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1 November 2016 Research in Your Backyard: Japan Contribution of PhRMA and EFPIA Member Companies to Japanese Society & Economy Through Clinical Trials of Innovative Medicines
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Page 1: Research in Your Backyard: Japan · 2013 26 (52%) 50 2014 23 (55%) 42 2015 22 2007 21 (57%) 37 20 (61%) 33 2008 18 (67%) 27 2009 20 (51%) 39 2010 22 (55%) 40 2011 16 (37%) 43 2012

1

November 2016

Research in Your Backyard: Japan

Contribution of PhRMA and EFPIA Member Companies to Japanese Society & Economy

Through Clinical Trials of Innovative Medicines

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2

Introduction: Who We Are 3

Pharmaceutical Industry and Society 5

Collaborating on Clinical Trials 7

R&D Spending, Trends, and Results 14

Summary: For Japanese society and patients 20

Contents

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3

Introduction: Who We Are

We are devoted to advancing public policies that support innovative medical research,yield progress for patients today, and provide hope for the treatments and cures of tomorrow

Mission

PhRMA Japan’s missionis to promote the health

of patients and contributeto the healthier lives of

all people

Mission

EFPIA Japan’s mission isto enhance the health of

Japanese patients byintroducing innovative

drugs and vaccines

PhRMA Japan represents U.S. basedpharmaceutical companies. Our

activities vary from promoting healthcaresystem reform to providing medical

information to patients.

EFPIA Japan represents R&D-based Europeanpharmaceutical companies. We focus on patientneeds in Japan, engage in discussions with keystakeholders regarding public health, and work

to improve the R&D environment forpharmaceutical companies.

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4

PhRMA and EFPIA member companies

PhRMA EFPIA

AbbVie GK

Amgen Astellas BioPharma K.K.

Biogen Japan Ltd.

Bristol-Myers Squibb K.K.

Celgene K.K.

Eli Lilly Japan K.K.

Janssen Pharmaceutical K.K.

MSD K.K.

Mundipharma K.K.

Pfizer Japan Inc.

Actelion Pharmaceuticals Japan Ltd.

AstraZeneca K.K.

Bayer Yakuhin, Ltd

Bracco-Eisai Co., Ltd.

Chugai Pharmaceutical Co., Ltd.

CSL Behring K.K.

Ferring Pharmaceuticals Co., Ltd.

Galderma (Japan) K.K.

GE Healthcare Japan Corporation

GlaxoSmithKline K.K.

Guerbet Japan K.K.

Ipsen Pharma SAS

Janssen Pharmaceutical K.K.

LEO Pharma K.K.

Lundbeck Japan K. K.

Merck Serono Co.,Ltd.

Mylan EPD G.K.

Nihon Servier Co.,Ltd.

Nippon Boehringer Ingelheim Co ., Ltd.

Novartis Pharma K.K.

Novo Nordisk Pharma Ltd.

Sanofi K.K.

Shire Japan K.K.

UCB Japan Co. Ltd.

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5

Pharmaceutical Industry and Society

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6

Pharmaceutical companies contribute to society andthe economy in multiple ways

Pharmaceutical companies collaborate with local clinics and hospitals to develop new drugs.This in turn provides economic stimulus and leads to innovative new medicines with better efficacy and safety profiles.

IncreasingProductivity

CreatingJobs

ImprovedSafety

BetterEfficacy

ClinicalTrials

BasicResearch

DrugDevelopment

EconomicStimulation

Innovative Drugs toPromote Healthier and

Longer Lives

Pharmaceutical Industry and Society

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7

Collaborating on Clinical Trials

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8

Discovering and developing new medicines is a long,complex, and costly process

Developing innovative medicines takes an average of 10-15 years and 2.6B USD. Less than 12% of the candidate medicines that make it into phase I clinical trials are approved. Many promising compounds fail

after pharmaceutical companies have spent substantial amounts of money on testing and clinical trials

DrugDiscovery Preclinical Clinical

TrialsRegulatory

ReviewScale-upto MFG.

