TIME TABLE Japanese Language Only English Only Related Interest Areas: ALL Clinical Operations Regulatory Affairs Statistics Clinical Data Management

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1 11 th Annual Meeting DIA JAPAN 2014 The Dawn of Medical Innovation that Transcends Boundaries November Tokyo Big Sight Ariake diahome.org/japan-11tham PROGRAM OVERVIEW Recent DIA initiatives have improved cooperation between government, industry, and academia for the purpose of promoting the commercialization of innovative medical technologies and products in Japan, Europe, and the US. These entities, with the participation of patients, have also worked toward dramatically improving the development of new medical technologies, drugs, and medical devices. These movements share the goal of overcoming common boundaries in order to achieve meaningful medical innovations. In Japan, two acts were enacted on November 20th, 2013 in order to bring world-class medical technology to the public. One new act, the Act Concerning Safety Assurance of Regenerative Medicine, etc., centered on Regenerative Medicine. In addition, the revision of the Pharmaceutical Affairs Act introduced an Accelerated Drug Approval Program with conditions and time limits based on the characteristics of regenerative and other medicines. Coupled with this framework of new regulations, breakthrough discoveries and inventions that originated in Japan, such as human induced pluripotent stem (ips) cells and the medical robot suit, are expected to expand the horizons for health care of the future. There are a wide variety of boundaries that we must transcend. These include the boundaries between industry, academia, government, and patients. There are also boundaries between specialized fields within science and technology; between pharmaceutical drugs, medical devices, and regenerative medicine; and between separate countries and regions. If the development of pharmaceutical drugs and medical devices only follows traditional methodologies and the assumptions of our current development environment, then it will become increasingly difficult to bring about revolutionary breakthroughs. It is essential that open innovation is encouraged in order to break down these existing barriers. This year, our conference title calls on us to transcend these boundaries, and even surpass what we have taken as common sense or expected practice up until now with a strong will to make changes that can create a revolution in medical care. Last year, the theme of the Japan Annual Meeting was Revolutionary Drug Development. This year, we would like to help you work across disciplines and areas of expertise to create medical innovation for the realization of a revolution in medical care that truly meets the needs of patients. Endorsement by MHLW, PMDA, JPMA, PhRMA, EFPIA, PDA and ISPE. Tabletop and Exhibit Opportunities Available For information, contact DIA Japan Nisso 22 Bldg. 7F, Azabudai, Minato-ku, Tokyo Japan Tel: Fax: DIAJapan@diajapan.org Simultaneous Translation Available PROGRAM CHAIRPERSON Hiroshi Watanabe, MD, PhD Hamamatsu University School of Medicine PROGRAM VICE-CHAIR Kenji Nagaya Nippon Kayaku Co., Ltd. PROGRAM COMMITTEE Kasumi Daidoji, MSc, RPh Eisai Co., Ltd. Hideki Hanaoka, MD, PhD Chiba University Akiko Ikeda Janssen Pharmaceutical K.K. Eiji Kajiwara MSD K.K. Kazuhiro Kanmuri, PhD Phizer Japan Inc. Kazutoshi Maki GENEX Partners Kana Maruyama GlaxoSmithKline K.K. Koichi Miyazaki, MSc, RPh Daiichi Sankyo Co., Ltd. Motohide Nishi, MBA Eli Lilly Japan K.K. Junichi Nishino, MSc, RPh Novartis Pharma K.K. Masayo Oishi, PhD Phizer Japan Inc. Satoshi Saeki Astellas Pharma Inc. Shuji Sumida Chugai Pharmaceutical Co., Ltd. Satoru Tsuchiya, MS Dainippon Sumitomo Pharma Co., Ltd. Naoyuki Yabana, PhD Pharmaceuticals & Medical Devices Agency Takeharu Yamanaka, PhD Yokohama City University School of Medicine PROGRAM ADVISOR Yoshihiko Ono MSD K.K. Junko Sato, PhD Pharmaceuticals & Medical Devices Agency DIA Global Center 21 Dupont Circle NW, Suite 300 Washington, DC Worldwide Offices Basel, Switzerland Beijing, China Horsham, PA, USA Mumbai, India Tokyo, Japan

2 TIME TABLE Japanese Language Only English Only Related Interest Areas: ALL Clinical Operations Regulatory Affairs Statistics Clinical Data Management Clinical Safety and Pharmacovigilance Project Management Chemistry, Manufacturing and Controls Others SUN NOV. 16 [MAIN VENUE] INTERNATIONAL CONFERENCE ROOM [TUTORIAL VENUE 1] ROOM 605 [TUTORIAL VENUE 2] ROOM 606 [TUTORIAL VENUE 3] ROOM 607 9:00-10:30 T1 Basic Introduction for Non-Specialist: Drug- Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guideline T2 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 T3 Action Learning for Six Sigma Analytical Tools Using Real Case Studies 10:30-11:00 BREAK 11:00-12:30 T6 Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology T7 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 T8 An Introduction to Adaptive Designs 12:30-13:30 LUNCH BREAK 13:30-13:40 WELCOME 13:40-13:50 OPENING REMARKS 13:50-14:00 GLOBAL DIA AWARD PRESENTATION 14:00-14:05 PROGRAM INSTRUCTIONS 14:05-14:20 SHORT BREAK 14:20-15:10 K1 KEYNOTE SPEECH 1 15:10-16:00 K2 KEYNOTE SPEECH 2 16:00-16:30 COFFEE BREAK 16:30-17:45 SP1 SPECIAL SESSION 17:45-18:00 SHORT BREAK 18:00-17:30 NETWORKING RECEPTION AT RECEPTION HALL MON NOV. 17 INTERNATIONAL CONFERENCE ROOM [VENUE 1] ROOM 605/606 [VENUE 2] ROOM 607 9:00-10:30 SESSION 1 V1-S1 Vision for the Future: Global Simultaneous Filing to the World First Approval - Strategies for Early NDA Approval V2-S1 Listen to What the Patient Has to Say - A Message from Patients to those Engaged in Drug Development 10:30-11:00 COFFEE BREAK 11:00-12:30 SESSION 2 V1-S2 Vision for the Future: Global Simultaneous Approval Efforts and Challenge for Simultaneous Review on Each Country (Tentative) V2-S2 Discussion about the Provision of Information for Patients - What is a Patient Oriented Information from the Regulatory Agencies, Pharmaceutical Companies, and Medical Professionals 12:30-14:00 LUNCH BREAK 14:00-15:30 SESSION 3 V1-S3 Global Contribution for Clinical Development from Japan V2-S3 How Can We Apply the Electric Health Records for Postmarketing Drug Safety in Japan? 15:30-16:00 COFFEE BREAK 16:00-17:30 SESSION 4 V1-S4 Virtual Meeting of PMDA s Scientific Consultation: Points to Maximize the Efficiency of the Meeting V2-S4 What Is the Benefit-risk Balance Assessment Which Japan Is Aiming For? Strategy for Generation of Useful Information which Contributes to Patients 17:30-17:45 SHORT BREAK 17:45-19:00 SP2 SPECIAL CHAT SESSION AT RECEPTION HALL TUE NOV. 18 [MAIN VENUE] INTERNATIONAL CONFERENCE ROOM [VENUE 1] ROOM 605/606 [VENUE 2] ROOM 607 9:00-10:30 SESSION 5 V1-S5 Commercialization of Regenerative Medical Products and Quality Assurance V2-S5 Is the Risk Management Plan Really Effective? Part I 10:30-11:00 COFFEE BREAK (STUDENT POSTER SESSION IN FRONT OF THE RECEPTION HALL) 11:00-12:30 SESSION 6 V1-S6 Expectation and Challenge for Regenerative Medical Products Development - What is Changed Based on the Revision of Pharmaceutical Affairs Law? V2-S6 Is the Risk Management Plan Really Effective? Part II 12:30-13:50 LUNCH BREAK 13:50-14:50 SP3 SPECIAL SESSION 14:50-15:00 BEST PRESENTER/STUDENT AWARD 15:00-15:30 COFFEE BREAK 15:30-17:00 R1 WHAT ARE EXPECTATIONS FOR ADAPTIVE LICENSING? 17:00-17:10 SHORT BREAK 17:10-18:25 SP4 PMDA TOWN HALL 18:25-18:30 CLOSING REMARKS

3 Japanese Language Only English Only Related Interest Areas: ALL Clinical Operations Regulatory Affairs Statistics Clinical Data Management Clinical Safety and Pharmacovigilance Project Management Chemistry, Manufacturing and Controls Others [TUTORIAL VENUE 4] ROOM 608 [TUTORIAL VENUE 5] ROOM 609 [STUDENT VENUE] ROOM 101 ROOM 102 SUN NOV. 16 T4 Coaching as a Diverse Communication Tool Across Functions and Areas T5 The Basics of Investigator Initiated Trial (IIT) Regulation 9:00-10:30 T9 Let s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! BREAK 9:20-12:30 10:30-11:00 STUDENT SESSION T10 HTA 2016? What Are the Challenges for Discussion on Drug Information: How It Japan? Is and How It Should Be Communicated with Patients 11:00-12:30 LUNCH BREAK 12:30-13:30 13:30-13:40 13:40-13:50 13:50-14:00 14:00-14:05 14:05-14:20 14:20-15:10 15:10-16:00 16:00-16:30 16:30-17:45 SHORT BREAK 17:45-18:00 NETWORKING RECEPTION AT RECEPTION HALL 18:00-19:30 [VENUE 3] ROOM 608 [VENUE 4] ROOM 609 [VENUE 5] ROOM 101 [VENUE 6] ROOM 102 MON NOV. 17 V3-S1 The Dawn of Advanced Regulatory Review & Consultation V4-S1 Points to Consider on the Biosimilar Development - Comparability Evaluation, Interchangeability, Advantage of Biosimilar Development - V5-S1 Leading Innovation with Stakeholders the Project Meeting Management V6-S1 Made in Academia: Seed Development Initiatives 9:00-10:30 SESSION 1 COFFEE BREAK 10:30-11:00 V3-S2 Medical Big Data Usage Hopes and Challenges in Clinical Development and Postmarketing Safety Surveillance V4-S2 Bridging the Gap between Bio-Ventures and the Pharmaceutical Industry to Form Drug-Making Partnerships V5-S2 Magic Bullets for Conflicts!! Case Study of Conflict Prevention and Resolution in R&D Projects V6-S2 ARO Activities to Facilitate Late- Phase Clinical Trials in Asia 11:00-12:30 SESSION 2 LUNCH BREAK 12:30-14:00 V3-S3 Lesson Learns of Adaptive Design from Case Example V4-S3 Innovation in Development of Orphan Drugs (1) Status Quo of Designation Scheme and Academia V5-S3 Brain Storming How We Can Conduct Clinical Trials A Company- Funded Company-Lead Trial is not the Only Way to Run a Clinical Trial V6-S3 Management of COI in Clinical Trials and Future Perspective 14:00-15:30 SESSION 3 COFFEE BREAK 15:30-16:00 V3-S4 Innovation of Clinical Development with Maximum Use of Existing Data V4-S4 Innovation in Development of Orphan Drugs (2) Diversifying Type of Operation and Companies V5-S4 Introduction to the Role of Medical Affairs for Research & Development Departments V6-S4 Application of Lean Six Sigma in DM Process Improvement in an Investigator- Initiated Clinical Trial 16:00-17:30 SESSION 4 SHORT BREAK 17:30-17:45 SPECIAL CHAT SESSION AT RECEPTION HALL 17:45-19:00 [VENUE 3] ROOM 608 [VENUE 4] ROOM 609 [VENUE 5] ROOM 101 [VENUE 6] ROOM 102 TUE NOV. 18 V3-S5 Multi-Regional Clinical Trials: Where Should It Be headed? V4-S5 Fostering Superior Talents involved in Drug Development and Evaluation -The Necessity of Human Resource Development and People-to-people Exchange beyond Boundaries - V5-S5 Risk-based Approach to Monitoring Part 1: Current Status and Outlook V6-S5 Genomic Sampling over Generations 9:00-10:30 SESSION 5 COFFEE BREAK (STUDENT POSTER SESSION IN FRONT OF THE RECEPTION HALL) 10:30-11:00 V3-S6 Beyond Japan: From Asian Studies to Global Studies V4-S6 Seeking for the Future Prosperity for Both Pharmaceutical Company and CRO V5-S6 Risk-based Approach to Monitoring Part 2: Implementation Status of TransCelerate Member Companies in Japan V6-S6 New Relationship of Drugs and Medical Devices will Open up the Future of the Health Care 11:00-12:30 SESSION 6 LUNCH BREAK 12:30-13:50 13:50-14:50 14:50-15:00 15:00-15:30 15:30-17:00 17:00-17:10 17:10-18:25 18:25-18:30

