4th DIA Cardiac Safety Workshop in

July 11-12, 2013 Ivy Hall -

OVERVIEW PROGRAM CHAIR Koki Nakamura, MD, PhD Drug eff ect on the cardiac repolarization and the potential for drug Takeda Pharmaceutical Company Limited induced arrhythmia has long been recognized as a public health issue. In November 2010 the Japanese Pharmaceuticals and Medical Devices PROGRAM VICE-CHAIR Agency (PMDA) ratifi ed the ICH-E14 guidance in Japan. In compliance with the ICH-E14 requirements, a Thorough QT (TQT) Study, or an Boaz Mendzelevski, MD alternative QT assessment program, must be provided in support BioClinica, Inc., United Kingdom of nearly all New Drug Applications (NDA) in Japan. The science of designing, conducting and analysing TQT studies and the experience of PROGRAM COMMITTEE running these programs in Japan are rapidly evolving. Hiroyuki Fukase, MD, PhD CPC Clinical Trial Hospital In addition, the recognition that cardiotoxicity of new drugs may Medipolis Medical Research Institute involve other cardiovascular (CV) targets and mechanisms, have led to Zhe Jin, MD, PhD clinical and regulatory focus on specifi c drug classes and therapeutic TAIHO Pharmaceutical Co., Ltd. areas associated with CV toxicity, including oncology, rheumatology, endocrinology and metabolism, etc. New regulations have been Yuji Kumagai, MD, PhD introduced in some major regulatory jurisdictions to assess and Kitasato University East Hospital mitigate such adverse cardiac drug eff ects. Kaori Shinagawa, MD, PhD Pharmaceuticals and Medical Devices Agency The 4th Cardiac Safety Workshop in Japan will provide an interactive (PMDA) platform to discuss the above and similar topics. Atsushi Sugiyama, MD, PhD Toho University

PROGRAM ADVISOR

Yoshiaki Uyama, PhD Pharmaceuticals and Medical Devices Agency (PMDA)

Simultaneous Translation Available

DIA Worldwide Headquarters 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA Tabletop Exhibit Opportunity For information, contact DIA Japan Regional Offi ces Nisso 22 Bldg. 7F, 1-11-10 Azabudai, Basel, Switzerland | Beijing, China | Mumbai, Tokyo, Japan | Washington, DC, USA Minato-ku, Tokyo 106-0041 Japan Tel: 81-3-5575-2130 | Fax: 81-3-3583-1200 email: [email protected] DAY 1 | THURSDAY, JULY 11, 2013 2

8:30-9:00 REGISTRATION MYRTOS (2F)  11:00-11:20 The Implementation Status of CV Safety Assessment 9:00-9:10 OPENING REMARKS MYRTOS (2F) Based on E14 Guideline in Japan Koki Nakamura, MD, PhD Kiyoshi Nobori Senior Director, Global Medical Aff airs-Japan, Takeda Development Reviewer, Offi ce of New Drug II, Pharmaceuticals and Medical Center Japan, Pharmaceutical Development Division, Takeda Devices Agency (PMDA) Pharmaceutical Company Limited  11:20-12:20 9:10-9:40 SESSION 1 - KEYNOTE PRESENTATION Panel Discussion SESSION CHAIR All speakers from this session Koki Nakamura, MD, PhD Senior Director, Global Medical Aff airs-Japan, Takeda Development 12:20-13:30 LUNCH BREAK SAFFRON (B2F) Center Japan, Pharmaceutical Development Division, Takeda Free Lunch Available Pharmaceutical Company Limited For Better Cardiac Safety Assessment 13:30-14:30 SESSION 3 MYRTOS (2F) Yuji Kumagai, MD, PhD Abstract Session Professor and Director, Clinical Trial Center SESSION CO-CHAIRS Kitasato University East Hospital Yuji Kumagai, MD, PhD Professor and Director, Clinical Trial Center 9:40-12:20 SESSION 2 MYRTOS (2F) Kitasato University East Hospital Global Regulatory Update Boaz Mendzelevski, MD Vice President of Cardiology, BioClinica, Inc., United Kingdom SESSION CO-CHAIRS Kaori Shinagawa, MD, PhD  13:30-13:45 Senior Scientist for Clinical Medicine, Pharmaceuticals and Medical Devices Agency (PMDA) Should the PR Interval be Corrected for Heart Rate Similarly to the QT Interval? Colette Strnadova, PhD Senior Scientifi c Advisor, Therapeutic Products Directorate, Health Boaz Mendzelevski, MD Canada Vice President of Cardiology, BioClinica, Inc., United Kingdom

