval
applications and other operational improvements of the Cartagena Act. These
activities resulted in revisions to the Minister of Economy, Trade and Industry manual
for application for ministerial approval (2014-09-26), in significant revisions to the
Ministry of Health, Labour and Welfare GILSP list, and in other relevant documents.

Support for the Japanese Government in International
Negotiations at COP-MOP (Conference of the Parties
serving as the Meeting of the Parties)

COP-MOP7 (Pyeongchang, Korea)

JBA attended COP-MOP7 (7th meeting of the Conference of the Parties serving
as the meeting of the Parties to the Cartagena Protocol on Biosafety), held in
PyeongChang, South Korea in October 2014, and attended COP12 (12th meetingof the Conference of the Parties to the Convention on Biological Diversity) asa scientific expert working with the Japanese government. JBA engaged in
discussions on guideline revisions for genetically modified organisms at COPMOP7, and provided expert knowledge-based counsel on a new candidate agenda
item, synthetic biology.

Science Communication

Publication of “Future Society Pioneered
through the Contributions of Biotechnology”

As a tool for communicating a future society visions built on biotechnology(technology, lifestyles, and industrial development trends), JBA is running a 10-partseries by leading experts in their respective fields in the magazine B&I .
“Recent Advances in and Future Prospects for Plant Breed Improvement
Technology” Ezura Hiroshi (Professor University of Tsukuba)“Toward a ‘Healthy & Happy’ Society: A Picture of Industry, Technology, andServices” Noboru Yumoto (Vice President AIST), Toshihiko Ooie (Deputy Director AIST)( 7 additional installments in past issues of B&I )“Future Society Pioneered
through the Contributions of Bio”

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Establishing the Infrastructureof Bioindustry

Provision of Technical Information on Key
Interest to Industry
The new technological domains of NBT (new breeding techniques) and synthetic
biology call for ongoing scrutiny in terms of both technological development trends
and regulatory trends, as areas that will have major impacts on not only basic
research but also commercial production. JBA provides up-to-date and accurate
information through seminars and other means, for the members to make use of
these technologies and respond aptly to regulations.

Yutaka Tabei

Seminar“Overview of New Breeding Techniques (NBT) and the State of
Research and Development”（2014-08-29）
Yutaka Tabei (Senior Principal Researcher, National Institute of Agrobiological

Sciences (NIAS))

This presentation discussed the potential for NBT which has attracted attention
as a fast, efficient breeding technique that does not leave traces of genetic
manipulation in successive generations along with related safety and necessary
regulatory issues.
Synthetic Biology Seminar: “Recent Scientific and Technological
Trends and Issues Surrounding Synthetic Biology”（2015-03-05）
Daisuke Kiga (Associate Professor, Tokyo Institute of Technology)
Kenji Tsuge (Project Assistant Professor, Keio University)
Masashi Tachikawa (Professor, Ibaraki University)
Among the recent fast moving areas of synthetic biology trend, artificial genetic
circuits and synthetic metabolic engineering were talked by two of the experts inJapan. Also the regulatory aspect from the view of socioeconomic view point was
introduced.

Daisuke Kiga

Kenji Tsuge

Masashi Tachikawa

Intellectual property

Securing intellectual property issues on venture companies as well as on
functional food ingredients were discussed by the working groups and issues wereidentified by face to face hearing and by questionnaires. Also we have submitted
position papers in two separate occasions on “natural principle” which a guidance
document was given from U.S. Supreme Court ruling by US Patent and Trademark
Office.

Industry-academia communicationand collaboration
Fostered Training for Young Company Employees:
JBA Bio-Leaders Course 2014

JBA held a training course for 30 trainees (23 men, 7 women; average age 31)
on September 2-4, 2014, at the Makuhari Seminar House in Chiba Prefecture.
Through group work, the trainees experienced the creation of business plans
based on technological seeds drawn from four themes and six patent applications
provided by the Japan Science and Technology Agency. A diverse range oftrainees from 21 companies to the program benefitted from this opportunity ofinter-industry communication.

Group work

Conducted Training for Graduate Students:
Short-term Internships at BioJapan
Taking advantage of the opportunity offered by BioJapan as an event that gathersmuch of the biotechnology industry, JBA also offered short-term internships tograduate students to learn about the biotechnology industry and better envision of
future working in the industry. In addition to involvement in lectures and debates,
practical training to let the students take part in seminar operation and involved inbusiness matching events, provided exposure to business settings.

