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10th Annual Meeting DIA Japan 2013

Nov 6 2013 9:00AM - Nov 8 2013 6:00PM | TFT Halls & Rooms TFT Building, 3-6-11 Ariake, Koto-ku, Tokyo 135-8071 Japan

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Overview 

Online Registration will close 9:00am Friday, November 1 (Tokyo time). Onsite Registration will be available.

Simultaneous Translation Available


In order to bring one new approved drug to market, many thousands of new chemical entities (NCEs) are screened during a series of preclinical and clinical studies. The complications in drug development have continued to increase despite the fact that drug development already requires lots of time and money. If you look at foreign countries, you will see nationwide commitments such as the NIH molecular libraries program.

The importance of early stage development has been identified in Japan and drug development of promising NCEs discovered by academia or venture capital firms is a particularly urgent issue. PMDA implemented a pharmaceutical affair consultation on R&D strategy in 2011 to support efficient drug development. MHLW also started to develop a clinical research infrastructure, including early-phase/exploratory clinical research hubs and clinical research centers in order to facilitate the development of medicinal products/medical devices. However, there are still many challenges to the development through cooperation among academia, government, industry, and patients.

In this conference, our primary topic is what academia, regulatory agencies, industry, and patients could do better to move ahead with discovery and fostering of innovative drugs. We are going to provide a wide range of informative sessions on topics such as the role of ARO and issues surrounding companion diagnostics for cancer. Moreover, we will discuss what we should do in the era of further globalized drug development from viewpoints of academia, regulatory, clinical and project management. The conference will feature 6-track sessions simultaneously to cover a variety of informative topics, such as amendment of pharmaceutical affairs law and Japan GCP.

As one of the features of the conference, we have invited many ICH professionals, as speakers or panelists, many of whom will also be attending the ICH Osaka meeting to be held shortly after the DIA Japan Annual Meeting. A wide range of professionals will share their views and knowledge, and build new relationships through this opportunity. We wish you all an enjoyable and informative conference.

 

Endorsement by MHLW, PMDA, JPMA and PhRMA is pending.

Hotel & Travel 

Attendees should make their room reservations as soon as possible. To reserve your room at the Sun Route Hotel Ariake or the Washington Hotel Tokyo Bay Ariake close to the venue, please contact below:

Hotel Sun Route Ariake
Address:     3-6-6, Ariake, Koto-ku, Tokyo 135-0063
Telephone:  +81-3-5530-3610
Inquiry:  https://www.sunroutehotel.jp/ariake/contact/
URL:     http://www.sunroute.jp/english/index.html

Washington Hotel Tokyo Bay Ariake
Address:     3-7-11, Ariake, Koto-ku, Tokyo 135-0063
Telephone:  +81-3-5564-0111
email:     webmaster@ariake-wh.com
URL:     http://tokyobay.washington-hotels.jp/

Contact Information 

DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku,
Tokyo 106-0041 Japan
Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAjapan@diajapan.org

Featured Speaker 

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Program Committee 

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Agenda  

Tutorials Wednesday, November 06, 2013

  • 9:00AM - 10:45AM

    #1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies

    Session Chair
    Rie Matsui, RPh
    Director, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR-International and Global Product Information, Pfizer Japan Inc.

    Global companies have developed Company Core Data Sheet (CCDS), and the number of Japanese label revisions based on CCDSs has increased. In most global companies, the CCDSs have been developed in Western headquarters. This tutorial will focus on how the safety content of CCDSs is generated and, in particular, on how to select ADRs and ADR frequency information is selected for inclusion in CCDS and for global implementation. It will be explained how the interpretation of the rules for writing adverse reaction section the US PI and the EU SmPC influences the content of CCDSs, and why some interpretations lead to information in CCDSs that cannot be implemented in other countries without major deviations. Particular problems with the implementation of some types of information in the Japanese PI are discussed. The tutorial also presents a “truly global” approach to selecting ADRs for CCDSs so that consistent global submissions are possible.

    Lecturer
    A. Leander Fontaine, Dr. med.
    President, Pharmiceutics, LLC

  • 9:00AM - 10:45AM

    #2: A New Project Manager: Team Management – What is needed to build effective project team?

    Registration is now closed for this Tutorial.


    Session Chairs
    Koji Iwasaki, PhD
    Director, Takeda Pharmaceutical Company Limited

    Koich Konno, PMP
    President, PM Consulting, Positive Intension

    A new project manager, who just assigned as Project manager by his supervisor, began to study “project management”, however, the actual his project does not wait for him to be ready to be PM. That is, with short time, he needs to learn project management and initiate to plan and execute his project. To start, of course, he plans to have “project kick-off meeting”. At this stage, what he should do? How does he influence to entire team, to be “performing” project team? He well knows that a high team performance would lead to project success, but how?In this session, the speakers will investigate and discuss how to create high performing team by creating credibility, sharing vision and objectives, and also how to overcome “forming-storming” stage, which teams often struggle with inefficiency and ineffectiveness in performance. This session will continue to cheer and support all new project managers!

    Lecturers
    The Team Management? – What is that?
    Koji Iwasaki, PhD
    Director, Takeda Pharmaceutical Company Limited

    The Team Management? How to do it?
    Koich Konno, PMP
    President, PM consulting, Positive Intension

  • 9:00AM - 10:45AM

    #3: Action Learning for Six Sigma Analytical Tools by Real Case Study ~ (Japanese Language Only)

    Maximum 30 Participants


    It’s very important for using appropriate tools through Six Sigma activity. We explain the overview of six sigma methodology, DMAIC (Define-Measure- Analysis-Improve-Control) and also introduce three analytical tools, as SIPOC, Process mapping and Fish-bone diagram which are applicable in not only Six Sigma project, but also our daily activities.

    This tutorial session is an interactive discussion using real case study and the participants can experience how to use tools for process improvement.

    Lecturers
    Hirotaka Inoue, PhD, MBA
    Manager, Project Management, Japan Vaccine Co., Ltd.

    Kazuhiko Kamiyama
    Clinical Trial Support and Compliance Japan, Pfizer Japan Inc.

    Masahiro Kaneko
    Manager, IQP Program Office, Novartis Pharma. K.K.

    Kazutoshi Maki
    Chairman, GENEX Partners

    Mika Ogasawara
    Clinical Informatics and Innovation, Japan CI&I, Pfizer Japan Inc.

    Yusuke Tsutsumi, PhD
    Clinical Development Division, Planning and Coordination
    Department, Mitsubishi Tanabe Pharma Corporation

  • 11:00AM - 12:45PM

    #4: HTA in practice in Europe - What are the challenges for Japan?

    Session Chair
    Bruno Rossi
    Head of Market Access, Bayer Yakuhin

    The debate on HTA continues in Japan, with a focus on trying to understand the methodology and how it could apply to the health care 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 the request for convergence between requirements from regulatory and HTA agencies for additional data. The session will briefly cover the basics of HTA, and how it is practiced in Europe with a particular emphasis on recent country developments, cooperation initiatives across Europe and the involvement of a broader circle of stakeholders. Turning to Japan, and to the necessary infrastructure underlying HTA, one case study will address the relevance of patient-reported outcomes to HTA and to drug development, and the challenges in their implementation.

    HTA Basic Short Course
    Miyuki Ezura
    Pfizer Holdings K.K.

    HTA in Practice in Europe, and its Continuous Evolution
    Bruno Rossi
    Head of Market Access, Bayer Yakuhin

    A Practical Case: PRO Relevance to HTA and their
    Utilization in Japan
    Erika Tanaka
    HEOR Project Leader, Bayer Yakuhin

    Panel Discussion

  • 11:00AM - 12:45PM

    #5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development

    Registration is now closed for this Tutorial.


    Session Chairs
    Shuji Sumida
    Group Manager, Quality & Regulatory Compliance Unit
    Chugai Pharmaceutical Co., Ltd.

    Koichi Konno, PMP
    Chief Executive, PM Consulting Positive Intention

    Due to the high uncertainty, also the low probability of success in the pharmaceutical R&D, Project RISK Management (PRM) is important to provide basics to manage uncertainty of projects. It is a management approach to RISK which may impact the goals of the project “Timeline”, “Deliverables” and “Resources”, etc. The importance of PRM is becoming higher in the R&D especially for innovative new drugs to satisfy unmet needs. This session introduce basic approach of qualitative and quantitative RISK analysis at project start-up, then after conducting the excise of RISK identification and response planning, the way of communication with executives on the RISK will be also discussed. It will be also discussed where is the common points with the Risk Management Plan which is mandated from this year to submit with NDA in Japan. First steps of PRM are visualization of RISK, necessary preparation (mitigation plans and contingency plan), then initiation of project.

    Lecturers
    Katsumi Yamamoto, PMP
    Associate Director/East Asia Keppra Lifecycle Leader,
    Development East Asia & Network, UCB Japan Co., Ltd.

    Koichi Konno, PMP
    Chief Executive, PM Consulting Positive Intention

    Shuji Sumida
    Group Manager, Quality & Regulatory Compliance Unit,
    Chugai Pharmaceutical Co., Ltd.

  • 11:00AM - 12:45PM

    #6: Control Strategy for Drug Substance Based on ICH M7 and Q11

    Session Chair
    Haruhiro Okuda, PhD
    Deputy Director General, National Institute of Health Sciences

    DNA reactive (mutagenic) impurities that have a potential to directly cause DNA damage has been discussed as ICH M7 and released for public comment. Current ICH quality guidelines apply to the marketed products, however, ICH M7 covers both of marketed products and investigational products during clinical development. In addition, ICH Q11 provides further clarification on the principles and concepts described in Q8, Q9 and Q10 as they pertain to the development and manufacture of drug substance. Risk management and scientific knowledge are used more extensively and develop appropriate control strategy applicable over the lifecycle of the drug substance. This session provides overview of ICH M7 for further understanding and control strategy of drug substance based on ICH M7 and Q11.

