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Conflict of interest presentation phD 2024drxrajdeep
8.2 Conflicts of Interest
8.2.1 What Is a Conflict of Interest?
The classical situation in which a researcher’s decision-making may be compro
mised because of certain financial interests is called a conflict of interest
(COI). Conflicts of interest are more common in the bio-medical and pharmaceuti
cal sciences, where large financial gains are at stake, and the development of new
medication is a costly affair. In the social sciences, financial conflicts of interest do
exist but the temptations differ from those of the bio-medical and pharmaceutical
science.
Let’s start with an example from the pharmaceutical sciences. Resnik (1998)
cites a classic case of a scientist who researched the effects of a certain medication
on the alleviation of common cold symptoms. The scientist also owned stock in a
company that produced the same medication he was researching (a tablet of zinc
lozenges). When their findings showed a positive result, the company’s stock soared,
from which the researcher benefited. This raised a serious question: Was the
researcher’s scientific judgement being influenced by the expectation of a finan
cial profit?
In the social sciences, direct financial gains are rarer. Rather, the problem lies
in indirect gains, having to do with the formation of dependency on the research
itself. Soudijn (2012) quotes the case of a Dutch psychologist, who set up a project
offering help to clients suffering from phobias. The clients received free treatment
(in the form of experimental therapy, given by his students) on the condition that
they agreed to participate in the research project. Thus, the clients became reliant
on the research as a means of free therapy. These dependency relationships obfus
cate the research project to the point that by today’s standards, the data would no
longer be considered valid, and although the research participants did not profit
from the research financially, financial gains (free therapy for the client) posed a
COI in this case.
Whether these influences actually impair a researcher’s judgement is not of
importance in our understanding of a COI. It is the potential to cloud or impair
judgement that defines the problem.
In any conflict of interest, objectivity as one of sciences’ key values is at stake:
• How do I know your conclusions are not biased?
• How can I trust your judgement?
In the coming sections, we discuss cases from within the social sciences where
differing financial interests were at stake to differing degrees (Box 8.2). Note that
not every situation with financial interests at stake automatically leads to a conflict
of interest. Furthermore, it can be difficult to establish whether a researcher acts in
bad faith or not.
181
8.2 Conflicts of Interest
Box 8.2: Funding Bias
Often regarded as a specific form of COI, the term funding bias indicates the
tendency found in scientific studies to support the interests of the study’s
f
inancial sponsor. Funding bias is
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4. TOP MESSAGE
We will continue to take on
the challenge of realizing
“Healthcare for You.”
For more than 70 years since our founding, we have
supported medical care with a focus on clinical testing.
We are now expanding into healthcare and pursuing
global business development to realize the goal of
“Healthcare for You” expressed in our company name.
As a standard-bearer for change in the industry, the H.U.
Group will continue striving to contribute to the future of
medical care and healthcare by sincerely responding to
people’s desire for good health.
Director, Chairman, President and Group CEO
H.U. Group Holdings, Inc.
04
5. Mission, Vision
Create new value in healthcare and thereby contribute to
human health and the future of medical care.
Mission
With our deep involvement in human health, we aim
to be a group that contributes to the development of
healthcare through trust and innovation.
V ision
What we hold dear is
the starting point for the creation of a prosperous future.
That is, the health of each and every person.
Because we have been watching over people’s health for many decades,
we are able to change the future of medical care
and create new possibilities in healthcare.
We will continue the challenge
to deliver optimal healthcare to each individual.
We will move forward, unceasingly.
Healthcare for You
For your health, for your future happiness.
For more
details on
H.U. Group
Philosophy
Company name changed to H.U. Group Holdings, Inc.
Foundation of SRL, Inc.
(Formerly Tokyo Special Reference Laboratories)
Establishment of Miraca Holdings, Inc.
(Business integration of Fujirebio and SRL)
Establishment of Fujirebio
Holdings, Inc.
Listed on the 2nd Section of the
Tokyo Stock Exchange
Listed on the 1st Section of the
Tokyo Stock Exchange
Listed on the 1st Section of
the Tokyo Stock Exchange
Foundation of
Nihon Stery, Inc.
Foundation of Fujirebio Inc.
(Formerly Fujizoki Pharmaceutical)
Started the manufacturing and marketing
of pharmaceutical products
Launch of the first
diagnostic product
Company name changed to Fujirebio
Listed on the 2nd Section of the
Tokyo Stock Exchange
1950
1966
1970
1983
1987 1987
1990
2001
2017
Nihon Stery became a wholly-
owned subsidiary
2000
Divestment of
pharmaceutical division
2000
2005
2020
1989 Company name changed to
SRL, Inc.
