4th dia cardiac safety workshop in japan
TRANSCRIPT
4th DIA Cardiac Safety Workshop in Japan
July 11-12, 2013Ivy Hall - Tokyo
PROGRAM CHAIR
Koki Nakamura, MD, PhDTakeda Pharmaceutical Company Limited
PROGRAM VICE-CHAIR
Boaz Mendzelevski, MDBioClinica, Inc., United Kingdom
PROGRAM COMMITTEE
Hiroyuki Fukase, MD, PhDCPC Clinical Trial HospitalMedipolis Medical Research Institute
Zhe Jin, MD, PhDTAIHO Pharmaceutical Co., Ltd.
Yuji Kumagai, MD, PhDKitasato University East Hospital
Kaori Shinagawa, MD, PhDPharmaceuticals and Medical Devices Agency (PMDA)
Atsushi Sugiyama, MD, PhDToho University
PROGRAM ADVISOR
Yoshiaki Uyama, PhDPharmaceuticals and Medical Devices Agency (PMDA)
DIA Worldwide Headquarters800 Enterprise Road, Suite 200
Horsham, PA 19044, USA
Regional Offi cesBasel, Switzerland | Beijing, China | Mumbai, India
Tokyo, Japan | Washington, DC, USA
Simultaneous Translation Available
Tabletop Exhibit OpportunityFor information, contact DIA JapanNisso 22 Bldg. 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 JapanTel: 81-3-5575-2130 | Fax: 81-3-3583-1200email: [email protected]
OVERVIEW
Drug eff ect on the cardiac repolarization and the potential for drug induced arrhythmia has long been recognized as a public health issue. In November 2010 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) ratifi ed the ICH-E14 guidance in Japan. In compliance with the ICH-E14 requirements, a Thorough QT (TQT) Study, or an alternative QT assessment program, must be provided in support of nearly all New Drug Applications (NDA) in Japan. The science of designing, conducting and analysing TQT studies and the experience of running these programs in Japan are rapidly evolving.
In addition, the recognition that cardiotoxicity of new drugs may involve other cardiovascular (CV) targets and mechanisms, have led to clinical and regulatory focus on specifi c drug classes and therapeutic areas associated with CV toxicity, including oncology, rheumatology, endocrinology and metabolism, etc. New regulations have been introduced in some major regulatory jurisdictions to assess and mitigate such adverse cardiac drug eff ects.
The 4th Cardiac Safety Workshop in Japan will provide an interactive platform to discuss the above and similar topics.
2
8:30-9:00 REGISTRATION MYRTOS (2F)
9:00-9:10 OPENING REMARKS MYRTOS (2F)Koki Nakamura, MD, PhDSenior Director, Global Medical Aff airs-Japan, Takeda Development Center Japan, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited
9:10-9:40 SESSION 1 - KEYNOTE PRESENTATION SESSION CHAIR
Koki Nakamura, MD, PhDSenior Director, Global Medical Aff airs-Japan, Takeda Development Center Japan, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited
For Better Cardiac Safety Assessment Yuji Kumagai, MD, PhDProfessor and Director, Clinical Trial CenterKitasato University East Hospital
9:40-12:20 SESSION 2 MYRTOS (2F)
Global Regulatory UpdateSESSION CO-CHAIRS Kaori Shinagawa, MD, PhDSenior Scientist for Clinical Medicine, Pharmaceuticals and Medical Devices Agency (PMDA)Colette Strnadova, PhDSenior Scientifi c Advisor, Therapeutic Products Directorate, Health Canada
9:40-10:00 Alternative ECG Assessment Strategies for Drugs that are Challenging to Assess by Conventional ICH E14 Type ApproachesColette Strnadova, PhDSenior Scientifi c Advisor, Health Canada
10:00-10:20 CV Safety Assessment of Oncology Compounds: A Regulatory UpdateKrishna Prasad, MB, BS, MD, FRCPClinical Assessor/Consultant CardiologistMedicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