Post-Marketing

Surveillance

PR

E-D

ISC

OV

ER

Y

Apply to conduct clinical trial

Apply for new

drug approval

PHASE3PHASE2

3-6 YEARS

PHASE1

6-7 YEARS 0.5-2 YEARS …

Source: Cost of Developing a New Drug, Tufts Center for the Study of Drug Development, Tufts School of Medicine. November 2014.

Collaborating on Clinical Trials

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9

What is a Clinical Trial?

Computer simulations and animal testing are not enough to determine the efficacy and safety of new drugs for people.Clinical trials are conducted in five phases with the aim of clarifying the impact of experimental drugs on humans.

Collaborating on Clinical Trials

Phase 0First-in-human trial with a small number of healthy adults (10 to 15)to gather data on what the drug does to the body and what the bodydoes to the drug

Phase 1Trial to test a drug with a small number of healthy adults (20 to 80) totest safety, determine a safe dosage range and identify side effects

Phase 2First trial using actual patients (100 to 300) to test efficacy of a newdrug and further evaluate its safety

Phase 3Trial with an increased number of patients (1,000 to 3,000) in order toconfirm its effectiveness, monitor side effects, and to compare it toexisting treatments

Phase 4After a new drug has been approved, Post Marketing Surveillance ofactual usage is conducted to confirm that the drug acts as expected

Source: PhRMA

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Therapeutic Area Example

10

Allergy

Infectious disease

Hematology

Respiratory disease

Oncology

Cardiology

Gastroenterology

CNS

Urology

Dermatology

Ophthalmology

Immunology

Musculoskeletal disease

Endocrine metabolic disease

Rare disease

What are Therapeutic Areas?

Therapeutic areas are general categories of illnesses, including the examples below

Allergic rhinitis, Asthma, Atopic dermatitis, etc.

Influenza, Hepatitis C/B, Herpes, etc.

Anemia, Hemophilia, etc.

COPD, Bronchiectasis, etc.

Gastric cancer, Lung cancer, Breast cancer, etc.

Heart failure, Brain ischemia, Hypertension, etc.

Gastric ulcer, Reflux esophagitis, etc.

Alzheimer’s disease, Depression, Epilepsy, etc.

Nocturia, Lupus nephritis, etc.

Acne, etc.

Age-related macular degeneration, Uveitis, etc.

Rheumatoid arthritis, Crohn’s disease, Psoriasis, etc.

Osteoporosis, Lower back pain, etc.

Diabetes mellitus, Hypercholesterolemia, Hyperphosphatemia, etc.

Gaucher disease, Myelofibrosis, Behcet’s disease, etc.

Collaborating on Clinical Trials

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11

Collaborating with Japanese institutions in conducting and supporting clinical trials

Conducting clinical trials involves collaboration between pharmaceutical companies and other institutions in Japan,such as hospitals, local clinics, and contract research organizations (CRO).

Collaborating on Clinical Trials

PEER REVIEWEDJOURNAL

DATA

REGULATORYAGENCY

DATA

CLINICHOSPITAL

PATIENTS

Decide to conduct clinical trialsand request support from CRO

Support pharmaceutical companieswith the coordination of clinical trials

Conduct trials performed by physicians and trained research professionals

Provide additional support to hospitalsand clinics during trials

CROPHARMACEUTICAL

COMPANIES

SMO

Pharmaceutical Companies CRO Hospitals / Clinics SMO(Site Management Organizations)

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12

Partnering with local Japanese medical institutions to conduct clinical trialsexpands the benefit of clinical trials to the hosting area

Conducting clinical trials for new drug development contributes to local Japanese economiesand improves the quality of life for people in Japan

Providing advancedtreatment

Medical facilities conducting clinical trials are able to provideadvanced medical treatments to their patients in these locales

Contributing tolocal economy

The spending on clinical trials in Japan goes to hospitals and clinicsnationwide and supports local economies