History of the H.U. Group
The Statement of H.U. Group
05
H.U. Group Corporate Profile
6. Patents
Number of Group Companies
Overview of Business Segments
As of March 2023
609
Number of patents held
(As of April 2023)
17
Number of patents
applications
(FY2022)
LTS
62.5%
HS
10.6%
Sales ratio by
business segment
IVD
26.9%
Consolidated Net Sales
272.9
billion yen 260.9
billion yen
FY2020 FY2021 FY2022
223.0
billion yen
Number of Employees
5,437
Permanent employees
6,124
Temporary employees
As of March 2023
Financial results for FY2022. The percentage
represents the proportion of consolidated sales.
ABOUT H.U. GROUP
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163.1
LTS
Lab Testing and its
related Services
billion
yen
70.1
IVD
In-Vitro
Diagnostics
billion
yen
27.8
HS
Healthcare-
related Services
billion
yen
Approx.
20
Overseas
Approx.
30
Japan
06
7. R&D Costs and Number of
Laboratories
Laboratories (As of March 2023)
R&D costs (FY2022)
Percentage of Employees
Taking Parental Leave
(Male/Female)
H.U. Group’s Long-Term
Environmental Targets
2050
2025
Total of five companies:
H.U. Group Holdings, Inc., Fujirebio Inc., SRL, Inc.,
H.U. Frontier, Inc., and Nihon Stery, Inc.
FY2022
Percentage of Female
Managers
100%
Female
Net Zero
CO2 (total emissions for Scope 1 and 2)
CO2 (total emissions
for Scope 1 and 2)
(base: FY2021)
2030
CO2 (total emissions
for Scope 1 and 2)
(base: FY2021)
37.8%
Redu
ction
16.8%
Redu
ction
CO2 (total emissions
for Scope 3)
(base: FY2021)
Redu
ction
22.5%
CO2 (total emissions
for Scope 3)
(base: FY2021)
Redu
ction
10.0%
20.2%
As of March 2023
71.4%
Male
¥ 9,556million
yen
Approx.50nationwide
07
H.U. Group Corporate Profile
8. The H.U. Group is a unique company
that offers both “Lab Testing and
its related Services (LTS)” and “In-
Vitro Diagnostics (IVD)” businesses. In
addition to these businesses, we are
also expanding into the “Healthcare-
related Services (HS)” business and
are continuing to challenge ourselves
to provide healthcare catered to the
individual.
Through trust and innovation, we offer optimal healthcare
solutions to all those who wish to be healthy.
OUR BUSINESS
Research & Development
R&D
LTS IVD HS
Unification of sales and marketing functions
Lab Testing and its
related Services
P09
In-Vitro Diagnostics
P10
Healthcare-related
Services
P11
P12
Unified group sales activities by the controlling sales company
By combining the sales and marketing functions of our main subsidiaries and utilizing the Group’s combined strength, we will
integrate the strengths of a wide range of products and services to offer optimized healthcare solutions to our customers.
Controlling sales company
08
9. Lab Testing and its related Services
Providing General Testing Services to Medical Institutions for Over a Half Century
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Japan’s Largest Laboratory Testing
Center with a Nationwide Network
We collect specimens from various medical institutions nationwide,
from medical offices and clinics to large hospitals, to conduct tests
at our laboratories. One of these is the H.U. Bioness Complex, one
of the largest facilities of its kind, which began operating in 2022.
The H.U. Bioness Complex achieves high reliability and efficiency
by reducing testing time through an automated inspection system
equipped with the latest equipment and AI robots.
At the H.U. Group, we are entrusted with over 200,000 laboratory tests
from medical institutions nationwide every day. In the field of clinical
testing, we boast 23.4%*1
of the domestic market, making us the top
clinical testing company in Japan. SRL, the core of our Lab Testing and
its related Services (LTS) business, specializes in “esoteric testing,” such
as genetic and oncology testing, which requires advanced technical
expertise. SRL currently does business with approximately 80% of the
large hospitals in Japan*2
. In the field of private healthcare facilities
(private hospitals or clinics), we do business with approximately 14,000
facilities*3
nationwide, contributing to local healthcare by providing
attentive and prompt services.
*1 Source: Clinical Laboratory Center Directory 2023, Yano Research Institute Ltd.
