製剤技術とGMPの最先端技術情報

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

前のページへ戻る

この記事に関連する商材情報

こちらの記事もご覧ください

TOP