Creating jobs Related stakeholders (local medical facilities and pharmaceuticalcompanies) employ local staff to support clinical trials

Collaborating on Clinical Trials

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13

PhRMA and EFPIA member companies conducted 825 clinical trials in 2015to deliver innovative medicines to patients in Japan

825CLINICAL TRIALS*

18,095SITES**

# of clinical trial conducted

201 ~

101 ~ 200

31 ~ 100

16+THERAPEUTIC AREAS

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

Source: www.clinicaltrials.gov (2015 data)*Figures do not include post marketing surveillance **Individual sites participating in multiple trials are counted multiple times

Collaborating on Clinical Trials

(+21% since 2013)

(+55% since 2013)

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14

PhRMA and EFPIA member companies conduct many clinical trialsacross all prefectures of Japan

Kanto Koshinetsu

Source: www.clinicaltrials.gov (2015 data)

Tohoku

Shikoku

Hokkaido

Hokuriku

Chugoku

Kyushu

Kinki

Tokai

Hokkaido 325

Toyama 76Ishikawa 130Fukui 65

Osaka 438Hyogo 324Kyoto 191Shiga 61Nara 67Wakayama 66

Tottori 43Shimane 56Okayama 188Hiroshima 183Yamaguchi 100

Fukuoka 415Saga 75Nagasaki 112Kumamoto 166Oita 93Miyazaki 59Kagoshima 128Okinawa 86

Tokushima 79Kagawa 107Ehime 174Kochi 78

Aichi 390Gifu 103Shizuoka 241Mie 100

Tokyo 611Kanagawa 359Saitama 237Chiba 346Ibaraki 173Tochigi 119Gunma 148Yamanashi 58Nagano 123Niigata 124

Aomori 67Iwate 93Miyagi 215Akita 57Yamagata 53Fukushima 86

Prefecture not specified 147

Collaborating on Clinical Trials

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15

R&D Spending, Trends, and Results

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16

PhRMA and EFPIA member companies contribute a significant shareof the research and development spending in Japan

Source: JPMA data based on company disclosures for fiscal year 2014* 72 JPMA companies ** 19 PhRMA and EFPIA member companies participating in JPMANote: The figures refer only to clinical research related spending during fiscal year 2014 disclosed by JPMA member companies

2014 Clinical Trial RelatedSpending in Japan Total*

R&D Spending, Trends, and Results

204B JPY

79B JPY2014 Clinical Trial RelatedSpending in Japan: PhRMA and EFPIA Subtotal**

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17R&D Spending, Trends, and Results

Source: PhRMA and EFPIA Japan joint research of 28 member companies (clinical trials conducted between April 2015 and March 2016)“Drug lag” refers to the delay to approve a new drug in Japan such as cases where approval is delayed compared to other countries, such as the U.S. and EuropeConducting more global simultaneous clinical trials shortens the drug lag**Simultaneous international submission refers to the submission of a new drug application (NDA) at the similar timing (within 3 months, in this study) as other countries, such as the U.S. and Europe

Reducing the “drug lag*”

PhRMA and EFPIA member companies are planning simultaneous international drug submissions**which will allow Japanese patients to be in the first wave of access to innovative medicines

Simultaneous international submissions plannedby PhRMA / EFPIA member companies

Completed simultaneous international submissions

Planned simultaneous international submissions

Simultaneous international submissions is not planned or not feasible

Simultaneous international submissions is under consideration

4%

45%

34%

17%

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18

Number of New Drugs Approved in Japan

Source: PMDA website *New drugs refer to New Molecular Entities only approved between April 2007 and March 2016 (Other approvals, such as new indications, are excluded)Besides the approvals obtained by PhRMA and EFPIA member companies, other approvals include products licensed from global companies

R&D Spending, Trends, and Results

19

(49%)

39

2013

26

(52%)

50

2014

23

(55%)

42

2015

22

2007

21

(57%)

37

20

(61%)

33

2008

18

(67%)

27

2009

20

(51%)

39

2010

22

(55%)