 9:40-10:00  13:45-14:00 Alternative ECG Assessment Strategies for Drugs that Drug Interaction Studies with Ketoconazole may Provide are Challenging to Assess by Conventional ICH E14 Type an Opportunity to Replace the TQT Study for 3A4 Approaches Substrates Colette Strnadova, PhD Börje Darpö, MD, PhD Senior Scientifi c Advisor, Health Canada Associate Professor of Cardiology, Pharmaceutical Consultant, Karolinska Institute, Sweden  10:00-10:20  14:00-14:15 CV Safety Assessment of Oncology Compounds: A Regulatory Update How can Processes in a Core ECG Laboratory Infl uence Assessment of Cardiac Repolarization in Thorough QT Krishna Prasad, MB, BS, MD, FRCP Clinical Assessor/Consultant Cardiologist Studies? Medicines and Healthcare products Regulatory Agency (MHRA), Snehal N. Kothari, MC, FACC United Kingdom Senior Medical Director Quintiles Cardiac Safety Services, India  10:20-10:40  14:15-14:30 FDA Recent Initiatives for Improving CV Safety Assessment Eff ect of a Meal on the QTC Interval is Used to Demonstrate ECG Assay Sensitivity in a Standard Japanese Karen A. Hicks, MD (pre-recorded presentation) Medical Offi cer, Division of Cardiovascular and Renal Products, PK Bridging Study Food and Drug Administration, USA Jöerg Täubel, MD, FFPM Chief Executive Offi cer Richmond Pharmacology Ltd., United Kingdom  10:40-11:00 The Future of the Thorough QT Study: The CSRC’s Perspective Börje Darpö, MD, PhD Associate Professor of Cardiology, Pharmaceutical Consultant, Karolinska Institute, Sweden DAY 1 | THURSDAY, JULY 11, 2013 3

14:30-17:30 SESSION 4 MYTROS (2F)  16:15-17:15 Experience in Pharmaceutical Companies Panel Discussion: SESSION CO-CHAIRS • How to Decide the Supra-therapeutic Dose: Timing Koki Nakamura, MD, PhD Versus Information of Special Population? Senior Director, Global Medical Aff airs-Japan, Takeda Development • Can we Replace TQT with Intensive Ph1? Center Japan, Pharmaceutical Development Division, Takeda Pharma- • How to Evaluate the Comprehensive CV Risks Including ceutical Company Limited BP and HR? Kaori Shinagawa, MD, PhD All speakers from this session and Senior Scientist for Clinical Medicine, Pharmaceuticals and Medical Kinue Nishioka, PhD Devices Agency (PMDA) Principal Reviewer, Offi ce of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA)  14:30-14:45 Hiroyuki Fukase, MD, PhD A TQT Study Case Where a Diff erent Method of Analysis Director, CPC Clinical Trial Hospital, Medipolice Medical Research was Requested Institute Masako Nakano, MD, PhD Yuji Kumagai, MD, PhD Clinical Pharmacology Medical, Eli Lilly Japan K.K. Professor and Director, Clinical Trial Center, Kitasato University East Hospital  14:45-15:00 Boaz Mendzelevski, MD Vice President of Cardiology, BioClinica, Inc., United Kingdom How to Determine the Supra-Therapeutic Dose in the QT/ Atsushi Sugiyama, MD, PhD QTc Study? Professor, Department of Pharmacology, School of Medicine, Shingo Tanaka Faculty of Medicine, Toho University Clinical Pharmacology, Takeda Pharmaceutical Company Limited

17:30-19:00 NETWORKING RECEPTION SAFFRON(B2F)  15:00-15:15 ECG Evaluation: Machine-reading Versus Manual Reading Koki Nakamura, MD, PhD Senior Director, Global Medical Aff airs-Japan, Takeda Development Center Japan, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited

 15:15-15:35 An Integrated ECG Monitoring Model with Uniform Standards Across Drug Development: Introducing the Novartis Clinical Safety Standard Guidelines Network with Professional Colleagues Pierre Jordaan, MD Anywhere Anytime! Cardiovascular Safety Expert, Drug Safety and Epidemiology, Novartis Pharma AG, Switzerland

