Special Talk

Fumiaki Koizumi

President, MercariMercari Inc.

Our Creative Service at CMIC

CRA work in the Pioneering
Period of the Job versus Now.

vol.

23

K A ZU O N A K A M U R A

Ta l k W i t h

F U M I A K I KO I ZU M I

People with Strong Wills Seize the Future:
Constantly Pursuing the Missions That Suit Every Passing Moment

Fumiaki Koizumi

President, Mercari, Inc.;
President/CEO, Kashima Antlers F.C. Co., Ltd.

Kazuo Nakamura

Chairman and CEO, CMIC HOLDINGS Co., Ltd.

People with Strong Wills Seize the Future: Constantly Pursuing the Missions That Suit Every Passing Moment

Work styles are currently at a turning point, with the spread of remote working alongside other changes. We
can see a significant challenge in aligning the direction of an organization’s mission with its people’s own
satisfaction in life and self-expression. What are the vital qualities that organizations and individuals need topursue? Fumiaki Koizumi has served as a leader in Japan’s Internet business, with the social media service
Mixi in the 2000s and the flea market app Mercari in the 2010s. CEO Nakamura listened to his story.

KAZUO NAKAMURA

Talk WithFUMIAKI KOIZUMI

over Twitter. It was like I was hitting onthem online (laughter). I gradually got
people to join me.
As the business made good progress,
it proved bit by bit that we were notjust speaking about a pipe dream, andNakamura You’re famous for playing aNakamura You grew up in a natural

opportunity when supply and demandleading role in Mercari’s rapid

environment, but how did you get

don’t match. This really piqued myexpansion. I’m embarrassed to say

involved with the Internet?

interest. The Internet began to spreadthat I didn’t know how much flea

Koizumi My first experience with aaround the time I started high school. I

market services like Mercari had

computer was in my first year of juniorbegan buying products in Shinjuku

spread before I came to know you. I’ve

high school. My school had manyand selling them like an agent within

been greatly looking forward to

Macs in the computer room, though

Internet communities for fashion

Nakamura I started the company in ahearing your story, owing to how you

they were uncommon at that time. I

lovers.

single room in an apartment too, so I

hard to integrate them in the team.

me about the mindset you have whencreated a completely new,started by drawing graphics, and thenI think this might have prompted myhad trouble gathering people. Young

Koizumi The Mercari team used to

managing your business?

game-changing service. Now, you’re

I came to make games and otherdesire to create a company related tomen in their prime didn’t pay attention

have many people who had an edge

Koizumi The phrase “winner takes all”

originally from Yamanashi, right?

things too. I wasn’t really much of a

the Internet one day.

to me. Women and people past

but were also flawed in some way. I

is common in the IT industry, so I

Koizumi Yes. I was born here ingeek though. I was the captain of theretirement age helped me out at the

had a lot of trouble thinking how toalways stay aware of the potential

Hokuto*1 in 1980, and I grew up

soccer team.

start. Looking back on it, we hadbring them together as a team. But

dangers. You might see rivalries

running around the plains. A

Nakamura It’s interesting how you

diversity from the beginning.

recently, I sometimes wish people

between strong parties at the start,

neuroscientist once told me that mydidn’t dive straight into geekdom.

Later, we sometimes had someactually had more of an edge. If you

but people, property and information

creativity originates from my

Koizumi I liked fashion, so I naturally

strange but very smart people joining

have people with ambitions of

end up coming to the organization

experience playing in these plains

went on to link the Internet withus. Those kinds of people saved us.

reaching the top, then it’s easier towith the most power, so thatwhen I was a child. I do agree that my

fashion. Nike Air Max 95 sneakers wereNakamura I imagine that there must

Koizumi When we started Mixi in themake a breakthrough if you encounterorganization becomes the standout

current way of living has been greatly

all the rage at the time. They were

have been many hurdles in spreading

2000s, there weren’t many workers

any issues.

leader.

affected by the way I gained theselling for over 10 times their regulara new service.

coming to the IT industry. But one

Nakamura We are living in complex

In the 18 months after Mercari wasattitude and habits to learn fromprice at one point, and they were a

