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4th DIA Cardiac Safety Workshop in Japan July 11-12, 2013 Ivy Hall - Tokyo PROGRAM CHAIR Koki Nakamura, MD, PhD Takeda Pharmaceutical Company Limited PROGRAM VICE-CHAIR Boaz Mendzelevski, MD BioClinica, Inc., United Kingdom PROGRAM COMMITTEE Hiroyuki Fukase, MD, PhD CPC Clinical Trial Hospital Medipolis Medical Research Institute Zhe Jin, MD, PhD TAIHO Pharmaceutical Co., Ltd. Yuji Kumagai, MD, PhD Kitasato University East Hospital Kaori Shinagawa, MD, PhD Pharmaceuticals and Medical Devices Agency (PMDA) Atsushi Sugiyama, MD, PhD Toho University PROGRAM ADVISOR Yoshiaki Uyama, PhD Pharmaceuticals and Medical Devices Agency (PMDA) DIA Worldwide Headquarters 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Regional Offices Basel, Switzerland | Beijing, China | Mumbai, India Tokyo, Japan | Washington, DC, USA Simultaneous Translation Available Tabletop Exhibit Opportunity For information, contact DIA Japan Nisso 22 Bldg. 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japan Tel: 81-3-5575-2130 | Fax: 81-3-3583-1200 email: [email protected] OVERVIEW Drug effect 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) ratified 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 specific 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 effects. The 4th Cardiac Safety Workshop in Japan will provide an interactive platform to discuss the above and similar topics.

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Page 1: 4th DIA Cardiac Safety Workshop in Japan

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.

Page 2: 4th DIA Cardiac Safety Workshop in Japan

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

Page 3: 4th DIA Cardiac Safety Workshop in Japan

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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

Page 4: 4th DIA Cardiac Safety Workshop in Japan

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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

Page 5: 4th DIA Cardiac Safety Workshop in Japan

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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

JOIN A COMMUNITY!Joining a Community is easy, convenient, and free as part of your DIA membership.

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DAY 2 | FRIDAY, JULY 12, 2013

Page 6: 4th DIA Cardiac Safety Workshop in Japan

REGISTRATION FORM: Register online or forward toDIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku, Tokyo 106-0041 Japantel +81-3-5575-2130  •  fax +81-3-3583-1200

4th DIA Cardiac Safety Workshop in Japan

Event #13305 • July 11-12, 2013 | Ivy Hall, Tokyo

DIA will send participants a confi rmation letter within 10 business days after receipt of their registration.

Registration Fees   If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks and reception (if applicable), and will be accepted by mail, fax, or online.

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All fees listed below include the 5% consumption tax

PARTICIPATION FEE

Member

* Early Bird Deadline:

June 20, 2013 (subject to change)

Early Bird* ¥61,950

Industry ¥67,200

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Non Profi t, Academic,

Medicals

¥26,250

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If paying a nonmember fee, please check one box above, indicating whether you want membership.

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TRAVEL AND HOTEL

There are a limited number of rooms at the Hotel Grand Palace at the reduced rates shown below. Room availability at this rate is guaranteed only until June 9, 2013 or until the room block is fi lled. Attendees should make their airline and room reservations as soon as possible.

Single ¥ 18,050/night  /  Twin ¥ 21,525/night

Address: 1-1-1 Iidabashi, Chiyoda-ku, Tokyo 102-0072, Japan

Telephone: +81-(0)3-3264-3078  /  Fax: +81-(0)3-3230-6822

email: [email protected]

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To reserve your room, please contact the Hotel Grand Palace above and mention the DIA Workshop or click here

for the Hotel Reservation Form.

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Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable.

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TABLETOP EXHIBIT INFORMATIONFor information, contact DIA JapanTelephone +81.(0)3.5575.2130 | Fax +81.(0)3.3583.1200email [email protected]

If you are interested in obtaining space for an exhibit, please check the box in the REGISTRATION FEE area on the left.