    Lecturers
    Overview of ICH M7 (Step 2)
    Yukio Aso, PhD
    Section Chief, National Institute of Health Sciences

    ICH M7/Q11, Expectations and Status; Including MHLW
    Sponsored Science Research Study
    Kazunori Takagi, PhD
    Principal Reviewer,
    Pharmaceuticals and Medical Devices Agency (PMDA)

Day 1 Wednesday, November 06, 2013

  • 9:00AM - 12:45PM

    Student Session: Global Clinical Development and Benefit-risk Assessment


    Session Chair(s):

    • Eisuke Nakata
      Student
      Tokyo University of Science, Japan
    • Yuya Shizume
      Graduate Student
      Musashino University, Japan
    • Misa Waraya
      Student
      Chiba University, Japan
    • Ryuta Yoshida
      Student
      Tokyo University of Science, Japan

    Student Session is the open place for students who are interested in development of pharmaceutical products to get together and learn about drug development through interaction with people from industry, regulatory and academia. It could be a great opportunity for students to develop their knowledge and skill to be a future leader. // In this session, we will get two lectures. One is about Global Clinical Development, and the other is how to consider Risk and Benefit of pharmaceutical products with several cases. After the lectures, we are going to gain more understanding about these themes by group discussion among students, presentation and feedback each other. // Another aim of this session is to get business skills such as communication skill that are required for global leaders.

    Speaker(s):

    • Drug Evaluation in Japan Local Development and Global Development
      Yoshiko Komuro, PhD
      Assistant Professor
      The University of Tokyo, Japan
    • Benefit & Risk Assessment - Several Approaches
      Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
  • 2:00PM - 2:20PM

    Welcome

    Speaker(s):

    • Ko Sekiguchi, MBA
      Director
      DIA JAPAN, Japan
    • Ling Su, PhD
      Strategic Advisor, Life Sciences
      Sidley Austin LLP, China
    • Barbara Lopez Kunz
      Global Chief Executive
      DIA, United States
    • Tatsuo Kurokawa, PhD
      Professor, Div. of Drug Development and Regulatory Sciences, Faculty of Pharmacy
      Keio University, Japan
  • 2:20PM - 2:40PM

    Award Presentation

    Speaker(s):

    • Barbara Lopez Kunz
      Global Chief Executive
      DIA, United States
    • Yuichi Kubo
      Vice President, Intellectual Propert, Business Strategy Division
      Daiichi Sankyo Co., Ltd., Japan
    • Toshiyoshi Tominaga, PhD
      Professor
      Osaka City University, Japan
    • Toshi Yoshinaga
      Director, Regulatory Affairs
      Healios K.K., Japan
  • 2:40PM - 3:10PM

    Opening Remarks: The Role of Universities to Educate Students for Developing the Field of Therapeutic Medicine

    Speaker(s):

    • Opening Remarks: The Role of Universities to Educate Students for Developing the Field of Therapeutic Medicine
      Yasushi Saito, MD,PhD
      President
      Chiba University, Japan
  • 3:40PM - 4:30PM

    Keynote Speech 1: The Ecosystem of Drug Development - Role of Universities adn Academic Health and Science Systems


    Session Chair(s):

    • No-image Yasushi Saito, MD,PhD
      President
      Chiba University, Japan

    Keynote Speech 1: The Ecosystem of Drug Development - Role of Universities adn Academic Health and Science Systems

    Speaker(s):

    • The Drug Development Ecosystem: Role for Academic Research Organizations
      Robert M. Califf, MD
      Vice Chancellor for Clinical Research, Duke Univ. Medical Center and Director
      Duke Translational Medicine Institute, United States
  • 4:30PM - 5:20PM

    Keynote Speech 2: The History and Future of ICH Activity Based on 20 Years Experience


    Session Chair(s):

    • No-image Tatsuo Kurokawa, PhD
      Professor, Div. of Drug Development and Regulatory Sciences, Faculty of Pharmacy
      Keio University, Japan

    Keynote Speech 2: The History and Future of ICH Activity Based on 20 Years Experience

    Speaker(s):

    • History and Future of ICH
      Fernand Sauer
      Honorary Director of the European Commission
      French Academy of Pharmacy, France

Day 2 Thursday, November 07, 2013

  • 9:00AM - 10:30AM

    [V1-S1] Drug Development thorough Collaboration with ARO and Future - Part 1


    Session Chair(s):

    • No-image Fumitaka Nagamura, MD,PhD
      Professor
      The University of Tokyo, Japan

    MHLW has started to provide budgetary support to 15 Core Clinical Research Centers nationwide since 2011. It also requests those centers to build a new infrastructure called ARO (Academic Research Organization) to conduct clinical trials by themselves. Each center has built an organization to suit their specialty and promoted some activities although their goals and strategies are various. Some organizations develop pharmaceutical products and medical devices for specific indications, some establish centers for phase 1 trials, some set up groups using networks. We expect you have a lot of questions on ARO. What kind of improvement did they implement who already introduced ARO? What kind of challenges do they face in particular? Is it possible for Academia to develop pharmaceutical products and medical devices? What is the role of researchers? How the collaboration among Industry and Regulatory has been facilitated? We will discuss these questions asked and issues and would like to find out common understanding to the basic question “what is ARO?”

    Speaker(s):

    • Attempt by Chiba University
      Hideki Hanaoka, MD,PhD
      Director of Clinical Research Center
      Chiba University, Japan
    • Attempt by National Cerebral and Cardiovascular Center
      Haruko Yamamoto, MD,PhD
      Director, Division of Advanced Medicine & Promoting Clinical Trials
      National Cerebral and Cardiovascular Center, Japan
    • Attempt by Kyushu University
      Yoichi Nakanishi, MD,PhD
      Director, Center for Clinical And Translational Research
      Kyushu University Hospital, Japan
    • Attempt by National Cancer Center Hospital East
      Toshihiko Doi, MD,PhD
      Chief, Dept. of Experimental Therapeutics, Exploratory Oncology
      National Cancer Center, Japan
  • 9:00AM - 10:30AM

    [V2-S1] Risk-based Approach to Monitoring


    Session Chair(s):

    • Satoshi Saeki
      Senior Manager
      Astellas Pharma Inc., Japan

    The process to assure accuracy of CRF data with source data thorough periodical onsite monitoring is resource intensive approach. However it is doubtful whether those are paid off by the data quality. In August 2011, FDA and EMA published draft guidance and reflection paper mentioning risk based approach to monitoring. Those clearly mentioned that they don’t require industries to conduct 100% SDV, and recommend: 1.) Greater reliance on centralized monitoring; 2.) On-site monitoring based on the identified risk, to perform preventive and corrective action; 3.) Different approach to critical data and noncritical data Through this session, you will be introduced overview and points to consider of the risk based approach to monitoring, as a new feature to assure study data quality.

    Speaker(s):

    • Overview of the Risk-based Approach to Monitoring
      Takahiro Negishi
      Data Science Expert Committee, JPMA
      Nippon Boehringer-Ingelheim Co., Ltd., Japan
    • Risk Management Plan: What should be done at the study planning and preparation phase?
      Kazuki Furuno
      Data Science Expert Committee, Drug Evaluation Committee, JPMA
      Mochida Pharmaceutical Co., Ltd., Japan
    • How should central and on-site monitoring work better?
      Yoko Kurose
      Compliance Oversight Lead, Clinical Trial Support and Compliance
      Pfizer Japan Inc., Japan
    • Risk-based Approach to Source Data Verification
      Ryoichi Muraoka, DVM
      Data Science Team Leader, Clinical Development Department
      Ajinomoto Pharmaceuticals Co., Ltd., Japan
  • 9:00AM - 10:30AM

    [V3-S1] New Initiative at the International Community ~ (English Language Only)


    Session Chair(s):

    • No-image Nobumasa Nakashima, PhD
      Director, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    ICH is one of the most representative bodies of international cooperation in the pharmaceutical area. One of the purposes of ICH is the international harmonization of guidelines on new drugs and their activities and accomplishments are highly acclaimed. Addition to ICH activities, various international cooperation has recently launched globally and regionally in a wide range of topics such as generic drugs and general regulatory affairs. Among these new initiatives, there are organizations whose outcomes have already been organized or soon to be and their activities attract close attention from affiliates. IPRF (International Pharmaceutical Regulatory Forum) in the scope of general pharmaceutical regulations, IGDRP (International Generic Drug Regulatory Pilot) in generic drugs, and US-Canada cooperation and PAHO in regional cooperation are some of the examples of those activities. In this session, speakers who play central roles in those new initiatives will introduce their current activities, future plans, and the effects on pharmaceutical companies. Discussion time is held at the end of the session.

    Speaker(s):

    • ASEAN Activities and International Cooperation (tentative)
      Yuppadee Javroongrit, PhD
      Senior Expert in Pharmaceuticals Standard
      Food and Drug Administration, MOPH, Thailand
    • Recent Tends of International Cooperation: US-Canada Regulatory Cooperation Council a Concrete Example of Regulatory Alignment Collaboration
      Louise Déry
      Director, Policy, Planning and International Affairs Directorate
      Health Canada, Canada
    • ANVISA’s International Activities
      Patrícia Pereira
      Study Coordinator
      INCOR- Hospital das Clinicas HCFMUSP São Paulo Brazil, Brazil
    • Generic Initiative: IGDRP (tentative)
      Mike Ward
      Manager, International Programs Division
      Health Canada, Canada
  • 9:00AM - 10:30AM

    [V4-S1] Multiregional Drug Development ~ (English Language Only)


    Session Chair(s):

    • No-image Norie Yasuda, PhD
      Director, North East Asia Hub, Clinical Operations & Biostatistics/DM
      Merck Serono Co., Ltd., Japan

    In a current clinical drug development strategy, efforts of simultaneous regulatory submission have been making to obtain registration and approval in Europe, the United States, and Japan. Multinational/ regional clinical trials have been the key practice in order to obtain simultaneous approvals in different regions. These trials include several geographic regions where ethic factors may differ and, as a result, the response to a drug may vary according to the different interethnic differences, racial background, and environmental and cultural factors, including the regional medical practice. Under such an environment, pharmaceutical companies have been trying and struggling with different courses of drug development strategy and operational model strategy to find a better, faster, and easier strategy with a specific drug and a specific indication in different regional and environmental settings. In this session, different development strategy approach and a new operational excellent initiative that global pharmaceutical companies have been pursuing will be discussed. The audience will be shared with the newest global/multiregional approach to a simultaneous regional drug development strategy including Japan and Asian countries.