Koizumi Both Mixi and Mercari had

person who did join us later became aand tough times with the Japaneseestablished, we raised a total of 4.3

nature as a child. Nothing beats naturesocial phenomenon. As I watched themany negative reactions at the start,

key person at the company. Thiseconomy continuing to be stagnant,billion yen in funding. We worked

when it comes to experiencing things

prices change for these products, I

but I believed that people would

individual learned programming on his

and with war and COVID-19

with high start-up costs to makefor real.

learned that there is a businesseventually come to use them.

own in high school, and he came toworldwide. At times like these, thesomething good, carry out

As the business grew, there was aour office one day at age 19 and asked

world needs talented people who canpromotions, and win customers. I

phase where the ambition we had at

us to hire him. He continued topave the way forward.

was scared that I would be unable toour founding to do it ourselves

distinguish himself from then on, andchanged to become our mission. Thishe became the Chief Development

phase was the most fun in the whole

Officer six years later. It’s pretty hard

process.

to hire talent like him after the

Nakamura I found it hard to gather

company has grown large. I think it

people when establishing my business.

was only possible because we were in

Did you have a similar experience?

the venture phase.

Nakamura The most important thing in

could drink as much as I liked once

Koizumi At the start, I was talking

Nakamura I can understand that. It

the IT industry is to become the de

we had come out on top.

about my aspirations as much as I

happened because the company wasfacto standard* . Coming from the

To tell you the truth, I was more

could. I was winning over people one

still developing. Unique and very smart

healthcare industry, this is a little hard

relieved than elated when I

people have amazing energy, but it’sfor me to conceptualize. Could you tellcould see we had become the

KAZUO
NAKAMURA

The Phase Where Ambition
Changes to Mission Is theMost Funat a time. I also reached out to people*1 This interview was held at the Nakamura Keith Haring Collection in Hokuto, Yamanashi.

so our network continued to grow.

The World Needs
Specialists with an Edge

FUMIAKI
KOIZUMItake care of my team if we did not

Seeking to Be the De facto
Standard to Make Our
Ideals a Reality

take first place, so I was working as
hard as I could to succeed. I stopped
drinking liquor despite my love for it,
and I was working until morning
every day. I kept telling myself that I

2*2 A protocol that has come to be recognized as an industry standard following competition between companies in the market. This is a standard for all
intents and purposesPeople with Strong Wills Seize the Future: Constantly Pursuing the Missions That Suit Every Passing Moment

KAZUO NAKAMURA

Talk WithFUMIAKI KOIZUMI

de facto standard. Some 20

Koizumi We seem to be polar

Japan during the heyday of

the ground. Nowadays, you need tophase at which we need to launch an

Nakamura However, society in recent

competitors had joined the market

opposites at first glance, but in fact weflip-phones in a partially isolated

know what is actually happening.

app to enrich the lives of people inyears has changed, in the sense thatpeople get attacked if they say

at the start, but there were only one

both want to make society better. We

environment. However, I feel Mixi wastheir working and regular lives, and toor two left at the end.

just have different approaches. It isslowly driven out by Twitter andfurther realize a recycling society.

something that doesn’t match others’

Nakamura That is completely different

more convenient for society if there is

Facebook when smartphones came on

It is crucial to keep rethinking youropinions. We need to make society afrom the industry that I am in. Nobody

one integrated service, and Mercari

the scene.

relationship with society as theplace where people can voice many

company grows.

different opinions; otherwise our

Desire to Continue as a
Mission-driven Company

would imagine a single entity winningseeks to create a world where people

In light of this experience, I strongly

everything in the world of new drug

don’t throw things out, so in that

focused on the competition being

Nakamura As we see a turning point indevelopment or science. It takes atsense, it is better for it to be a de facto

global with Mercari, and on entering aworkstyles within the present day, it isleast 10 years to develop one newstandard.

world where only one platform reigns

more important than ever for

drug, so it takes perseverance.

