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Registration Open

Opening & Introduction by IABS President, John Petricciani (Formerly with WHO and US FDA)

Welcome Note by Chief Executive PMDA (Co-sponsor), Tatsuya Kondo

Welcome Note by JST (Co-sponsor), Shoichiro Tonomura 

Session 1  Keynote Lecture

Chairs: Kunihiko Suzuki (FIRM, Japan)

Current regenerative medicine field and the implications of changing regulations.

Mahendra Rao（NIH/NIAMS, USA）

Break

Session 2  Introduction of the meeting including the concept of a minimum consensus package plus case by case approaches for evaluating human cell therapy products [hCTPs]

Chairs: Surapol Issaragrisil (Mahidol Univ., Thailand)

Challenges for developing a minimum consensus package plus case by case approaches for evaluating cell therapy products

Takao Hayakawa (Kindai Univ., Japan)

Lunch

Session 3  Specific points to consider for the evaluation and control of hCTPs that are different from those of traditional biological/biotechnological protein products (1)

Chairs:, Jean-Hugues Trouvin (Univ. Paris Descartes, France), Pierrette Zorzi-Morre (Formerly with AFSSAPs, France)

3.1　GXPs

Daisaku Sato (PMDA, Japan)

3.2  CPC

Tomohiro Morio (Tokyo medical and dental university, Japan)

3.3  Starting cells, other raw materials, manufacture-related substances and non-cellular component constituting the complex final products, if any

Daisuke Maeda (PMDA, Japan)

3.4  Establishment of　relevant　cell line, cell bank and/or critical intermediate(s); processing of cells

Glyn Stacey (NIBSC, UK)

3.5  Preparation of desired cell products, Formulation, Characterization of cells at critical stages

 Jean-Hugues Trouvin (Univ. Paris Descartes, France)

Break

3.6  Verification of manufacturing process and consistency of manufacture, process control, comparability

Karin Hoogendoorn (Novartis, Switzerland)

3.7  Product stability, quality control of final products, storage and transport procedure at critical steps

Pierrette Zorzi-Morre (Formerly with AFSSAPs, France)

3.8  Industry View

Junichi Koga (JPMA, Japan )

Panel Discussion

Moderators: Anthony Ridgway and Jean-Hugues Trouvin

Speakers and Carl Burke (Janssen R&D, USA)

End of Day 1

Networking Reception

8:45

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11:50

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Registration Open

Session 4  Specific points to consider for the evaluation and control of hCTPs that are different from

                      those of traditional biological/biotechnological protein products (2)

Chairs: Jimmy McBlane (MHRA, UK), Yoji Sato (NIHS, Japan)

4.1 Pre-clinical safety evaluation

 Jimmy McBlane (MHRA, UK)

4.2 Proof of Concept, mode of action, biodistribution

Akifumi Matsuyama (NIBIO, Japan)

4.3 Clinical Issues

Kazuo Yano, Masayuki Yamato (Tokyo Women’s Medical Univ., Japan)　

Break

4.4 Industry View

Kentaro Yoshimatsu (JPMA, Japan)

Panel Discussion

Moderators: Christopher Bravery and Yoji Sato

Speakers and Carl Burke (Janssen R&D, USA)

Lunch

Session 5  Identification of specific points/issues for specific types of products,

                      as well as very critical points/issues for various types of products (1)

Chairs: Glyn Stacey (NIBSC, UK), Takashi Aoi (Kobe Univ., Japan)

5.1    Somatic cells, Somatic stem cells (Autologous, Allogeneic)

Glyn Stacey (NIBSC, UK)

5.2    iPS (iPS-like) Cells (Autologous, Allogeneic)

Takashi Aoi (Kobe Univ, Japan)

5.3    ES cells

Akihiro Umezawa (NICHD, Japan)

Session 6  Identification of specific points/issues for specific types of products,

                     as well as very critical points/issues for various types of products (2)

Chairs: Anthony Ridgway (Health Canada, Canada)

6.1 Adventitious agents (Virus, sterility, and prion evaluation on cell sources, final products,

culture media and ancillary products; use of human/animal derived raw materials other than target cells)

Hiroyuki Yokote (The Chemo-Sero-Therapeutic Res. Inst, Japan)

Break

6.2    Specifications

Takao Hayakawa (Kindai Univ., Japan) , Norihisa Sakamoto (PMDA, Japan)

6.3    Potency

Anthony Ridgway (Health Canada, Canada)

6.4 Measurement reliability over the product lifecycle: The need for reference materials of hCTPs

Christopher Bravery（Formerly with MHRA, UK）

6.5    Tumorigenicity

Yoji Sato (NIHS, Japan)

6.6 WHO considerations

Ivana Knezevic (WHO) , John Petricciani (Formerly with WHO and US FDA)  

Panel Discussion

Moderators: John Petricciani and Takao Hayakawa

Speakers and Daisaku Sato

Concluding Remarks

John Petricciani （IABS President, USA）

CLOSE OF MEETING