4 DIA Japan 2014: 11 th Annual Meeting SCHEDULE AT-A-GLANCE SUNDAY, NOVEMBER 16 8:30 Registration for Tutorial Sessions 9:00-12:30 Tutorial Sessions 9:10 Registration for Student Session 9:20-12:30 Student Session 9:30 Exhibitor Registration 12:30 Attendee Registration 12:30-20:00 Exhibit Hall Opens 13:30-13:50 Welcome & Opening Remarks 13:50-14:00 DIA Awards Ceremony 14:00-14:05 Program Instruction 14:05-14:20 Short Break 14:20-15:10 Keynote Speech 1 by Dr. Hiroo Imura 15:10-16:00 Keynote Speech 2 by Dr. Satoshi Furukawa 16:00-16:30 Coffee Break & Exhibit Hall Innovation Theater Presentations 16:30-17:45 Special Session 18:00-19:30 Networking Reception TUESDAY, NOVEMBER 18 8:30 Attendee & Exhibitor Registration 9:00-15:30 Exhibit Hall Opens 9:00-10:30 Sessions 5 10:30-11:00 Coffee Break & Exhibit Hall Innovation Theater Presentations/ Student Poster Session 11:00-12:30 Sessions 6 12:30-13:50 Lunch & Exhibit Hall Innovation Theater Presentations/Luncheon Seminars*. 13:50-14:50 Special Session by Dr. Yoshiyuki Sankai 14:50-15:00 Best Presentation Award Ceremony 15:00-15:30 Coffee Break & Exhibit Hall Innovation Theater Presentations 15:30-17:00 Roundtable Session 17:00-17:10 Short Break 17:10-18:25 PMDA Town Hall 18:25-18:30 Closing Remarks *Registration required. MONDAY, NOVEMBER 17 8:30 Attendee & Exhibitor Registration 9:00-19:00 Exhibit Hall Opens 9:00-10:30 Sessions 1 10:30-11:00 Coffee Break & Exhibit Hall Innovation Theater Presentations 11:00-12:30 Sessions 2 12:30-14:00 Lunch & Exhibit Hall Innovation Theater Presentations/Luncheon Seminars* 14:00-15:30 Sessions 3 15:30-16:00 Coffee Break & Exhibit Hall Innovation Theater Presentations 16:00-17:30 Sessions 4 17:45-19:00 Communities Special Chat Session 4

5 DAY 1 NOVEMBER 16 TUTORIALS 9:00-10:30 TUTORIAL 1 Room 605 9:00-10:30 TUTORIAL 2 Room 606 Basic Introduction for Non-Specialist: Drug- Drug Interaction and Summary of Change in New Japanese Drug-Drug Interaction Guideline Basic Knowledge of Drug-Drug Interaction and Introduction to New Japanese Drug-Drug Interaction Guideline Related Interest Area(s): CO, RA, Clinical Pharmacology, Clinical Development, Postmarketing, Clinician, Pharmacist Level: Beginner Language: Japanese Language Only Drug-drug interaction? It seems to be complicated, so let s leave it to the specialists. That may be current thinking, but will this attitude serve us in the future? New Japanese drugdrug interaction guidelines include drastic changes, such as the application of physiological-based pharmacokinetic (PBPK) models and concrete directions in the descriptions on package inserts. These changes will impact not only pharmacokinetic departments, but other segments of the industry as well, such as regulatory affairs, clinical development and postmarketing, and clinicians and pharmacists who use this information. This program will provide a basic understanding of drug-drug interaction and the background of new Japanese drug-drug interaction guidelines. The program will also explain the impact of these changes on package inserts. This information can help change I don t know to I understand! Koji Chiba, PhD Professor Laboratory of Clinical Pharmacology Yokohama College of Pharmacy Evaluations of Drug-Drug Interaction in the Process of New Drug Development and Description of the Obtained Information in the Product Labeling Akihiro Hisaka, PhD Professor Geriatric Pharmacology and Therapeutics Faculty of Pharmaceutical Sciences, Chiba University Current Status of the Transporter-Mediated Drug Interactions and Its Risk Assessment Kazuya Maeda, PhD Laboratory of Molecular Pharmacokinetics Graduate School of Pharmaceutical Sciences The University of Tokyo Q&A SESSION All speakers above Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 1 Related Interest Area(s): CO, RA, CP Level: All Since 2012, EU health authorities have issued a series of guidelines detailing their expectations on performance of pharmacovigilance for medicinal products in the European Union. This session will present those requirements affecting safety-labeling decision-making as part of the pharmacovigilance activities and explain, how the EU expectations will influence the design of the Global Labeling Process as well as the maintenance of Company Core Data Sheets in globally acting companies. Rie Matsui Director, Regional Labeling Head for Asia International Labeling Group Pfizer Japan Inc. The impact of the EU Pharmacovigilance Legislation on the Global Labeling Process and the management of Company Core Data Sheets Barbara Lachmann, MD Barbara Lachmann Labeling Consulting 11:00-12:30 TUTORIAL 7 Room 606 Next Steps for Content of Company Core Data Sheet Prepared by Western Companies - Part 2 Related Interest Area(s): CO, RA, CP Level: All Company Core Data Sheets should be designed in a way that their content is suitable for implementation in national labeling in any country of the world. This session will explain important aspects of EU labeling requirements to be considered when creating Company Core Data Sheets in globally acting companies, to allow for adequate implementation in EU marketing authorisation applications or variations. Rie Matsui Director, Regional Labeling Head for Asia International Labeling Group Pfizer Japan Inc. Creating Company Core Data Sheets under Consideration of EU Labeling Requirements Barbara Lachmann, MD Barbara Lachmann Labeling Consulting 5

6 DAY 1 NOVEMBER 16 TUTORIALS 9:00-10:30 TUTORIAL 3 Room 607 9:00-10:30 TUTORIAL 4 Room 608 Action Learning for Six Sigma Analytical Tools Using Real Case Studies Related Interest Area(s): All Level: Beginner Language: Japanese Language Only It s very important to use appropriate tools when applying the Six Sigma process. In this program, we explain the methodology behind Six Sigma, DMAIC (Define-Measure-Analysis-Improve- Control). We will also introduce two analytic tools, Process mapping and Fish-bone diagrams, which are applicable in not only the Six Sigma project, but also in our day-to-day work activities. This session will be an interactive discussion using real case studies. Participants will learn how to apply these tools for process improvement. LECTURERS Kazuo Ichikawa, PhD, PMP Director Global Project Management Department, R&D Div. Daiichi Sankyo Co., Ltd. Kazuhiko Kamiyama Senior Manager Clinical Trial Support and Compliance Development Operations Pfizer Japan Inc. Mika Ogasawara Senior Manager (GreenBelt) Japan Clinical Informatics & Innovation Development Operations Pfizer Japan Inc. Goshi Ozawa Clinical Trial Manager (BlackBelt) Integrated Development Associates Co., Ltd. Naoko Taguchi Clinical Development Center Data Science Department Asahi Kasei Pharma Corporation Eri Ubukata Clinical Development Center Clinical Coordination Asahi Kasei Pharma Corporation Coaching as a Diverse Communication Tool Across Functions and Areas Related Interest Area(s): PM Level: Beginner Language: Japanese Language Only In the last DIAJ annual meeting (2013), we shared the idea of using coaching tools as an effective communication process for driving projects. This session is designed as a workshop to learn theoretical concepts (coaching psychology and neuro-linguistic programming) as well as basic skills of coaching through roleplaying involving participants. Also, we would like to explore by means of dialog how we can make the most of these skills and tools in different situations of a project. 1. Theoretical concepts of coaching 2. Basic skills for active listening 3. Basic skills for GROW model 4. Dialog Takashi Sato Manager Kyowa Hakko Kirin Co., Ltd. LECTURERS Koichi Konno Chief Executive PM Consulting Positive Intention Takashi Sato Manager Kyowa Hakko Kirin Co., Ltd. Noriko Yoshida Mochida Pharmaceutical Co., Ltd. 6

7 DAY 1 NOVEMBER 16 TUTORIALS 9:00-10:30 TUTORIAL 5 Room :00-12:30 TUTORIAL 6 Room 605 The Basics of Investigator Initiated Trial (IIT) Regulation Related Interest Area(s): All Level: Beginner Language: Japanese Language Only Investigator Initiated Trial (IIT) has an indispensable role of advancement of medicine, because IITs assume the role of awareness of treatment effectiveness, building evidences for standards therapies and developing new treatments for patients. IIT has gained name recognition since last year due to repeated media exposure. Unfortunately, the most media coverage was disturbing, and the public is rigorously questioning how an IIT should to be in Japan. Persons who engage in IIT are required to fully understand the international ethical guidelines and the related regulations in addition to high ethical standards when conducting a research. Currently, IIT is in revolutionary times: guidelines for ethical standards are under amendment. This tutorial session will provide an opportunity to learn the latest regulation, guidelines, and trends of IIT. Targeted audience includes physicians, nurses, pharmacists, and persons in pharmaceutical industry. Fumiaki Kobayashi, PhD CEO CTD Inc. LECTURER Haruko Yamamoto, MD, PhD Director Dpt. of Advanced Medical Technology Development Research & Development Initiative Center National Cerebral & Cardiovascular Center Prediction for Human Pharmacokinetics and Safety Using Systems Pharmacology Related Interest Area(s): CO, RA, ST, CP Level: Beginner, Intermediate Language: Japanese Language Only This session will present the prediction of human pharmacokinetics and safety from in vitro data using the systems pharmacology approach. In addition, we will discuss IVIVE (in vitro to in vivo extrapolation) and physiologically-based pharmacokinetics (PBPK), and PBPK approach-based prediction for inter-individual variability regarding pharmacokinetic prediction. Furthermore, we will show the prediction for pediatric PK/PD using PBPK approach in order to optimize the pediatric dose. Conversely, we will focus on the safety issues regarding the prediction for QT interval prolongation. While herg assay and clinical QT interval evaluation should be performed under the current guidelines, computer simulation and the PK/PD modeling approach for cardiac safety evaluation should become the main stream in the near future. In this program, we will present computer simulation to predict action potentials and human ECGs. Akihiro Hisaka, PhD Professor, Geriatric Pharmacology and Therapeutics Faculty of Pharmaceutical Sciences, Chiba University Prediction of Pharmacokinetics Using Physiologicallybased PK Modeling Koji Chiba, PhD Professor Laboratory of Clinical Pharmacology Yokohama College of Pharmacy In Vitro In Vivo Extrapolation and Prediction for Cardiotoxicity Using Simcyp Cardiac Safety Simulator Hidefumi Kasai Certara G.K. 7

8 DAY 1 NOVEMBER 16 TUTORIALS 11:00-12:30 TUTORIAL 8 Room :00-12:30 TUTORIAL 9 Room 608 An Introduction to Adaptive Designs Related Interest Area(s): CO, RA, ST, CDM, PM, CMC Level: Beginner, Intermediate Language: English Only This tutorial will cover an introduction to adaptive designs. The choice of design, adaptive or fixed, depends on many factors (such as uncertainty of compound attributes) and needs to be considered within the context of the entire clinical plan. Expected audiences are both statisticians and non-statisticians who are involved in study planning and execution. Bayesian and Frequentist methodologies which can be used to perform adaptations in a trial will be described and how they can be used in adaptive designs will be illustrated. Trial simulations are useful and often necessary to understand the operating characteristics of a design. Real examples of simulations will be provided. Case studies of several types of adaptive designs will be provided including sample size re-estimation, adaptive treatment allocation, group sequential designs, and seamless designs. Regulatory as well as implementation challenges of adaptive designs will be discussed. Brief summaries in Japanese will be provided between parts. Hiroshi Nishiyama, PhD Senior Research Scientist, Statistical Sciences Eli Lilly Japan K.K. An Introduction to Adaptive Designs with Case Studies of Several Types of Adaptive Designs Zachary Skrivanek, PhD Global Statistical Science/Principal Research Scientist Eli Lilly and Company Let s Learn and Talk about Project Management Basics of the Clinical Study in Medical Institutes! Related Interest Area(s): All Level: Beginner Language: Japanese Language Only The main objective of this tutorial program is to introduce how to utilize the concept of Project Management (PM) for conducting of effective and efficient clinical studies, especially in the case of Investigator Initiated Trial (IIT) in the medical institutes. In this tutorial program, we would like to share the issues and improved point while conducting IITs, and some skills in PM basic framework. Then we would also like to introduce some processes and rules which were implemented in the pharmaceutical industry in order to understand of the PM tools,for the communication planning at the medical institutes. We hope this training will provide all of you to get a flavor of resolving issues and challenges of the day-to-day and improve your IIT process effectively and efficiently by utilizing PM tool, and build and strengthen the network among participants who have similar interests and challenges. Shuji Sumida Department Manager Quality & Regulatory Compliance Dept. Quality & Regulatory Compliance Unit Chugai Pharmaceutical Co., Ltd. DIAJ PM Community Communication Skills in Investigator Initiated Trial Yoko Kazami Kitasato Academic Research Organization Kitasato University Project Management Essentials in Clinical Trial Atsushi Tsukamoto, PhD Senior Director, Global Project Management Daiichi Sankyo Company, Ltd. DIAJ PM Community Tips on Project Management in Clinical Trial Kouji Iwasaki, PhD Director Global Medical Affairs Japan Department Takeda Pharmaceutical Co., Ltd. DIAJ PM Community 8