15:35-16:05 COFFEE BREAK SAFFRON (B2F) DIA ConneX You  16:05-16:10 DIA’s members-only social networking- A Case of Being Exempted from Conducting a TQT Study, style website is a vital resource for profes- with Conditions, For a Compound Used Worldwide for sionals like you looking to connect with others Many Years in your field and improve your job performance. Yoshitaka Isaka, PhD Japan Senior Research Scientist, Clinical Pharmacology Medical, Thousands of your colleagues Eli Lilly Japan K.K. will be part of DIA ConneX, so don’t get left behind.  16:10-16:15 A Phase 1, Open-label Study to Evaluate the Cardiac Safety How Can DIA ConneX Help You? of a Cytotoxic Cancer Drug X in Patient with Advanced đƮ!0ƫ*/3!./ƫ0+ƫ+*ġ0$!ġ&+ƫ Solid Tumors questions Zhe Jin, MD, PhD đƮƫ !//ƫ/$.! ƫ.!/+1. !/ƫ/1 $ƫ/ƫ Pharmacovigilance Department white papers and articles Taiho Pharmaceutical Co., Ltd. đƮƫ!03+.'ƫ3%0$ƫ0$+1/* /ƫ+"ƫ5+1.ƫ colleagues worldwide

Get connected at www.diahome.org/DIAconnex. DAY 2 | FRIDAY, JULY 12, 2013 4

8:20-8:40 REGISTRATION MYRTOS (2F) 11:00-13:00 SESSION 6 MYRTOS (2F) Blood Pressure as a CV Safety Endpoint 8:40-10:30 SESSION 5 MYRTOS (2F) SESSION CO-CHAIRS Translational Medicine Hiroyuki Fukase, MD, PhD Director, CPC Clinical Trial Hospital SESSION CO-CHAIRS Medipolice Medical Research Institute Hiroyuki Fukase, MD, PhD Boaz Mendzelevski, MD Director, CPC Clinical Trial Hospital, Medipolice Medical Research Vice President of Cardiology, BioClinica, Inc., United Kingdom Institute Atsushi Sugiyama, MD, PhD Professor, Department of Pharmacology, School of Medicine, Faculty  11:00-11:20 of Medicine, Toho University Drug-induced Blood Pressure Changes: Mechanism and Clinical Relevance  8:40-9:00 Shinchiro Ueda, MB, ChB, PhD Professor, Department of Clinical Pharmacology & Therapeutics, Integrated Cardiac Safety: Preclinical and Early Clinical Graduate School of Medicine, University of the Ryukyus Data Hiroyuki Fukase, MD, PhD Director, CPC Clinical Trial Hospital, Medipolice Medical Research  11:20-11:40 Institute Detection of Drug-induced Blood Pressure Changes in Drug Development  9:00-9:20 Masaki Mogi, MD, PhD Associate Professor, Department of Molecular Cardiovascular Limitations of Current Methodology for Cardiac Safety Biology and Pharmacology, Ehime University Graduate School of Assessment Medicine Keiji Yamamoto, DVM, MBA, PhD Director, Japan Drug Safety Research Laboratories, Takeda Pharmaceutical Company Limited  11:40-12:00 Assessment of Blood Pressure Responses in Clinical Drug  9:20-9:40 Development Jeff Heilbraun Use of miRNA for Detection of Cardiotoxicity Director, Strategic Development Koh Ono, PhD BioClinica, Inc., USA Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine  12:00-12:20  9:40-10:00 Regulatory Considerations for Off -target Drug-induced Blood Pressure Changes Emerging Technology: New Biomarkers, iPS etc. Rajnikanth Madabushi, PhD Atsushi Sugiyama, MD, PhD Team Leader, Division of Clinical Pharmacology I, OCP, OTS, Professor, Department of Pharmacology, School of Medicine, CDER, Food and Drug Administration, USA Faculty of Medicine, Toho University