10:20-10:40FDA Recent Initiatives for Improving CV Safety Assessment Karen A. Hicks, MD (pre-recorded presentation)Medical Offi cer, Division of Cardiovascular and Renal Products, Food and Drug Administration, USA
10:40-11:00The Future of the Thorough QT Study: The CSRC’s Perspective Börje Darpö, MD, PhD Associate Professor of Cardiology, Pharmaceutical Consultant, Karolinska Institute, Sweden
11:00-11:20The Implementation Status of CV Safety Assessment Based on E14 Guideline in Japan Kiyoshi NoboriReviewer, Offi ce of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA)
11:20-12:20 Panel Discussion All speakers from this session
12:20-13:30 LUNCH BREAK SAFFRON (B2F)Free Lunch Available
13:30-14:30 SESSION 3 MYRTOS (2F) Abstract Session SESSION CO-CHAIRS Yuji Kumagai, MD, PhDProfessor and Director, Clinical Trial CenterKitasato University East HospitalBoaz Mendzelevski, MDVice President of Cardiology, BioClinica, Inc., United Kingdom
13:30-13:45 Should the PR Interval be Corrected for Heart Rate Similarly to the QT Interval? Boaz Mendzelevski, MDVice President of Cardiology, BioClinica, Inc., United Kingdom
13:45-14:00 Drug Interaction Studies with Ketoconazole may Provide an Opportunity to Replace the TQT Study for 3A4 Substrates Börje Darpö, MD, PhD Associate Professor of Cardiology, Pharmaceutical Consultant, Karolinska Institute, Sweden
14:00-14:15 How can Processes in a Core ECG Laboratory Infl uence Assessment of Cardiac Repolarization in Thorough QT Studies? Snehal N. Kothari, MC, FACCSenior Medical DirectorQuintiles Cardiac Safety Services, India
14:15-14:30 Eff ect of a Meal on the QTC Interval is Used to Demonstrate ECG Assay Sensitivity in a Standard Japanese PK Bridging Study Jöerg Täubel, MD, FFPMChief Executive Offi cerRichmond Pharmacology Ltd., United Kingdom
DAY 1 | THURSDAY, JULY 11, 2013
3
14:30-17:30 SESSION 4 MYTROS (2F)
Experience in Pharmaceutical CompaniesSESSION CO-CHAIRS Koki Nakamura, MD, PhDSenior Director, Global Medical Aff airs-Japan, Takeda Development Center Japan, Pharmaceutical Development Division, Takeda Pharma-ceutical Company Limited Kaori Shinagawa, MD, PhDSenior Scientist for Clinical Medicine, Pharmaceuticals and Medical Devices Agency (PMDA)
14:30-14:45 A TQT Study Case Where a Diff erent Method of Analysis was Requested Masako Nakano, MD, PhDClinical Pharmacology Medical, Eli Lilly Japan K.K.
14:45-15:00How to Determine the Supra-Therapeutic Dose in the QT/QTc Study? Shingo Tanaka Clinical Pharmacology, Takeda Pharmaceutical Company Limited
15:00-15:15ECG Evaluation: Machine-reading Versus Manual ReadingKoki Nakamura, MD, PhDSenior Director, Global Medical Aff airs-Japan, Takeda Development Center Japan, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited
15:15-15:35An Integrated ECG Monitoring Model with Uniform Standards Across Drug Development: Introducing the Novartis Clinical Safety Standard Guidelines Pierre Jordaan, MDCardiovascular Safety Expert, Drug Safety and Epidemiology, Novartis Pharma AG, Switzerland
15:35-16:05 COFFEE BREAK SAFFRON (B2F)
16:05-16:10A Case of Being Exempted from Conducting a TQT Study, with Conditions, For a Compound Used Worldwide for Many YearsYoshitaka Isaka, PhDJapan Senior Research Scientist, Clinical Pharmacology Medical, Eli Lilly Japan K.K.
16:10-16:15 A Phase 1, Open-label Study to Evaluate the Cardiac Safety of a Cytotoxic Cancer Drug X in Patient with Advanced Solid TumorsZhe Jin, MD, PhD Pharmacovigilance DepartmentTaiho Pharmaceutical Co., Ltd.