9 DAY 1 NOVEMBER 16 TUTORIALS DAY 1 NOVEMBER 16 STUDENT SESSION 11:00-12:30 TUTORIAL 10 Room 609 9:20-12:30 STUDENT SESSION Room 101 HTA 2016? What are the challenges for Japan? Related Interest Area(s): RA, HEOR Level: Intermediate Language: Japanese Language Only The debate on HTA continues in Japan, with a focus on trying to understand the methodology and how it could apply to the healthcare system in this country. At the same time in Europe, the field of HTA is in rapid evolution due to refinements to the methodology of HTA itself, but also because of the request for convergence between requirements from regulatory and HTA agencies for additional data. The session will briefly cover the basics of HTA, and its implications for Japan. Bruno Rossi Head of Market Access Bayer Yakuhin HTA Basic Short Course Ataru Igarashi Assistant Professor, Dept of Drug Policy & Management The University of Tokyo The Impact of HTA Hiroki Sakai PwC PRTM Management Consultants Regulatory Implications and Interface with HTA Ryosuke Minami Economic Affairs Division, Health Policy Bureau Ministry of Health, Labour and Welfare Panel Discussion All speakers above Discussion on Drug Information; How It Is and How It Should be Communicated with Patients Related Interest Area(s): All Level: Beginner Language: Japanese Language Only Now more than ever, it is increasingly important for patients to have access to both correct and appropriate drug information. Drug manufacturers and health care providers should carefully consider how to provide such information to patients properly. In this session, three educational lectures will be delivered: the first one is about the basic concepts of drug information from the viewpoint of government, the next one is about the principles and basic concepts of package inserts (considered the foundation of all drug information), and the final one is an examination as to how health care providers deliver drug information to patients on-site. Following these lectures, we shall endeavor to deepen our understandings about these pertinent topics by means of group discussions, presentations, and mutual feedback. An additional aim of this session is to help develop business skills, such as interpersonal communication, which is required for working effectively in a global environment. SESSION CO-CHAIRS Mitsuo Ishikawa Graduate Student Graduate School of Pharmaceutical Science, Keio University Hotaka Maruyama Graduate Student Graduate School of Pharmaceutical Science, Keio University Ayako Ono Undergraduate Student Faculty of Pharmaceutical Sciences, Chiba University Daichi Yaguchi Undergraduate Student Faculty of Pharmacy, Musashino University LECTURERS Osamu Komiyama Senior Manager, Statistical Research & Consulting Group Clinical Statistics, Pfizer Japan Inc. Yoichi Ishikawa Director, Department of Pharmacy National Center for Child Health & Development Kazushige Murayama, PhD Lecturer, Faculty of Pharmacy, Musashino University ADVISERS Hironobu Saito, PhD VP, New Drug Regulatory Affairs Dept. Daiichi Sankyo Co., Ltd. Eri Sekine Head of Oncology Biometrics and DM Department, Oncology Development, Novartis Pharma K.K. Kasumi Daidoji, MSc, RPh Associate Director, Corporate Medical Affairs Headquarters Drug Fostering and Evolution Coordination Department Eisai Co., Ltd. 9

10 DAY 1 NOVEMBER 16 WELCOME AND KEYNOTE SESSIONS 13:30-13:40 WELCOME Ko Sekiguchi Director, DIA Japan Barbara Lopez Kunz Global Chief Executive, DIA International Conference Room Tatsuo Kurokawa, PhD Chair, DIA Advisory Council of Japan Professor, Division of Drug Development & Regulatory Sciences Faculty of Pharmacy, Keio University It is a great opportunity that we can listen to Dr. Imura s future vision who is really leading various significant initiatives in medical society now which transcend boundaries. TBC Hiroo Imura, MD, PhD President Foundation for Biomedical Research and Innovation 13:40-13:50 OPENING REMARKS PROGRAM CHAIR Hiroshi Watanabe, MD, PhD Professor, Deparment of Clinical Pharmacology & Therapeutics Hamamatsu University School of Medicine 13:50-14:00 GLOBAL DIA AWARDS PRESENTATION PRESENTER Barbara Lopez Kunz Global Chief Executive, DIA AWARD WINNERS Junichi Nishino, MSc, RPh Head, Regulatory Operation & Prescribing Information Group Drug Regulatory Affairs Department Regulatory Affairs & Quality Assurance Division Novartis Pharma K.K. Hidetoshi Shuto Senior Fellow, Corporate Research & Development Div. Nitto Denko Corporation Atsushi Tsukamoto, PhD Senior Director, Global Project Management Daiichi Sankyo Co., Ltd. 14:00-14:05 PROGRAM INSTRUCTIONS PROGRAM VICE-CHAIR Kenji Nagaya General Manager, Clinical Data Management and Biostatistics Pharmaceutical Development Division, Nippon Kayaku Co., Ltd. 14:20-15:10 KEYNOTE SPEECH 1 International Conference Room Kazuhiko Mori Director, Evaluation and Licensing Division Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Keynote speech 1 of 2014 DIA Japan Annual Meeting will be presented by Dr. Hiroo Imura, President of Foundation for Biomedical Research and Innovation (FBRI). Dr. Imura successively held number of important positions such as President of University of Kyoto, Member of Council for Science, Technology and Innovation and since 2014 as President of FBRI has been leading the largest medical cluster in Japan promoting practical application of advanced medical science such as regenerative medicine. Further as Chairman of General Assembly of The Japan Association of Medical Science 2015 Kansai, Dr. Imura is challenging to new initiatives which will enhance innovation in medical science and medical treatment to be participated by all stakeholders including various professional fields, generations and patients and families. 15:10-16:00 KEYNOTE SPEECH 2 International Conference Room Junichi Nishino, MSc, RPh Chiar, DIA Japan Contents Committee Head, Regulatory Operation & Prescribing Information Group Drug Regulatory Affairs Department Regulatory Affairs & Quality Assurance Division Novartis Pharma K.K. Transcending Boundaries and Challenges - International Space Station Satoshi Furukawa, MD, PhD JAXA Astronaut / Surgeon CJAXA Dr. Satoshi Furukawa was born in 1964, in Yokohama, Kanagawa. He received a Doctor of Medicine in 1989 and a Doctor of Philosophy degree in Medical Science in 2000, from the University of Tokyo. From 1989 to 1999, he worked in the Department of Surgery at the University of Tokyo, the Department of Anesthesiology at JR Tokyo General Hospital, and the Department of Surgery at Ibaraki Prefectural Central Hospital and at Sakuragaoka Hospital. In 1999, Dr. Furukawa was selected by the National Space Development Agency of Japan (NASDA, currently Japan Aerospace Exploration Agency) as a Japanese astronaut candidate for the International Space Station (ISS). He started NASDA s Basic Training program and was certified as an astronaut in Dr. Furukawa participated in ISS Advanced Training, as well as supporting the development of the hardware and operation of the Japanese Experiment Module Kibo and he was certified as a Soyuz-TMA Flight Engineer in In February 2006, He was qualified for flight assignments aboard the space shuttle as a Mission Specialists (MS). From June to November 2011, Dr. Furukawa stayed on the ISS for 165 days as a flight engineer for the Expedition 28/29 mission. His mission included experiments in Kibo, and ISS maintenance. He also supported the last space shuttle mission, STS-135. He flew on the Soyuz TMA-02M spacecraft (27S) for both launch and return. In this Keynote session, Dr. Furukawa will deliver a lecture about his motivation for becoming an astronaut from a doctor, his experiences and messages for transcending boundaries. 16:00-16:30 COFFEE BREAK 10

11 DAY 1 NOVEMBER 16 OPEN PLENARY 16:30-17:45 SPECIAL SESSION International Conference Room Tatsuo Kurokawa, PhD Professor, Division of Drug Development and Regulatory Sciences Faculty of Pharmacy Keio University Ten years have passed since PMDA was established and the agency continues to develop various strategies for aiming to be one of the world s leading regulatory agencies, releasing PMDA International Vision and Roadmap For this session, Dr. Tatsuya Kondo, Chief Executive of PMDA will provide updates on their international activities and cooperation. We will also invite top executive of overseas regulatory agency as a speaker to discuss future visions for international collaboration. Presentation 1 Tatsuya Kondo, MD, PhD Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA) Future Visions for International Regulatory Collaboration: Australian Perspective John Skerritt, PhD Therapeutic Goods Administration (TGA), Australia 18:00-19:30 NETWORKING RECEPTION Reception Hall Please join us at the Opening Networking Reception in the Reception Hall for an excellent opportunity to see your old friends and to make new acquaintances, while visiting the booths of exhibiting companies and academic affiliations. 11

12 DAY 2 NOVEMBER 17 SESSION 1 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 9:00-10:30 SESSION 1 VENUE 1 ROOM 605/606 [V1-S1] Vision for the Future: Global Simultaneous Filing to the World First Approval - Strategies for Early NDA Approval Related Interest Area(s): All Level: Intermediate The primary objective of global simultaneous development and NDA filing is to make new drugs available to patients across regions without lag time. Today, global simultaneous filing is no longer a rare experience, and even more applications are successfully obtaining the first NDA/approval in Japan ahead of other regions. In the first part of the session, we will focus on the topic of the first submission in Japan ahead of other regions, where medical writer and regulatory affairs personnel from pharmaceutical companies will speak about various strategies on drug development and dossier preparation for NDA. In the second part, representatives from pharmaceutical companies and PMDA will discuss issues that may affect efficient preparation of a dossier and/or review aiming for early approval. These topics will be expanded upon for further discussion in following panel discussion. The discussion will also include several additional topics, such as the still-controversial Japan-specific requirements for CTD preparation, recently announced MHLW-own strategies on Sakigake Package, and CDISC data application. Satomi Ando, MSc Head, Medical Writing and Communication Dept. Development Division Novartis Pharma K.K. An Experience of the First Submission in Japan Ahead of Other Regions: A Case of Global NDA Filing for 2 Indications in 1 Submission Tomohiko Kumakura, MSc Senior Director Daiichi Sankyo Co., Ltd. Opportunities and Challenges in the Preparation of a World-First Japan Filing in a Global Development Project Yuka Wakimura, PhD Associate Director Janssen Pharmaceutical K.K Panel Discussion All speakers above and Katsuhiko Ichimaru, MSc Director Office of Review Management Review Planning Division Pharmaceuticals and Medical Devices Agency (PMDA) Yoshinori Murakami, PhD Group Manager Medical Writing Dept. Janssen Pharmaceutical K.K VENUE 2 ROOM 607 [V2-S1] Listen to What the Patient Has to Say - A Message from Patients to Those Engaged in Drug Development - Related Interest Area(s): All Level: Beginner, Intermediate Do you really understand the pains and desires of your patients? It is very rare for New Drug R&D staff to talk to patients directly. DIA is excited about the opportunity to share the Voice of Patients. Representatives from patient groups will discuss their opinions about new drug development in clinical trials. This should be a starting point for learning about collaborations between pharmaceutical companies, health care professionals and patients. * Please note that the presentations and disease names below are subject to change without notice. Kazumichi Kobayashi Senior Research Fellow Office of Pharmaceutical Industry Research Mental Pain with Neurofibromatosis type 1 (NF1) Patient with Recklinghausen s Disease Reality of the Werner Syndrome Patients and Wishes for the Promotion of Treatment Research Patient with Werner Syndrome My Experience : Having a Diagnosis of PKD Patient with Polycystic Kidney Disease Patient s Voice - Current Situation of Relapsing Polychondritis and Expectations of Patient s Role for Treatment Research - Patient with Relapsing Polychondritis Can Patients Really Talk about All? Tateo Ito President Japan Patient Association VENUE 3 ROOM 608 [V3-S1] The Dawn of Advanced Regulatory Review and Consultation Related Interest Area(s): CO, RA, ST, CDM Level: Intermediate Language: English Only Starting in 2016, the Advanced Regulatory Review & Consultation in PMDA will begin. The US FDA is developing information on Providing Regulatory Submissions in Electronic Format following the 2012 FDA Safety & Innovation Act (FDASIA). Furthermore, the utilization of electronic clinical trial data is currently being discussed in the EU. It is expected that the establishment of Advanced Regulatory Review & Consultation will improve decision-making in drug development and the utilization of electronic clinical trial data. This session will discuss the pros and cons of these initiatives and how they affect the industry. Motohide Nishi, MBA Director, Asia Pacific Data Sciences & Solutions Development Center of Excellence, Asia Pacific Eli Lilly Japan K.K. From PMDA s Perspective (Tentative) Mayumi Shikano, PhD Office Director, Manager Office of Standards and Guidelines Development, Advanced Review with Electronic Data, Promotion Group, Pharmaceuticals and Medical Devices Agency Japan (PMDA) From FDA s Perspective (Tentative) <Remote Presentation via Internet> Ron Fitzmartin, PhD, MBA Senior Advisor, Data Standards Program OSP, CDER, FDA From Industry s Perspective (Tentative) Hironobu Saito, PhD VP, New Drug Regulatory Affairs Dept. Daiichi Sankyo Co., Ltd. CDISC Perspective (Tentative) Bron Kisler Vice President, Global Strategic Initiatives, CDISC Panel Discussion All speakers above 12