    Speaker(s):

    • Simultaneous Development of New Treatments in Oncology; What special challenges and opportunities exist for Japan and Asia?
      Stephen Uden
      Department Head, Oncology Development
      Novartis Pharma K.K., Japan
    • New Development Opportunity at North East Asia Hub
      Morihiro Watanabe, MD,PhD
      Head, Clinical Development Center, R&D Japan, North East Asia Hub
      Merck Serono Co., Ltd., Japan
    • TransCelerate – How Collaboration is it going to change the Research & Development landscape in Japan?
      Toshiaki Sato, MD,PhD
      Head of Japan Clinical Sciences and Operations, R&D
      Sanofi K.K., Japan
  • 9:00AM - 10:30AM

    [V5-S1] Application of Coaching and Development for Project Team Building


    Session Chair(s):

    • No-image Koichi Konno
      PM Consulting Positive Intention, Japan

    In pharmaceutical R&D project team, how to interact for project managers toward team members would give great impact on a team performance. Coaching is one of the most important leadership which project managers to utilize, as the most recent PMBOK (version 5) employed the coaching skill as the required skill for project managers. The process of coaching is quite similar to project management process, and the concept can be applied to all processes from mission/goal setting to problem solving and lessons and learned. In this session, the speakers will provide knowledge, process, and thought process on coaching through collaborative efforts and transition coaching which would lead to breakthrough, and discuss to apply those to effective team management.

    Speaker(s):

    • Coaching as a Project Management Skill
      Takashi Sato
      Kyowa Hakko Kirin Co., Ltd., Japan
    • System Coaching – To Reveal and Leverage the Potential of the Team
      Nao Inoue
      Director, Faculty of CRR Japan
      WAKE UP Co., Ltd., Japan
    • Application of Coaching and Development for Project Team Building
      Koichi Konno
      PM Consulting Positive Intention, Japan
  • 9:00AM - 10:30AM

    [V6-S1] Recommendations for Developing Postmarketing Surveys and Clinical Investigations Using SSMIX Standardized Storage


    Session Chair(s):

    • Kiyoshi Kubota, MD,PhD,FISPE
      Professor, Department of Pharmacoepidemiology
      The University of Tokyo, Japan

    The Standardized Structured Medical record Information exchange (SS-MIX) was started in 2006 as the project supported by MHLW for promoting the exchange of the standardized medical information. Free software developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). Four academic societies and three pharma industry parties collaboratively worked to prepare the recommendations for developing postmarketing surveys and clinical investigations, and made available to the public in November 2012. The recommendations consisted of 7 parts; (1) information with high accuracy and granularity, (2) as the backup system, (3) the “new user” design, (4) fast and efficient data collection in surveys (5) evaluation of risk minimization action plan, (6) possible use cases in clinical trials, (7) as source data. In this session, working group members will provide presentations from many angles and audience would understand the possible use cases of SS-MIX standardized storage.

    Speaker(s):

    • Medical Institutions Implementing SS-MIX: What can be done?
      Michio Kimura, MD,PhD
      Professor and Director, Department of Medical Informatics
      Hamamatsu University School of Medicine, Japan
    • SS-MIX Could Make a Difference in Postmarketing Surveys and Pharmacoepidemiological Studies
      Kotonari Aoki
      The Federation of Pharmacuetical Manufacturer's Associations of Japan
      Chugai Pharmaceutical Co., Ltd., Japan
    • SS-MIX Could Make a Difference in Drug Developments and Clinical Trials
      Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
  • 11:00AM - 12:30PM

    [V1-S2] Drug Development thorough Collaboration with ARO and Future Prospects - Part 2


    Session Chair(s):

    • No-image Fumitaka Nagamura, MD,PhD
      Professor
      The University of Tokyo, Japan

    MHLW has started to provide budgetary support to 15 Core Clinical Research Centers nationwide since 2011. It also requests those centers to build a new infrastructure called ARO (Academic Research Organization) to conduct clinical trials by themselves. Each center has built an organization to suit their specialty and promoted some activities although their goals and strategies are various. Some organizations develop pharmaceutical products and medical devices for specific indications, some establish centers for phase 1 trials, some set up groups using networks. We expect you have a lot of questions on ARO. What kind of improvement did they implement who already introduced ARO? What kind of challenges do they face in particular? Is it possible for Academia to develop pharmaceutical products and medical devices? What is the role of researchers? How the collaboration among Industry and Regulatory has been facilitated? We will discuss these questions asked and issues and would like to find out common understanding to the basic question “What is ARO?”

    Speaker(s):

    • Attempt by National Center for Child Health and Development
      Hidefumi Nakamura, MD,PhD
      Chief, Division for Clinical Trials
      National Center for Child Health and Development, Japan
    • Attempt by the University of Tokyo Hospital
      Takashi Moritoyo, MD,PhD
      Head, Phase 1 Unit, Clinical Research Support Center
      The University of Tokyo Hospital, Japan
    • Ideal ARO Model from Sponsor’s Perspective
      Kazuhisa Uchiyama
      Senior Director
      Daiichi Sankyo Co., Ltd., Japan
    • Expectation for the ARO - Regulatory Perspective
      Yoshiaki Uyama, PhD
      Manager, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 11:00AM - 12:30PM

    [V2-S2] What is going on after J-RMP implementation?


    Session Chair(s):

    • Shoji Takamatsu, PhD
      Office Director, Office of Safety II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    In Japan, draft RMP should be submitted as an attachment of CTD1.11. It is disclosed on PMDA website once a product is launched. To deal with this situation, each company is developing RMPs referring e.g., EU RMP. Meanwhile, more excellent and effective risk management are oriented in EU/US according to implementation of EU GVP/PDUFA V. In this session, the most recent situation is updated by EU/ US and Japan from regulatory perspective, and both industries and competent authorities discuss current issues and solutions for them.

    Speaker(s):

    • Changes between pre- and post implementation of RMP in Japan and future concerns – especially both from NDA review process and inquiries regarding safety
      Tomoko Misaki
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Difference between EU-BRMP and Japan-RMP – Those features perspectives
      Junko Sato, DrSc,PhD
      Director, Division of Regulatory Cooperation, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Impact of PDUFA V from risk management perspective - Where it is and where to go (TBC)
      Gerald J. Dal Pan, MD
      Director, Office of Surveillance and Epidemiology, CDER
      FDA, United States
    • Company perspective: Changes after implementation of Japanese RMP
      Yoshiaki Ohashi, PhD
      Global PV Head, General Manager of Drug Safety Division
      Chugai Pharmaceutical Co., Ltd., Japan
  • 11:00AM - 12:30PM

    [V3-S2] Asia Town Hall


    Session Chair(s):

    • No-image Nobumasa Nakashima, PhD
      Director, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Japan is the second largest pharmaceutical market in the world and as a member of ICH, Japan plays a primary role in pharmaceutical regulations. In the recent years, the international positioning of Asia has enhanced as the center of development, manufacturer, supplier and market of pharmaceuticals. In addition, most of Asian countries are regarded as “pharma-emerging” countries and their efforts attract attentions from European countries, the US, and industry. In Japan, Abe Cabinet established the “Reconstruction Project” and evaluation on the partial amendment of Pharmaceuticals Affairs Act, and APAC (Asia Partnership Conference of Pharmaceutical Association) has been advocated by the industry. In other Asian countries such as Singapore and Chinese Taipei, proactive regulatory reformation and international cooperation has been proceeding. In this session, representatives from Asian regulatory agencies and industry will explain current situation and trends of each country, and discuss future direction of Asian cooperation.

    Speaker(s):

    • Promoting Medical Innovation “Health and Medical Care Strategy”
      Mitsuaki Kamata
      Director, Pharmaceutical and Food Safety Bureau
      Ministry of Health, Labour and Welfare, Japan
    • Cooperation in Asia (with focus on APAC) from industry point of view
      Yutaka Tsuchiya
      Chairman (Deputy President (Representative Corporate Officer)),
      Eisai Co., Ltd., Japan
    • Recent Trend of Pharmaceutical Regulations in Singapore
      Christina Lim, PhD
      Senior Director, International Relations, Health Product Regulation Group
      Health Sciences Authority, Singapore
    • Recent Trend of Pharmaceutical Regulations in Taiwan
      Meir-Chyun Tzou, PhD
      Director, Division of Drugs and New Biotechnology Products
      Food and Drug Administration, Department of Health, Taiwan
    • Recent Trend of Pharmaceutical Regulations in Korea
      Sun-Hee Lee, PhD
      Director General, Drug Evaluation Department
      Ministry of Food and Drug Safety (MFDS), Korea, Republic of
  • 11:00AM - 12:30PM

    [V4-S2] Effective Consultation Strategy in the Global Development Based on Consultation Examples of Japan and Other Regions


    Session Chair(s):

    • Fumi Yamamoto
      Office Director, Office of New Drug II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    While the global development is advanced, global clinical trials has become one of the most important choices of development strategy. However, many hurdles are existed when performing global clinical trials in fact. To get over hurdles and/or to reduce hurdles, it has been the important point in the development strategy that develops a consultation strategy taking into account the order or consultation items. In this session, based on some examples that have been approved by global clinical trials etc., consultation strategy with regulatory authorities of foreign countries, challenges to be solved and points to consider for consultation items are presented from point of view of PMDA and companies. After that, a better consultation strategy and regulatory development strategy will be discussed.