 12:20-13:00  10:00-10:30 Panel Discussion Panel Discussion All speakers from this session and All speakers from this session and Yuji Kumagai, MD, PhD Katsuyoshi Chiba, PhD Professor and Director, Clinical Trial Center, Kitasato University Senior Researcher, Medical Safety Research Laboratories, R&D East Hospital Division, Co., Ltd. Krishna Prasad, MB, BS, MD, FRCP Pierre Jordaan, MD Clinical Assessor/Consultant Cardiologist, Medicines and Cardiovascular Safety Expert, Drug Safety and Epidemiology, Healthcare products Regulatory Agency (MHRA), United Novartis Pharma AG, Switzerland Kingdom Kaori Shinagawa, MD, PhD 10:30-11:00 COFFEE BREAK SAFFRON (B2F) Senior Scientist for Clinical Medicine, Pharmaceuticals and Medical Devices Agency (PMDA) Colette Strnadova, PhD Senior 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, PhD Pharmacovigilance Department Taiho Pharmaceutical Co., Ltd. JOIN A COMMUNITY! Joining a Community is easy, convenient, Atsushi Sugiyama, MD, PhD Professor, Department of Pharmacolgoy, School of Medicine, Faculty and free as part of your DIA membership. of Medicine, Toho University  14:00-14:20 DIA Communities allow members to Overview of Oncology Drugs Cardiotoxicity and its exchange information, explore industry Potential Clinical Impact hot topics, and build a professional Mitsuhiro Fukata, MD Department of Medicine and Biosystemic Science, Kyushu network through a discipline-specifi c, University Graduate School of Medical Sciences. global or regional Community. Network and share information and ideas through  14:20-14:40 state-of-the-art online media Trial Design for Detecting/Monitoring Oncology CV Safety and forums. Boaz Mendzelevski, MD Vice President of Cardiology, BioClinica, Inc., United Kingdom

 14:40-15:00 Go to www.diahome.org/Community Drug-induced Heart Failure/Cardiac imaging in Oncology Trials to join the Community of your choice. Yuichi Ando, MD, PhD Professor, Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital

 15:00-15:20 To become a DIA member, go to Pharmacogenetics of Oncology Drug Safety Assessment www.diahome.org/membership. Shyh-Yuh Liou, PhD Director, Clinical Pharmacology, Clinical Data Science Dept. Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited

 15:20-16:00 Panel Discussion All speakers from this session and Ikuo Horii, PhD Global Consultant, Pfi zer Inc. and Visiting Professor, Showa University

16:00-16:10 CLOSING REMARKS Boaz Mendzelevski, MD Vice President of Cardiology, BioClinica, Inc., United Kingdom REGISTRATION FORM: Register online or forward to TRAVEL AND HOTEL DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku, There are a limited number of rooms at the Hotel Grand Palace at Tokyo 106-0041 Japan the reduced rates shown below. Room availability at this rate is tel +81-3-5575-2130 • fax +81-3-3583-1200 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. 4th DIA Cardiac Safety Workshop in Japan Single ¥ 18,050/night / Twin ¥ 21,525/night Event #13305 • July 11-12, 2013 | Ivy Hall, Tokyo Address: 1-1-1 Iidabashi, Chiyoda-ku, Tokyo 102-0072, Japan DIA will send participants a confi rmation letter within 10 business days after receipt of their registration. Telephone: +81-(0)3-3264-3078 / Fax: +81-(0)3-3230-6822 email: [email protected] Registration Fees If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks and reception (if applicable), URL: http://www.grandpalace.co.jp/english/index.html and will be accepted by mail, fax, or online. To reserve your room, please contact the Hotel Grand Palace Join DIA now to save on future meetings and to enjoy the benefi ts of membership for a full above and mention the DIA Workshop or click here year! www.diahome.org/Membership for the Hotel Reservation Form.

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Phone Number Required Fax Number 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

概要 プログラム委員長 武田薬品工業株式会社 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 中村 浩己 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。 プログラム副委員長 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 BioClinica, Inc. 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 Boaz Mendzelevski れます。

プログラム委員 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 一般財団法人 メディポリス医学研究財団 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 シーピーシー治験病院 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 深瀬 広幸 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 大鵬薬品工業株式会社 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 金 哲 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 北里大学東病院 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 熊谷 雄治 交換ができることと期待しております。

独立行政法人 医薬品医療機器総合機構 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 品川 香 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 東邦大学 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 杉山 篤 心より祈念しております。 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

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7F Tel: 03-5575-2130 Fax: 03-3583-1200 email: [email protected] DIA Worldwide Headquarters 800 Enterprise Road, Suite 200 Horsham, PA 19044, USA 日本語・英語間の同時通訳あり Regional Offi ces Basel, Switzerland | Beijing, China | Mumbai, India Tokyo, Japan | Washington, DC, USA

1日目 | 2013年 7月11日（木） 2

8:30-9:00 受付 ２階ミルトス  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 9:00-9:10 開会の挨拶 ２階ミルトス 実施状況 武田薬品工業株式会社 独立行政法人 医薬品医療機器総合機構 中村 浩己 野堀 潔