16:15-17:15Panel Discussion:• How to Decide the Supra-therapeutic Dose: Timing
Versus Information of Special Population?• Can we Replace TQT with Intensive Ph1?• How to Evaluate the Comprehensive CV Risks Including
BP and HR? All speakers from this session andKinue Nishioka, PhDPrincipal Reviewer, Offi ce of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA)Hiroyuki Fukase, MD, PhDDirector, CPC Clinical Trial Hospital, Medipolice Medical Research InstituteYuji Kumagai, MD, PhDProfessor and Director, Clinical Trial Center, Kitasato University East HospitalBoaz Mendzelevski, MDVice President of Cardiology, BioClinica, Inc., United KingdomAtsushi Sugiyama, MD, PhDProfessor, Department of Pharmacology, School of Medicine, Faculty of Medicine, Toho University
17:30-19:00 NETWORKING RECEPTION SAFFRON(B2F)
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DAY 1 | THURSDAY, JULY 11, 2013
4
8:20-8:40 REGISTRATION MYRTOS (2F)
8:40-10:30 SESSION 5 MYRTOS (2F)
Translational Medicine SESSION CO-CHAIRS Hiroyuki Fukase, MD, PhDDirector, CPC Clinical Trial Hospital, Medipolice Medical Research Institute Atsushi Sugiyama, MD, PhD Professor, Department of Pharmacology, School of Medicine, Faculty of Medicine, Toho University
8:40-9:00Integrated Cardiac Safety: Preclinical and Early Clinical DataHiroyuki Fukase, MD, PhDDirector, CPC Clinical Trial Hospital, Medipolice Medical Research Institute
9:00-9:20Limitations of Current Methodology for Cardiac Safety Assessment Keiji Yamamoto, DVM, MBA, PhDDirector, Japan Drug Safety Research Laboratories, Takeda Pharmaceutical Company Limited
9:20-9:40Use of miRNA for Detection of CardiotoxicityKoh Ono, PhDDepartment of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
9:40-10:00Emerging Technology: New Biomarkers, iPS etc. Atsushi Sugiyama, MD, PhDProfessor, Department of Pharmacology, School of Medicine, Faculty of Medicine, Toho University
10:00-10:30Panel Discussion All speakers from this session andKatsuyoshi Chiba, PhDSenior Researcher, Medical Safety Research Laboratories, R&D Division, Daiichi Sankyo Co., Ltd.Pierre Jordaan, MDCardiovascular Safety Expert, Drug Safety and Epidemiology, Novartis Pharma AG, Switzerland
10:30-11:00 COFFEE BREAK SAFFRON (B2F)
11:00-13:00 SESSION 6 MYRTOS (2F)Blood Pressure as a CV Safety Endpoint SESSION CO-CHAIRS Hiroyuki Fukase, MD, PhDDirector, CPC Clinical Trial HospitalMedipolice Medical Research InstituteBoaz Mendzelevski, MD Vice President of Cardiology, BioClinica, Inc., United Kingdom
11:00-11:20Drug-induced Blood Pressure Changes: Mechanism and Clinical RelevanceShinchiro Ueda, MB, ChB, PhDProfessor, Department of Clinical Pharmacology & Therapeutics, Graduate School of Medicine, University of the Ryukyus
11:20-11:40Detection of Drug-induced Blood Pressure Changes in Drug Development Masaki Mogi, MD, PhDAssociate Professor, Department of Molecular Cardiovascular Biology and Pharmacology, Ehime University Graduate School of Medicine
11:40-12:00Assessment of Blood Pressure Responses in Clinical Drug Development Jeff HeilbraunDirector, Strategic DevelopmentBioClinica, Inc., USA
12:00-12:20Regulatory Considerations for Off -target Drug-induced Blood Pressure Changes Rajnikanth Madabushi, PhDTeam Leader, Division of Clinical Pharmacology I, OCP, OTS, CDER, Food and Drug Administration, USA
12:20-13:00Panel Discussion All speakers from this session andYuji Kumagai, MD, PhDProfessor and Director, Clinical Trial Center, Kitasato University East HospitalKrishna Prasad, MB, BS, MD, FRCPClinical Assessor/Consultant Cardiologist, Medicines and Healthcare products Regulatory Agency (MHRA), United KingdomKaori Shinagawa, MD, PhDSenior Scientist for Clinical Medicine, Pharmaceuticals and Medical Devices Agency (PMDA)Colette Strnadova, PhDSenior Scientifi c Advisor, Health Canada
13:00-14:00 LUNCH BREAK SAFFRON (B2F)Free Lunch Available
DAY 2 | FRIDAY, JULY 12, 2013
5
14:00-16:00 SESSION 7 MYRTOS (2F)
Cardio-oncology SESSION CO-CHAIRS Zhe Jin, MD, PhDPharmacovigilance DepartmentTaiho Pharmaceutical Co., Ltd. Atsushi Sugiyama, MD, PhD Professor, Department of Pharmacolgoy, School of Medicine, Faculty of Medicine, Toho University
14:00-14:20Overview of Oncology Drugs Cardiotoxicity and its Potential Clinical Impact Mitsuhiro Fukata, MDDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences.