    Speaker(s):

    • Actual Case of Regulatory Authority Meetings Conducted Simultaneously in Japan, the US and the EU
      Kaoru Masuda
      Regulatory Strategy & Policy 3, Regulatory Affairs
      Pfizer Japan Inc., Japan
    • Consultation Strategy with Health Authorities in Global Simultaneous Development
      Eiko Tomita, MBA
      Senior Executive Officer, Vice President, Global Regulatory Sciences Japan
      Bristol-Myers K.K., Japan
    • Regulatory View Based on Amassed Cases of Global Clinical Trial Consultation
      Naoyuki Yabana, PhD
      Review Director, Office of New Drug III
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 11:00AM - 12:30PM

    [V5-S2] Effective Collaboration and Recent Trend of Project Leader and Project Manager ~ (English Language Only)


    Session Chair(s):

    • Catherine Ohura, MS,PMP
      Senior Director, Japan R&D Operation and Executive Officer, BMKK
      Bristol-Myers Squibb, Japan

    The primary focus of this session will be on the importance of understanding the roles of Project Management and Project Leadership functions. The goal is to identify the ideal roles and responsibilities of Project Mangers (PM) and Project Leaders (PL) in addition to emphasizing the criticality of creating partnership between the two roles in order to move projects in the most efficient and strategically sound manner. Roles will be identified and defined based on selected milestones of drug development phase (IND through NDA) with practical examples.Change in roles will be shown through these examples in order to understand that there may be different skills/roles for PMs and PLs required depending on the phase of drug development.

    Speaker(s):

    • Project Leader’s Perspective – What does a PL do?
      Akihisa Mori, PhD
      Deputy Director, Business Development, CNS
      Kyowa Hakko Kirin Co., Ltd., Japan
    • Project Manager’s Perspective – What does a PM do?
      Akiko Miyano
      Japan
    • Project Management and Project Leadership for successful project
      Yoshiaki Shibao
      CEO and President
      Innovation Management Co., Ltd., Japan
  • 11:00AM - 12:30PM

    [V6-S2] Drug Evaluation with Small Clinical Trials


    Session Chair(s):

    • Satoru Tsuchiya, MS
      Biostatistics Group, Data Science, Drug Development Div.
      Dainippon Sumitomo Pharma Co., Ltd., Japan

    In the process of developing medical products, statistical hypothesis testing is generally performed in the phase III trial. However, there is a case when limited numbers of patients are available to the study within a reasonable time frame for the purpose of the statistical testing. Such clinical studies are defined as small clinical trials (SCTs). Examples of constraints that lead to a SCT include, but not limited to, 1.) rare disease, where the target population is very small, 2.) clinical assessment with big burden for patients, 3.) pediatric disease, where recruiting large number of patients is very difficult, and 4.) target population of the trial is disease with specific genetic mutation. Recently, SCTs have been widely conducted, so being able to conduct them with scientific rigor is of increasing importance. In this session, presenters from industry, government and academia will provide the points to consider evaluating medical products with SCTs.

    Speaker(s):

    • Drug Development and Evaluation with Small clinical Trials from the regulatory Point of view
      Hideki Suganami, PhD
      Manager, Statistical Analysis Section, Pharmaceutical Developmetn Dept.
      Kowa Company, Ltd., Japan
    • Drug Development and Evaluation with Small Clinical Trials from the Regulatory Point of View
      Harumasa Nakamura, MD
      Deputy Review Director, Office of New Drug III
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Takeharu Yamanaka, PhD
      Head, Department of Biostatistics
      National Cancer Center, Japan
  • 2:00PM - 3:30PM

    [V1-S3] Globalization of ICH Guidelines ~ (English Language Only)


    Session Chair(s):

    • No-image Toshiyoshi Tominaga, PhD
      Professor
      Osaka City University, Japan

    In its history of about 20 years, ICH has published about 70 guidelines, which have been contributing to global development of drugs as the standards to assure their quality, safety, and efficacy. Nowadays, other countries than the ICH founding members (US/EU/Japan. plus Canada, Switzerland, and WHO), i.e. BRICS countries, South Korea, Taiwan and Singapore have been actively participating in drug development. The role of such countries’ regulatory authorities has been gaining importance in promulgating the ICH guidelines outside the founding member countries/regions to facilitate global drug development. The Global Cooperation Group, subcommittee to the Steering Committee of the ICH, has been contributing to the global use of the guidelines. With the representatives from regional harmonization initiatives (RHIs), such as APEC and ASEAN, and individual countries in addition to the ICH founding members, the Group been facilitating the non-founding members’ inputs for the process of drafting the guidelines and their acquisition of necessary trainings to implement the guidelines. The activities also serve to increase the transparency of the ICH process. Noteworthy is the importance of cooperation among and bi-directional communication between those making guidelines and those using the product guidelines. With today’s strengthening trend of globalization, it is an opportune moment to discuss how globalization of ICH activity is being advanced. This session submits the viewpoints of the founding members (regulatory as well as industry member) and non-founding member to explore the activities’ future direction.

    Speaker(s):

    • Regulators Forum and ICH Global Cooperation Group Activities
      Justina A. Molzon, JD,MSc
      Associate Director for International Programs, Office of Strategic Program CDER
      FDA , United States
    • Information Sharing of Global Regulatory Intelligence and ICH Guideline
      Mike Ward
      Manager, International Programs Division
      Health Canada, Canada
    • Regulatory Harmonisation – Industry Perspective
      Peter K. Honig, MD,MPH
      Vice President and Head, Global Regulatory Affairs and Patient Safety
      AstraZeneca Pharmaceuticals LP, United States
    • GCG Regulators’ view on Regional Approaches on ICH Guidelines
      Yuppadee Javroongrit, PhD
      Senior Expert in Pharmaceuticals Standard
      Food and Drug Administration, MOPH, Thailand
  • 2:00PM - 3:30PM

    [V2-S3] Current Status and Perspectives for the Development of Companion Diagnostics and Personalized Medicine - Part 1


    Session Chair(s):

    • No-image Yoshinobu Tanaka
      Associate Director, Oncology/Neuroscience & Ophthalmology Group
      MSD K.K., Japan
    • No-image Takeharu Yamanaka, PhD
      Head, Department of Biostatistics
      National Cancer Center, Japan

    In promoting personalized medicine, the environment for developing companion diagnostics (CoDx) is essential. A delayed CoDx development may lead to a delay in the market release of a drug and there is thus increasing demand on drugs and diagnostic drugs to be developed in an integrated manner. However, in order to achieve this goal, multifaceted issues such as time line alignment for the concurrent development of drugs and CoDx, sharing of risk/ benefit among corporations, and intellectual property (IP) concerning gene patents must be tackled. In this session, we would like various parties including regulatory authorities, corporations which have actually developed CoDx, and bio IP experts to present their most up-to-date knowledge on the current status and issues in CoDx development and discuss and share the actions that will be required for optimal development of CoDx in the future.

    Speaker(s):

    • Points to Consider: Concurrent Development of Companion Diagnostics and Corresponding New Drugs. What are Issues? Where are We? Where are We Going?
      Masaaki Urata, PhD
      Reviewer, Office of Medical Devices II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Current Issues and Future Direction of Quality Control for Molecular Diagnostics – Challenges between IVD and LDT
      Mikio Kawahara
      Director and COO
      Riken Genesis Co., Ltd., Japan
    • Current Strategy for Companion Diagnostics Development in Pharmaceutical Company
      Shigeru Takeshita, MSc
      Manager, Clinical Pharmacology, Astellas Pharma Global Development
      Astellas Pharma Inc., Japan
  • 2:00PM - 3:30PM

    [V3-S3] Implementation of an Innovative Labeling Hub in Asia including Japan and Integration with Global Model Point of View


    Session Chair(s):

    • No-image Rie Matsui, RPh
      Director, Regional Labeling Head for Asia International Labeling Group
      Pfizer Japan Inc., Japan

    Many global companies operate a centralized labeling model in which the Company Core Data Sheet (CCDS) is handled by the Headquarters organization while local health care professional information and patient leaflets are handled by staff based in local offices. This session will provide an overview of how global labeling systems handle implementation of CCDS information in the US-PI and EU-SmPC, as well as a case study discussion on the implementation of a regional hub model for Asia. Consideration of differences in practice across countries and companies, as well as the prospects for future initiatives around labeling such as a harmonization will be discussed. The session will also offer a perspective on how the industry is managing the integration and alignment of global safety and labeling systems and governance to ensure end-to-end oversight and implementation of patient safety information.

    Speaker(s):

    • Implementation of Global Safety Labeling in US and EU Countries
      A. Leander Fontaine, DrMed
      President
      Pharmiceutics, LLC., United States
    • [V3-S3] Implementation of an Innovative Labeling Hub in Asia including Japan and Integration with Global Model Point of View
      Rie Matsui, RPh
      Director, Regional Labeling Head for Asia International Labeling Group
      Pfizer Japan Inc., Japan
    • Reiko Sato, PhD
      Director, Office of Safety II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 2:00PM - 3:30PM

    [V4-S3] Regulation, Development, and Future of Biosimilars


    Session Chair(s):

    • Teruyo Arato, PhD
      Professor, Department of Regulatory Science
      Hokkaido University Graduate School of Medicine, Japan

    Regulatory guidance, development and regulatory path for approval, and use of Biosimilar products are underway. And larger products such as antibody product become target to develop. The questions arises on these type of product position such as whether Bio-similar should be accelerate, whether requirement on clinical studies, whether difference exist among ICH regions and/or non ICH regions, whether reference products position are agreed. On the other hand, innovative license holder moves against Bio-similar products by extensive LCM including bio-better aspects. Discussion should cover patients first and health economy aspects to lead understanding of these new category of biologics products.

    Speaker(s):

    • Regulatory Status of biosimilar in Japan
      Reiko Yanagihara, PhD
      Reviewer, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Does the MHLW biosimilar guideline need an update? A look at the regulatory situation in Japan, Europe and US
      Martin Schiestl, PhD
      Scientific & Regulatory Advisor
      Sandoz, Austria
    • Opinions from Generic Drugs Developer
      Hideaki Nomura
      President & CEO
      Fujifilm Kyowa Kirin Biologics Co., Ltd., Japan
    • Review and approval system of Biosimilar Products in Korea
      Young-Eun Kim, PhD
      Scientific Officer, Recombinant Protein Products Division
      National Institute of Food and Drug Safety Evaluation (NIFDS), Korea, Republic of
  • 2:00PM - 3:30PM

    [V5-S3] Virtual Meeting of PMDA’s Scientific Consultation: Points to Maximize an Efficiency of the Meeting ~ (Japanese Language Only)


    Session Chair(s):

    • No-image Yoshiaki Uyama, PhD
      Manager, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    It is critical for both applicant and regulator to have proper understanding of the objectives of the consultation including the background or fundamental problems faced in order to implement the meeting result. 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. The panelists replicate common consultation by using virtual new product, which will provide some ideas on how to avoid miscommunication and how to maximize the value of consultation.

