2月4日（火）、5日（水）
5TH IABS CELL THERAPY CONFERENCE 2020
●Objectives of the meeting
This meeting will bring together an outstanding and diverse group of speakers from regulatory agencies, industry, and academia, all of whom are at the forefront of the cell therapy (CT) field. The major objective of the meeting is to make continuous efforts toward international convergence of core scientific elements and evaluation for ensuring quality and safety of human cell therapy products (hCTPs).
The 5th IABS CT meeting will build further considerations on outcomes of previous meetings and relevant papers with respect to the scientific basis for the research, development, evaluation, and standardization of hCTPs derived from substantially manipulated human cells, which include stem cells and stem cell line derived products and CAR-T cell products. Core scientific elements for CMC, nonclinical, and clinical studies will be identified and addressed so that they can be commonly employed among interested parties as a basic consensus package for product development and assessment. In addition, some issues that are derived unique structural and biological features of hCTPs and need to further studies and discussions continuously in order to improve, solve or even break through will be covered. These include: characterization of cells and determination of their critical quality attribute (CQA); relationship between CQA and safety/efficacy of the final products; potency measurement; setting specifications; comparability study; tumorigenicity testing; development of new analytical methodologies among others.
●開催概要
日時：2020年2月4日（火）、5日（水）
会場：室町三井ホール&カンファレンス
東京都中央区日本橋室町三丁目2番1号 COREDO室町テラス3階
（https://www.mitsui-mice.jp/nihonbashi/muromachi/access/）
申し込み・詳細：https://5th-cell-therapy-tokyo-2020.iabs.org/
●プログラム（詳細はこちらから）
1日目 | 2020年2月4日（火）
08:00 Registration Photo session
09:00 Welcome remarks
Dr. Yoji SATO, Chair; National Institute of Health Sciences (NIHS), Japan
09:15 Opening remarks
Prof. Jean-Hugues TROUVIN, IABS; University Paris Descartes, France
Chairperson Prof. Jean-Hugues TROUVIN, IABS; University Paris Descartes, France
09:15 Keynote address Stem cells and their clinical applications
Dr. Yoshiki SAWA, Osaka University & JCRM
Chairperson TBC
09:55 Keynote address Points to consider for the evaluation of human cell therapy products
Session 1 - Global regulatory landscape of cell therapy products
Chairpersons: Dr. Daisaku SATO, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Ivana KNEZEVIC, World Health Organization, Switzerland
10:35 Regulatory perspectives on cell therapy development in North America
Dr. Stephen OH, CBER / FDA, U.S.A.
10:55 Regulatory perspectives on cell therapy development in Europe
Dr. Matthias RENNER, Paul-Ehrlich-Institut (PEI), Germany
11:15 Regulatory perspectives on cell therapy development in Japan
Dr. Daisaku SATO, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
11:35 Lunch
13:00 Regulatory perspectives on cell therapy development in India TBC
13:20 Regulatory perspectives on cell therapy development in Taiwan
Dr. Wen-Yi HUNG, Taiwan FDA (TFDA), Taiwan
13:40 Regulatory perspectives on cell therapy development in Korea
Dr. Jounghee BAEK, National Institute of Food and Drug Safety Evaluation (NIFDS) / Ministry of Food and Drug Safety (MFDS), Korea
14:00 Perspectives of the World Health Organization on the development of cell therapy products
Dr. Ivana KNEZEVIC, World Health Organization, Switzerland
14:20 Coffee break
Session 2 - Sustainable availability of qualified raw materials for manufacturing of hCTPs
Chairpersons: Dr. T. AOI, Kobe University, Japan
Prof. Glyn STACEY, International Stem Cell Banking Initiative, United Kingdom
14:40 Quality and safety of raw materials (except starting cells)
TBC
15:00 Evaluation and quality control of tissue derived somatic cells as raw materials of hCTPs (including Donor screening, Autologous vs Allogeneic)
TBC
15:20 Evaluation and quality control of PSCs as raw materials of hCTPs (including Donor screening, Autologous vs Allogeneic)
TBC
15:40 Development of storage and transportation procedures for cells during manufacturing process
Dr. Christian BARKEY, Barkey GmbH, Germany
16:00 Short break Educational lectures
Chairperson Dr. Shin KAWAMATA, Kobe Medical Center, Japan
16:10 New analytical technologies for cells (single cell analysis)
Dr. Piero CARMINCI, RIKEN, Japan
16:50 New analytical technologies for cell therapy products (in-line monitoring)
Shimadzu, Dr. Takashi SUZUKI, Shimazu, Japan
17:10 Short break
Panel discussion
Moderator Prof. Glyn STACEY, International Stem Cell Banking Initiative, United Kingdom Quality standards of biological raw materials for manufacturing of cell therapy product Chairs & Speakers of Session 2 & Educational Lectures
18:15 Networking Reception
19:45 End of Day 1
2日目 | 2020年2月6日（木）
Chairpersons: Dr. Ken-ichiro HATA, Forum for Innovative Regenerative Medicine (FIRM), Japan
09:00 Keynote address The world's first clinical study for corneal cell sheets made from human iPS cells
Dr. Kohji NISHIDA, Osaka University, Japan
Session 3 - Tumorigenicity Assessment of cell therapy products
Chairpersons: Dr. Hiroto BANDO, Fuji Film, Japan
Dr. Lucilia MOURIES, Health and Environmental Sciences Institute (HESI), U.S.A.