14:20-14:40Trial Design for Detecting/Monitoring Oncology CV Safety Boaz Mendzelevski, MDVice President of Cardiology, BioClinica, Inc., United Kingdom
14:40-15:00 Drug-induced Heart Failure/Cardiac imaging in Oncology TrialsYuichi Ando, MD, PhDProfessor, Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
15:00-15:20Pharmacogenetics of Oncology Drug Safety Assessment Shyh-Yuh Liou, PhDDirector, Clinical Pharmacology, Clinical Data Science Dept. Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited
15:20-16:00Panel DiscussionAll speakers from this session andIkuo Horii, PhDGlobal Consultant, Pfi zer Inc. and Visiting Professor, Showa University
16:00-16:10 CLOSING REMARKS Boaz Mendzelevski, MDVice President of Cardiology, BioClinica, Inc., United Kingdom
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DAY 2 | FRIDAY, JULY 12, 2013
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4th DIA Cardiac Safety Workshop in Japan
Event #13305 • July 11-12, 2013 | Ivy Hall, Tokyo
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概要
日本版ICH-E14ガイドラインの運用が2010年に開始されてから約3年が
経過し、QT延長リスク評価の概念は、ある程度浸透したことと存じます。
一方、QT延長リスク評価が困難なケースや、薬剤開発における心電図
評価の位置づけ方に悩むケースも、同時に経験されていることが推察さ
れます。
過去の第1~3回DIAカーディアック・セイフティ・ワークショップでは、QT
延長リスクを主とする心電図評価について協議し、日本においても、グ
ローバルと一貫した心電図評価方法を共有することに貢献して参りまし
た。今回の第4回ワークショップにおいては、検討内容を更に発展させる
とともに、実際の経験を踏まえた疑問や提言について議論を交わしたい
と考えております。また、「発表者-フロア」一体型の活発な議論を行う
ために電子投票システムを導入し、産官学の立場を超えた率直な意見
交換ができることと期待しております。
心臓安全性評価についても「世界から日本へ」を「日本から世界へ」に転
換する時が近づいているのではないでしょうか。本ワークショップにご参
加頂き、楽しみながらサイエンスの議論の輪に加わって頂けますことを
心より祈念しております。
第4回 DIA カーディアック
セイフティ・ワークショップ
2013年7月11日(木)~12日(金)
アイビーホール 青山
プログラム委員長
武田薬品工業株式会社
中村 浩己
プログラム副委員長
BioClinica, Inc.Boaz Mendzelevski
プログラム委員
一般財団法人 メディポリス医学研究財団
シーピーシー治験病院
深瀬 広幸
大鵬薬品工業株式会社
金 哲
北里大学東病院
熊谷 雄治
独立行政法人 医薬品医療機器総合機構
品川 香
東邦大学
杉山 篤
プログラムアドバイザー
独立行政法人 医薬品医療機器総合機構
宇山 佳明
日本語・英語間の同時通訳あり
卓上展示申込受付中詳細については、ディー・アイ・エー ジャパンまでお問い合わせください。
〒106-0041 東京都港区麻布台1-11-10 日総第22ビル7FTel: 03-5575-2130Fax: 03-3583-1200 email: [email protected]
2
8:30-9:00 受付 2階ミルトス
9:00-9:10 開会の挨拶 2階ミルトス
武田薬品工業株式会社
中村 浩己
9:10-9:40 セッション 1 基調講演 2階ミルトス 座長
武田薬品工業株式会社
中村 浩己For Better Cardiac Safety Assessment 北里大学東病院
熊谷 雄治
9:40-12:20 セッション 2 2階ミルトス
Global Regulatory Update座長
独立行政法人 医薬品医療機器総合機構
品川 香Health CanadaColette Strnadova
9:40-10:00 Alternative ECG Assessment Strategies for Drugs that are Challenging to Assess by Conventional ICH E14 Type ApproachesHealth CanadaColette Strnadova