*2
According to SRL research (Based on the number of transactions with
facilities with 300 or more beds)
*3
According to SRL research (Based on the number of transactions with private
healthcare facilities with less than 300 beds)
Initiatives for Advanced Medical Care
As innovations in personalized medicine continue to advance, testing
technologies in advanced medicine are becoming increasingly
sophisticated. In addition to companion diagnostics-related tests,
which are necessary for cancer treatment, we focus on omics analysis,
including whole genome sequencing (WGS) and proteome analysis,
which could lead to the development of new diagnostic methods.
Global Support for the Research
and Development of Medicine
Utilizing expertise and advanced technology developed over
30 years of fully supporting clinical trials and tests, as well as a
domestic and global network, we offer comprehensive support
for clinical trials and research. The precision of the tests, as well
as services such as pre-trial setup work, specimen collection and
transport, measuring, result reports, and data management,
offered with consistent traceability and are of the highest quality.
With regard to in-group coordination with the CRO (Contract
Research Organization), we also offer total support for clinical
trials and research from start to finish.
Development of Services
Combining Healthcare and ICT
In response to the demand for enhanced local healthcare and
preventive medicine, we are developing new solutions that combine
ICT and various services. In addition to promoting the digitalization
of testing information, we are working to enhance the value of
our services in the LTS business by supporting further utilization
of test results by offering SaaS (Software as a Service) for general
practitioners and PHR (Personal Health Record) for consumers in an
integrated manner.
Main company
LTS
09
H.U. Group Corporate Profile
10. Strengthening Our RD and Promoting a New
Global Strategy with a Tripolar Structure with
Bases in Japan, the United States, and Europe
Operating under Fujirebio Holdings, subsidiaries located in
Japan, the United States, and Europe go beyond company
boundaries and promote the new global strategy, delivering in-
vitro diagnostics worldwide.
The driving force behind our growth is our research and
development (RD) capabilities. By continually strengthening our
RD efforts, we strive to commercialize “only one” markers ahead of
other companies. With a focus on Japan, we utilize our own platform
to demonstrate the clinical value of these markers. Furthermore,
through partnerships with in-vitro diagnostics companies worldwide,
we utilize the CDMO (Contract Development and Manufacturing
Organization) business model to expand our reach globally.
A Global Leader in the Testing
for Neurodegenerative Diseases
Since developing and launching a biomarker for early detection
of the plaques associated with Alzheimer’s disease in 1995, we
have served as a global leader in testing for neurodegenerative
diseases. For over 25 years, we have continued to expand our RD
efforts and reagent lineup.
Our initiatives have been strengthened through the 2010 acquisition
of Innogenetics N.V. (current Fujirebio Europe N.V.). In the field
of Alzheimer’s disease, we obtained approval for a cerebrospinal
fluid reagent, which is compatible with our fully automated
chemiluminescent enzyme immunoassay system. Approval was
obtained in Japan, the United States, and Europe, and it was
successfully launched. We are also working on the development of
blood-based reagents, which are experiencing a growing demand.
We have already developed six markers that are available as
research reagents. Additionally, we are preparing for the regulatory
submission of these blood-based reagents in major countries.
In 2022, we acquired ADx NeuroSciences N.V., a Belgian
biotech company that has developed biomarkers specifically for
neurodegenerative diseases such as Alzheimer's. In addition to our
involvement in the development of neurodegenerative disease-
related markers beyond those for Alzheimer’s disease, we will supply
key raw materials to global in-vitro diagnostics companies through a
CDMO business model.
Developing a Platform
That Shapes Future Testing
Since 1992, we have utilized our proprietary fully automated
chemiluminescent enzyme immunoassay system. This platform has
gained high recognition and has been supporting medical institutions
and testing centers for over 30 years. In addition, in 1997, we launched
a rapid diagnostics kit that does not require a special testing device.
As the kit provides convenient and quick test results, it serves as
a platform for testing infectious diseases such as influenza and
COVID-19, and we have been expanding its reagent lineup.
In 2022, we acquired Fluxus, Inc., an innovative company located in
Silicon Valley, United States. Together with the company, we have been
jointly developing a diagnostic platform utilizing ultra-high sensitivity
detection technology. Building upon the existing platform functions,
we will strive to develop a platform that shapes future testing.
Main company
In-Vitro Diagnostics
Proven Pioneer and Partner to the Diagnostics Industry
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IVD
10
11. Supporting Efficient
Hospital Operation
Nihon Stery specializes in in-house sterilization at
the central supply rooms in hospitals and external
sterilization at the Sterilization Centers (eight domestic
centers). We also offer a range of other services,
including operating room support, endoscopy room
support, medical equipment maintenance and
inspection, and logistics management and transportation
services. By providing total support for important tasks
related to hospital administration work, including the
sale of medical equipment, supplies, and consumables
related to central supply rooms and operating rooms,
we not only enhance operational efficiency and leverage
economies of scale but also contribute to creating an
environment where physicians and nurses can focus on
medical treatment.