13 DAY 2 NOVEMBER 17 SESSION 1 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 9:00-10:30 SESSION 1 (CONT.) VENUE 4 ROOM 609 [V4-S1] Points to Consider on the Biosimilar Development - Comparability Evaluation, Interchangeability, Advantage of Biosimilar Development - Related Interest Area(s): All Level: Intermediate, Advanced This program will cover the current state and challenges of using biosimilar products from development to approval, as well as their usage in hospitals. Topics will be covered from the viewpoints of industry, government, and academia. Now that the first biosimilar antibody has been approved in Japan, the challenges for biological products that have complicated structure and interchangeability will also be discussed. In addition, the switch from innovator drugs to biosimilar drugs at medical institutions will be discussed, as well. Teruyo Arato, PhD Professor, Department of Regulatory Science Hokkaido University Graduate School of Medicine Biosimilar: Medical Needs and Clinical Development in Japan (Tentative) Yoshihiro Nambu, MD, PhD Chief Medical & Scientific Officer Head of Pharmaceutical Development Pharmaceuticals Group Nippon Kayaku Co.,Ltd. Quality of Biosimilar Product - From a Viewpoint of CMC Katsuya Nishino Representative Director Executive Vice President JCR Pharmaceuticals Co., Ltd. How to Think Extrapolation and Bio Similarity of Products in PMDA Review (Tentative) Reiko Yanagihara, PhD Principal Reviewer Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Devices Agency (PMDA) How to Decide the Interchangeability from Innovator Drugs to Biosimilars. Why Can You Switch Or Not? (Tentative) Susumu Yokoya, MD, PhD Vice-Director National Center for Child Health & Development VENUE 5 ROOM 101 [V5-S1] Leading Innovation with Stakeholders the Project Meeting Management Related Interest Area(s): All Level: Beginner It is important to manage communication in cross-functional projects to produce innovation with stakeholders. One important communication management tools are meetings. Meetings are not only for progress reports, but for process management from project initiation to closing. The capability to manage meetings helps achieve project goals. In this session, members will learn the basics of meeting managements and the process design of project meetings, and discuss their applications in real-life settings. Kouji Iwasaki, PhD Director Global Medical Affairs Japan Department Takeda Pharmaceutical Co., Ltd. DIAJ PM Community Shuji Sumida Department Manager Quality & Regulatory Compliance Dept. Quality & Regulatory Compliance Unit Chugai Pharmaceutical Co., Ltd. DIAJ PM Community Koichi Konno Chief Executive PM Consulting Positive Intention DIAJ PM Community Kouji Iwasaki, PhD Director Global Medical Affairs Japan Department Takeda Pharmaceutical Co., Ltd. DIAJ PM Community VENUE 6 ROOM 102 [V6-S1] Made in Academia: Seed Development Initiatives Related Interest Area(s): CO, RA, PM Level: Beginner, Intermediate In Japan, there are 15 core clinical research centers receiving strong support from the government. Their academic expertise is integral to the field of seed development. Overcoming obstacles to transfer the results of basic research into clinical research is not easy for academia, and collaboration with pharmaceutical companies and regulatory agencies is indispensable. Furthermore, there are expectations for the development of a Japanese NIH and national strategy districts. In this session, we will focus on several examples of successful seed development in medical institutions. In addition, we will examine the issues, direction, and solutions of the possibilities and outputs of drug development from the strategic viewpoint on pharmaceutical affairs of regulatory agencies. Hideki Hanaoka, PhD Director of Clinical Research Center Chiba University Hospital Drug discovery - Role and Significance of Academia - Toshio Miyata, MD, PhD Associate Executive Vice President Tohoku University Identification and Modification of Novel Anti-Microbial Peptide toward Topical Wound-Healing Drug Hironori Nakagami, MD, PhD Professor United Graduate School of Child Development Osaka University A Clinical Trial for A Rare Disease: Capitalize on The Physician s Perspective Sonoko Misawa, MD, PhD Assistant Professor, Department of Neurology Chiba University Panel Discussion All speakers above and Hisashi Koike Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA) Naoyuki Yabana, PhD Review Director Office of New Drug III Pharmaceuticals and Medical Devices Agency (PMDA) 13

14 DAY 2 NOVEMBER 17 SESSION 2 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 11:00-12:30 SESSION 2 VENUE 1 ROOM 605/606 [V1-S2] Vision for the Future: Global Simultaneous Approval Efforts and Challenge for Simultaneous Review on Each Country Related Interest Area(s): All Level: Intermediate In this session, we will focus on the process of submission to approvals in the review period, as well as global simultaneous submission and its challenges. The main topics include the issue of submission timing of answer as the analysis of trends in questionnaires in each authority (PMDA/FDA/EMA). (NOTE I don t know what this means.) During the panel discussion, we will discuss the issues between PMDA and companies regarding the challenges of simultaneous review, and the differences of each authority. Fumiaki Kobayashi, PhD CEO CTD Inc. Comparison of the Queries During a Simultaneous Review by PMDA/FDA/ EMA Kazumi Sunamura Director Regulatory Strategy & Policy 2 Pfizer Japan Inc. Review Experience of Global Simultaneous Submission and Challenges Chitose Nishida Manager Regulatory Excellence Dept GlaxoSmithKline K.K. Considering Point and Future Networking with Foreign Regulatory Authorities in Global Simultaneous Review Toyotaka Iguchi, MD, PhD Review Director Office of New Drug V Pharmaceuticals and Medical Devices Agency (PMDA) Panel Discussion All speakers above VENUE 2 ROOM 607 [V2-S2] Discussion About the Provision of Information for Patients What is a Patient- Oriented Information from the Regulatory Agencies, Pharmaceutical Companies, and Medical Professionals? Related Interest Area(s): CO, RA, CDM, CP, PM, Academia Level: All In Europe, pharmaceutical companies are obligated to prepare Patient Leaflets. Patient Leaflets are written in a simple language to help patients understand the content. Patients can thus obtain information, designed specifically for patients, about any medications prescribed. In Japan, the Patient Medication Guide or Drug Information Sheet is prepared for some drugs; however, patients and their families still have difficulty in obtaining or understanding appropriate information about diseases or drugs. Pharmaceutical companies have not well understood the current situation in Japan. In this session, the regulatory agencies, pharmaceutical companies, and medical professionals will present their view on the current state, and what future actions are needed, including their request regarding the provision of information for patients. In addition, they will share and discuss with attendees topics related to information for patients. Mayumi Mochizuki, PhD Professor Keio University Faculty of Pharmacy Shinobu Uzu Director, Safety Division Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Michiko Yamamoto, PhD Professor Showa Pharmaceutical University Masami Kojima The Mainichi Newpapers Co., Ltd. Chiyomi Takahashi Japan Pharmaceutical Information Center Takako Yamazaki CANCER RIBBONZ VENUE 3 ROOM 608 [V3-S2] Medical Big Data Usage Hopes and Challenges in Clinical Development and Postmarketing Safety Surveillance Related Interest Area(s): CO, CDM, CP, CMC Level: Beginner Big data have recently brought global attention to various industries in many different ways. One could say; that Japan has fallen far behind in the practical usage of big data compared to the rest of the world. Japan is now starting to revise the policies that regulate personal data usage. Given the significant attrition rates in research and development (R&D), to plan and conduct appropriate clinical trials based on scientific grounds is becoming more and more crucial. In addition, optimization of post marketing safety measures using drug usage data of the real world clinical setting is desirable. This session introduces a few examples of big data usage overseas and discusses Japan s current situation and challenges. Tomiaki Morikawa, PhD, MBA Associate Professor Graduate School of Media and Governance Keio University US Cases of Medical Data Usage Jeff Elton, PhD, MBA Managing Director, Global Life Sciences Management Consulting Accenture R&D Out of Big Data Creating Health Together Rami Suzuki, PhD President, Senior Group Officer Global Business Development Unit, ECL Eisai Co., Ltd. Leveraging Big Data to Drive Appropriate Usage of Medicinal Products Hiroshi Tamada, MD, PhD, MBA Vice President, Executive Officer Japan Medical Affairs & Pharmacovigilance Bristol-Myers K.K. A Case of Medical Data Usage in a Clinic Yasuhiko Munakata, MD, PhD CEO, Munakata Yasuhiko Clinic Panel Discussion All speakers above 14

15 DAY 2 NOVEMBER 17 SESSION 2 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 11:00-12:30 SESSION 2 (CONT.) VENUE 4 ROOM 609 [V4-S2] Bridging the Gap between Bio-ventures and the Pharmaceutical Industry to Form Drug-Making Partnerships Related Interest Area(s): CO, RA, Academia Level: Intermediate The Faculty of Pharmacy, Musashino University, and the Office of Pharmaceutical Industry Research (OPIR) have performed investigations and gap-analysis surveys between bio-ventures and pharmaceutical companies. First, three speakers will present their own experiences and thoughts from the point of view of investor, advisor, and portfolio manager of a pharmaceutical company. In addition, a researcher from Musashino University will briefly present the outcome of the survey. All members, including session chairs, will take part in a panel discussion to discuss topics such as What is the bottleneck to be a partner, How to find a clue to a solution, What is the best approach for the future collaboration. SESSION CO-CHAIRS Satoshi Toyoshima, PhD Professor, Faculty of Pharmacy Graduate School of Pharmaceutical Sciences Musashino University Kazumichi Kobayashi Senior Research Fellow Office of Pharmaceutical Industry Research Challenges in Building of the Ecosystem of Drug Discovery and Development Koichi Ashida Managing Director Innovation Network Corporation of Japan Who are the Clients for Bio-Ventures? The Impact of Changing Market Environment of Healthcare and Pharmaceutical on Growth of Bio-Venture Tetsushi Inada, PhD President and Managing Director Pharma-East Insight, Inc. Harness Innovation in Japan for Global Drug R&D: Opportunities, Challenges and Pfizer Approach Shinji Ogawa, PhD Senior Manager Japan Portfolio & Project Management Pfizer Japan Inc. Analysis of Perception Gap on Alliance Activities between Japanese Biotechnology Venture Companies and Pharmaceutical Companies Masafumi Shimokawa Faculty of Pharmacy Graduate School of Pharmaceutical Sciences Musashino University Panel Discussion All speakers above VENUE 5 ROOM 101 [V5-S2] Magic Bullets for Conflicts!! Case Study of Conflict Prevention and Resolution in R&D Projects Related Interest Area(s): All Level: All In pharmaceutical R&D projects, there are conflicts caused by different positions of responsibilities, which happen frequently. Unnecessary conflict should be avoided. However conflict itself can be a trigger of breakthrough and the opportunity to build team s functionality stronger. In this session, we would like to introduce methodology and tools of project management, Six Sigma and facilitation to prevent and resolve the conflicts, through a case study of an R&D project. We hope that those clues are useful for your business from now. SESSION CO-CHAIRS Michiyo Tani, MBA Manager Foresight Group Atsushi Tsukamoto, PhD Senior Director Global Project Management Daiichi Sankyo Co., Ltd Proactively Addressing Conflicts - Learnings from a Facilitation Methodology Akira Kato Manager Research & Consulting Division, Society & Industry Design The Japan Research Institute Let s Prevent Unnecessary Conflict by Using Project Management Tools! Yasuo Fukushima, PhD Manager Daiichi Sankyo Co., Ltd To Lead the Healthier Resolution of Conflict with Six Sigma Tool ~ Such a Useful Way of Six Sigma Tool ~ Yusuke Tsutsumi, PhD Assistant Manager Global Management Group Development Planning and Coordination Department Development Division Mitsubishi Tanabe Pharma Corporation VENUE 6 ROOM 102 [V6-S2] ARO Activities to Facilitate Late-Phase Clinical Trials in Asia Related Interest Area(s): CO Level: Beginner The need for efficient management in clinical trials has been on the rise with the increase of clinical trials in Asia. Some clinical trial centers and universities established their ARO (Academic research Organization) to support clinical studies through a standpoint of academia or physicians, which includes not only site monitoring but data management or medical writing. The range of the services is dependent on the request from investigators or sponsors. Speakers share their unique experiences and ideas on how to manage clinical studies efficiently and effectively while focusing on how the organization of this type adapts to clinical trials and how to make the most of ARO. The discussion includes recent activities relating to clinical trial consortium or collaboration across countries in Asia to facilitate late-phase clinical trials in order to achieve our ultimate goal, the delivering of medicinal product to the patients. Koichi Miyazaki, MSc, RPh Senior Director Regulatory Affairs Group, Asia Development Department Daiichi Sankyo Co., Ltd. An Overview of the Clinical Trial Consortium and New Strategies for Collaboration Moo Hyun Kim, MD, PhD Director Global Clinical Trial Center Dong-A University Clinical Trial Consortium in Taiwan K. Arnold Chan, MD, ScD Director, Clinical Trial Center National Taiwan University Hospital ARO Activities to Facilitate Late-Phase Clinical Trial in Japan Hideki Hanaoka, MD, PhD Director Clinical Research Center Chiba University Panel Discussion All speakers above 15