9:10-9:40 セッション 1 基調講演 ２階ミルトス  11:20-12:20 座長 パ ネ ル ディスカッション 本セッション全ての講演者 武田薬品工業株式会社 中村 浩己 For Better Cardiac Safety Assessment 12:20-13:30 ランチブレイク 地下２階サフラン 北里大学東病院 軽食をご用意しております 熊谷 雄治

13:30-14:30 セッション 3 ２階ミルトス 9:40-12:20 セッション 2 ２階ミルトス Abstract Session Global Regulatory Update 座長 座長 北里大学東病院 独立行政法人 医薬品医療機器総合機構 熊谷 雄治 品川 香 BioClinica Inc. Health Canada Boaz Mendzelevski Colette Strnadova  13:30-13:45 Should the PR Interval be Corrected for Heart Rate  9:40-10:00 Similarly to the QT Interval? Alternative ECG Assessment Strategies for Drugs that BioClinica Inc. are Challenging to Assess by Conventional ICH E14 Type Boaz Mendzelevski Approaches Health Canada Colette Strnadova  13:45-14:00 Drug Interaction Studies with Ketoconazole may Provide an Opportunity to Replace the TQT Study for 3A4  10:00-10:20 Substrates CV Safety Assessment of Oncology Compounds: Karolinska Institute A Regulatory Update Börje Darpö Medicines and Healthcare products Regulatory Agency (MHRA) Krishna Prasad  14:00-14:15 How can Processes in a Core ECG Laboratory Infl uence  10:20-10:40 Assessment of Cardiac Repolarization in Thorough QT FDA Recent Initiatives for Improving CV Safety Studies? Assessment Quintiles Cardiac Safety Services Food and Drug Administration Snehal N Kothari Karen Hicks (録画ビデオによる講演)

 14:15-14:30 Eff ect of a Meal on the QTC Interval is Used to  10:40-11:00 Demonstrate ECG Assay Sensitivity in a Standard Japanese The Future of the Thorough QT Study: The CSRC’s PK Bridging Study Perspective Richmond Pharmacology Ltd. Karolinska Institute Jöerg Täubel Börje Darpö 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  16:15-17:15 Experience in Pharmaceutical Companies パ ネ ル ディスカッション 座長 トピック : • How to Decide the Supra-therapeutic Dose: Timing 武田薬品工業株式会社 Versus Information of Special Population? 中村 浩己 • Can we Replace TQT with Intensive Ph1? 独立行政法人 医薬品医療機器総合機構 • How to Evaluate the Comprehensive CV Risks Including 品川 香 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  14:30-14:45 西岡 絹恵 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 一般財団法人 メディポリス医学研究財団 日本イーライリリー株式会社 シーピーシー治験病院 中野 真子 深瀬 広幸 北里大学東病院 熊谷 雄治  14:45-15:00 BioClinica Inc. QT/QTc試験におけるSupra-therapeutic Doseを設定するた Boaz Mendzelevski めのアプローチとは？ 東邦大学 武田薬品工業株式会社 杉山 篤 田中 真吾

17:30-19:00 情報交換会 地下２階サフラン  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

 15:15-15:35 An Integrated ECG Monitoring Model with Uniform Network with Professional Colleagues Standards Across Drug Development: Introducing the Anywhere Anytime! Novartis Clinical Safety Standard Guidelines Novartis Pharma AG Pierre Jordaan

DIA ConneX You 15:35-16:05 コーヒーブレイク 地下２階サフラン DIA’s members-only social networking- style website is a vital resource for profes- sionals like you looking to connect with others  16:05-16:10 in your field and improve your job performance. 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、 TQT 条件付きながら 試験の実施が免除されたケース Thousands of your colleagues 日本イーライリリー株式会社 will be part of DIA ConneX, so 井阪 圭孝 don’t get left behind.

How Can DIA ConneX Help You?  16:10-16:15 đƮ!0ƫ*/3!./ƫ0+ƫ+*ġ0$!ġ&+ƫ A Phase 1, Open-label Study to Evaluate the Cardiac Safety questions of a Cytotoxic Cancer Drug X in Patient with Advanced đƮƫ !//ƫ/$.! ƫ.!/+1. !/ƫ/1 $ƫ/ƫ Solid Tumors white papers and articles

大鵬薬品工業株式会社 đƮƫ!03+.'ƫ3%0$ƫ0$+1/* /ƫ+"ƫ5+1.ƫ colleagues worldwide 金 哲 Get connected at www.diahome.org/DIAconnex. 2日目 | 2013年 7月12日（金） 4

