5th DIA Cell and Gene Therapy Products Symposium in Japan
“Regenerative Medicine from Innovation to Industrialization”
Development of regenerative medicines in Japan has attracted international interest since implementation of the Regenerative Medicine Promotion Act in 2013 to establish the framework for the rapid development, regulation, and practical use of these products. As a result of accelerated clinical development, originating both in Japan and overseas, of regenerative medicines for intractable diseases, several regenerative medicine products have been put into practical therapeutic use in Japan. This accelerated development has also clearly and concretely identified issues for improvement at every stage of these complex processes from R&D through commercialization and consumer use, and post-market safety evaluation.
DIA Japan’s Regenerative Medicines Symposium, held annually since 2016, provides the leading platform for all stakeholders in industry, government, and academia to share the issues they face and explore solutions together through constructive discussions on these and related topics. This year’s title, Regenerative Medicine from Innovation to Industrialization, illustrates the evolution of this Symposium since our 1st DIA Cell Therapy Products Symposium in Japan in 2016. This evolution ensures opportunities for urgent and active discussion and has engaged experts from industry, government, and academia in this symposium annually and continuously.
Introducing the "practical application" of regenerative medicine into the theme for this 2020 Symposium builds upon the "industrialization" topic of previous symposiums, which addressed consistent development and delivery of quality products to patients in medical settings. The two-day agenda for this 2020 Symposium addresses these and related issues.
Day 1 will highlight updates on ICH Q5A (Viral Safety, etc. of Biotechnology-Derived Pharmaceuticals) as essential to delivering regenerative medicine products without delay. Discussions that will help confirm and put into practice concepts that form the basis for the quality of regenerative medicine will address the operational and utilization aspects of the supplemental "Technical requirements and standards common to the evaluation of the quality and safety, etc. of human cell products" (MCP) being prepared for release. The last session will share one company’s experience with equivalence/ homogeneity evaluation, the key and critical component to building efficient and stable manufacturing systems, based on an appropriate industrialized change control strategy.
Day 2 will discuss anticipated distribution issues and distribution case studies for these products, which require more advanced supply systems because they are more sophisticated and complex, from the aspects of regulators, patients, and medical institution management. Day 2 will conclude with a survey of Asia to introduce the views of the regulatory authorities on development of regenerative medicine products in Asian countries and activities aimed at regulatory harmonization in Asia.
The 5th DIA Cell and Gene Therapy Products Symposium in Japanwill also feature keynote lectures by key opinion and thought leaders from Japan and overseas. On Day 1, Dr. Johnes Blümel (Paul Ehrlich Institute) will speak about current and future viral safety assessments of biological products, and Dr. Takayuki Aoi (Kobe University) will talk about current and anticipated future developments in cancer therapy research using iPS cells. On Day 2, Dr. Takanori Takebe (Yokohama City University, Tokyo Medical and Dental University) will introduce symposium attendees to cutting-edge research including organ regeneration from stem cells, and Mr. Fumihito Takanashi (Medical Device Evaluation Division, Pharmaceutical Safety & Environmental Health Bureau, Ministry of Health, Labour & Welfare) will deliver a lecture on Japan’s efforts in the harmonization of Asian regulations needed to develop effective and safe regenerative medicine products as One Asia.
This year’s symposium will be presented as a webinar, the standard gathering format in our "new normal," and has been planned to ensure interactive online communication. Days 1 and 2 will be presented and packaged as one program.
This package includes download service so attendees can fully utilize these presentation materials, recorded sessions, and keynote lectures in their own home or work environments*.
The 5th DIA Cell and Gene Therapy Products Symposium in Japancontinues to provide a respected and cutting-edge forum for continued discussions among industry, academia, and government to advance the development and practical use of regenerative medicine products in Japan. It also continues to grow as a valuable networking venue that allows you to bring the latest updates and issues in product development and industrialization back into your own practical work, along with expert knowledge and insights for solving these issues. We look forward to seeing you this year.
*Please note that there may be restrictions on recording and sharing materials based on the content and nature of each session or lecture.
Who should attend?
Daisaku Sato, PhD, MPharm, RPh • Director, Compliance & Narcotics Division
Ministry of Health, Labour and Welfare, Japan
Yasuko Terao, PhD • Director, External Collaboration and Portfolio Management Department
Janssen Pharmaceutical K.K., Japan
Teruyo Arato, PhD • Professor, Clinical Research and Medical Innovation Center
Hokkaido University Hospital, Japan
Masaki Kasai, PhD • Principal Reviewer, Office of Cellular and Tissue-basaed Products
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshie Tsurumaki • Group Manager, Cell & Gene Franchise
Novartis Pharma K.K., Japan
Kazunobu Oyama, PhD •
Hiromi Okabe, PhD • Associate Director, Development Regulatory Affairs Dept.
Daiichi Sankyo Co., Ltd., Japan
Masafumi Onodera, MD, PhD • Director, Center of Gene Cell Therapy Promotion,
National Center for Child Health and Development, Japan
Satoru Hayata, MS •
Sobi Japan, Japan
Hiroyuki Suda, MSc • VP, Clinical Development Strategy
KORTUC Inc., Japan
Sumimasa Nagai, MD, PhD • Institute for Advancement of Clinical and Translational Science(iACT)
Kyoto University Hospital, Japan
Yoji Sato, PhD • Head, Division of Cell-Based Therapeutic Products
National Institute of Health Sciences, Japan
Akiko Ikeda, RPh • Associate Director, Regulatory Development Dept.
Janssen Pharmaceutical K.K., Japan