Plenary Speakers

Challenge andPromise in
Cell andVaccine Therapyin Asia

Hiroshi Shiku (Mie University)
Mitsuru Miyata (Nikkei Business Publications, Inc.)

Speakers
Japan

Tsuyoshi Ando (Pharmaceuticals and Medical Devices Agency)
Yoko Funakoshi (SBI Biotech Co., Ltd.)
Satoshi Hamada (Mitsui & Co., Ltd.)
Miki Isogai (PharmaBio Co.)
Yoshiji Kimura (MEDINET Co., Ltd.)Naoto Matsuda (Toyo Seikan Kaisha, Ltd.)
Fumitaka Nagamura (The University of Tokyo)
Hidenori Nakajima (Astellas Pharma Inc.)
Yosuke Ozawa (Japan Tissue Engineering Co., Ltd.)
Tomoki Todo (The University of Tokyo)
Korea

Jay Lee (Medipost Co., Ltd.)China

Di Xu (Sino-American iCell (Shanghai) Biotechnology Co., Ltd.)

Toward Clinical Approvalfor Commercialization
October 16 (Tue), 2012 9:00–18:15

Malaysia

Ishak Mat (Advanced Medical & Dental Institute, Universiti Sains Malaysia)
Australia

Dominic Wall (Cell Therapies Pty Ltd.)The Institute of Medical Science, The University of Tokyo,
Auditorium (Main building 1F)

TaiwanChing-Yu Lu (Center for Drug Evaluation)
Organising Committee

Hiroshi Kiyono (The University of Tokyo)
Ken-ichi Arai (The University of Tokyo)
Sumiko Watanabe (The University of Tokyo)

Supported by• Special Coordination Funds for Promoting Science & Technology, MEXT
Establishment of a life science research network in Asia
(Principal Investigator; Hiroshi Kiyono)• Genomic Drug Discovery Forum
Co-sponsored by• NPG Nature Asia-Pacific• The Japan Institute of International Affairs• Tomy Digital Biology Co., Ltd.

(http://www.ims.u-tokyo.ac.jp/imsut/en/)

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ーアジア連携による製品化をめざしてー

Challenge and Promise in Cell and Vaccine Therapy in Asia
-Toward Clinical Approval for Commercialization2012 October 16 (Tue) 9:00〜18:15

Venue:

Institute of Medical Science, University of Tokyo,
Auditorium (Main building 1F)
URL: http://www.ims.u-tokyo.ac.jp/imsut/en/Opening
Sumiko Watanabe(IMSUT)

09：00-09：10

Introduction
09：10-09：40

Chair : Yoichi Furukawa

Hiroshi Shiku（University of Mie ）Session 1

Cancer Immunotherapy; Integration of T cell Biology
with Nanogel- and Vector-Technology in Translational Research

The experiences of companies already started cell therapy
Chair : Tadashi Matsumoto

Yosuke Ozawa(J-TEC)
Jay Lee（Medipost, Korea）

09：40-10：10
10：10-10：40

Special Lecture

KFS and Issues in Commercializing Regenerative Medicine in Japan
World’s First off-the-shelf allogeneic cord-blood stem cell drug CARTISTEM® - Journey to the market from the scratch.

Oncolytic Virus and Cell Therapy for Cancer
Chair : Masaaki Muramatsu

10：40-11：05

Tomoki Todo(IMSUT)

11：05-11：20

Break

Clinical Development of Oncolytic Virus Therapy

The experiences of companies already started cell therapy

Session 1

Chair : Tadashi Matsumoto

Kunihiko Suzuki(Medinet Co.,Ltd.)

11：20-11:40

Alternative Path in Practice of Cell Therapy with using Immuno-Cells

Special Lecture

Chair
Chair : Ken-ichi
Arai: Ken-ichi A

11：40-12：30

Mitsuru Miyata(Nikkei BP Inc.)

12：30-13：30

LunchSession 2Foreign and Domestic companies/organizations trying to develop cell therapy

Social and Legal Issues on Regenerative Medicine and Vaccine

Chair : Ken-ichi Arai

13：30-13：50
13：50-14：10
14：10-14：40
14：40-15：00
15：00-15：20
15：20-15：30

Di Xu(iCell, China)
Yoko Funakoshi(SBI Biotech Co.,Ltd.)
Ishak Mat(AMDI, Malaysia)
Hidenori Nakajima(Astellas Pharma Inc.)
Satoshi Hamada(Mitsui & Co.,Ltd.)BreakThe clinical research of DCCIK immunotherapy technology in advanced
cancer patients
SBI Biotech’s strategy for the Business development of Dendritic CellTherapy

Mitsui’s healthcare investment strategy

Session 3

Supporting activities providing equipments and/or facilities for approval of cell therapy
Chair : Robert Whitter

15：30-15：50
15：50-16：20
16：20-16：40

Naoto Matsuda(Toyo Seikan Kaisha,
Dominic Wall
(Cell Therapy Australia)
Miki Isogai(Pharmabio, Japan)

Session 4

Development of a GMP-compliant Automated Cell Culture System Using a
Closed System Bag Kit
Bringing cell therapy from the lab to the world
Products and services to support development of cell based medicine inJapan

Regulatory Considerations and Collaboration
Chair : Sumiko Watanabe

16：40-17：00
17：00-17：20
17：20-17：50
17：50-18：00

Approaches of Regulatory Agencies in US/EU for the promotion of Cell
Fumitaka Nagamura（IMSUT）
Therapies
Tsuyoshi Ando
PMDA's Efforts in Medical Innovation - Regenerative Medicine(PMDA)
Ching-Yu Lu
The Regulation and Development of Cell Therapy Products in Taiwan(CDE,Taiwan )Matthew Salter(NPG Nature Asia-Pacific)

Concluding remarks
18：00-18：15

Ken-ichi Arai
(The University of Tokyo)

18：30-20：30

Reception（8F Tomy Hall, Hospital Building)