16 DAY 2 NOVEMBER 17 SESSION 3 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 14:00-15:30 SESSION 3 VENUE 1 ROOM 605/606 [V1-S3] Global Contribution for Clinical Development from Japan Related Interest Area(s): CO, RA, Academia,, Clinical Pharmacology, Clinical Development, Clinician Level: Intermediate Since the Basic Principles on Global Clinical Trials was implemented in 2007, the Japanese tactic to participate in early global development has been actively discussed and the simultaneous approvals utilizing this concept have become reality. In this session, as a next step of participation in multi regional clinical trials, presenters will provide ideas of how can Japan actively contribute to global clinical development. In the panel discussion, the values that Japan can provide to global clinical development will be discussed based on the ideas in the presentations. SESSION CO-CHAIRS Naomi Nagai, PhD Senior Scientist (Pharmacokinetics) Pharmaceuticals and Medical Devices Agency (PMDA) Masayo Oishi, PhD Clinical Pharmacology, Clinical Research Pfizer Japan Inc. Meaningful Asian Phase I for Global Drug Development Koji Chiba, PhD Professor Laboratory of Clinical Pharmacology Yokohama College of Pharmacy Advanced PET Molecular Imaging Technology for the Drug Development from Pharmacokinetics and DDS to Super-early Diagnosis Tomotaka Shingaki, PhD Research Scientist Molecular Dynamics Imaging Unit Division of Bio-function Dynamics Imaging RIKEN Center for Life Science Technologies Public-Private Partnership in Japan for Global Clinical Development: Present Status and Operational Challenges Yuji Sato, MD, PhD Professor Center for Clinical Research Keio University School of Medicine Panel Discussion All speakers above VENUE 2 ROOM 607 [V2-S3] How Can We Apply the Electric Health Records for Postmarketing Drug Safety in Japan? Related Interest Area(s): RA, CP Level: Beginner Recently in Japan, the secondary use of some Electronic Health Records (EHR) databases has been made available for postmarketing drug safety. In this session, speakers from a regulatory agency, academia, and a pharmaceutical industry organization will discuss postmarketing drug safety using EHR. At the end of the session, we will have a panel discussion focusing on current issues and the future direction of postmarketing drug safety by using EHR in Japan. SESSION CO-CHAIRS Kiyoshi Kubota, MD, PhD President Japanese Society for Pharmacoepidemiology Chieko Ishiguro, BPharm, MPH Pharmacoepidemiologist Pharmaceuticals and Medical Devices Agency (PMDA) Remarks from the Viewpoint of Regulatory Agency Maki Komamine, BPharm Pharmacoepidemiologist Pharmaceuticals and Medical Devices Agency (PMDA) Remarks from the Academic Viewpoint Takuhiro Yamaguchi, PhD Professor Graduate School of Medicine Tohoku University Remarks of the Pharmaceutical Industry Organization Kotonari Aoki Manager Chugai Pharmaceutial Co., Ltd. The Paradigm without Japanese style Post-marketing Surveillance (PMS) Tatsuo Kagimura, MPH Translational Research Informatics Center Panel Discussion All speakers above VENUE 3 ROOM 608 [V3-S3] Lessons Learned of Adaptive Design from Case Example Related Interest Area(s): CO, RA, ST, PM Level: Intermediate Statistical approaches to adaptive designs have been proposed throughout the past decade. However, the industry has very little experience with such designs, especially in Japan. In this session, we ll introduce recent examples of such studies from two companies, share regulatory agency s perspective from PMDA, and have a panel discussion to discuss the operational management, including regulatory challenges and planning of adaptive study designs. The first example is a novel Bayesian adaptive, an inferentially seamless phase 2/3 study for an experimental drug to treat diabetes (AWARD-5), which was used for the US/ EU NDA submissions. The second example includes examples of sample size re-estimation applied to an Asian study, including Japan, in overactive bladder patients, etc. The final talk will be on PMDA s perspectives in the consideration of adaptive design clinical trials based on their experiences discussing adaptive design in clinical trial consultation meetings. Expected audiences are both statisticians and nonstatisticians who are involved in study planning and execution. Yasuo Ohashi, PhD Professor Department of Integrated Science and Engineering for Sustainable Society Chuo University A Bayesian Adaptive Seamless Phase 2/3 Design Incorporating a Clinical Utility Index (Dulaglutide Combined with Metformin in Type 2 Diabetes; AWARD-5) Zachary Skrivanek, PhD Principal Research Scientist Global Statistical Science Eli Lilly and Company Experience of Sample Size Re-estimation for Registration Studies in Japan Shintaro Hiro, PhD Clinical Statistics Pfizer Japan Inc. A Regulatory Perspective on the Use of Adaptive Design in Drug Development Hiroyuki Sato Reviewer Pharmaceuticals and Medical Devices Agency (PMDA) Panel Discussion All speakers above 16

17 DAY 2 NOVEMBER 17 SESSION 3 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 14:00-15:30 SESSION 3 (CONT.) VENUE 4 ROOM 609 [V4-S3] Innovation in Development of Orphan Drugs (1) Status Quo of Designation Scheme and Academia Related Interest Area(s): CO, RA, Academia, Patients Level: Beginner The designation scheme for orphan drugs was established in 1993 in Japan, and since them, various incepted have been provided for the development of orphan drugs. Recently, because of recent medical and scientific advancement, advanced technologies have significantly evolved and medical views on unmet medical needs are becoming diversified. Expectations for drug discovery research will be much higher in the future. This session consists of two parts. Members will hear regulatory viewpoints from the authorities about scheme of Orphan designate system and any activities by academia to discuss how to improve the status in orphan drug development in Japan. Moreover, various business models in orphan development will be shared, for example NPO s activity to introduce a new drug in Japan. SESSION CO-CHAIRS Yasuhiro Kanatani Department Head Department of Health Crisis Management National Institute of Public Health Satoru Hayata Head of Centre Rare Diseases Medicine Development Centre GlaxoSmithKline KK Japan Status on Orphan Designation Past, Present and Future Views Daiju Okuda Evaluation and Licensing Division Ministry of Health, Labour and Welfare Current Situation of Investigator Initiated Development of Orphan Drugs Approaches from Academia Masanori Fukushima, MD, PhD Director Translational Research Informatics Center An Alternative Approach in Development of Orphan Drugs Taro Inaba KOINOBORI Associate Inc. Panel Discussion All speakers above VENUE 5 ROOM 101 [V5-S3] Brain Storming How We Can Conduct Clinical Trials - A Company-Funded Company-Lead Trial is Not Only the Way to Run a Clinical Trial Related Interest Area(s): CO, RA, PM, Academia, Government Level: Intermediate, Advanced Cancer rates in Japan have been steadily increasing. Now one-in-two Japanese will develop cancer. It seems that many anti-cancer drugs have been developed globally. However, it is unusual to have a company-sponsored clinical trial focusing on Japanese or Asian specific diseases, or rare diseases. It is unfortunate for the clinical researchers, physicians and patients to know that the proposed clinical trials in such diseases are not able to be conducted for various reasons. However, a company sponsored clinical trials is not the only way to run a clinical trial. Recently many academic researchers, academic organizations, and funding companies have begun planning and conducting clinical trials in such diseases by themselves. In this session, we will brainstorm ideas and new concepts for these clinical developments and these potential issues. Tomoko Hirohashi, PhD Director, Clinical research Oncology Pfizer Japan Inc. Brain Storming How We Can Conduct Clinical Trials? A Company-Funded Company-Lead Trial is Not Only the Way to Run a Clinical Trial?- Introduction Tomoko Hirohashi, PhD Director, Clinical research Oncology Pfizer Japan Inc. Clinical Development Strategy Including Company-Initiated Clinical Study Tomio Nakamura Senior Director, Asia Clinical Development Oncology Group Eisai Co., Ltd. Drug Development Based on The Collaboration between Academia and The Companies- Proposal and Requests from Academia- Koichi Goto, MD, PhD Chief, Division of Thoracic Oncology National Cancer Center Hospital East Experience of Collaboration with External Partners - The Case of Non- Domestic Company - Akihira Mukaiyama Manager, Medicines development, GlaxoSmithKline K.K. Panel Discussion All speakers above VENUE 6 ROOM 102 [V6-S3] Management of COI in Clinical Trials and Future Perspective Related Interest Area(s): CO, RA, ST, CDM, CP, Academia Level: Beginner Drug development is a collaborative work between investigators and pharmaceutical industries. Since the existence of COI is inevitable, managing COI in the conduct of clinical trials is needed to ensure the integrity of the research and to protect the welfare of human subjects. Based on the identification of COI, the nature and source of funding and financial incentives offered to the investigators must be disclosed to a participant in a clinical trial and ethics committee. Unfortunately, there are serious misconducts of clinical trials lacking the quality and reliability of data collected and concealing COI in Japan. This session will discuss the strategies for overcoming the drawbacks in clinical trials in Japan, especially the rational management of COI. SESSION CO-CHAIRS Yasuhiro Fujiwara, MD, PhD Director, Strategic Planning Bureau National Cancer Center Hiroshi Watanabe, MD, PhD Professor Clinical Pharmacology & Therapeutics Hamamatsu University School of Medicine Management of COI in Clinical Trials and Future Perspective Saburo Sone, MD, PhD Executive Managing Director Tokushima Municipal Hospital Management of COI in Clinical Trials from Investigator s Point of View Yasuhiro Fujiwara, MD, PhD Director, Strategic Planning Bureau National Cancer Center Management of COI in Clinical Trials from Sponsor s Point of View Masakazu Kitagawa ACRONET, Corp 17

