Menu Back to 4th-DIA-Cell-and-Gene-Therapy-Products-Symposium-in-Japan

Overview

4th DIA Cell and Gene Therapy Products Symposium in Japan
- Development and Practical Use of Cell and Gene Therapy Products in Japan and Across the Globe -
Day 1: Cell and Gene Therapy Products; New Challenges in Global Development
Day 2: Cell and Gene Therapy Products; Reality of “From Bench to Bedside”

Click Here to View the Program

Accelerated by new regulatory and legal systems that came into practice in 2013, development of regenerative medicine in Japan has attracted considerable international attention. Many recent advances in the development of cell therapy products in Japan have been reported in articles not only in scientific journals but in more general publications. These advancements and reports have revealed numerous issues in the development, distribution, and post-market management of these products.

Since 2016, DIA Japan has brought together stakeholders involved in developing cell therapy products, particularly from industry and academia, for our annual Cell Therapy Products Symposium, and we announce with great pleasure that our 4th Cell and Gene Therapy Products Symposium is scheduled for December 16-17, 2019.

The mission of this Symposium – to exchange insights and ideas with relevant regulatory and other government authorities that deepen mutual understanding and resolve issues of concern around these products – has remained unchanged since 2016. But in 2018, we expanded our agenda to include gene therapy, reflecting scientific progress in this area as well as requests from these stakeholders. Our agenda for 2019 has further expanded to cover essential challenges and issues encountered in each stage of development, in a global development strategy, for these novel therapeutics.

For 2019, three key opinion leaders will deliver keynote addresses on their cutting-edge research; Professor Kounosuke Mitani, Saitama Medical University, on genome editing; Professor Koji Eto, CiRA, on platelet production from iPS cells; and Professor Hiroshi Shiku, Mie University, on CAR-T research. In addition, speakers from PMDA will be joined by speakers from FDA and EMA to share through lectures and joint panel discussions the current state of regulatory and related frameworks across Japan, Europe, and the US.

While this program presents the opportunity to attend either the first or second day independently, we invite you to participate through both days. For example, approaching the comparability of cell/gene products will be discussed on day one; day two will discuss updates on the Cartagena Act and on the concepts and requirements for long-term post-marketing follow-up.

We hope that our 4th Cell and Gene Therapy Products Symposium will continue to provide the best framework for exchanging knowledge and sharing insights about these products in Japan, and also provide high-value networking opportunities for you and your colleagues. We look forward to your active participation in Tokyo.

Who should attend?

Cell therapy/gene therapy product development professionals in biopharmaceutical companies, medical devices companies, venture capital companies, regulatory agencies, or academia.

Program Committee

  • Daisaku  Sato, PhD, MPharm
    Daisaku Sato, PhD, MPharm Chief Management Officer & Associate Centre Director for Advanced Evaluation
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Yasuko  Terao, PhD
    Yasuko Terao, PhD Director, External Collaboration and Portfolio Management Department
    Janssen Pharmaceutical K.K., Japan
  • Teruyo  Arato, PhD
    Teruyo Arato, PhD Professor, Clinical Research and Medical Innovation Center
    Hokkaido University Hospital, Japan
  • Masaki  Kasai, PhD
    Masaki Kasai, PhD Principal Reviewer, Office of Cellular and Tissue-basaed Products
    Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Satoru  Hayata, MS
    Satoru Hayata, MS Head of Center, Rare Diseases Medicine Development Centre
    GlaxoSmithKline K.K., Japan
  • Keiji  Miyamoto
    Keiji Miyamoto Principle, Regulatory Affairs Group, Post-Marketing Regulatory Affairs Dept.
    Daiichi Sankyo Co., Ltd., Japan
  • Sumimasa  Nagai, MD, PhD
    Sumimasa Nagai, MD, PhD Senior Assistant Professor, Translational Research Center
    The University of Tokyo Hospital, Japan
  • Hiromi  Okabe, PhD
    Hiromi Okabe, PhD Manager, Global Regulatory Management Group, New Drug Regulatory Affairs Dept.
    Daiichi Sankyo Co., Ltd., Japan
  • Masafumi  Onodera, MD, PhD
    Masafumi Onodera, MD, PhD Head, Department of Human Genetics / Chief, Division of Immunology
    National Center for Child Health and Development, Japan
  • Hiroyuki  Suda, MSc
    Hiroyuki Suda, MSc Senior Director, Clinical Operation Department
    Oncolys BioPharma Inc., Japan
  • Yoshie  Tsurumaki
    Yoshie Tsurumaki Senior Incubator Program Manager, CTL019 Incubator Dept, Oncology Dev. & MA Dept
    Novartis Pharma K.K., Japan
  • Akiko  Ikeda, RPh
    Akiko Ikeda, RPh Senior Manager, Policy Intelligence Dept., Integrated Market Access Division
    Janssen Pharmaceutical K.K., Japan
  • Yoji  Sato, PhD
    Yoji Sato, PhD Head, Division of Cell-Based Therapeutic Products
    National Institute of Health Sciences, Japan
Load More

Contact us


Please contact DIA Japan for further information.

Send Email
+81.3.6214.0574

Digital Learning Catalog

DIA Learning: eLearning Soultions
Download