Nakamura I think your approach issupreme. We even branched out into

companies to share details with every

Decentralized activity is essential totruly amazing in the way you capture

America.

employee about the absolute core

prevent research from stagnating. We

everyone’s needs and create an

Nakamura Once a company grows toareas that are non-negotiable.

strive to make competition. That’s why

ecosystem to make society better.

business will not go well, and it will beCreating the Future
through the Sheer Powerof Aspirations

no fun, either. That is diversity in its
genuine sense.
Koizumi I feel it is more important thanever to hold onto your own opinion
despite a flurry of other views. Whilea reasonable size, it can get enoughKoizumi I always talk about our

Nakamura If you place focus on

younger people are more familiar withyou see many new bio ventures. My

income from domestic business.

mission until I am blue in the face—individuals living their own lives to thesocial media, I have noticed inmindset is based on an approach for

Companies like these tend to prioritize

about what the company stands forfullest, it is essential for people to feelparticular that many have beenbolstering their foundation in theand the future we want to create. I

fulfilled with their lives. It is also crucial

attacked for their views online anddomestic market, and so they lag

want the company to be mission-

to respect each other. If you respecttend to see communication asothers rather than trying to force yoursomething constrictive as they fear

maintaining diversity through this kindof metabolism.

It Is Crucial to Retain a Feelfor Things on the Groundbehind in going international. And if

driven, and I feel it was able to grow in

healthcare communication channel

Nakamura If someone makes a goodthey do seek to go overseas once theysuch a short time because of thisvalues on them, the world will be a

expressing opinions that differ fromcalled harmo based on electronic

drug it will spread across the world

reach that stage of growth, they tend

mission-driven approach.

better place, and you will see newothers. It is extremely important tomedicine notebooks, and we need thisinstantly, so there is always a sense of

to only think of buying a company in

I am actually in the middle oftechnologies appear as well.

hold onto your own opinions.

However, we are currently making a

to become the de facto standard. This

fear within the drug industry because

America. But I don’t think that’s thereplanning our mission in line with our

Koizumi The debate on diversity tends

Nakamura Do you have any advice foris a completely different approach

you cannot avoid internationalright way to do it. How do you

10th anniversary, so we are returning

to focus on superficial aspects likeyounger people, or for people looking

from my mindset, so I am not strong incompetition.

perceive the idea of goingto discussions on the vital qualities we

gender, but it would be better to focus

to start a company?

this area. I have called on younger

Koizumi I went through a hitch like thatinternational?

need to pursue.

on diversity in areas closer to the heart

Koizumi First of all, they need to have

employees to exert efforts in thisonce too myself, actually. We built

Koizumi We also have requests fromNakamura We are seeking to goof things.

a strong will. Both you and I haveregard.

Mixi as a de facto standard within

investors to acquire overseas

beyond just curing diseases, and to

Nakamura The essence of diversity iscreated a future for ourselves throughcompetitors. However, you can’t tell if

think about what we can do to makefound within us. The key is to have thethe sheer power of our aspirations,

you are doing business correctly if you

society a better place where everyone

power to take on challenges andright? There is more fear in our current

don’t have a feel for the kind of

can live according to their own will. We

accept other people for who they are.

chaotic and unpredictable times, but I

customer base there is and the kind of

have incorporated this mindset into

Koizumi To me, diversity and inclusion

think people should believe incommercial practices that are there.

our Creed* . We have a morningmeans that everyone has a place

themselves and aim to be optimistic.

It would be fine if you jump in first andmeeting at CMIC to which all

where they feel comfortable, that

The most important thing is tostart business, and then decide

employees are welcome to join. At thiseveryone can express themselves, andmaintain a strong will and discoverwhether M&As are appropriate, but I

meeting, I always ask people to revisit

that the direction of their self-

something.

wouldn’t approve of making a decision

our ideals and to be courageous in

actualization is aligned with the

Nakamura Thank you for taking theonly based on due diligence*taking on new challenges.

company’s mission. This applies totime to talk with me today.

materials. I want to jump in myself,

Koizumi I feel that we have entered asociety in general, not just companies.