10:00-10:20 CV Safety Assessment of Oncology Compounds: A Regulatory UpdateMedicines and Healthcare products Regulatory Agency (MHRA)Krishna Prasad
10:20-10:40FDA Recent Initiatives for Improving CV Safety Assessment Food and Drug AdministrationKaren Hicks(録画ビデオによる講演)
10:40-11:00The Future of the Thorough QT Study: The CSRC’s PerspectiveKarolinska Institute Börje Darpö
11:00-11:20日本におけるE14ガイドラインに基づいた心血管系リスク評価の実施状況 独立行政法人 医薬品医療機器総合機構
野堀 潔
11:20-12:20 パネルディスカッション 本セッション全ての講演者
12:20-13:30 ランチブレイク 地下2階サフラン
軽食をご用意しております
13:30-14:30 セッション 3 2階ミルトス Abstract Session 座長
北里大学東病院
熊谷 雄治BioClinica Inc.Boaz Mendzelevski
13:30-13:45 Should the PR Interval be Corrected for Heart Rate Similarly to the QT Interval? BioClinica Inc.Boaz Mendzelevski
13:45-14:00 Drug Interaction Studies with Ketoconazole may Provide an Opportunity to Replace the TQT Study for 3A4 Substrates Karolinska InstituteBörje Darpö
14:00-14:15 How can Processes in a Core ECG Laboratory Infl uence Assessment of Cardiac Repolarization in Thorough QT Studies? Quintiles Cardiac Safety ServicesSnehal N Kothari
14:15-14:30 Eff ect of a Meal on the QTC Interval is Used to Demonstrate ECG Assay Sensitivity in a Standard Japanese PK Bridging Study Richmond Pharmacology Ltd.Jöerg Täubel
1日目 | 2013年 7月11日(木)
3
14:30-17:30 セッション 4 2階ミルトス
Experience in Pharmaceutical Companies座長
武田薬品工業株式会社
中村 浩己独立行政法人 医薬品医療機器総合機構
品川 香
14:30-14:45 TQT試験で事前に定めた解析方法と異なる方法による結果の提示を求められたケース 日本イーライリリー株式会社
中野 真子
14:45-15:00QT/QTc試験におけるSupra-therapeutic Doseを設定するためのアプローチとは? 武田薬品工業株式会社
田中 真吾
15:00-15:15心電図評価におけるマシンリーディングとマニュアルリーディングの違い 武田薬品工業株式会社
中村 浩己
15:15-15:35An Integrated ECG Monitoring Model with Uniform Standards Across Drug Development: Introducing the Novartis Clinical Safety Standard Guidelines Novartis Pharma AGPierre Jordaan
15:35-16:05 コーヒーブレイク 地下2階サフラン
16:05-16:10長年にわたり世界中で広く使用されている化合物において、条件付きながらTQT試験の実施が免除されたケース日本イーライリリー株式会社
井阪 圭孝
16:10-16:15 A Phase 1, Open-label Study to Evaluate the Cardiac Safety of a Cytotoxic Cancer Drug X in Patient with Advanced Solid Tumors大鵬薬品工業株式会社
金 哲
16:15-17:15
パネルディスカッショントピック:• How to Decide the Supra-therapeutic Dose: Timing
Versus Information of Special Population?• Can we Replace TQT with Intensive Ph1?• How to Evaluate the Comprehensive CV Risks Including
BP and HR? 本セッション全ての講演者及び独立行政法人 医薬品医療機器総合機構
西岡 絹恵
一般財団法人 メディポリス医学研究財団
シーピーシー治験病院
深瀬 広幸
北里大学東病院
熊谷 雄治
BioClinica Inc.Boaz Mendzelevski
東邦大学
杉山 篤
17:30-19:00 情報交換会 地下2階サフラン
Get connected at www.diahome.org/DIAconnex.