Page 7: 4th DIA Cardiac Safety Workshop in Japan

DIA Worldwide Headquarters800 Enterprise Road, Suite 200

Horsham, PA 19044, USA

Regional Offi cesBasel, Switzerland | Beijing, China | Mumbai, India

Tokyo, Japan | Washington, DC, USA  

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] 

Page 8: 4th DIA Cardiac Safety Workshop in Japan

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)

Page 9: 4th DIA Cardiac Safety Workshop in Japan

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

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1日目 | 2013年 7月11日(木)

Page 10: 4th DIA Cardiac Safety Workshop in Japan

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)

Page 11: 4th DIA Cardiac Safety Workshop in Japan

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

JOIN A COMMUNITY!Joining a Community is easy, convenient, and free as part of your DIA membership.

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network through a discipline-specifi c, global or regional Community. Network

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2日目 | 2013年 7月12日(金)

Page 12: 4th DIA Cardiac Safety Workshop in Japan

会議参加申込書 一般社団法人ディー・アイ・エー・ジャパン Fax:03-3583-1200 〒106-0041 東京都港区麻布台1-11-10 日総第22ビル7F Tel: 03-5575-2130

第4回 DIAカーディアックセイフティ・ワークショップ          [カンファレンスID #13305]

2013年7月11日~12日  | アイビーホール 青山

◆ 参加申込方法DIAウェブサイト(www.diahome.org)よりお申し込み頂くか、この申込書に必要事項をご記入の上、FAXまたはメール添付[email protected]にてお申し込みください。受理後、10営業日以内にEメールにて申込受領書を送付いたします。

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また、DIA各種機関紙の入手、DIAウェブサイトの会員専用ページへのアクセス等、種々の特典が得られます。不明な点がございましたら、ディー・アイ・エー・

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は、書面にて参加者名と振込日をディー・アイ・エー・ジャパンまでお知らせください。振込に関する手数料は、振込人負担でお願いいたします。

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入金

アルファベット(英語)でご記入くださいLast Name ( 姓 ) First name ( 名 ) Middle Initial Degrees Dr. Mr. Ms.

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* 参加のキャンセルは、お申し込み受理後、2013年7月4日までは手数料として一般会員・非会員とも20,000円、政府/大学関係者については会員・非会員とも10,000円を申し受けます。それ以降のキャンセルについては参加費全額を申し受けますのでご注意ください。同一会社からの参加変更は可能ですが、その際はお早めにディー・アイ・エー・ジャパンまでお知らせください。(会員資格の譲渡はできませんので、非会員としての参加費を申し受ける場合があります。) 参加をキャンセルされる際には、必ず書面にてディー・アイ・エー・ジャパンまでご連絡願います。会場は変更される場合がありますので予めご了承ください。

【DIAが取り扱う個人情報について】 お申し込みいただいた個人情報はDIAからの会議案内送付等の目的にのみ使用させていただきます。

会 員

非 会 員

一般早期割引 2013年6月20日までのお申込み

2013年6月21日以降のお申込み

政府関係

政府関係

政府関係

非営利団体/大学関係/医療従事者

\59,000(税抜) \61,950(税込)

\64,000(税抜) \67,200(税込)

\25,000(税抜) \26,250(税込)

\25,000(税抜) \26,250(税込)

\74,000(税抜) \77,700(税込)

\79,000(税抜) \82,950(税込)

\40,000(税抜) \42,000(税込)

\40,000(税抜) \42,000(税込)

\79,000(税抜) \82,950(税込)

\40,000(税抜) \42,000(税込)

\25,000(税抜)  \26,250(税込)

会員登録する

会員登録しない

登録費 \15,750 を含む

早期割引 2013年6月20日までのお申込み一般

2013年6月21日以降のお申込み

非営利団体/大学関係/医療従事者

非営利団体/大学関係/医療従事者

一般