18 DAY 2 NOVEMBER 17 SESSION 4 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 16:00-17:30 SESSION 4 VENUE 1 ROOM 605/606 [V1-S4] Virtual Meeting of PMDA s Scientific Consultation: Points to Maximize an Efficiency of the Meeting Related Interest Area(s): CO, RA, ST Level: Beginner Language: Japanese Only It is critical for both applicant and regulator to have a proper understanding of the objectives of a consultation, including the background or fundamental problems faced in order to make a productive discussion in the scientific consultation or NDA review process possible. In reality, however, the usefulness or comprehension varies depending on how the issues are addressed or how the opinions are written in the briefing or response materials. This session will focus on PMDA scientific consultation. In this session, the panelists will replicate typical consultation by using virtual new product. This will provide some ideas on how to avoid miscommunication and how to maximize the value of consultation. The panelists acting as applicants will replicate the process how they decide their response policy to the inquiry from PMDA and how they find a compromise. Conversely, panelists acting as PMDA will disclose the heated internal discussion that isn t open to the public. Just as in last year s session, the session will use a voting system. Other topics of discussion include CMC, nonclinical study, and phase III study including multiregional clinical trial, among others. Yoshiaki Uyama, PhD Director, Division of Epidemiology, Office of Safety I, Pharmaceuticals and Medical Devices Agency (PMDA) Panelists Hideki Hanaoka, MD, PhD Director of Clinical Research Center (CCRC) & Professor, Chiba University Hospital National University Cooperation Yoshihiro Higashiuchi, MS Senior Regulatory Scientist, Therapeutic Area Regulatory Affairs, Eli Lilly Japan K.K. Motoko Ishikawa, MS Reviewer, Office of New Drug III, Pharmaceuticals and Medical Devices Agency (PMDA) Fumiaki Kobayashi, PhD CEO, CTD Inc. Yoshiko Komuro, PhD Deputy of Review Director, Office of New Drug II, Pharmaceuticals and Medical Devices Agency (PMDA) Yomei Matsuoka Senior Director, Safety Evaluation & Planning Group IV, Pharmacovigilance Department Quality and Safety Management Division Daiichi Sankyo Co. Ltd Atsushi Noguchi, MS Coordinator, Medical Information Database Division, Office of Safety I, Pharmaceuticals and Medical Devices Agency (PMDA) Hiroshi Takeda, MS Reviewer, Office of New Drug III Pharmaceuticals and Medical Devices Agency (PMDA) VENUE 2 ROOM 607 [V2-S4] What is the Benefit-risk Balance Assessment which Japan is Aiming for? - Strategy for Generation of Useful Information which Contributes to Patients - Related Interest Area(s): CO, RA, ST, CDM, CP Level: Beginner, Intermediate These sessions have covered benefit-risk balance assessment in previous annual meetings held in Japan. However, there were few opportunities to convey the Japanese approach for benefit-risk balance assessment to the world. In this session, we will reaffirm the relationship between BRMP and PBRER, which are fundamental to benefit-risk balance assessment and its periodic report. Subsequently we will get a better understanding of the current status of the leading countries. Furthermore, we will discuss Japanese future vision, and share opinions about the contribution to patients from the global viewpoint. Rei Maeda Senior Regulatory Scientist Surveillance & Epidemiology Global Patient Safety Japan Quality and Patient Safety, Eli Lilly Japan K.K. Positioning Benefit-risk Balance Assessment in Japan From Company s Point of View Osamu Komiyama Senior Manager, Statistical Research & Consulting Group, Clinical Statistics Pfizer Japan Inc. JPMA Data Science Sub Committee Current Situation of Benefit-risk Balance Assessment in EMA Francesco Pignatti, MD Head of Oncology, Haematology, Diagnostics European Medicines Agency Current situation of Benefit-risk Balance assessment in FDA Patrick Frey Director, Office of Program and Strategic Analysis, CDER FDA The Future Direction of Japan Regarding Benefit-risk Balance Assessment Akiko Hori, MD, PhD Director Office of Safety II Pharmaceuticals and Medical Devices Agency (PMDA) Panel Discussion All speakers above VENUE 3 ROOM 608 [V3-S4] Innovation of Clinical Development with Maximum Use of Existing Data Related Interest Area(s): CO, RA, ST Level: Beginner, Intermediate Because a process of clinical evaluation formulates iterative procedure of scientific research, it is very attractive to use existing information in clinical trial designs or statistical methodologies as a more effective approach in clinical development, especially in the population of difficult data collection. With improvements of computational calculation capability as well as developments of methodologies, application examples have recently increased in actual clinical trial setting. PMDA has a plan to utilize submission data more effectively, therefore, further usage of these methodologies is expected. This session will provide concepts and cases about the PBPK (Physiologically-Based Pharmacokinetic) model, which predicts human PK from non-clinical PK data and pediatric PK from adult PK data, along with various clinical trial designs (Oncology Phase 1, Seamless adaptive design and clinical trial for pediatric or rare diseases) that utilize existing data (such as adult data and foreign data) in terms of the Bayesian approach. The session will also discuss both the potential and the challenges. Eri Sekine Head of Oncology Biometrics and DM Department, Oncology Development Novartis Pharma K.K. PK/PD Modeling & Simulation Using Physiologically-based Pharmacokinetic Model Hidefumi Kasai Certara G.K. What Advantage Can Clinical Trial Designs to Optimize Existing Information Tomoyuki Kakizume, PhD Novartis Pharma K.K. Modeling & Simulation in Drug Development for Pediatric or Rare Diseases Naoki Isogawa, PhD Pfizer Japan Inc. 18

19 DAY 2 NOVEMBER 17 SESSION 4 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 16:00-17:30 SESSION 4 (CONT.) VENUE 4 ROOM 609 [V4-S4] Innovation in Development of Orphan Drugs (2) Diversifying Type of Operation and Companies Related Interest Area(s): CO, RA, Academia, CRO, Patients Level: Beginner In the second part of this session, various business models in orphan development will be shared, such as a new business model by CRO, and approaches to development of ultra orphan drugs by respective companies. Conventional development strategies and methods may not be efficient in this field, and approaches with new innovative ideas would be necessary. We could hear how to think development strategy of orphan drugs from regulator s point of view, and discuss how to more improve the status including thinking of new business model in orphan drug development. SESSION CO-CHAIRS Satoru Hayata Head of Centre Rare Diseases Medicine Development Centre GlaxoSmithKline KK Yasuhiro Kanatani Department Head Department of Health Crisis Management National Institute of Public Health Development of Orphan Drugs Regulatory Viewpoints from PMDA, e.g. Necessity of Early Exploratory Studies - Ken Sakushima Specially Appointed Expert Office of Cellular and Tissue-based Products, Office of New Drug III Pharmaceuticals and Medical Devices Agency (PMDA) New Business Model for the Development and Market launch of Orphan Drugs Hiroshi Kosaku IPD Company President CMIC Holdings Co., Ltd. Development of Ultra Orphan Drugs and It s Advancement Shigeki Shimasaki Executive Officer, COO of R&D Nobelpharma Co., Ltd Orphan Drug Development in Genzyme Japan Masaki Osawa Regulatory Affairs, Genzyme Japan Panel Discussion All speakers above VENUE 5 ROOM 101 [V5-S4] Introduction to the Role of Medical Affairs for Research and Development Department Related Interest Area(s): All Level: Beginner How to facilitate the Medical Affairs department (MA) is currently a topic of ongoing debate in Japanese Pharmaceuticals. In contrast to Europe and the US, where the role and contribution of MA is established, opportunities for collaboration with MA in Japan to let R&D department know the role of MA has been somewhat limited. The purpose of this session is to provide a basic understanding of the function of MA, focusing mainly on its relevance to the R&D department, as well as the process of product life cycle management as a whole. SESSION CO-CHAIRS Taku Seriu, MD, PhD Executive Operating Officer Head of New Product Evaluation and Development Otsuka Pharmaceutical Co., Ltd. Takeharu Yamanaka, PhD Professor Department of Biostatistics, Yokohama City University School of Medicine Role of Medical Affairs after Launching Products Kazuya Iwamoto, MD, PhD Director Medical, Biogen Idec Japan Role of Medical Affairs in Development Phase Tamura Masahiro Head Post Marketing Clinical Research, Medical Operations, Sanofi K.K. Medical Affairs Department in Japan: Current Status and Issues Eiji Harada, MD, MBA Clinical Research Physician Medicines Development Unit Japan, Eli Lilly Japan K.K. Current Status of Medical Affairs Department in Japan Kouji Iwasaki, PhD Director Global Medical Affairs Japan Department Takeda Pharmaceutical Co., Ltd. VENUE 6 ROOM 102 [V6-S4] Application of Lean Six Sigma in DM Process Improvement in an Investigator Initiated Clinical Trial Related Interest Area(s): CO, ST, CDM, PM Level: Beginner An increase in investigator-initiated clinical studies has been evident in Japan. Coincidentally, there have been several issues addressed in the process, such as team and other operational aspects that are compared with the clinical studies driven by pharma companies. Six Sigma has been wildly accepted and applied to various business environments as a problem-solving methodology in western countries. Six Sigma has expanded its applicability by combining lean management, called Lean Six Sigma. DIA Japan has introduced Lean Six Sigma in clinical studies, and aims to demonstrate its value in an investigator-initiated clinical research. In this session, we will introduce a case where Lean Six Sigma is applied to a data management process in investigator-initiated clinical research in Japan. Yoichi M. Ito, PhD Associate Professor, Department of Biostatistics Hokkaido University Graduate School of Medicine DIA Six Sigma Community Introduction of Lean Six Sigma A Systematic Approach for Problem Solving Hirotaka Inoue, PhD, MBA Head, Leading Changes Office Japan Development & Medical Affairs GlaxoSmithKline KK DIA Six Sigma Community DM Process Improvement in an Investigator initiated Clinical Trial Using Lean Six Sigma (Part I) Aya Uchiyama Technical Assistant, Division of Clinical Trial Management, Center for Translational Research, Hokkaido University DIA Six Sigma Community DM Process Improvement in an Investigator Initiated Clinical Trial Using Lean Six Sigma (Part II) Tomoko Kubota Japan Development & Medical Affairs Medicines Development (Metabolic Pathway & Cardiovascular) GlaxoSmithKline KK DIA Six Sigma Community Panel Discussion All speakers above 19

20 DAY 2 NOVEMBER 17 SPECIAL CHAT SESSION 17:45-19:00 SPECIAL CHAT SESSION Reception Hall Let s Chat! Presented by DIA Community Related Interest Area(s): All Level: Beginner Language: Japanese Language Only Eri Sekine Head of Oncology Biometrics and DM Department, Oncology Development, Novartis Pharma K.K. Special Chatting Sessions will be provided for members to exchange opinions, questions, or issues that arise during the day-to-day work. Young or experienced attendees, academia or students, investigational sites or PMDA please sit around our table and be our companions! Let s talk together. Members of DIA Japan Communities (Regulatory Affairs/Clinical Operations/Statistics/Clinical Data Management/Clinical Safety and Pharmacovigilance/Project Management) will be facilitators and support casual discussion in a free-discussion format of small groups of people. Some chairs and speakers from the sessions will also join the discussion. A variety of topics will be set at each table. Please visit us and join the discussion of a theme in which you are interested. The views and opinions expressed in Chatting are those of the individual participants and should not be attributed to DIA, affiliates, or any organization with which the participants is employed or affiliated. Non-Japanese speakers are welcomed to this session. If you are interested, please talk to a member of staff. 20

21 Take Advantage of the Benefits that come with having a DIA Membership. 55 Members-only conference registration discounts on all DIA conferences and offerings across the globe. 55 Members-only free archived webinars - Take advantage of a hot topic webinar as a complimentary member benefit without leaving your desk. 55 Therapeutic Innovation & Regulatory Science - DIA s peer-reviewed, scholarly journal (formerly the Drug Information Journal) including 40 years of indexed and archived scientific articles all available online. (6 issues) 55 Global Forum - your member digital newsmagazine featuring practical tips, regulatory and global updates. (6 issues) 55 Contract Service Organization (CSO) Directory - searchable vendor and support services directory. 55 Communities - DIA s Communities discipline specific groups that network regionally and globally, share best practices, knowledge resources and the latest information related to your field all online and available Current Regional India Communities Include: Clinical Safety and Pharmacology Clinical Data Management Global Outsourcing Medical Writing Regulatory Affairs Risk-based Monitoring Scientific Working Group (SWG) 55 DIA Online Member Directory - Network locally and globally via DIA ConneX your platform for sharing documents and discussions, connecting with colleagues and developing your own network of colleagues and industry thought leaders. 55 Knowledge resources at featuring videos, podcasts, presentation downloads, publication archives, and robust searching and sorting tools to get the information you need, when you need it. Including DIA s Global Resources: 55 DIA Daily - This daily enewsletter features summaries of breaking news in the pharmaceutical, biotechnology, and medical device fields gathered from thousands of global news sources. Become A DIA Member Today! Your DIA membership features online access to all of the member benefits including DIA s world-class publications delivered digitally. 55 SmartBrief - Two times per week, receive the latest news and information related to diagnostic and therapeutic product innovations. 55 Career Center - Search for employment opportunities and submit your resume, all confidentially and online. For more information about membership, please DIAJapan@diajapan.org. diahome.org/membership 211