    Speaker(s):

    • [V5-S3] Virtual Meeting of PMDA’s Scientific Consultation: Points to Maximize an Efficiency of the Meeting ~ (Japanese Language Only)
      Yoshiaki Uyama, PhD
      Manager, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 2:00PM - 3:30PM

    [V6-S3] Now, Let’s have a Direct Discussion with Patients for the Drug Discovery and Development


    Session Chair(s):

    • No-image Hiroshi Watanabe, MD,PhD
      Professor, Dept of Clinical Pharmacology & Therapeutics
      Hamamatsu University School of Medicine, Japan

    Everyone wishes to deliver safer and more effective drugs as early as possible to patients. To achieve this, it is important to learn about the patients’ wishes and take proper action based on patients’ requirements during drug development. Although the chance to establish face-to-face communication with patients is increasing, it is still rare for people working in pharmaceutical industries. This session, started last year, continues to focus on what we should learn from patients for future drug development. For example, the priority of the patients’ needs or wishes, the economic stumbling blocks in daily life, other difficulties for the patients and the issues of corporate activities among stakeholders. Based on the discussion from each point of view, the patients, the government, the medical profession and the pharmaceutical industries, we would like to seek the possibility of mutual and fruitful collaboration for future “Drug Discovery and Development” & “Drug Fostering and Evolution”.

    Speaker(s):

    • Eiko Uchida
      Founder and Chief
      Breast Cancer Patient Support Group BOUGAINVILLA, Japan
    • Noriko Murakami
      Founder and President
      Pulmonary Hypertension Association (PHA), Japan
    • Drug Information and Patients
      Tomiko Tawaragi
      Associate Executive Director
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Patient-Focused Drug Development
      Kazumichi Kobayashi, RPh
      Senior Research Fellow, Office of Pharmaceutical Industry Research
      Japan Pharmaceutical Manufacturers Association (JPMA), Japan
  • 4:00PM - 5:30PM

    [V1-S4] The Future of ICH ~ (English Language Only)


    Session Chair(s):

    • Akira Kawahara, PhD,MPharm,RPh
      JPMA, Japan
    • No-image Nobumasa Nakashima, PhD
      Director, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Through its 20 years’ activities, ICH finalized more than 70 guidelines, and many countries other than Japan, the US and Europe are getting to make use of those guidelines. In addition, activities of ICH have been increasing its importance increasingly in the world where science and technology is progressing remarkably and development, supply and sales of medicinal products are globalizing. Taking into account such circumstances, ICH members discuss subjects such as the governance of ICH including its membership, new topics to be considered at ICH to revitalize activities, maintaining transparency, and promoting globalization of ICH activities. In this session, representatives from Japanese, US and European regulatory agencies and from ICH industry will give presentations on the current and future activities of ICH and international cooperation from their points of view, and discuss the future shape of ICH. Discussion time is held at the end of the session.

    Speaker(s):

    • Future Activity of ICH from MHLW/PMDA’s Point of View
      Naoyuki Yasuda
      International Planning Director, Pharmaceutical Affairs, Minister's Secretariat
      Ministry of Health, Labour and Welfare (MHLW) , Japan
    • Future Activity of ICH From the FDA Point of View
      Theresa M. Mullin, PhD
      Director, Office of Strategic Programs, CDER
      FDA, United States
    • Future Activity of ICH from the EU Point of View
      Emer Cooke, MBA
      Head of International Affairs
      European Medicines Agency, European Union , United Kingdom
    • The Future of ICH – Industry Perspective
      Peter K. Honig, MD,MPH
      Vice President and Head, Global Regulatory Affairs and Patient Safety
      AstraZeneca Pharmaceuticals LP, United States
  • 4:00PM - 5:30PM

    [V2-S4] Current Status and Perspectives for the Development of Companion Diagnostics and Personalized Medicine - Part 2


    Session Chair(s):

    • No-image Yoshinobu Tanaka
      Associate Director, Oncology/Neuroscience & Ophthalmology Group
      MSD K.K., Japan
    • No-image Takeharu Yamanaka, PhD
      Head, Department of Biostatistics
      National Cancer Center, Japan

    In promoting personalized medicine, the environment for developing companion diagnostics (CoDx) is essential. A delayed CoDx development may lead to a delay in the market release of a drug and there is thus increasing demand on drugs and diagnostic drugs to be developed in an integrated manner. However, in order to achieve this goal, multifaceted issues such as timeline alignment for the concurrent development of drugs and CoDx, sharing of risk/ benefit among corporations, and intellectual property (IP) concerning gene patents must be tackled. In this session, we would like various parties including regulatory authorities, corporations which have actually developed CoDx, and bio IP experts to present their most up-to-date knowledge on the current status and issues in CoDx development and discuss and share the actions that will be required for optimal development of CoDx in the future.

    Speaker(s):

    • Trend of Gene Patents and Its Impact on Development of Companion Diagnostics
      Koichi Sumikura, PhD
      Associate Professor
      National Graduate Institute for Policy Studies, Japan
  • 4:00PM - 5:30PM

    [V3-S4] Past, current and future of Benefit Risk Balance assessment- Where we are and where we will be


    Session Chair(s):

    • No-image Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan

    In EU/US, industries and governments have worked on the establishment of the methodology on benefit-risk balance assessment since around 2006. The part of benefit was created in Module V Risk management plan, which is new GVP regulation in July 2012 in EU. It was changed from traditional vision focusing mainly on safety to concept of benefit including the patient’s viewpoint systematically. In DSUR, the similar consideration is employed. Furthermore, in PDUFA V, which was started from last October in US, it was stated that the methodology of them will be established within five years. Meanwhile, in Japan, the discussion of them was just started under the leadership of the industries in 2012, and it was argued about the necessity for cooperation activity between industries and governments in the DIA last year. In this session, speakers from EU/US and Japan will introduce trials and experiences from past to present and will share an idea regarding future plans and direction.

    Speaker(s):

    • Overview for Benefit-Risk Assessment for Medications
      Tomomi Kimura, MD,PhD
      TF Lead, TF1, JPMA Data Science Subcommittee
      Janssen Pharmaceutical K.K., Japan
    • Expectation for PBRER and its foresight – Insights from current situation both in EU and in Japan
      Junko Sato, DrSc,PhD
      Director, Division of Regulatory Cooperation, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • IMI-PROTECT Work Package 5 - Concept, results and the future of benefit-risk integration and representation in medicine
      Deborah Ashby, PhD,MSc
      Professor of Medical Statistics and Clinical Trials
      Imperial College London, United Kingdom
    • BR balance assessment during life cycle of medicinal products (TBC)
      Gerald J. Dal Pan, MD
      Director, Office of Surveillance and Epidemiology, CDER
      FDA, United States
  • 4:00PM - 5:30PM

    [V4-S4] Issues to be Addressed from the Result of Metrics Analyses - Maximizing Japan’s Strength


    Session Chair(s):

    • No-image Takuya Oshida, MSc
      Vice President, Head of Clinical Development
      Astellas Pharma Inc., Japan

    Recent years have seen improvements in the environments and performance of domestic clinical trials to a level competitive with those overseas thanks to the efforts by pharmaceutical companies, regulatory agencies, medical institutions, etc. To demonstrate the presence of Japan in the global development of drugs, however, we need to address various issues yet to be solved while leveraging our strength of operational excellence. In this session, we intend to explore which issues are further to be addressed for future clinical trials in this country, under the constantly changing environment.

    Speaker(s):

    • The Transition of Clinical Trials Environment in Japan
      Toko Shimomukai
      JPMA, Clinical Evaluation Expert Committee, Drug Evaluation Committee
      Japan Tobacco Inc., Japan
    • Performance Analysis of Local Clinical Trials Using Metrics from Viewpoint of Japanese Pharmaceutical Company
      Yuji Kawamura
      Senior Manager, Clinical Development Administration
      Astellas Pharma Inc., Japan
    • The Performance of Domestic Clinical Trials Conduction from the Global CRO Point of View
      Koji Ando
      Director
      Quintiles Transnational Japan K.K., Japan
  • 4:00PM - 5:30PM

    [V4-S4] Issues to be Addressed from the Result of Metrics Analyses - Maximizing Japan’s Strength


    Session Chair(s):

    • Fumiaki Kobayashi, PhD
      President
      CTD Inc., Japan

    Thanks to the winning of the Nobel Prize for iPS cells, numerous efforts are now being made for regenerative medicine in academia as well as in the pharmaceutical industry. The development of regenerative medicinal products is however still evolving, with a number of issues remaining to be solved. In this session, we will explain the points to consider from the perspective of review of the regenerative medicinal products and discuss the current development situation, the issues surrounding the development, and how to address such issues from the viewpoint of our industry, the government, and academia.

    Speaker(s):

    • PMDA’s Efforts in Consultation and Review of Cellular and Tissue-based Products
      Tetsuya Kusakabe, PhD
      Coordination Director
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Development of Regenerative Medicinal Products - Discussion from the Academia’s Position
      Akifumi Matsuyama, PhD
      Foundation for Biomedical Research and Innovation, Japan
    • Regenerative drug-discovery supporting business
      Junichi Mineno, PhD
      Vice President of Gene Medicine Business Unit
      Takara Bio Inc., Japan
  • 4:00PM - 5:30PM

    [V6-S4] Frontline of the Development of Medical Devices


    Session Chair(s):

    • Koji Ikeda, PhD
      Professor, Clinical Research, Innovation and Education Center
      Tohoku University Hospital, Japan

    It is well known that propulsion of medical-related industry looking ahead to longevity society is included in Strategy for the Rebirth of Japan. At present, rejuvenation of the domestic medical device industry utilizing the technology of Japan has come under spotlight. Even though similar measures have been implemented so far, some of them have resulted in failure, and this reveals that the challenges which already seemed to have been solved in medicine are still bottlenecks. In this program, I will visualize the challenges in development of medical devices and discuss its breakthrough. Especially, I would like to share the effect expected from pharmaceutical companies breaking into the market with PMDA as well as medical doctors specialize in development of both medicine and medical devices, and individuals related to a company, hoping that these discussions set off the birth of new home grown medical devices.