40

2011

16

(37%)

43

2012

Bringing innovation to Japanese patients

PhRMA and EFPIA member companies obtained approvalfor 185 new drugs* in Japan over the last 9 years

Japan Total

PhRMA and EFPIA Member Companies

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19

Source: PMDA website *New indications refer to New Molecular Entities approved between April 2007 and March 2016, as well as new indications approved for existing drugsBesides the approvals obtained by PhRMA and EFPIA member companies, other approvals include products licensed from global companies

R&D Spending, Trends, and Results

33

(52%)

63

36

(59%)

61

38

(50%)

76

35

(46%)

76

55

(54%)

102

41

(42%)

97

41

(47%)

88

48

(52%)

92

46

(47%)

97

2013 2014 20152007 2008 2009 2010 2011 2012

Continuing investment in Japan to treat more conditions

PhRMA and EFPIA member companies obtained approvalfor 373 new indications* in Japan over the last 9 years

Number of New Indications Approved in Japan

Japan Total

PhRMA and EFPIA Member Companies

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20

Summary: For Japanese society and patients

We are devoted to advancing public policies that support innovative medical research,yield progress for patients today, and provide hope for the treatments and cures of tomorrow

PhRMA and EFPIA member companies’ clinical research stimulates local economies through:- Collaboration with local Japanese clinics and hospitals to develop new drugs

- Funding clinical trials to develop innovative new medicines with better efficacy and safety profiles

PhRMA and EFPIA member companies invest heavily in clinical trials across all prefectures Japan:- 825 (+21% since 2013) clinical trials across more than 16 therapeutic areas conducted in 2015

- Rapid increase in clinical trials is the result of the premium for new drug development, introduced by the

Ministry of Health, Labour and Welfare in 2010

PhRMA and EFPIA member companies make continuous efforts and investment in Japan to allow Japanese patients to be in the first wave of access to innovative medicines:- Spent 79B JPY in the research and development in Japan in 2014

- Contribute around half of the new drug approvals in Japan

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21

To download an electronic version of this presentation,

please go to www.efpia.jp or www.phrma-jp.org, or scan the QR code above

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22

Appendix - Research Activity Map

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23

Prefecture Views

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24

825CLINICAL TRIALS SITES 16+

THERAPEUTIC AREAS

Prefecture Views

18,095Japan

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

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25

Aichi

15

Prefecture Views

390 973

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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26

Akita

13

Prefecture Views

57 116

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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27

Aomori

11

Prefecture Views

67 132

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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28

Chiba

16+

Prefecture Views

346 687

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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29

Ehime

14

Prefecture Views

174 269

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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30

Fukui

14+

Prefecture Views

65 115

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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31

Fukuoka

16+

Prefecture Views

415 1,110

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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32

Fukushima

14

Prefecture Views

86 204

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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33

Gifu

15+

Prefecture Views

103 215

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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34

Gunma

15+

Prefecture Views

148 291

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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35

Hiroshima

16+

Prefecture Views

183 392

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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36

16+

Prefecture Views

Hokkaido

325 912

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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37

Hyogo

16+

Prefecture Views

324 765

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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38

Ibaraki

16+

Prefecture Views

173 389

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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39

Ishikawa

16+

Prefecture Views

130 228

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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40

Iwate

15+

Prefecture Views

93 159

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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41

Kagawa

14

Prefecture Views

107 194

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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42

Kagoshima

14+

Prefecture Views

128 233

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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43

Kanagawa

16+

Prefecture Views

359 1,013

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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44

Kochi

13

Prefecture Views

78 125

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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45

Kumamoto

16+

Prefecture Views

166 294

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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46

Kyoto

16+

Prefecture Views

191 415

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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47

Mie

15+

Prefecture Views

100 202

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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48

Miyagi

16+

Prefecture Views

215 394

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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49

Miyazaki

14

Prefecture Views

59 108

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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50

Nagano

16+

Prefecture Views

123 260

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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51

Nagasaki

14

Prefecture Views

112 227

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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52