09:40 In vivo testing for detection of residual PSCs
Dr. N. TANAKA, Terumo, Japan 09:55 In vitro testing for detection of residual PSCs
Dr. AZUMA, Fuji Film, Japan
10:10 In vitro testing for detection of transformed cells in cell therapy products
Dr. K. BANDO, Sumitomo Dainippon Pharma, Japan
10:25 Non-clinical biodistribution study
Dr. KAMIYAMA, Astellas, Japan
10:40 HESI CT-TRACS International Experimental Consortium
Dr. Lucilia MOURIES, Health and Environmental Sciences Institute (HESI), U.S.A.
10:55 Short break
Panel discussion
Moderator Dr. Yoji SATO, Chair; National Institute of Health Sciences (NIHS), Japan Tumorigenicity Assessment of cell therapy products Chairs & Speakers of Session 3 & Educational Lectures
11:35 Lunch
Chairpersons: Dr. Akihiro UMEZAWA, (NCCHD)
13:00 CAR-T Story from EMA's Viewpoint
Dr. Matthias RENNER, Paul Ehrlich Institut (PEI), Germany; European Medicines Agency (EMA), The Netherlands
13:30 CAR-T Story from PMDA/MHLW's Viewpoint
Dr. Yoshiaki MARUYAMA, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Session 4 – Characterization and QC of hCTPs and/or their critical intermediates: identification of critical quality attributes (CQA)
Chairpersons: Dr. M. YAMATO, Tokyo Women’s Medical University, Japan
Dr. Ingrid MARKOVIC, Genentech, U.S.A.
14:00 How to identify CQA of the cell product(s) at critical step(s) of mfg. process to ensure consistency of products
Dr. Shin KAWAMATA, Foundation for Biomedical Research and Innovation (FBRI), Japan
14:20 How to identify CQA for QC of hCTPs (including setting Specifications)
Dr. Ingrid MARKOVIC, Genentech, U.S.A
14:40 How to establish potency of hCTPs
Dr. Andrew CHANG, Novo
15:00 Potential comparability study using QA at early development stage of hCTPs: When, How?
Dr. Pierrette ZORZI-MORE, formerly AFSSAP
Panel discussion
Moderator Dr. Andrew CHANG, Novo Characterization, specifications (especially, potency), and comparability of hCTPs
Dr. YAMATO & Speakers of Session 4
16:10 Short break
Session 5 – Panel discussion
Moderator Prof. Jean-Hugues TROUVIN, IABS; University Paris Descartes, France
Toward international convergence of core scientific elements and evaluation of hCTPs Chairs of all the sessions
16:20 Potential scientific elements commonly useful for evaluation of most of hCTPs with respect to CMC Ongoing discussion/consideration issues Subjects to be taken flexible case-by-case approach
17:05 Wrap-up – Summary Day 1 & Day 2
Dr. Yoji SATO, Chair; National Institute of Health Sciences (NIHS), Japan
17:25 Closing remarks
Prof. Jean-Hugues TROUVIN, IABS; University Paris Descartes, France
17:35 End Day 2