3

4

learn through that process, and build a
PROFILE

Nakamura You can’t convince anyone

Born in Yamanashi Prefecture in 1980. After graduating from the School of Commerce at Waseda University, he managed the IPOs ofInternet-focused companies such as Mixi and DeNA at Daiwa Securities SMBC. He joined Mixi in 2006 and supervised the entire
Corporate Division as Director, Executive Officer, and CFO. After leaving the company in 2012, he supported several startups, and thenjoined Mercari, Inc. in December 2013. He became Director in March 2014, and then President & COO in April 2017. He is currently
Director and President of the company while also maintaining a role as President/CEO of Kashima Antlers F.C. Co., Ltd.

if you don’t have a feel for things on*3 Preliminary surveys on the status of a company’s management and finances

Fumiaki Koizumi

strategy step by step.

*4 CMIC’s CREED is CMIC Group’s corporate philosophy, and was established in 2016

Our Creative Service at CMIC

Clinical Research Associates‛

Work in the Pioneering Period of the Job versus Now

Now
In some cases,
consulting andclinical departments
at CROs support thecreation of
protocols.
They propose site
selection incooperation with a sitemanagement
organization (SMO).

They convene an
Institutional Review
Board (IRB) at the trialsite to obtain approvals
for the clinical trial.

Review andunderstandingof theprotocolDuring thePioneering Period–

Little was known about
CROs and CRAs, which
often led to suspicion...

“CRO? Why is the
manufacturer not coming?”

Preparation
for Clinical
Investigation
TrialsIn 1992, CMIC began operations as Japan‛s firstContract Research Organization (CRO), and in 1994
the Japan CRO Association was established.
The 1997 GCP Ministerial Ordinance clarified theposition of CROs, which dramatically increased theneed for them.
In 1998, the Japan CRO Association published a
Monitor Education Manual, which was the first step
toward improving the monitor training system.
We had to review all
source documents inperson or match source
documents to CRFs
(Source Document
Verification—SDV).

of medical
institutions andphysicians

Approval by
the Institutional
Review Board(IRB)

Signing ofClinical Trial
Agreement

Signing of acontract

Clinical Research Associates (CRAs) are responsible for supporting thesmooth progress of clinical trials and ensuring the reliability of data.
They work in a wide range of areas from contracting with clinical trialsites, to preparing for clinical trials, promoting subject enrollment
and monitoring.
While the essence of the work has not changed, the approach used haschanged dramatically over the past 30 years.

Many facilities were notaccustomed to clinical
trials, and it was noteasy to gain theirunderstanding about ourbusiness and have themsign contracts.

Clinical Trial
Conduct andMonitoring
Transporting
investigational
products was partof the CRA‛s job.

Supporting site personnel
unfamiliar with clinical trials“WhatshouldI do?”

Subject
enrollment wasdone by fax.

Preparation for Clinical Trial Start-Up
and Promotion of Subject Enrollment

They negotiate withthe trial site and sign aclinical trial agreement.

They hold a study meeting
to explain the details of
the clinical trial to allparties involved.
They discuss the details
with the clinicalinvestigators/
Clinical Research
Coordinators(CRCs) until allquestionsare answered.

Explanationof clinical trial
contents

Delivery ofinvestigational
products

Clinical Trial
Termination
Procedures
An appropriate action istaken, such as confirming
the seriousness of theevent with the clinicalinvestigator if an adverse
event is detected.

Adverseevent
handling

Inquiry
handling

Review ofCase Report
Forms(CRFs)

Paper CRFs werecollected, and data
entry was done
in-house.

Electronic Data
Capture (EDC)
The system collects data electronically:
Clinical trial sites enter clinical trial data
directly into PCs or other devices.
A clinical trial cannot begin without thePromotion ofsubject
enrollment

participation of subjects.
CRAs work closely with the clinicalinvestigators and CRCs to increase theparticipation rate of clinical trials.
The delivery of investigational
products has become mainly
outsourced to transportation andlogistics companies.