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Discussion

Activity Report 2015

Access to Genetic Resources and Benefit-sharing
Awareness Raising Activities on Access to Genetic
Resources and Benefit-Sharing [ABS]JBA has continuously contributed to enhance public awareness and understandingof access to genetic resources and benefit-sharing (ABS). We organize public
seminars in major cities nationwide to provide users of genetic resources with up-todate information on ABS. We also conduct individual on-site seminars in responseto requests from companies, universities and research institutes. As a tool forawareness raising activities, we translated the Nagoya Protocol into Japanese anddeveloped the Guidelines on Access to Genetic Resources for Users.

Help Desk on ABS

ABS open seminar

JBA has established Help Desk, i.e. consultation service concerning ABS, to provide
advice to potential users of genetic resources, free-of-charge and on a confidential
basis. We conducted 34 consultations in fiscal 2014 and has handled more than 510
consultations since establishing Help Desk in 2005.

Support for International Negotiations on ABS

JBA has supported the Japanese government in international negotiations on ABS.
When the Nagoya Protocol entered into force in October 2014, we participated in thefirst meeting of the Conference of the Parties serving as the meeting of the Parties
to the Nagoya Protocol (COP-MOP1) held in Pyeongchang, Republic of Korea

AwardsGuidelines on Access to Genetic
Resources for Users,
2nd Edition (left)
and its English translation (right)

JBA promotes scientific research that contributes to the growth and development of
bioindustry by offering awards.

Japan Bioindustry Association Award■ Hiroyuki
Mizuguchi

Osaka University■ Generation of functional hepatocytes fromhuman induced pluripotent stem cells andthe application for drug toxicity testing

Fermentation and Metabolism
Research Award■ Shigenobu
KishinoKyoto University■ Development of functional fatty acids
using gut microbial specific fatty acidmetabolism

Japan Bioindustry Association Award■ ShinKurihara■ Discovery of novel polyamine metabolicand transport pathways and their
Ishikawa Prefectural University application for human health■ Motoyuki
Shimizu

Meijo University■ Epigenetic regulation of fungal metabolic
genes by changes in intracellular redox
balanceAward for Researches on Chemical
and Biological Materials■ Masato
Ikeda■ Development of hydrogels based on
stimuli-responsive nanofibers for bioapplications■ Hiroshi
Nonaka■ Development of a highly sensitive platform
structure for hyperpolarized magnetic
resonance probes

Gifu University

Kyushu University(currently University of Tokyo)■ Junji
Fukuda■ Design of zwitterionic oligopeptides forelectrochemical cell detachment and its
Yokohama National University
use for regenerative medicine

Fermentation and Metabolism Research Award

Award for Researches on Chemical
and Biological Materials

14…………………… A-4 Exit Hatchobori Sta. Tokyo metro Hibiya line
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JBA website

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JBA invites members to make useof the seminars, video streaming,the Biotechnology School, and otherdiverse contents offered by JBA topromote bio-innovation.

Mayor of school

Ⅰ

Subscription to JBA’s journal, Bioscience and Industry (B&I)＊ Subscription to JBA’s bimonthly journal Bioscience & Industry (B&I) is free.
＊ Other JBA publications are available at a discount.
Ⅱ

Participation in JBA’s Board of Directors, committees,
study groups, etc.

Members of JBA’s Board of Directors, committees, study groups, etc. are able to comment
on JBA’s operations and activities. (Specifics may differ according to member category.)
Ⅲ

Participation in policy measure recommendations, etc.

Members participating in committees, study groups, and other groups operated by JBA
are able to deliberate, consider, and comment on government science and technology
policy measures, national and local government regulations, etc.
Ⅳ

Participation in events held by JBA

B&I is a bimonthly journal that provides
members with easy-to-understand overviews of new and advanced academic
articles in the field of bioscience, bio-relatedindustry and government trends in Japanand overseas, and more.

＊ Members are able to participate at no cost or discounted cost in lectures, seminars,
training courses, consultations, networking events, and other events held by JBA, andthereby have early access to up-to-date information on research and development
and policy measures.
＊ Members are able to access members-only materials on the JBA website and freely
browse the above information and other content on JBA’s activities.
Ⅴ

Participation in planning and proposal for national researchand development projects

Members are able to participate in committees, study groups, etc. operated by JBA, andparticipate in drafting government research and development projects, drafting survey
research projects, and proposing plans to relevant government ministries and agencies.
Ⅵ

Use of seminar video streaming

Members are able to view a portion of JBA’s lectures, packed with up-to-date information,
via PC.

Association of the members, by the members, for the members

Japan Bioindustry Association

Grande Bldg. 8F
2-26-9 Hatchobori Chuo-ku Tokyo 104-0032, Japan
TEL+81-3-5541-2731 FAX+81-3-5541-2737
URL: http://www.jba.or.jp/