As a medical partner, we are continuously striving to
meet the diverse needs of rapidly evolving healthcare
institutions. To that end, we focus on human resource
development, quality improvement activities, and
business development to form a group of professional
technicians who can respond to the latest medical
needs and provide highly specialized technical skills and
solutions.
Providing Safe and Reliable
Nursing Care Equipment
At Care’x Inc., we provide bulk rentals of nursing care
equipment, supplying equipment such as wheelchairs
and nursing beds through designated nursing care
equipment rental businesses. In order to support the
safety and security of users, we propose and provide
nursing care equipment tailored to each individual’s
needs and conduct thorough quality management for
cleaning, disinfection, and preparation work.
Home Medical and Nursing
Services That Support Life in
Familiar Surroundings
“I want to be true to myself and live in familiar
surroundings.” In response to such needs, Care’x
provides home medical care and nursing services. We
provide total support for users, with a focus on home-
visit nursing, where nurses visit individuals’ homes to
provide various types of care. We also offer in-home
care support and operate home nursing care services.
In recent years, we have started expanding our services
to meet the growing demand for more comprehensive
care, including services not covered by insurance.
Main company
Healthcare-related Services
One-stop Service Providing Total Support and Assisting Efficient Nursing Care Operations
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HS
Main company
11
H.U. Group Corporate Profile
12. The H.U. Group is constantly looking ahead to the medical and healthcare
needs of the future and engaged in RD to provide new value.
To complement the technological and development capabilities in
laboratory testing and diagnostics that we have accumulated since
our foundation, in 2017 we established H.U. Group Research Institute
G.K. (HRI). Since then we have worked to generate innovation
through a diverse range of activities not bound by conventional
approaches to RD.
Strengthening the Group’s RD
capabilities and the system
In fiscal 2020, we established the Research and Development
Strategy Division to drive the Group-wide integration of our RD
functions. While the RD departments of each business and HRI
pursue their respective activities, the Research and Development
Strategy Division promotes and strengthens organic Group-wide
collaboration in strategy, issues, resources, and other areas to
drive new value creation based on Group strengths.
The RD division of the IVD business has built a solid technology
platform in diagnostic reagent development, while the RD
division of the LTS business has know-how in new technology
evaluation and introduction. By further strengthening and
leveraging these abilities, we will be in a position to rapidly develop
and bring to market highly distinctive new products. Meanwhile,
adopting diverse new technologies at an early stage, mainly
through HRI, will enable us to engage in product and service
development in new technologies and new fields. We believe
that this will allow our technology platforms to make still greater
contributions to society, medical treatment, and healthcare.
Promoting technology development for next-
generation medical treatment and healthcare
The medical and healthcare environment is changing rapidly and
becoming increasingly complex due to factors such as the advent of
personalized medicine, advances in digitalization and AI technology,
and the restricted access to medical care following the outbreak of
the pandemic. The H.U. Group will put in place human resources
and technology platforms to enable a swift response to these major
changes in the operating environment. To lead the change within
the industry, we are also actively promoting RD activity and human
resource development across a diverse range of research fields.
By also actively promoting mergers and acquisitions, business
alliances, and open innovation, and by utilizing and adopting the
technology and business platforms of universities, medical and
research institutions, enterprises, and other external organizations
in Japan and overseas, we aim to bring to market products and
services of value in the shortest time possible.
Research and Development
Creating innovation through integrated RD activities
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RD
H.U. Group RD system
Innovation through RD collaboration
●
Development of
diagnostic reagents
●
Development of
unique and market-
leading products
●
Development of
innovative analysis
technology ● Technology platforms
● Medical AI/big data
●
Group collaboration/
human resource development
●
Development and
introduction of new tests
●
Promotion of
AI technology and
mechanization
H.U. Group Research Institute
Sharing of strategies,
technologies, and
resources
Research
and Development
Strategy Division
Main company
12
13. H.U. Bioness Complex: H.U. Group’s Core Facility
Symbol of H.U. Group’s Mission to “Create New Value in Healthcare”
The H.U. Group’s core facility, the H.U. Bioness Complex, houses cutting-edge clinical testing laboratories
capable of processing hundreds of thousands of tests a day, RD facilities for creating innovation, a large
hall that can accommodate approximately 200 people with a simultaneous interpretation booth, and more.