    Speaker(s):

    • Environment Surrounding the Development of Medical Devices
      Koji Ikeda, PhD
      Professor, Clinical Research, Innovation and Education Center
      Tohoku University Hospital, Japan
    • Review and Consultation Systems on Medical Devices
      Yuka Suzuki, PhD
      Director, Office of Medical Devices II
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • New-born Regulatory Science for Medinomics
      Isao Tsuchii
      Business Operator
      Green Field, Japan
    • The Need for Innovative Medical Device Development
      Hiroyoshi Yokoi, MD
      Medical Doctor
      Kokura Memorial Hospital, Japan
  • 5:30PM - 7:00PM

    Special Talk Session: Let’s Chat over a Glass of Wine! ~ (Japanese Language Only)


    Session Chair(s):

    • No-image Junichi Nishino, MSc,RPh
      Head, Regulatory Operation & Prescribing Information Group, Drug RA Dept.
      Novartis Pharma K.K., Japan
    • No-image Yoshiaki Uyama, PhD
      Manager, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Do you hesitate to say something for fear of saying the wrong thing at regular session in DIA Japan annual meeting? In this session, we would like to chat regarding current situation of drug development and/or environment surrounding health care in Japan among participants heart to heart with glass of wine. We have no fixed theme in this session. Discussion topics is free, so anybody can join us. Young attendees are welcome cordially! Please ask question and deliver your opinion regardless of affiliation and position. We will wait at exhibition hall for you. The views and opinions expressed in this session 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.

Day 3 Friday, November 08, 2013

  • 9:00AM - 10:30AM

    [V1-S5] Team Medical Care and Ethics


    Session Chair(s):

    • Hideki Hanaoka, MD,PhD
      Director of Clinical Research Center
      Chiba University, Japan

    In the traditional health care model it has been pointed out that health care professionals played a central role in providing medical care, which sometimes resulted in lack of communication among departments and lack of regard for patient needs. Thus, a new health care model “team medical care” is proposed in which health care professionals mutually cooperate each other and provide patient-centered care. In the patient-centered team medical care all medical professionals involved focus on patient-oriented care. At the same time a patient is expected to bear a responsibility as a team member. Doctors should not be the sole decision maker. It is desired that patients should be fully informed of his/her medical treatment and test by doctors and understand and agree to the content before making a decision on the appropriate medical treatment. In this session we reaffirm patient should be the key player in determining health care options in medical informed consent and discuss what the team medical care is from the viewpoint of health care professionals other than clinicians.

    Speaker(s):

    • Yuichi Maru
      Clinical Research Center
      Chiba University Hospital, Japan
    • Ethics Issue from the Viewpoint of Sponsor
      Tomonari Adachi
      Senior Director, Legal & Compliance
      Astellas Pharma Inc., Japan
    • Kaori Muto, PhD
      Professor, The Insitute of Medical Science
      The University of Tokyo, Japan
  • 9:00AM - 10:30AM

    [V2-S5] Adaptive Licensing ~ (English Language only)


    Session Chair(s):

    • Yasuhiro Fujiwara, MD,PhD
      Director, Strategic Planning Bureau
      National Cancer Center, Japan

    In recent innovative drug development, one of the challenges is what level of efficacy and safety should be confirmed at the time of regulatory approval even though a certain level of uncertainty remains. This session will deliver speeches about new concept “adaptive licensing” from regulator, academia, and industry. The panel discussion will explore how approval process should be in future.

    Speaker(s):

    • Concept and Implementation of Adaptive Licensing in EU (Remote presentation via internet)
      Tomas Salmonson, PhD
      CHMP Chair
      European Medicines Agency, Sweden
    • Academic Expectation on the Future Drug Approval System
      Yasuhiro Fujiwara, MD,PhD
      Director, Strategic Planning Bureau
      National Cancer Center, Japan
    • Industry Perspective on the System of Future Drug Approval
      Satoshi Kawaoto
      Corporate Officer, Head of Drug Regulatory Affairs Dept.
      Novartis Pharma K.K., Japan
    • Regulatory Perspective on Future Direction of Drug Approval System in Japan
      Daisaku Sato, PhD
      Director, Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 9:00AM - 10:30AM

    [V3-S5] Regulatory Communication – What will be occurred by implementation of Key Action Date to the review process?


    Session Chair(s):

    • No-image Yoshihiko Ono
      Executive Director, Head of Regulatory Affairs, Japan Development
      MSD K.K., Japan

    “To deliver good medicines to patients” is the important task. In order to achieve this goal, it is necessary to handle review smoothly after filing an application for approval. Last year, we particularly discussed as to the importance of good communication between the PMDA and applicants. This year, we’ll take the discussion one step further, from viewpoint of “How to make efficient communication with the PMDA in appropriate timing in the review process.” Currently, key Action Dates of query, response, reporting, etc. are determined for each PMDA consultation, but there is no big problem. When the concept of this “Key Action Date” is introduced to approval review process, what will occur? What will be brought to the review process? We’ll have discussion about the feasibility and the advantages and disadvantages of the introduction and consider deeply about “good review process”, exchanging opinions between companies and the authorities.

    Speaker(s):

    • Should the key Action Date be set in the J-NDA review process ? - Comparison to EMA/CP.
      Hirotaka Chaki
      Head of Regulatory Information Management
      Bayer Yakuhin, Ltd., Japan
    • Should the key Action Date be set in the J-NDA review process? - The merit and demerit
      Hiroyuki Sato
      Deputy General Manager, Product Development Regulatory Affairs Dept
      Shionogi & Co., Ltd., Japan
    • Current situation of J-NDA review process and management
      Shinobu Uzu
      Office Review Director, Office of New Drug I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 9:00AM - 10:30AM

    [V4-S5] Toward Utilization of CDISC Standards at J-NDA Submission - Part 1


    Session Chair(s):

    • Hidetoshi Misawa
      Japan CDISC Coordinating Committee (J3C)
      Pfizer Japan Inc., Japan
    • Yasunori Yoshida
      Director, Office of Review Management
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    FDA has utilized submitted data in CDISC format and plans to mandate the CDISC data submission for all sponsors. It is expected that, by utilizing CDISC data, the J-NDA reviews and consultation meetings would become more efficient and regulatory science studies using accumulated data would be activated, e.g., modeling and simulation. “Japan Revitalization Strategy -JAPAN is BACK-”, which states Eliminate Lag by 2020, was approved in a Cabinet meeting on June 14, 2013. The Strategy for Health and Medical Care states “PMDA should actively work on analyses and research of clinical data and construct more sound and efficient evaluation/decision processes at the review and the consultations. “ To achieve these goals, it becomes increasingly important for every stakeholder to use CDISC standards in Japan as well. Because CDISC standards are the unique global standards, Japanese data in CDSIC format would contribute to global health and medical care. This session will provide presentations by PMDA, industry, CDISC community in Japan and ARO, and discuss on current situations, a future direction, and challenges.

    Speaker(s):

    • Briefing on Advanced Review/Consultation System of the PMDA
      Yasunori Yoshida
      Director, Office of Review Management
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • The Meaning of Submitting CDISC Data for J-NDA; Industry Perspectives
      Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
    • What is CDISC?: Let’s Learn a Whole Picture
      Michiyo Mori
      Janssen Pharmaceutical K.K., Japan
  • 9:00AM - 10:30AM

    [V5-S5] Current and Future: Medical Affairs and Medical Scientific Liaison (MSL)


    Session Chair(s):

    • Kazuya Iwamoto, MD,PhD
      Director, Medical Affairs Committee, Japanese Assoc. of Pharmaceutical Mediicine
      Biogen Idec Japan Ltd., Japan

    Recently, Medical Affairs and Medical Scientific Liaison (MSL) have been expanding rapidly in Japan, however, expected roles may vary among individual companies and the importance of these functions may be penetrated less sufficiently into both internal and external customers compared with western countries. In this session, we will present the outline of Medical Affairs and MSL and will try to figure out what are expected to Medical Affairs and MSL in Japan through discussions based on the results of surveys on Medical Affairs and MSL which PwC PRTM and we have conducted targeting for pharmaceutical companies in Japan.

    Speaker(s):

    • Current and Future: Medical Affairs and Medical Scientific Liaison (MSL)
      Kazuya Iwamoto, MD,PhD
      Director, Medical Affairs Committee, Japanese Assoc. of Pharmaceutical Mediicine
      Biogen Idec Japan Ltd., Japan
    • Current Status and Future Perspective of Medical Affairs Organization in Japan
      Yoichi Inoue, JD,MD
      Medical Affairs Committee, Japanese Assoc. of Pharmaceutical Medicine (JAPhMed)
      MSD K.K., Japan
    • Survey on the Functions and Challenges of Medical Scientific Liaison (MSL) in the Pharmaceutical industry
      Hiroshi Aino, MD,PhD
      Dainippon Sumitomo Pharma Co., Ltd., Japan
  • 9:00AM - 10:30AM

    [V6-S5] Pharmacopoeia and Biologics


    Session Chair(s):

    • Teruhide Yamaguchi, PhD
      Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Pharmacopoeia is a set of pharmaceutical quality standards in the country. The major developed countries have own pharmacopoeia. In the European Union, the European pharmacopoeia (EP) is used among the member countries. On the other hand, Pharmacopoeial discussion group (PDG) has been working to harmonize monographs and general chapters since 1989 in order to correspond to the internationalization of pharmaceutical production and distribution. This session will focus on specific issues of biologics (e.g. monoclonal antibody and impurity control of protein preparation) which are expected to be internationally harmonized in the future. Each representative from JP (the Japanese Pharmacopoeia), EP and USP (the United States Pharmacopeia) will introduce the current situation and states of the biologics. The goal is to share the information from each pharmacopoeia and discuss the next challenges for the future.