8:20-8:40 受付 ２階ミルトス 11:00-13:00 セッション 6 ２階ミルトス Blood Pressure as a CV Safety Endpoint 8:40-10:30 セッション 5 ２階ミルトス 座長 Translational Medicine 一般財団法人 メディポリス医学研究財団 座長 シーピーシー治験病院 一般財団法人 メディポリス医学研究財団 深瀬 広幸 シーピーシー治験病院 BioClinica Inc. 深瀬 広幸 Boaz Mendzelevski 東邦大学 杉山 篤  11:00-11:20 Drug-induced Blood Pressure Changes: Mechanism and Clinical Relevance  8:40-9:00 Integrated Cardiac Safety: Preclinical and Early Clinical 琉球大学 Data 植田 真一郎 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  11:20-11:40 Detection of Drug-induced Blood Pressure Changes in Drug Development  9:00-9:20 愛媛大学 Limitations of Current Methodology for Cardiac Safety 茂木 正樹 Assessment 武田薬品工業株式会社 山本 恵司  11:40-12:00 Assessment of Blood Pressure Responses in Clinical Drug Development  9:20-9:40 BioClinica, Inc. Jeff Heilbraun Use of miRNA for Detection of Cardiotoxicity 京都大学 尾野 亘  12:00-12:20 Regulatory Considerations for Off -target Drug-induced Blood Pressure Changes  9:40-10:00 Food and Drug Administration Emerging Technology: New Biomarkers, iPS etc. Rajnikanth Madabushi 東邦大学 杉山 篤  12:20-13:00 パ ネ ル ディスカッション  10:00-10:30 本セッション全ての講演者及び パ ネ ル ディスカッション 北里大学東病院 本セッション全ての講演者及び 熊谷 雄治 第一三共株式会社 Medicines and Healthcare products Regulatory Agency (MHRA) 千葉 克芳 Krishna Prasad Novartis Pharma AG 独立行政法人 医薬品医療機器総合機構 Pierre Jordaan 品川 香 Health Canada Colette Strnadova 10:30-11:00 コーヒーブレイク 地下２階サフラン

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

 14:00-14:20 DIA Communities allow members to Overview of Oncology Drugs Cardiotoxicity and its exchange information, explore industry Potential Clinical Impact 九州大学 hot topics, and build a professional 深田 光敬 network through a discipline-specifi c, global or regional Community. Network and share information and ideas through  14:20-14:40 state-of-the-art online media Trial Design for Detecting/Monitoring Oncology CV Safety and forums. BioClinica Inc. Boaz Mendzelevski

Go to www.diahome.org/Community  14:40-15:00 to join the Community of your choice. 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 To become a DIA member, go to  15:00-15:20 www.diahome.org/membership. Pharmacogenetics 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 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。

◆ 参加費用 (該当するにチェックしてください) 会員資格が失効している方および非会員の方は、会員登録(更新)することにより、会員価格にてご参加いただけます。 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・ ジャパンまでお問い合わせください。

会員 ◆ 請求書をご希望の方は下の に チェックを入れてください。 早期割引 2013年6月20日までのお申込み  \59,000（税抜） \61,950（税込） 一般  請求書を希望します 2013年6月21日以降のお申込み  \64,000（税抜） \67,200（税込）

政府関係  \25,000（税抜） \26,250（税込）

非営利団体／大学関係／医療従事者  \25,000（税抜） \26,250（税込） DIA Japan 使用欄

非会員 Date

早期割引 2013年6月20日までのお申込み  \74,000（税抜） \77,700（税込） No. 会員登録 一般 する 2013年6月21日以降のお申込み  \79,000（税抜） \82,950（税込） 登録費 受領書 \15,750 政府関係  \40,000（税抜） \42,000（税込） 送付 を含む 非営利団体／大学関係／医療従事者  \40,000（税抜） \42,000（税込） Invoice 一般  \79,000（税抜） \82,950（税込） 会員登録 政府関係  \40,000（税抜） \42,000（税込） しない 入金 非営利団体／大学関係／医療従事者  \25,000（税抜） \26,250（税込）

◆ お支払方法 ご希望の支払方法にチェックを入れてください（受領書もしくは請求書到着後にご入金ください） [支払方法] □銀行振込 みずほ銀行 神谷町支店 普通 1273382 （口座名義）一般社団法人ディー・アイ・エー・ジャパン □クレジットカード 使用可能クレジットカード（どちらか1つにチェック） □VISA □MasterCard カード有効期限(mm/yy) カード番号

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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。

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