The facility’s concepts are to “Connect”, “Show”, and “Nurture”.
Bioness is a hub for value creation for the benefit of human life. Where people with knowledge and
expertise can connect with one another, share information and technology, and nurture new co-creation in
health care.
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Connect
Connect to the future with
state-of-the-art technology
●
Connect with the world
through collaboration
●
Connect people in an open
space
Show
Show the world our advanced
laboratory
●
Show the potential of a safe and
efficient research facility
●
Show the world our
state-of-the-art complex
Nurture
Nurture employees with well-
equipped wellness facilities
●
Nurture a healthy corporate
culture
“Never Stop Testing”: BCP measures
We are strengthening our BCP measures so that
our operations can continue even in the event of
a disaster. As a result, the Laboratory and RD
buildings are able to continue operations for three
days (72 hours) even after a major earthquake.
Seismically base
isolated structure:
Testing Laboratory and
RD buildings
Earthquake resistant
structure:
Administration and
Welfare buildings
Installation of water
tanks in the Testing
Laboratory building
Installation of
emergency generators
Facility overview
Location : Akiruno City, Tokyo, Japan
Site area : Approx. 122,000 m²
Floor area : Approx. 66,000 m² (Total area of Testing
Laboratory, RD, Administration and Welfare buildings)
13
H.U. Group Corporate Profile
14. Please scan for
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Europe
Japan
United States
The H.U. Group’s Global Expansion
Regarding In-Vitro Diagnostics business, the H.U. Group
provides a wide range of products and services with
locations in over 100 countries throughout the world,
including some in the United States, Europe, and Asia. We
are accelerating our global expansion to provide optimal
health care to people around the world.
Fujirebio Europe N.V. 〈Belgium〉
Sagamihara Plant, Fujirebio Inc.
Fujirebio Diagnostics, Inc. 〈US〉
14
15. Our Sustainability
Our Sustainability Roadmap
The H.U. Group has announced KPIs (key performance indicators) and targets related to sustainability
efforts in the form of our Sustainability Roadmap, which follows H.U.’s Medium-term Plan: H.U. 2025. We are
continuing to strengthen our sustainability efforts.
Our Approach to Sustainability
The H.U. Group Management Philosophy consists of three main declarations: Mission, Vision, and Values. We believe we can fulfill our
sustainability through our business activities, which we base on our management philosophy. By means of this framework, we create
strong relationships with a wide range of stakeholders, engaging in initiatives to solve social issues through our business activities.
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Environmental
E
● CO2 emissions: -12.6% (base: FY2021)
● Waste plastic recycling rate: 82%
Social
S
● Percentage of female managers: 22%
● Percentage of male employees taking parental leave: 90%
● Percentage of employees answering “Satisfied with my jobs” to the questionnaire: 55%
● Maintaining White 500 status
● Average annual training*1
time per employee: Over 30 hours
● Excellent response rate (A) on UNGC Self Assessment tool: 75%*2
● Meetings with our suppliers to exchange opinions on sustainability: 30 companies*2
*1 Including DX trainings
*2 FY2022–FY2024
Governance
G
●
Incorporation of non-financial indicators into compensation for directors and executive
officers
● Internal directors will not have a dual role on the Nominating Committee
Two-Year Targets (FY2023–2024)
Contributions to SDGs
Since 1950, when our company was established as
Fujizoki Pharmaceutical, the H.U. Group has been
contributing to solving various social issues, including
the spread of infectious diseases. Going forward, we
will continue to contribute to SDGs through realizing
sustainability via our corporate activities and through
social infrastructure essential for supporting medical
care.
SDGs we are focusing on:
15
H.U. Group Corporate Profile
16. https://www.hugp.com
H.U. Group Holdings, Inc.
Date of publication: July 2023 Printed in Japan
CORPORATE PROFILE
Corporate name H.U. Group Holdings, Inc.
Headquarters Akasaka Intercity AIR, 1-8-1, Akasaka, Minato-ku,
Tokyo 107-0052, Japan
TEL: +81-3-6279-0801 (switchboard number)
Representative: Shigekazu Takeuchi,
Director, Chairman, President and Group CEO
Foundation December 18, 1950
Capital stock 9,274 million yen (as of March 31,2023)
Permanent employees 5,437 (Consolidated) (as of March 31,2023)
Listed stock market Tokyo Stock Exchange, Prime Market (Stock Code: 4544)
Management structure Company with three committees under the Companies Act of Japan
Main subsidiaries SRL, Inc., Fujirebio Inc. and Nihon Stery, Inc.
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