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08:50 - 09:00

Chairperson’s Opening Remarks

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Showing of Streams
10:30 - 11:15

Morning Coffee

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Showing of Streams
12:45 - 14:00

Lunch and Networking

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Showing of Streams
15:30 - 16:00

Afternoon Coffee

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Showing of Streams
17:00 - 17:05
End of Day Two

End of Day Two

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08:50 - 09:00 10 mins
Chairperson’s Opening Remarks
09:00 - 09:20 20 mins
Regulatory Updates and Recent Progress: US, Japan and EU
Regenerative medicine product regulations in Japan - Enhancing the development of Advanced Therapies?
  • Colin Lee Novik - Managing Director, CJ Partners Inc., Japan
09:20 - 09:40 20 mins
Info
Regulatory Updates and Recent Progress: US, Japan and EU
Recent regulatory innovation in cell therapy in Taiwan
  • I-Ning Tang - Team Leader, Center for Drug Evaluation (CDE)

In today’s presentation, I will introduce the regulatory history of cell therapy medicinal products in Taiwan, then I will provide the audience with statistics regarding the current status of cell therapy clinical trials. Also, I will talk about the recent regulatory innovative measures in order to reduce the regulatory burden and facilitate the approval process of clinical trials and market authorizations.

09:40 - 10:00 20 mins
Regulatory Updates and Recent Progress: US, Japan and EU
Discussion Panel: Working towards a cooperative framework for regulatory harmonisation across Asia
  • Colin Lee Novik - Managing Director, CJ Partners Inc., Japan
  • I-Ning Tang - Team Leader, Center for Drug Evaluation (CDE)
  • Antonio Lee, Ph.D. - CEO, Medipost America Inc.
10:00 - 10:30 30 mins
Regulatory Updates and Recent Progress: US, Japan and EU
Spotlight Presentation
10:30 - 11:15 45 mins
Morning Coffee
11:15 - 11:45 30 mins
Regional Spotlight Session – Case Studies and Pipeline Updates – Japan
hES Case Study
  • Hideto Yamaguchi - Executive Director, Head of Technical Operations, Astellas Institute for Regenerative Medicine (AIRM)
11:45 - 12:15 30 mins
Regional Spotlight Session – Case Studies and Pipeline Updates – Japan
MSC Case Study
12:15 - 12:45 30 mins
Regional Spotlight Session – Case Studies and Pipeline Updates – Japan
Spotlight Presentation
12:45 - 14:00 75 mins
Lunch and Networking
14:00 - 14:30 30 mins
Regional Spotlight Session – Case Studies and Pipeline Updates – China
CART/ CAR product case study
  • Ting He - CEO, ImmunoChina Pharmaceuticals Co, Ltd., China
14:30 - 15:00 30 mins
Info
Regional Spotlight Session – Case Studies and Pipeline Updates – China
Engineer CAR-T cells for improving cancer immunotherapy
  • Yarong Liu - Director of Research and Development, HRAIN Biotechnology Co., Ltd.

Adoptive cell therapy using T cells genetically engineered to express either T-cell receptors or chimeric antigen receptors (CAR) have emerged as promising cancer immunotherapy strategies. On the basis of dramatic results, autologous T cells engineered to express a chimeric antigen receptor specific for the CD19 B lymphocyte molecule have recently been approved by the FDA for treatment of refractory pre-B cell acute lymphoblastic leukemia and diffuse large B cell lymphoma. CAR T technology has now been shown to achieve success in hematological malignancies, but the relapse after CAR-T needed to be considered. Also Attempts to target tumor-associated antigens in solid tumors have achieved limited success so far. To overcome these obstacles, we have developed several strategies including optimizing CAR design, improving CAR-T persistence/survival in vivo via co-expressing mIL15, improving tumor-specificity of CAR-T cells via a conditionally active masked CAR, and hostiling tumor microenvironment via generating armored CAR-T.

15:00 - 15:30 30 mins
Regional Spotlight Session – Case Studies and Pipeline Updates – China
Spotlight Presentation
15:30 - 16:00 30 mins
Afternoon Coffee
16:00 - 16:30 30 mins
Regional Spotlight Session – Case Studies and Pipeline Updates – China cntd. And Rest of Asia
TriCAR-T / gp100 program for the treatment of melanoma – case study
16:30 - 17:00 30 mins
Regional Spotlight Session – Case Studies and Pipeline Updates – China cntd. And Rest of Asia
Stem Cell Case Study
  • Steve Oh - Institute Professor & Scientist, Bioprocessing Technology Institute
17:00 - 17:05 5 mins
End of Day Two