22 DAY 3 NOVEMBER 18 SESSION 5 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 9:00-10:30 SESSION 5 VENUE 1 ROOM 605/606 [V1-S5] Commercialization of Regenerative Medical Products and Quality Assurance Related Interest Area(s): CO, RA, PM, CMC Level: All In Japan, the development of regenerative medical products is expected to grow. This session consists of two parts. In the first part, the current situation and the challenges from development to commercialization for regenerative medical products will be explained from the viewpoint of industry, government, and university. Then, in the panel discussion, we will discuss the challenges at the early developmental stage (donor, autologous/allogenic cells), clinical stage (outsourcing for cell growth and storage under new law) and application stage (GMP and the Standards for Bioderived Raw Materials). SESSION CO-CHAIRS Teruo Okano, PhD Professor Tokyo Women s Medical University Akihiro Umezawa, MD, PhD Deputy Center Director for Cellular and Tissuebased Products, Center for Product Evaluation Pharmaceuticals and Medical Devices Agency (PMDA) Status and Introduction for Guidance for Regenerative Medical Products after Revision of Pharmaceutical Affairs Law of Japan Yoji Sato, PhD Head Division of Cellular and Gene Therapy Products National Institute of Health Sciences (NIHS) Expectation for Regenerative Medical Products from Academia Toshiyuki Owaki, PhD Associate Professor Institute of Advanced Biomedical Engineering and Science Tokyo Women s Medical University Challenge to quality control of autologous cell products for regenerative medicine through experience from JACE R and JACC R Kenichiro Hata Japan Tissue Engineering Co., Ltd. Panel Discussion All speakers above VENUE 2 ROOM 607 [V2-S5] Is the Risk Management Plan Really Effective? Part I Related Interest Area(s): CO, RA, CP Level: All The RMP was introduced last April in Japan. Although the framework of postmarketing safety measures appears to be consolidated, there were not many discussions on RMP contents; it is often said that Japan s postmarketing system remains basically unchanged. Now, RMPs of over 20 products were published on the PMDA website. Both companies and regulatory authorities have accumulated experience on RMPs, and it is highly beneficial to set up a forum for exchanging issues about RMPs and share them among relevant parties, including health care professionals. In this session, we will discuss the problems of RMPs and pharmacovigilance plans, which are clinically meaningful, and to explore the possibility of cooperation of better postmarketing safety measure for well-considered benefit-risk balance. SESSION CO-CHAIRS Takuko Sawada Senior Vice President Global Development Pharmaceutical Development Division Shionogi & Co., Ltd. Junko Sato, PhD Division Director Division of Regulatory Cooperation Pharmaceuticals and Medical Devices Agency (PMDA) From New Drug Reviewer s Point of View Naoyuki Yabana, PhD Review Director Office of New Drug III Pharmaceuticals and Medical Devices Agency (PMDA) From Domestic Company s Point of View Yomei Matsuoka Senior Director, Safety Evaluation & Planning Group IV, Pharmacovigilance Dept Daiichi Sankyo Co., Ltd. From Foreign Company s Point of View Lyo Inuyama, MD Operating Officer, Head of Medical Affairs Bayer Yakuhin, Ltd. From Safety Reviewer s Point of View Noriyuki Komiyama Office of Safety II Pharmaceuticals and Medical Devices Agency (PMDA) VENUE 3 ROOM 608 [V3-S5] Multi-Regional Clinical Trials: Where Should it Be Headed? Related Interest Area(s): CO, RA, ST, CP, PM Level: Beginner, Intermediate Multi-Regional Clinical Trials (MRCT) are the norm. For Japan, MRCT is needed and has been promoted so that there is no lag in drugs. MRCT is the important choice in drug development strategies to deliver innovative medicines to patients across the world. MRCT is different from Multi-National Trials, conducted in the past mainly in the US and Western Europe, in that the MRCTs take care of ethnic differences in the planning, conducting, and interpreting, and in that many countries, including previously non-ich countries, are participating in the MRCTs. Japan experienced a period of sequential bridging before global simultaneous development became popular. Now the ICH-E17 guidelines have started discussion for its preparation. It is useful to review and re-think our consideration on MRCTs. In this session, we will discuss the trend of ICH-E17, the review of our experiences, and a new proposal of planning and interpretation of MRCTs. This will be followed by a panel discussion among stakeholders. We hope this discussion would foster a discussion of where MRCT should be headed. Hironobu Saito, PhD VP, New Drug Regulatory Affairs Dept. Daiichi Sankyo Co., Ltd. Presentation 1 Yoshiaki Uyama, PhD Director, Division of Epidemiology, Office of Safety I, Pharmaceuticals and Medical Devices Agency (PMDA) Proposal for Interpreting the Results from MRCT and Its Reflection onto the MRCT Planning Osamu Komiyama Senior Manager, Statistical Research & Consulting Group, Clinical Statistics Pfizer Japan Inc. Panel Discussion All speakers above and Seiki Kanazawa Senior Director, Data Management Group, Data Science Astellas Pharma Inc. Eri Sekine Head of Oncology Biometrics and DM Department, Oncology Development Novartis Pharma K.K. 22

23 DAY 3 NOVEMBER 18 SESSION 5 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 9:00-10:30 SESSION 5 (CONT.) VENUE 4 ROOM 609 [V4-S5] Fostering Superior Talents involved in Drug Development and Evaluation - The Necessity of Human Resource Development and People-to-people Exchange beyond Boundaries - Related Interest Area(s): All Level: Intermediate Required ideal talent is changing with the change of the times, and human resource development plan should be mapped out or revised in anticipation of the trend of drug development strategy, regulation and/or environmental change with information technology. The current trends require persons who can demonstrate their ability at the international stage of simultaneous global development, but what will the trends be after 10 years? SESSION CO-CHAIRS In this session, the responsible persons for training/ Yuji Fukuda human development in academy, industry, and government (PMDA) will talk about their successful Manager experiences, issues to overcome, and ideal settings. In Eli Lilly Japan K.K. the panel discussion, we would like to discuss benefits, difficulties, and importance of exchanging human resources among academy, industry, and PMDA. We hope this session will inspire young associates who have uncertainty about the future career path and managers who are distressed about their subordinate s human/career development. Junichi Nishino, MSc, RPh Head, Regulatory Operation & Prescribing Information Group, Drug Regulatory Affairs Department, Regulatory Affairs & Quality Assurance Division Novartis Pharma K.K. From PMDA s Perspective Tomoko Ohsawa, PhD Director for Personnel Coordination Office of General Affairs Pharmaceuticals and Medical Devices Agency (PMDA) From Industry s Perspective Keiko Ebihara, PhD Director, EPD Regulatory Affairs and Market Access Abbott Japan From Medical-care Facility s Perspective Akihiro Hirakawa, PhD Lecturer Biostatistician Center for Advanced Medicine and Clinical Research Nagoya University Graduate School of Medicine Panel Discussion All speakers above VENUE 5 ROOM 101 [V5-S5] Risk-based Approach to Monitoring Part 1: Current Status and Outlook Related Interest Area(s): CO, RA, ST, CDM, QA/ QC Level: Beginner In Japan, the risk-based approach to monitoring (RBM) has been presented mainly as an outline. However, the pilot studies have been conducted mainly by industries whose headquarters are located outside of Japan. And an aggressive discussion for RBM implementation has been done, even though the pilot studies have not been conducted. At this session, we will update the current status of RBM implementation through questionnaires to the pharmaceutical industry. In addition, we will discuss the outlook of RBM implementation, including both sponsor and investigational site view. Naoyuki Yasuda Director, Office of Conformity Audit Pharmaceuticals and Medical Devices Agency (PMDA) Current Status of RBM Implementation in Japan Reiko Oku Data Science Expert Committee, Drug Evaluation Committee Japan Pharmaceutical Manufacturers Association Teijin Pharma Limited Items to be Covered by the Sponsor at the Study Preparation Phase Ryoichi Muraoka Data Science Expert Committee, Drug Evaluation Committee Japan Pharmaceutical Manufacturers Association Ajinomoto Pharmaceuticals Co., Ltd. The Expectations for Institutions and the Proposal from Sponsors on RBM Yuri Kitayama Clinical Evaluation Expert Committee, Drug Evaluation Committee Japan Pharmaceutical Manufacturers Association Otsuka Pharmaceutical Co.,Ltd. Points to Consider for RBM Implementation: A View from Investigational Site Yukiko Enomoto Clinical Research Center Nihon University Itabashi Hospital Case of Astellas [As the first presentation of V5-S6] Yosuke Kubota Astellas Pharma Inc. VENUE 6 ROOM 102 [V6-S5] Genomic Sampling Over Generations Related Interest Area(s): CO, RA, CDM, CP, PM, Academia Level: Intermediate Since genomic factors are recognized as crucially involved in responses and side effects of drugs, collection of genomic samples is much more emphasized for efficient drug development, optimized dosage and risk management through the product life cycle. In addition, broad consent to be used in future research should be thoroughly considered in the collecting and storing of genomic samples. Although the sufficient accumulation of genomic data is fundamental for the pharmacogenomics approach, the collection of such samples has defects, partly because of variable perception and interpretation by IRB, variable levels of understanding for the needs of genomic sampling by subjects, and differing positions on using samples for future research use. In this session, we would clarify the issues in genomic samples collection and discuss how to obtain the adequate genomic sample sets from clinical trials in Japan. Akihiro Ishiguro, PhD Principal Reviewer, Office of New Drug V Pharmaceuticals and Medical Devices Agency (PMDA) Pharmacogenetics Research Based on the Biobank Japan Project Michiaki Kubo, MD, PhD Deputy Director Center for Integrative Medical Sciences, RIKEN Valuable Genomic Sampling and Storing from Clinical Trials for Drug Development Koji Suematsu Manager, PGx, Clinical Development Taisho Pharmaceutical Co., Ltd Chair of Steering Committee Japan PGx Data Science Consortium Current Ethical Obstacles for Genomic Sampling and Storing from Clinical Trials Kenji Matsui, MD, PhD Head, Office for Research Ethics & Bioethics The National Cerebral and Cardiovascular Center Genomic Sampling Methodologies for Future Use Yu Sakamoto Reviewer, Office of New Drug III Pharmaceuticals and Medical Devices Agency (PMDA) Panel Discussion All speakers above 23

24 DAY 3 NOVEMBER 18 SESSION 6 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 11:00-12:30 SESSION 6 VENUE 1 ROOM 605/606 [V1-S6] Expectation and Challenge for Regenerative Medical Products Development - What is Changed Based on the Revision of Pharmaceutical Affairs Law? Related Interest Area(s): CO, RA, ST, CP, CMC Level: Beginner, Intermediate SESSION CO-CHAIRS Teruo Okano, PhD Professor, Tokyo Women s University Akihiro Umezawa Deputy Center Director for Cellular and Tissuebased Products, Center for Product Evaluation Pharmaceuticals and Medical Devices Agency (PMDA) In Japan, the development of regenerative medical products is expected to grow. This session consists of two parts. In this second part, we will focus on the new regulation of regenerative medical products. The revision of the Pharmaceutical Affairs Law will be effective at the end of November, Under this revised law, a new approach is expected to develop innovate regenerative medical products and accelerate the derivation of them for the patient. In the panel discussion, we will consider what we are able to change in Japan using this new system. Exposition of New Regulation in the Revision of Pharmaceutical Affairs Law - For Correct Understanding of Conditional & Time Limited Approval - Daisaku Sato, PhD Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA) Expectation and Challenge for Regenerative Medical Product Development from View of a Japanese Biotech Company Kiyoshi Okada, MD, PhD Project Associate Professor, Osaka University Expectation and Challenges for Regenerative Medical Product Development: a Japanese Biotech Company s Perspectives Kunihiko Suzuki Member of the Board, MEDINET Co., Ltd. Global Development of Regenerative Medical Products: Opportunities for Accelerated Approval Pathways and Challenges of Global Development Katherine Tsokas, J.D. Senior Director, Global Regulatory Affairs Janssen Research & Development, LLC Panel Discussion All speakers above VENUE 2 ROOM 607 [V2-S6] Is the Risk Management Plan Really Effective? Part II Related Interest Area(s): CO, RA, CP Level: All SESSION CO-CHAIRS Takuko Sawada Senior Vice President Global Development Pharmaceutical Development Division Shionogi & Co., Ltd. Junko Sato, PhD Division Director, Division of Regulatory Cooperation Pharmaceuticals and Medical Devices Agency (PMDA) The RMP was introduced in last April in Japan. Although the framework of postmarketing safety measures appears to be consolidated, there were not many discussions on RMP contents; and it is often said that Japan s postmarketing system remains basically unchanged. Now, RMPs of over 20 products were published on the PMDA website. Both companies and regulatory authorities have accumulated experience on RMPs, and it is highly beneficial to set up a forum for exchanging issues about RMPs and share them among relevant parties, including health care professionals. In this session, we will discuss the problems of RMPs and pharmacovigilance plans, which are clinically meaningful, and explore the possibility of cooperation of better postmarketing safety measure for wellconsidered benefit-risk balance. From New Drug Health Care Professional s Point of View Masaaki Mori, MD Associate Professor Department of Pediatrics Yokohama City University Hospital Panel Discussion All speakers from Part I and Part II VENUE 3 ROOM 608 [V3-S6] Beyond Japan: From Asian Studies to Global Studies Related Interest Area(s): CO, RA Level: Beginner, Intermediate Shintaro Omuro Astellas Pharma Inc. Although various pharmaceutical companies have now accumulated experience in Asian multinational studies and global studies, such exposure is still only limited to certain members (e.g., members from the Asian Development Department, or members working on global studies). During this multinational session, the pros and cons of Japan local study, Asian study and global study will be discussed by three experts from clinical development, regulatory, and CRO. A panel discussion will also take place subsequently to highlight recent issues and to discuss how to solve them with the most current knowledge. Participants who previously focused only on Japan local development are also welcome. The goal of this session is to provide useful hints and tips for you to consider in your clinical development strategy in the near future. Think about Asian Studies and Global Studies - From Regulatory Perspective Ari Fujishiro Associate Director, Regulatory Affairs Group Asia Development Dept Daiichi Sankyo Co., Ltd. Efficient Collaboration of Asian and Global Development - From Clinical Development Perspective - Yu Hasegawa, MSc Astellas Pharma Inc. Optimizing Collaboration with Global CROs in Asian and Global Studies Tetsu Yung, PhD, MBA Senior Project Manager Clinical Development Services Covance Japan Panel Discussion All speakers above 24

