4th DIA Cardiac Safety Workshop in Japan July 11-12, 2013 Ivy Hall - Tokyo 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, India 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