Nara

13

Prefecture Views

67 131

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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53

Niigata

13

Prefecture Views

124 218

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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54

Oita

13

Prefecture Views

93 169

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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55

Okayama

15+

Prefecture Views

188 320

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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56

Okinawa

11

Prefecture Views

86 146

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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57

Osaka

16+

Prefecture Views

438 1,484

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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58

Saga

11

Prefecture Views

75 123

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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59

Saitama

16+

Prefecture Views

237 652

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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60

Shiga

13

Prefecture Views

61 121

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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61

Shimane

13

Prefecture Views

56 89

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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62

Shizuoka

16+

Prefecture Views

241 490

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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63

Tochigi

14

Prefecture Views

119 213

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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64

Tokushima

14

Prefecture Views

79 128

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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65

Tokyo

16+

Prefecture Views

611 2,418

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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66

Tottori

13+

Prefecture Views

43 73

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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67

Toyama

13

Prefecture Views

76 149

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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68

Wakayama

12

Prefecture Views

66 114

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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69

Yamagata

12

Prefecture Views

53 110

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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70

Yamaguchi

13

Prefecture Views

100 198

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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71

Yamanashi

16+

Prefecture Views

58 98

Allergy

Cardiology

CNS

Rare Diseases

Endocrine Metabolic Disease

Gastroenterology

Hematology

Dermatology

Immunology

Infectious Disease

Musculoskeletal Disease

Ophthalmology

Respiratory Disease

Urology

Others

Oncology

CLINICAL TRIALS SITES

THERAPEUTIC AREAS

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72

Therapeutic Area Views

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73

29CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

722Allergy

TRIALS

Phase 14%

Phase 346%

Phase 223%

Phase 44% 29

Undefined23%

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74

Cardiology

57CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

2,368

TRIALS

Phase 12%

Phase 354%

Phase 216%

Phase 47% 57

Undefined21%

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75

CNS

49CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

714

TRIALS

Phase 110%

Phase 373%

Phase 210%

Phase 46%

49

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76

Dermatology

7CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

111

TRIALS

Phase 114%

Phase 343%

Phase 229%

Phase 414%

7

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77

Endocrine metabolic disease

82CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

3,739

82TRIALS

Phase 13%

Phase 353%

Phase 27%

Phase 415%

Undefined23%

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78

Gastroenterology

8CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

432

TRIALS

Phase 338%

Undefined63%

8

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79

Hematology

36CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

219

36TRIALS

Phase 231%

Undefined11%

Phase 358%

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81Phase 221%

80

Immunology

81CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

3,163

TRIALS

Phase 13%

Phase 361%

Phase 43%

Undefined13%

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81

Infectious disease

34CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

490

34TRIALS

Phase 03%

Phase 410% Phase 3

43%

Undefined30%

Phase 17%

Phase 27%

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82

Musculoskeletal disease

11CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

213

11TRIALS

Phase 236%

Phase 49%

Phase 355%

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83

Oncology

331CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

3,354

331TRIALS

Phase 125%

Phase 341%

Phase 227%

Phase 42%

Undefined6%

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84

Ophthalmology

18CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

273

18TRIALS

Phase 26%

Phase 433%

Phase 317%

Undefined44%

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28

85

Rare disease*

28CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

587

TRIALS

Phase 14%

Phase 346%

Phase 229%

Undefined21%

* Rare disease includes conditions such as:Gaucher Disease, Myelofibrosis, and Bahcet’s Disease,which could not be categorized into other therapeutic areas

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86

Respiratory disease

20CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

1,209

20TRIALS

Phase 220%

Phase 45%

Phase 355%

Undefined20%

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87

Urology

14CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

365

14TRIALS

Phase 115%

Phase 415%

Phase 362%

Undefined8%

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88

Others

20CLINICAL TRIALS SITES PHASES

Therapeutic Area Views

136

20TRIALS

Phase 120%

Phase 320%

Phase 210%

Phase 415%

Undefined35%


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