DIA ConneX You DIA’s members-only social networking- style website is a vital resource for profes- sionals like you looking to connect with others in your field and improve your job performance.
Thousands of your colleagues will be part of DIA ConneX, so don’t get left behind.
Network with Professional ColleaguesAnywhere Anytime!
How Can DIA ConneX Help You?
questions
white papers and articles
colleagues worldwide
1日目 | 2013年 7月11日(木)
4
8:20-8:40 受付 2階ミルトス
8:40-10:30 セッション 5 2階ミルトス
Translational Medicine 座長
一般財団法人 メディポリス医学研究財団
シーピーシー治験病院
深瀬 広幸
東邦大学
杉山 篤
8:40-9:00Integrated Cardiac Safety: Preclinical and Early Clinical Data一般財団法人 メディポリス医学研究財団
シーピーシー治験病院
深瀬 広幸
9:00-9:20Limitations of Current Methodology for Cardiac Safety Assessment 武田薬品工業株式会社
山本 恵司
9:20-9:40Use of miRNA for Detection of Cardiotoxicity京都大学
尾野 亘
9:40-10:00Emerging Technology: New Biomarkers, iPS etc. 東邦大学
杉山 篤
10:00-10:30パネルディスカッション 本セッション全ての講演者及び第一三共株式会社
千葉 克芳Novartis Pharma AGPierre Jordaan
10:30-11:00 コーヒーブレイク 地下2階サフラン
11:00-13:00 セッション 6 2階ミルトス
Blood Pressure as a CV Safety Endpoint 座長
一般財団法人 メディポリス医学研究財団
シーピーシー治験病院
深瀬 広幸BioClinica Inc.Boaz Mendzelevski
11:00-11:20Drug-induced Blood Pressure Changes: Mechanism and Clinical Relevance琉球大学
植田 真一郎
11:20-11:40Detection of Drug-induced Blood Pressure Changes in Drug Development 愛媛大学
茂木 正樹
11:40-12:00Assessment of Blood Pressure Responses in Clinical Drug Development BioClinica, Inc.Jeff Heilbraun
12:00-12:20Regulatory Considerations for Off -target Drug-induced Blood Pressure Changes Food and Drug AdministrationRajnikanth Madabushi
12:20-13:00パネルディスカッション 本セッション全ての講演者及び北里大学東病院
熊谷 雄治Medicines and Healthcare products Regulatory Agency (MHRA)Krishna Prasad
独立行政法人 医薬品医療機器総合機構
品川 香Health CanadaColette Strnadova
13:00-14:00 ランチブレイク 地下2階サフラン
軽食をご用意しております
2日目 | 2013年 7月12日(金)
5
14:00-16:00 セッション 7 2階ミルトス
Cardio-oncology 座長
大鵬薬品工業株式会社
金 哲東邦大学
杉山 篤
14:00-14:20Overview of Oncology Drugs Cardiotoxicity and its Potential Clinical Impact 九州大学
深田 光敬
14:20-14:40Trial Design for Detecting/Monitoring Oncology CV Safety BioClinica Inc.Boaz Mendzelevski
14:40-15:00 Drug-induced Heart Failure/Cardiac imaging in Oncology Trials名古屋大学医学部附属病院
安藤 雄一
15:00-15:20Pharmacogenetics of Oncology Drug Safety Assessment 武田薬品工業株式会社
劉 世玉
15:20-16:00パネルディスカッション 本セッション全ての講演者及びファイザー株式会社/昭和大学
堀井 郁夫
16:00-16:10 閉会の挨拶
BioClinica Inc.Boaz Mendzelevski
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2日目 | 2013年 7月12日(金)
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