5th IABS Cell Therapy Conference in Tokyo · IABS Cell and Gene Therapy Committee Chair: Takao...

5 th IABS Cell Therapy Conference in Tokyo Toward international convergence of core scientific elements and evaluation of human cell therapy products 4-5 February 2020 Registration fees: *Early registration (before 17 January 2020) Trainee / Student*/Special Government : IABS member US$ 80 Non-IABS member US$ 100 Academia / Other Government / Research Institute IABS member US$ 250 Non-IABS member US$ 300 Industry IABS member US$ 600 Non-IABS member US$ 700 *Regular registration (after 17 January 2020) Trainee / Student*/Special Government : IABS member US$ 130 Non-IABS member US$ 150 Academia / Other Government / Research Institute IABS member US$ 300 Non-IABS member US$ 350 Industry IABS member US$ 650 Non-IABS member US$ 750 *Registration must be accompanied by a letter from program director/ supervisor confirming Trainee/Student status. Please visit the workshop website: https://www.iabs.org/ https://iabs-tokyo-2020.jimdofree.com/ Secretariat: Hitomi MURAOKA Division of Cell-Based Therapeutic Products National Institute of Health Sciences (NIHS) 3-25-26, Tonomachi, Kawasaki-ku, Kawasaki-shi 210-9501, JAPAN E-mail : [email protected] Access Information: https://www.mitsui-mice.jp/nihonbashi/en/muromachi/access/ Muromachi Mitsui Hall & Conference 3F COREDO Muromachi Terrace 3-2-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-0022 Japan CHUO St. Muromachi Mitsui Hall & Conference 3-2-1, Nihonbashi Muromachi, Chuo-ku, Tokyo 103-0022, Japan https://www.mitsui-mice.jp/nihonbashi/en/muromachi/ Organized by: International Alliance for Biological Standardization (IABS) With the support from: Osaka University Graduate School of Medicine IABS Cell and Gene Therapy Committee Chair: Takao HAYAKAWA, Ph.D. AGENDA (Draft on 27 November 2019): ※Please refer to the HP for the latest information. Day 1 – Tuesday, 4 FEBRUARY 2020 Keynote Address 1 Stem cells and their clinical applications ：Dr. Yoshiki Sawa (Osaka Univ.& JSRM) Keynote Address 2 Points to consider for the evaluation of human cell therapy products: TBA Session 1 Global regulatory landscape of cell therapy products Session 2 Sustainable availability of qualified raw materials for manufacturing of hCTPs Educational Lectures New analytical technologies for cell therapy products and related materials Panel Discussions Quality standards of biological raw materials for manufacturing of cell therapy product Networking Reception Day 2 – Wednesday, 5 FEBRUARY 2020 Keynote Address 3 The world's first clinical study for corneal cell sheets made from human iPS cells: Dr. Kohji Nishida (Osaka Univ.) Session 3 Tumorigenicity Assessment of cell therapy products Panel Discussions Tumorigenicity Assessment of cell therapy products Keynote Address 4 CAR-T Story from EMA's Viewpoint: Dr. Matthias Renner (PEI) CAR-T Story from PMDA/MHLW's Viewpoint: Dr. Yoshiaki Maruyama(PMDA) Session 4 Characterization and QC of hCTPs and/or their critical intermediates :identification of critical quality attributes (CQA) Panel Discussions Characterization, specifications (especially, potency), and comparability of hCTPs Session 5 (Panel Discussions) Toward international convergence of core scientific elements and evaluation of hCTPs

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Transcript of 5th IABS Cell Therapy Conference in Tokyo · IABS Cell and Gene Therapy Committee Chair: Takao...

Page 1: 5th IABS Cell Therapy Conference in Tokyo · IABS Cell and Gene Therapy Committee Chair: Takao HAYAKAWA, Ph.D. AGENDA(Draft on 27 November 2019): ※Please refer to the HP for the

5th IABS Cell Therapy Conference in TokyoToward international convergence of core scientific elements

and evaluation of human cell therapy products

4-5 February 2020

Registration fees: *Early registration (before 17 January 2020) Trainee / Student*/Special Government : IABS member US$ 80 Non-IABS member US$ 100 Academia / Other Government / Research Institute IABS member US$ 250 Non-IABS member US$ 300 Industry IABS member US$ 600 Non-IABS member US$ 700 *Regular registration (after 17 January 2020) Trainee / Student*/Special Government : IABS member US$ 130 Non-IABS member US$ 150 Academia / Other Government / Research Institute IABS member US$ 300 Non-IABS member US$ 350 Industry 　IABS member US$ 650 　Non-IABS member US$ 750*Registration must be accompanied by a letter from program director/ supervisor confirming Trainee/Student status.

Please visit the workshop website: https://www.iabs.org/https://iabs-tokyo-2020.jimdofree.com/

Secretariat:Hitomi MURAOKADivision of Cell-Based Therapeutic ProductsNational Institute of Health Sciences (NIHS)3-25-26, Tonomachi, Kawasaki-ku, Kawasaki-shi 210-9501, JAPANE-mail : [email protected]

Access Information:https://www.mitsui-mice.jp/nihonbashi/en/muromachi/access/Muromachi Mitsui Hall & Conference3F COREDO Muromachi Terrace3-2-1 Nihonbashi-Muromachi, Chuo-ku, Tokyo 103-0022 Japan

St.

Muromachi Mitsui Hall & Conference3-2-1, Nihonbashi Muromachi, Chuo-ku, Tokyo 103-0022, Japanhttps://www.mitsui-mice.jp/nihonbashi/en/muromachi/

Organized by:International Alliance for Biological Standardization (IABS)

With the support from:Osaka University Graduate School of Medicine

IABS Cell and Gene Therapy Committee Chair: Takao HAYAKAWA, Ph.D.

AGENDA (Draft on 27 November 2019):※Please refer to the HP for the latest information.

Day 1 – Tuesday, 4 FEBRUARY 2020Keynote Address 1 Stem cells and their clinical applications： Dr. Yoshiki Sawa (Osaka Univ.& JSRM)Keynote Address 2 Points to consider for the evaluation of human cell therapy products: TBASession 1 Global regulatory landscape of cell therapy products

Session 2 Sustainable availability of qualified raw materials for manufacturing of hCTPs

Educational Lectures New analytical technologies for cell therapy products and related materials

Panel Discussions Quality standards of biological raw materials for manufacturing of cell therapy product

Networking Reception

Day 2 – Wednesday, 5 FEBRUARY 2020Keynote Address 3 The world's first clinical study for corneal cell sheets made from human iPS cells: Dr. Kohji Nishida (Osaka Univ.)Session 3 Tumorigenicity Assessment of cell therapy products

Panel Discussions Tumorigenicity Assessment of cell therapy products

Keynote Address 4 CAR-T Story from EMA's Viewpoint: Dr. Matthias Renner (PEI)CAR-T Story from PMDA/MHLW's Viewpoint: Dr. Yoshiaki Maruyama(PMDA)

Session 4 Characterization and QC of hCTPs and/or their critical intermediates :identification of critical quality attributes (CQA)

Panel Discussions Characterization, specifications (especially, potency), and comparability of hCTPs

Session 5 (Panel Discussions) Toward international convergence of core scientific elements and evaluation of hCTPs