25 DAY 3 NOVEMBER 18 SESSION 6 Related Interest Areas: Clinical Operations (CO) Regulatory Affairs (RA) Statistics (ST) Clinical Data Management (CDM) Clinical Safety and Pharmacovigilance (CP) Project Management (PM) Chemistry, Manufacturing and Controls (CMC) 11:00-12:30 SESSION 6 (CONT.) VENUE 4 ROOM 609 [V4-S6] Seeking for the Future Prosperity for Both Pharmaceutical Company and CRO Related Interest Area(s): CO, RA, ST, CDM Level: Beginner SESSION CO-CHAIRS Shogo Nakamori Corporate VP and GM Japan PAREXEL International Hiroshi Kosaku Corporate Officer CMIC Holdings Co., Ltd. The CRO industry in Japan has been growing for more than 20 years and is now firmly established in the pharmaceutical arena. The next step is to create a partnership for both pharmaceutical companies and CRO to prosper. Both parties need to consider past experience, including its successes and failures, during the course of actual operation. While placing high importance on the efficiency of clinical trials with maintaining the quality and integrity of the data, such as Risk-based Monitoring, it is obvious that we cannot discuss future prosperity for both parties without further mutual understanding. In this session, we will discuss the future relationship between pharmaceutical companies and CRO by exchanging and sharing ideas with industry panelists. Suggestions to CRO from Clients Side (Tentative) Naohisa Yokota Corporate Officer, Research and Development Sanofi K.K. Suggestions to CRO from Clients Side (Tentative) Yoko Ishige Team Leader, CNS Group Clinical Operation Dainippon Sumitomo Pharma Co., Ltd. Suggestions to Clients from CRO Side (Tentative) Shogo Nakamori Corp Vice President and General Manager Japan PAREXEL International Panel Discussion All speakers above and VENUE 5 ROOM 101 [V5-S6] Risk-based Approach to Monitoring Part 2: Implementation Status of TransCelerate Member Companies in Japan Related Interest Area(s): CO, RA, ST, CDM, Other Level: Beginner In 2012, TransCelerate BioPharma Inc., a company composed mainly of western companies, was established for the purpose of promoting the efficiency of clinical development activities. Some documents and tools, including a position paper for RBM, have been issued by TransCelerate, and they have been referred to as standard concepts and approaches for RBM implementation. In this session, representatives from member companies in TransCelerate will provide case studies of RBM in Japan. SESSION CO-CHAIRS Yuji Fukuda Manager Eli Lilly Japan K.K. Naoyuki Yasuda Director, Office of Conformity Audit Pharmaceuticals and Medical Devices Agency (PMDA) Case of Astellas [Scheduled for the last part of V5-S5 due to time constraints] Yosuke Kubota Astellas Pharma Inc. Case of GlaxoSmithKline Masayuki Kanezaki GlaxoSmithKline K.K. Case of Bristol-Myers Yumi Ichimoto Regional Clinical Operations Japan Bristol-Myers K.K. Case of Nippon Boehringer Ingelheim Junichi Hamada Nippon Boehringer Ingelheim Co., Ltd. Panel Discussion Speakers from Part I and Part II VENUE 6 ROOM 102 [V6-S6] New Relationship of Drugs and Medical Devices Will Open up the Future of the Health Care Related Interest Area(s): CO, CDM, CP, CMC Level: Beginner Even in the therapeutic area where medical treatment by drugs has been traditionally common the treatment by medical devices has started for the patients who are resistant to treatment by drugs. Further such medical devices like PDT Laser and Vascular Embolization Beads which increase effectiveness of medical treatment when used together with drugs have been used for treatment of certain cancer which has been traditionally difficult to treat. As above, beyond combination products such as drug eluting stent the innovative combined usage of drug and medical devices has opened new phase of opportunities for new medical treatment As combined usage of drugs and medical devices is getting more complex how to evaluate the clinical benefit of such combined products is also getting complex. Since the criteria of clinical evaluation is different between drugs and medical devices because of their product characteristics it is important to start discussion for clinical evaluation criteria and methodology for new medical treatment by combined usage of drugs and medical devices. Koji Ikeda, PhD Professor, Clinical Research Innovation and Education Center Tohoku University Hospital Considering Drug and Device on the Clinical trial Process Isao Tsuchii Business Operator Green Field The Future of Clinical Evaluations for Pharmaceuticals and Medical Devices Naoyuki.Makuta CEO Mediwrite Co.,Ltd Difference of Medical Devices and Drugs in Clinical Trials Planning Masato Nakamura, MD, PhD Professor Division of Cardiovascular Medicine Toho University Ohashi Medical Center Clinical Evaluation; comparison of Medical Devices and Drug Yuka Suzuki, PhD Director of Office of Medical Devices II Pharmaceuticals and Medical Devices Agency (PMDA) Panel Discussion All speakers above 25

26 DAY 3 NOVEMBER 18 SPECIAL SESSION and ROUND TABLE 13:50-14:50 SPECIAL SESSION International Conference Room Medical Contributions With A New Perspective That Transcends Boundaries Related Interest Area(s): All Level: Beginner Kazuhiko Mori Director, Evaluation and Licensing Division Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Robot Suit HAL is the world s first cyborg-type robot developed by full use of Cybernics which is a new academic field (fused and interdisciplinary technology related to human, machine and information) consisting of neuroscience, motor physiology, robotics, information technology, behavior science, system integration technology, law, ethics and business management. HAL enhances and strengthens the limb motion of its wearer by detecting the weak bioelectrical signals through the body from the brain which generates the nerve signal to control the musculoskeletal system and promotes treatment for functional improvement, regeneration and acquisition for disabled people by spinal cord injury or stroke and also supports self-independent motion like activity of daily life and nursing-care motion when care-giver lifts patients. HAL has obtained CE marking, the certificate for all EU countries, as the first robotic therapeutic device and in Germany, application of public workers compensation insurance to cover the costs of using HAL for medical treatment has been implemented. Now, medical contributions with a new perspective that transcends boundaries are accelerating by research and development in the field of new combined therapies such as HAL therapy with regenerative medicine and/or pharmaceuticals. Yoshiyuki Sankai, PhD Professor Graduate School of Systems & Information Engineering The University of Tsukuba President and CEO CYBERDYNE Inc. Prof. Sankai University of Tsukuba / CYBERDYNE Inc. 14:50-15:00 BEST PRESENTER/STUDENT AWARD International Conference Room 15:00-15:30 COFFEE BREAK 15:30-17:00 ROUND TABLE International Conference Room What are Expectations for Adaptive Licensing? Level: Intermediate Related Interest Area(s): RA, CP, PM SESSION CO-CHAIRS Kazuhiko Mori Director, Evaluation and Licensing Division Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare Yoshihiko Ono Executive Director, Head of Regulatory Affairs Japan Development, MSD K.K. Adoptive Licensing (AL) is getting much attention as a system for improving access to new medicines or medical technologies with high medical needs. The EMA has already considered Medicine s Adaptive Pathways (MAPs) or Medicine s Adaptive Pathways to Patients (MAPPs) and launched a pilot project. In Japan, the Act on the Safety of Regenerative Medicine was enacted, permitting early approval of tissueengineered medical products, which is thought to be a kind of AL. When institutionalizing AL, how far efficacy and safety should be ensured in order to permit access to medicines based on limited data, as well as how to assess the risks and benefits, are all important issues. In this session, we ll grasp the benefits and the problems of AL and discuss the expected system. Implementation of Adaptive Licensing in Europe Francesco Pignatti, MD Head of Oncology, Haematology, Diagnostics European Medicines Agency Perspective on the Regulatory Schema of the Adaptive Licensing for Pharmaceuticals Daisaku Sato, PhD Office Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Device Agency (PMDA) Industry Perspective on the Future Regulatory System for Drug Approval Hiromichi Shirasawa, MD Vice President and Executive Officer, Head of Japan Development MSD K.K. 17:00-17:10 SHORT BREAK 17:10-18:25 PMDA TOWN HALL International Conference Room PMDA Town Hall Related Interest Area(s): All Level: All SESSION CO-CHAIRS Tomiko Tawaragi Chief Safety Officer Pharmaceuticals and Medical Device Agency (PMDA) Hiroshi Watanabe, MD, PhD Professor Deparment of Clinical Pharmacology & Therapeutics Hamamatsu University School of Medicine This session is provided for you to discuss with Pharmaceuticals and Medical Devices Agency (PMDA) members on your interests. To make this session really meaningful, we welcome your active participation. See you at the session! PANELISTS: Kensuke Ishii, PhD Office of Medical Devices III Pharmaceuticals and Medical Device Agency (PMDA) Yoshiko Komuro, PhD Deputy of Review Director, Office of New Drug II Pharmaceuticals and Medical Device Agency (PMDA) Emiko Kondo Office Director, Office of Safety I Pharmaceuticals and Medical Device Agency (PMDA) Michiyo Sakiyama Office of New Drug V Pharmaceuticals and Medical Device Agency (PMDA) Daisaku Sato, PhD Office Director, Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Device Agency (PMDA) Yasunori Yoshida Office Director, Office of Review Management Pharmaceuticals and Medical Device Agency (PMDA) 18:25-18:30 CLOSING REMARKS International Conference Room Hiroshi Watanabe, MD, PhD Professor Deparment of Clinical Pharmacology & Therapeutics Hamamatsu University School of Medicine 26

27 DAY 3 NOVEMBER 17 OTHER INFORMATION Accessing Presentations Available presentations will become accessible to Full-Program registrants about a week before the meeting and an announcement on how to access presentations will be sent to the registrants. Please note that this does not include all of the presentations but only those that were provided to DIA by a submission date. Meeting handouts will NOT be provided, except for some of Tutorial Sessions. Tutorial-only registrants will not be able to access to the posted presentations. Private Social Function Policy DIA does not allow hospitality functions to be held during any DIA educational offerings, scheduled Exhibit Hall hours, or social events. Below are the only hours that are acceptable for hospitality functions: Saturday, November 15 All times are acceptable Sunday, November 16 Before 8:00 and after 20:30 Monday, November 17 Before 8:00 and after 20:00 Tuesday, November 18 Before 8:00 and after 18:30 Unless otherwise disclosed, DIA acknowledges that the statements made by speakers/instructors are their own opinions and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers/instructors and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media is prohibited without prior written consent from DIA. DIA Community (Previous SIAC) What is DIA Community? DIA Communities are one of the many member benefits that DIA offers. Each Community provides a discipline-specific community where members can share common experiences and knowledge and connect with others in their field. The core purpose of Communities is to bring industry, vendor, academic, regulator, payer, health care provider, and patient groups together to interact in a neutral forum to network, share learning, discuss topics and issues, and develop resolutions of relevance to a particular functional area or topic associated with drug development. While learned sharing (including program development) and networking are core to Communities, identifying and dealing with industry issues can bring value back to the drug development industry and ultimately their membership. Communities also assist DIA in identifying professional development needs in particular interest areas, and in providing information to members to meet their career and professional development needs. Benefits of DIA Communities Members share common experiences and knowledge and connect with others in their field. Members can become involved directly or indirectly to program development of relevant DIA Workshops. Members are part of Japan and the global community, and can participate in meetings, learning sessions, or events involving both. Introduction of Japan DIA Community Project Management, Data Management, Statistics and Six Sigma Japan Communities to be Established in the Future There are many DIA Communities that exist as Global Communities, but not as Japan Communities. If you are interested in any of these communities, please join Global Community. You can communicate with DIA members outside of Japan. Or you can establish a new Japanese Community yourself! Please contact DIA Japan if you would like to know more details. To join Japan Community: Please contact to DIA Japan Tel: DIAJapan@diajapan.org To join a Global Community: Login at My DIA to check your membership status Click on Manage My Communities Join the communities of your choice Not a DIA member yet? Become a DIA member, go to Please visit our DIA Booth at the Japan Annual Meeting for more information! 27