BIOBANKING TO INNOVATION
Koh Furuta1, Hiroki Nakae2, Kazuhiko Okano3, Shin-ichiro Fujii4, Koichiro Yuji5, Yoshihito Nakajima6, Junko Ikeda2, Hiroyuki Kobayashi7,
Naoko Shobayashi2, Tatsuaki Tsuruyama8, Hiroyuki Uchiyama9, Yasunari Yamanaka10
1. Kanagawa Cancer Center Hospital, Yokohama, Japan. 2. Japan Multiplex bio-Analysis Consortium, Tokyo, Japan. 3. ACTmed Co., Ltd., Tokyo, Japan.
4. Bio-Medical Standards Group, National Metrology Institute of Japan National Institute of Advanced Industrial Science and Technology, Tsukuba, Japan.
5. Project Division of International Advanced Medical Research, Institute of Medical Science, the University of Tokyo, Tokyo, Japan. 6. LPD MarketingManager, Thermo Fisher Scientific Japan, Tokyo, Japan. 7. Axcelead Drug Discovery Partners, Inc., Fuijisawa, Japan. 8. Department of Drug andDiscovery Medicine, Pathology Division, Graduate School of Medicine, Kyoto University, Kyoto, Japan. 9. Nissui Pharmaceutical Co. Ltd., Tokyo, Japan.
10. RIKEN, Tsukuba, JapanREPRODUCIBILITYBACKGROUND

Reproducibility is the key to the precision medicine: no matter how the methods of clinical
trials change, reproducibility is the basis of reliability of end-products (Drugs & IVDs).
With Biobanking

Before Biobanking

Banked Human Samples

AnimalExperiments
AnimalExperiments

GlobalGlobalGlobalGlobalsamplessamplesGlobalGlobalsamplessamplesGlobalGlobalsamplessamplesGlobalGlobalsamplessamplesGlobalGlobalsamplessamplesGlobalGlobalsamplessamplessamplessamplesAnimalExperiments

Human samples
Region A
samples

Region B
samples

Region C
samples

BACKGROUND
Examples of systems
to guarantee“Reproducibility”

ISO 20387“Recording of Timestamp”
ISO/TC 276/WG 5“Database QC”

Ethnic Diversity

Clinical trials

Clinical trials

Drugs & IVDs

Drugs & IVDs

ISO 13485
ISO 14155

FACILITATION

Accumulation of biospecimens andassociated data

INNOVATION

Facilitate to access theaccumulated biospecimens andassociated data

Increased installation ofbiobanking facility

More efficientresearch anddevelopment inboth academia
and industry

Increased industrial
needs of bio specimens
and associated data
Biobanks in Japan needto link with each otherand network

ISO 20387 Biotechnology— Biobanking — General
Requirements for
Biobanking

With/without biobanking, reproducibility must be always guaranteed for the stakeholders &patients who get benefit from drugs & IVDs.

CIBER’s BASIC PRINCIPLES
To support the market

CIBER NETWORKS
Based on ISBER model & BBMRI-ERIC model

Common GoodsDonation-baseInternational

Industry

Expertise
Medical Data
Biological Samples
Knowledge

Primary
Data
Generation

Expertise
Funds
Diagnostics
Drug discovery

Cooperation

Pharmaceutical
Bio Tech
IVDs Companies

BiobankBusinessNetworkPartners

Omics data

Public(not-for-profit)

products

data

Private(profit)

SupportResearch

SupportGovernment
Agencies

Partners
SOURCE: BBMRI-ERIC-Associated Expert Centres / Trusted Partners V2.0

CIBER PROSPECTUS
The direction of the current medical services in the world is towards the precision medicine
based on the genomic medicine. One of the infrastructures of this environment is the storage
and/or utilization of bioresources including data. At this point in time, discussions regarding
standardization are started in the ISO framework. Some criticized that standardization isnegative to progress in technologies. History tells us, however, in some situation
standardization may be positive to innovation if direction of standardization is properly placed.
We can say that discussions shall be driven by users of biorepositories, not by providers.
History indicates us again that innovations are with users of technologies. Although theprecision medicine seems promising, some critics point out that the precision medicine may
produce medical divide. One solution to these inputs could be to set up the opened
framework of biological and environmental repositories. Considering the roles of biologicaland environmental repositories, it is urgent for the current generation to prepare andmaintain this framework in a sustainable way.

CONCLUSIONSThe non-profit organization, CIBER, based in Tokyo Japan focuses on:i. to introduce the standardization systems to guarantee the reproducible results forbiobank stakeholders & patients.
ii. to facilitate setting up business models to meet the needs of biobank users/customers.
iii. to facilitate applying internationally common platforms, standardized methods, and bestpractices.
iv. to facilitate setting up conformity assessment eco system including self-assessment,contract, and/or certification/ accreditation.
v. to facilitate innovations in the biotechnology field.
Mega Biobanks

Along with declining birthrate and the following population aging, it is easily assumed thatpublic funds may not afford to provide supports to all the social infrastructures. Under thesecircumstances, users of biological and environmental repositories as private partners areexpected to participate to this framework in a proactive and pre-competitive manner.

NationalCenter
BiobankNetwork（NCBN）

AMED networks

We, mainly users of biological and environmental repositories, decided to network
horizontally and further set up a corporation of “Council for Industrial use of Biological andEnvironmental Repositories (CIBER)” to commit to support a part of roles of medical
infrastructure under international standards. Goal of a corporation of “Council for Industrial
use of Biological and Environmental Repositories (CIBER)” is to support the social
infrastructure without medical divide not only to ourselves but also to our next generations.

★ Networking★
Small size BB

UNIV

Prefectur
al

Univ

CEN
TER

Univ

CEN
TER

Research
institutes

Private bb

PRI
VATE

PRI
VATE

PRI
VATE

PRI
VATE

★SOPs・Best Practices・Standards★
★Pipelines/bridging★
Academia
Pharma製薬企業
製薬企業

2018, January 22
Founders★Networking★
Medium size BB

IVD
companies
診断薬企業
診断薬企業

Bio Tech
研究者
研究者

Researchers
研究者
研究者★Users’ Forum & Center/Dissemination of information★

Council for Industrial use of Biological and Environmental Repositories
Head Office Location: 6F Sanseido bldg. 2-4-10, Koujimachi, Chiyoda-ku, Tokyo 102-0083 JAPANhttps://ciber.or.jp/