    Speaker(s):

    • Current situation and issues in Japanese Pharmacopoeia
      Nana Kawasaki, PhD
      Head, Division of Biological Chemistry and Biologicals
      National Institute of Health Sciences, Japan
    • European Pharmacopoeia update in the field of biologicals
      Emmanuelle Charton, PhD
      Deputy Head, European Pharmacopoeia Department
      European Directorate for the Quality of Medicines and HealthCare, France
    • Biologic Standards – USP Perspective
      Ranjan Chakrabarti, PhD
      Vice President, Biologics & Biotechnology Dept
      United States Pharmacopeia - India, India
  • 11:00AM - 12:30PM

    [V1-S6] Current Situation of Early and Exploratory Clinical Studies as one of the Leading Countries with Drug Development


    Session Chair(s):

    • Atsushi Ohtsu, MD,PhD
      Director, Exploratory Oncology Research & Clinical Trial Center
      National Cancer Center, Japan

    In recent years, high-quality and speedy clinical trials in Japan have started recognized overseas, starting a trend for Japan to conduct FIH and POC studies, which used to be preceded by foreign countries. In order to spread the growing strength of Japan, collaboration among academia, industry, and regulatory agencies is particularly essential. In this session, we will discuss the current status and future prospects of early and exploratory clinical trials from the points of view of academia, industry, and regulatory agencies.

    Speaker(s):

    • Efforts by National Cancer Center EPOC
      Toshihiko Doi, MD,PhD
      Chief, Dept. of Experimental Therapeutics, Exploratory Oncology
      National Cancer Center, Japan
    • Positioning and Future Prospects of Early and Exploratory Clinical Trials in Japan in Terms of Development Strategies by Pharmaceutical Companies
      Koichi Katsura, MD,PhD
      Head of R&D Japan, Site Head of R&D North East Asia Hub
      Merck Serono Co., Ltd., Japan
    • Japan’s Strategic Cooperation with Academia to take the Initiative in Early and Exploratory Clinical Studies
      Hideki Maeda, MSc,RPh
      Senior Director, Head of Oncology, Clinical Development III
      Astellas Pharma Inc., Japan
    • Japan’s Strategic Cooperation with Academia to take the Initiative in Early and Exploratory Clinical Studies
      Yuta Ogawa
      Office of Clinical Trial Promotion, Research and Development Division
      Ministry of Health, Labour and Welfare, Japan
  • 11:00AM - 12:30PM

    [V2-S6] Global Simultaneous Submission - Lessons Learned and Overcoming Next Challenges


    Session Chair(s):

    • Satomi Ando, MSc
      Head, Medical and Scientific Communication in Clinical Development Division
      Novartis Pharma K.K., Japan

    The session in the last year was a good and first opportunity to share information on this theme, where medical writers from domestic and foreignaffiliated pharmaceutical companies spoke about experiences and issues relevant to simultaneous NDA filing in global development. Since then, experiences of global simultaneous filing have been steadily increasing. Some are successful in simultaneous approval or the first approval in Japan ahead of other regions, but others failed to achieve a goal despite development strategy. Some faced challenges specific to simultaneous filing in NDA review process, resulting in longer time to approvals, or giving-up approval in the worst case. This year’s session will take up issues to address toward success (earlier approval); what is a key to success of global simultaneous filing, and what are roles of medical writers to contribute to earlier approval. We will have presentations from Medical Writers with many experiences of simultaneous filing, and also presentation from standpoint of NDA reviews from PMDA reviewer. Panel discussion will follow to deepen discussions.

    Speaker(s):

    • Aim for Simultaneous Approval Beyond Simultaneous NDA from CTD Author’s Perspective
      Yoko Hirano, MSc
      Pfizer Japan Inc., Japan
    • Through Experience of Global Simultaneous Submission, Review, and Approval - Changing and Expanding Possibility of Medical Writer’s Role
      Ayako Sato, MA
      Medical Writer
      Novartis Pharma K.K., Japan
    • Reviewer Perspective for Global Simultaneous Submission and Approval
      Aki Nakai
      Review Director, Office of New Drug IV
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 11:00AM - 12:30PM

    [V3-S6] How to keep a Good Drug with Positive B/R Balance for a Long Period after Approval


    Session Chair(s):

    • No-image Yoshiaki Uyama, PhD
      Manager, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    While post-marketing drug safety evaluation has been strengthened, there is growing concern that the process focuses more on risk of the product than the benefit. The imbalanced evaluation overestimates the negative aspect, which may result in withdrawn from the market unreasonably. It is critical to evaluate the benefit and the risk equally to maintain a supply of necessary drug to the patients, but the process of benefit evaluation still remain unargued. This session will deliver speeches about how to garner evidence of benefit for appropriate post-marketing benefit/risk evaluation. The speakers will discuss future evaluation model at panel discussion.

    Speaker(s):

    • What is the right benefit/risk assessment?
      Kazuhiko Mori, MSc
      Managing Director, Kobe Cluster
      Foundation for Biomedical Research and Innovation, Japan
    • New paradigm on benefit/risk evaluation
      Masahiro Takeuchi, DrSc,MPH
      Professor,Dept. of Clinical Medicine (Biostatistics & Pharmaceutical Medicine)
      Kitasato University School of Medicine, Japan
    • A way to conduct the appropriate benefit/risk evaluation: Industry’s perspective
      Hironobu Saito, PhD
      VP, New Drug Regulatory Affairs Dept.
      Daiichi Sankyo Co., Ltd., Japan
  • 11:00AM - 12:30PM

    [V4-S6] Toward Utilization of CDISC Standards at J-NDA Submission - Part 2


    Session Chair(s):

    • Hidetoshi Misawa
      Japan CDISC Coordinating Committee (J3C)
      Pfizer Japan Inc., Japan
    • Yasunori Yoshida
      Director, Office of Review Management
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    FDA has utilized submitted data in CDISC format and plans to mandate the CDISC data submission for all sponsors. It is expected that, by utilizing CDISC data, the J-NDA reviews and consultation meetings would become more efficient and regulatory science studies using accumulated data would be activated, e.g., modeling and simulation. “Japan Revitalization Strategy -JAPAN is BACK-”, which states Eliminate Lag by 2020, was approved in a Cabinet meeting on June 14, 2013. The Strategy for Health and Medical Care states “PMDA should actively work on analyses and research of clinical data and construct more sound and efficient evaluation/decision processes at the review and the consultations. “ To achieve these goals, it becomes increasingly important for every stakeholder to use CDISC standards in Japan as well. Because CDISC standards are the unique global standards, Japanese data in CDSIC format would contribute to global health and medical care. This session will provide presentations by PMDA, industry, CDISC community in Japan and ARO, and discuss on current situations, a future direction, and challenges.

    Speaker(s):

    • Overview of CDISC SDTM (Study Data Tabulation Model)
      Taku Shimizu
      DM
      AC Medical, Inc., Japan
    • Overview of CDISC ADaM (Analysis Data Model)
      Yumiko Asami
      Manager
      Daiichi Sankyo Co., Ltd., Japan
    • Experience in Preparing Clinical Data Submission to the FDA
      Satoru Tsuchiya, MS
      Biostatistics Group, Data Science, Drug Development Div.
      Dainippon Sumitomo Pharma Co., Ltd., Japan
    • From ARO’s Perspective
      Norihiro Sato, MD,PhD
      Vice Chair, ARO Council
      Hokkaido University Hospital, Japan
  • 11:00AM - 12:30PM

    Session 6 / Venue 5: Drug Supply in the Disaster or Emergency


    Session Chair(s):

    • Tadaharu Goto
      Director General
      Japan Pharmaceutical Manufacturers Association, Japan

    Speaker(s):

    • Management of the Wholesale at the Time of the East Japan Great Earthquake Disaster Example of the Vitalnet
      Naoei Furui
      Chairperson, The GL for Natural Disaster Countermeasures, JPWA
      VITAL-NET Inc., Japan
    • Efforts to support the disaster-stricken area and to maintain the medical care system
      Kanehiko Hisamichi, PhD
      Vice Director, Department of Pharmaceutical Sciences
      Tohoku University, Japan
    • The continuation of product supply after the earthquake
      Nobutaka Kakubari
      Executive Corporate Officer, Head of Production Division
      ASKA Pharmaceutical Co., Ltd., Japan
  • 11:00AM - 12:30PM

    [V6-S6] Deploying Lean Six Sigma in your Organization - Problem Solving Approaches in Research and Development


    Session Chair(s):

    • Kazutoshi Maki
      Chairman
      GENEX Partners, Japan

    Lean Six Sigma has been implemented/deployed into the R&D organization since 2005 or earlier, but there are ongoing discussions on the success factors and barriers to implement/deploy this methodology as well as the tips to proceed the Lean Six Sigma project successfully in GEMBA level. In this session, we will discuss those by reviewing the previous cases with: 1.) Service quality viewpoint, 2.) Customer’s standpoint; and 3.) Expert’s knowledge/experiences.