The clinical investigatoris contacted if
inconsistent data isfound in a CRF.
Clinical trials are monitored
as to whether they are
conducted in compliance withgood clinical practice (GCP)and protocols. The data in thesource documents is checked
as whether they have been
accurately entered into EDC.
Sampled data may bemonitored (Risk BasedMonitoring: see next page)
instead of surveying all cases.

In international joint
clinical trials, the casereport form (CRF) checks
and confirms responses are
all carried out in English.

Our Creative Service at CMICIn this issue, we will introduceof the CMIC Group.

the current CRA operations

How has CRA work evolved over the past 30 years?
In the pioneering days, the term "monitor" was used instead of CRA (Clinical Research Associate), and many
physicians and medical institutions were not familiar with CROs (Contract Research Organizations) and were
not familiar with clinical trials either. The need for CROs increased dramatically with the implementation of
the new GCP Ministerial Ordinance in 1997, which clarified the legal basis for CROs. Comparing then andnow, it is fair to say that it has become much easier to conduct clinical trials because medical institutions
have a better understanding of not only GCP and their roles to be performed in clinical trials but also theroles of CRAs and CRCs (clinical research coordinators) in clinical trials. The most significant change in CRA's
operations is a shift to an electronic data-capturing process (EDC) from the one based on paper CRFs (casereport forms). In the past, CRA’s work required visiting medical institutions several times a week, and it wassaid that one had to like traveling to do the job. Today, with the rise of remote interviewing, which has been
rapidly implemented due to the COVID-19 pandemic, there has been a shift to a variety of work styles thatcombine home and office work with business travel. In anticipation of changes to clinical trials, CMIC's clinical
trial monitoring operations have evolved significantly over the past 30 years. CMIC, which has the largest
number of CRAs in Japan at 1,100, will continue to lead clinical trial monitoring by proactively taking action
to respond to changes in the clinical trial environment, such as the introduction of Decentralized Clinical
Trials (DCT) and the adoption of concomitant drug error checking using harmo®*.
*harmo®: A medical information collaboration system (https://www.harmo.biz/) based on an electronic medication registry thatallows patients to manage medication information centrally, easily and reliably, and share and utilize this information withmedical professionals.

What is RBM?
Risk Based Monitoring (RBM) is a more efficient and effective monitoring method based on the concept of
improving the quality of clinical trials by focusing on how to manage and prevent problems, rather than deal
with them after they have occurred. Until now, 100% data reconciliation has been mandatory, and the maintask of monitoring has been to find and solve problems by doing so. Due to the increasing scale of trials andthe diversity of participating countries, the method in which all data is verified is time-consuming and costly,
but it does not reduce the incidence of quality problems in clinical trials. As such, improvements in this area
have been sought. Advances in information technology have also helped the adoption of RBM, as CRFs haveshifted to EDC, i.e., from paper to electronic media. This environment enables us to check data in advance.
Since the establishment of CMIC's RBM, CMIC has supported more than 10 studies in a wide range of fields
and at various development phases, meeting all kinds of needs, including monitoring-led RBM and data
management-led RBM. We have already received manufacturing and marketing approval for a project inwhich CMIC's RBM was implemented. The company has also signed a pilot agreement in May 2021 with
Lokavant, which provides solutions for an efficient implementation of RBM using machine learning and has
started a joint project.

Are there any changes in our clients?
More and more clients, including domestic and foreign venture companies, are looking to CMIC to guidethem through the entire development process. In these cases, our work begins with an introduction to
Japanese pharmaceutical regulations. There are an increasing number of international joint clinical trials, etc.,
where English is required for data collection (CRFs), queries to CRFs*, provision of materials and Q&A,
meetings, and more. In addition, there are an increasing number of overseas companies that do not haveoffices in Japan among our clients. CMIC serves as an in-country clinical-trial caretaker (ICCC) to carry out
various procedures necessary to request clinical trials on behalf of such overseas companies in order tomarket pharmaceutical products in Japan. In order to respond to these various changes, the CRA works aspart of a project team.
*Queries: Inquiries issued to clinical trial institutions due to the finding of inconsistencies in CRF data.