    Speaker(s):

    • Service Quality Improvement of Help Desk which sponsor Outsources for Conducting Clinical Trial - From a Sponsor’s Standpoint
      Kouichi Ichikawa
      Associate Director, JDCAM 6 Group, Development and Clinical Alliance Management
      Pfizer Japan Inc., Japan
    • The Quantification of Issues and Clues to Solution(s) on the Source Data Verification (SDV) - From a Study Site Viewpoint
      Kazuhiko Kamiyama
      Senior Manager, Clinical Trial Support & Compliance
      Pfizer Japan Inc., Japan
    • Key Success Factors of Implementing SixSigma Project into the R&D Organization
      Masahiro Kaneko
      Manager, IQP Program Office
      Novartis Pharma K.K., Japan
  • 12:30PM - 2:00PM

    Luncheon Session: Protecting our Innovative Medicines: The Biopharmaceutical Industry’s Collaboration Against Doping Abuse in Sports ~ (Japanese Language Only)


    Session Chair(s):

    • Tatsuya Kamiuchi
      Drug Safety Coordination Dept.
      Chugai Pharmaceutical Co., Ltd., Japan

    As illustrated by recent high-profile media reports, would-be dopers and their enablers find many ingenious and unethical ways to obtain and misuse medicines in a dangerous and unapproved manner for performance enhancement in sporting events. The fight against doping is thus a constant challenge for the biopharmaceutical industry as well as regulators, anti-doping agencies, sports organizations, and law enforcement agencies. The risks to individual athletes – both professional and amateur – of inappropriate, uncontrolled and unsafe use of medicines for doping are real and ever-present. Novel medicines are particularly attractive to would-be dopers precisely because they are new and are believed to be undetectable. The biopharmaceutical industry is ideally positioned to support anti-doping agencies in recognizing and addressing the misuse of new medicines. This session examines the opportunities for industry collaboration with antidoping agencies to identify and pre-empt potential doping abuse of new medicines and identifies areas for further development.

    Speaker(s):

    • National Partnership Between an Anti-doping Agency and Pharmaceutical Industries for the Promotion of Sporting Integrity ~ (Japanese Language Only)
      Takao Akama, MD,PhD
      Vice President
      Japan Anti-Doping Agency (JADA), Japan
    • The Biopharmaceutical Industry’s Collaboration Against Doping Abuse of Medicines in Sport – Recent Experience ~ (Japanese Language Only)
      Tatsuya Kamiuchi
      Drug Safety Coordination Dept.
      Chugai Pharmaceutical Co., Ltd., Japan
  • 2:00PM - 2:20PM

    Special Speech: Messages for the 10th Memorial Round Table Future Drug Development and Regulatory Science

    Speaker(s):

    • Messages for the 10th Memorial Round Table Future Drug Development and Regulatory Science
      Tatsuya Kondo, MD,PhD
      Chief Executive
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 2:20PM - 3:50PM

    Drug Development in the Future


    Session Chair(s):

    • No-image Tatsuo Kurokawa, PhD
      Professor, Div. of Drug Development and Regulatory Sciences, Faculty of Pharmacy
      Keio University, Japan

    How will medical products be developed in the future in an increasingly globalized world? Drug developments from the bridging strategy to global clinical trials have been changed and the variations of development are also increasing, it has been important business strategy how a company get a marketing authorization for pharmaceuticals in global strategy. In addition, the proportion of targeting strategy, which it is a world-class new trend drug therapy with companion diagnostics, antibody and orphan drugs etc., is greater. When we turn our eyes to the domestic situation, it is existed unique Japanese issue that expensive medicines are increasingly tight in the budget, including medical insurance. Under these circumstances, regulators and heads of R&D department will exchange their opinions about the future drug development, including how to develop drug in the future and how a way of thinking of Regulatory authorities change in the future etc.

    Speaker(s):

    • Sandra Milliagan presentation
      Sandra A. Milligan, JD,MD
      VP, Regulatory Affairs, Immunology, Infectious Disease & Ophthalmology
      Genentech Inc., A Member of the Roche Group, United States
    • Haruhisa Hirosaki presentation
      Haruhisa Hirosaki
      Corporate Executive, Executive Vice President, Head of Japan Development
      Astellas Pharma Inc., Japan
    • Hiromichi Shirasawa presentation
      Hiromichi Shirasawa, MD
      Vice President and Executive Officer, Head of Japan Development
      MSD K.K., Japan
    • Dalvir Gill presentation
      Dalvir Gill, PhD
      Chief Executive Officer
      TransCelerate Biopharma Inc, United States
    • Daisaku Sato presentation
      Daisaku Sato, PhD
      Director, Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 4:10PM - 5:40PM

    Round Table 2: Japanese ARO Model


    Session Chair(s):

    • No-image Fumitaka Nagamura, MD,PhD
      Professor
      The University of Tokyo, Japan
  • 5:40PM - 5:50PM

    Best Presenter Award
  • 5:50PM - 6:00PM

    Closing Remarks

    Speaker(s):

    • Yasushi Saito, MD,PhD
      President
      Chiba University, Japan

Exhibits  

The 10th Annual Meeting DIA Japan 2013 offers interested companies following exhibit and support opportunities.

  • Industry Exhibit Booth Space (2475 x 2475 mm) - ¥420,000
  • Academia Tabletop Space (2300 x 1400 mm) - ¥105,000
  • Lunch Time and Coffee Break Presentation - ¥189,000
  • Program Adversitment Insertions (see brochure for pricing)
  • Congress Bag Insert - ¥31,500

All prices include 5% Consumption Tax

Useful Links:

  • A+ Inc.
  • ADM Korea Inc.
  • A-PACT (Alliance for Pac-Asia Clinical Trials)
  • ArisGlobal KK
  • Bell Medical Solutions, Inc.
  • BioClinica Inc.
  • Biotrial
  • Bracket
  • Chiba University Hospital Clinical Research Center
  • Clinical Investigation and Research Unit, Gunma University Hospital
  • Clinical Trial & Research Network IBARAKI
  • CMIC HOLDINGS Co., Ltd.
  • EPS Group
  • Foresight Group, LLC
  • Hangzhou Tigermed Consulting Co., Ltd.
  • Huntingdon Life Sciences Co., Ltd.
  • Information Services International - Dentsu, Ltd.
  • Integrated Development Associates Co., Ltd.
  • inVentiv Health Clinical
  • inVentiv Medical Communications
  • Kyushu University Hospital
  • LSK Global Pharma Services Co., Ltd.
  • Medidata Solutions K. K.
  • Mitsubishi Chemical Medience Corporation
  • Moravia Life Sciences

Registration Fees 

Member

Member Academia
¥19000.00
Member Government
¥29000.00
Member Standard (Early-bird thru 10/23/13)
¥78000.00

Non-Member

NonMember Academia
¥19000.00
NonMember Government
¥44000.00
NonMember Standard
¥93000.00
Registration Fees for Additional Offerings
#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies - Member Academia Rate
¥2000.00
#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies - Member Government Rate
¥3000.00
#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies - Member Standard (Early-bird thru 10/23/13) Rate
¥12000.00
#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies - NonMember Academia Rate
¥2000.00
#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies - NonMember Government Rate
¥3000.00
#1: Point to Consider: Safety Content of Company Core Data Sheet Prepared by Western Companies - NonMember Standard Rate
¥12000.00
#2: A New Project Manager: Team Management - Member Academia Rate
¥2000.00
#2: A New Project Manager: Team Management - Member Government Rate
¥3000.00
#2: A New Project Manager: Team Management - Member Standard (Early-bird thru 10/23/13) Rate
¥12000.00
#2: A New Project Manager: Team Management - NonMember Academia Rate
¥2000.00
#2: A New Project Manager: Team Management - NonMember Government Rate
¥3000.00
#2: A New Project Manager: Team Management - NonMember Standard Rate
¥12000.00
#3: Action learning for Six Sigma analytical tools by real case study - Member Academia Rate
¥2000.00
#3: Action learning for Six Sigma analytical tools by real case study - Member Government Rate
¥3000.00
#3: Action learning for Six Sigma analytical tools by real case study - Member Standard (Early-bird thru 10/23/13) Rate
¥12000.00
#3: Action learning for Six Sigma analytical tools by real case study - NonMember Academia Rate
¥2000.00
#3: Action learning for Six Sigma analytical tools by real case study - NonMember Government Rate
¥3000.00
#3: Action learning for Six Sigma analytical tools by real case study - NonMember Standard Rate
¥12000.00
#4: HTA in practice in Europe - What are the challenges for Japan? - Member Academia Rate
¥2000.00
#4: HTA in practice in Europe - What are the challenges for Japan? - Member Government Rate
¥3000.00
#4: HTA in practice in Europe - What are the challenges for Japan? - Member Standard (Early-bird thru 10/23/13) Rate
¥12000.00
#4: HTA in practice in Europe - What are the challenges for Japan? - NonMember Academia Rate
¥2000.00
#4: HTA in practice in Europe - What are the challenges for Japan? - NonMember Government Rate
¥3000.00
#4: HTA in practice in Europe - What are the challenges for Japan? - NonMember Standard Rate
¥12000.00
#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development - Member Academia Rate
¥2000.00
#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development - Member Government Rate
¥3000.00
#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development - Member Standard (Early-bird thru 10/23/13) Rate
¥12000.00
#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development - NonMember Academia Rate
¥2000.00
#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development - NonMember Government Rate
¥3000.00
#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development - NonMember Standard Rate
¥12000.00
#6: Control Strategy for Drug Substance Based on ICH M7 and Q11 - Member Academia Rate
¥2000.00
#6: Control Strategy for Drug Substance Based on ICH M7 and Q11 - Member Government Rate
¥3000.00
#6: Control Strategy for Drug Substance Based on ICH M7 and Q11 - Member Standard (Early-bird thru 10/23/13) Rate
¥12000.00
#6: Control Strategy for Drug Substance Based on ICH M7 and Q11 - NonMember Academia Rate
¥2000.00
#6: Control Strategy for Drug Substance Based on ICH M7 and Q11 - NonMember Government Rate
¥3000.00
#6: Control Strategy for Drug Substance Based on ICH M7 and Q11 - NonMember Standard Rate
¥12000.00
Group Discounts

There are no Group Discounts for this event.

 


SPECIAL BUNDLED PRICING: Save when you register for these combinations! Special discounts apply when purchasing 2 Tutorials. Save even more by purchasing Full Program at the same time. Please see Registration Form for more details.

(1) Full Program + 2 Tutorials (Morning of November 6) OR

(2) Full Program + Advanced Regulatory Affairs Training Course in Japan (November 6 from 9:00-13:00) 


CANCELLATION POLICY: On or before October 30, 2013
Administrative fee that will be withheld from refund amount:
Industry (Member or Nonmember) = ¥20,000
Government/Academia/Nonprofit (Member or Nonmember) = ¥10,000
Tutorials Only (Member or Nonmember) = ¥2,000

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

DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

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