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Informa
07:30 - 08:20

Registration

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08:20 - 08:30

Chairperson’s Opening remarks

  • Steve Oh - Institute Professor & Scientist, Bioprocessing Technology Institute
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Showing of Streams
10:30 - 11:15

Morning Coffee and Networking

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Showing of Streams
Showing of Streams
12:45 - 14:00

Lunch, Networking and Live Labs

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Showing of Streams
15:30 - 16:00

Afternoon Coffee

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Showing of Streams
17:30 - 17:35
Chairperson’s Closing Remarks

Chairperson’s Closing Remarks

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17:35 - 19:35

Networking Drinks and Evening Social Event

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07:30 - 08:20 50 mins
Registration
08:20 - 08:30 10 mins
Chairperson’s Opening remarks
  • Steve Oh - Institute Professor & Scientist, Bioprocessing Technology Institute
08:30 - 09:00 30 mins
Manufacturing and Process Development Strategies – Novel Technologies for Efficient Scale Up and Scale Out
Biology inspired cell therapy manufacturing
  • Nick Timmins, PhD - Vice President, Process Science, Bluerock Therapeutics
09:00 - 09:30 30 mins
Manufacturing and Process Development Strategies – Novel Technologies for Efficient Scale Up and Scale Out
Scale-up production of human pluripotent stem cells and 3D multicellular micro-tissues with differentiated functional cells
  • Norio Nakatsuji - Professor Emeritus, Kyoto University
09:30 - 10:00 30 mins
Info
Manufacturing and Process Development Strategies – Novel Technologies for Efficient Scale Up and Scale Out
Discussion Panel: Manufacturing Technologies and Continuous Improvement
  • Norio Nakatsuji - Professor Emeritus, Kyoto University
  • Kim Raineri - VP Innovation, NIKON CeLL innovation Co., Ltd., Japan
  • Antonio Lee, Ph.D. - CEO, Medipost America Inc.
  • Dr. Ohad Karnieli, Ph.D., MBA - CEO & Co-founder, Atvio Biotech
  • Nick Timmins, PhD - Vice President, Process Science, Bluerock Therapeutics
This strategic panel will focus on new technologies and considerations for driving state of the art manufacturing. Topics to be discussed include:
  • New cell lines for therapies
  • Novel bioreactors
  • Novel microcarriers
  • Economy of scale considerations
  • Compact instrument alternatives
10:00 - 10:30 30 mins
Manufacturing and Process Development Strategies – Novel Technologies for Efficient Scale Up and Scale Out
Spotlight Presentation
10:30 - 11:15 45 mins
Morning Coffee and Networking
11:15 - 11:45 30 mins
Manufacturing and Process Development Strategies – Novel Technologies for Efficient Scale Up and Scale Out
CAR-T Cell Therapy Development for Solid Tumor Treatment —Challenges & Opportunities
  • Chien-Tsun Kuan - Deputy Executive Director, Institute of Biologics Development Center for Biotechnology, Taiwan
11:45 - 12:15 30 mins
Info
Strategies and Facility Design for Commercial Manufacturing – End to End Solutions
A forward look at the future of cell therapy manufacturing
  • Kim Raineri - VP Innovation, NIKON CeLL innovation Co., Ltd., Japan
  • What does the future of manufacturing look like?
  • Review of different technologies out there
  • Where do the gaps lie?
12:15 - 12:45 30 mins
Info
Strategies and Facility Design for Commercial Manufacturing – End to End Solutions
A presentation from Miltenyi Biotec
12:45 - 14:00 75 mins
Lunch, Networking and Live Labs
14:00 - 14:30 30 mins
Info
Reducing the Cost of Manufacturing – Costs of Goods Calculations, Automation and Robotics
Case Study: Commercialisation Experience of a Somatic Stem Cell Product
  • Antonio Lee, Ph.D. - CEO, Medipost America Inc.
  • Case study
  • Facility management and design of process
14:30 - 15:00 30 mins
Info
Reducing the Cost of Manufacturing – Costs of Goods Calculations, Automation and Robotics
Enabling commercial scale-out of T-cell manufacturing
  • Dr. Ohad Karnieli, Ph.D., MBA - CEO & Co-founder, Atvio Biotech
  • What are the key challenges in scaling an autologous process for commercial?
  • The role of closed systems in scalability
  • Understanding and controlling Key Quality Attributes
15:00 - 15:30 30 mins
Reducing the Cost of Manufacturing – Costs of Goods Calculations, Automation and Robotics
Spotlight Presentation
15:30 - 16:00 30 mins
Afternoon Coffee
16:00 - 16:30 30 mins
Info
Monitoring quality across the process - Process and automated analytics for cell, gene and gene edited cell therapies
Regenerative medicine product regulations in Japan - Enhancing the development of Advanced Therapies?
  • Colin Lee Novik - Managing Director, CJ Partners Inc., Japan
  •    Case study
16:30 - 17:00 30 mins
Info
Monitoring quality across the process - Process and automated analytics for cell, gene and gene edited cell therapies
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.

17:00 - 17:30 30 mins
Info
Monitoring quality across the process - Process and automated analytics for cell, gene and gene edited cell therapies
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.
  • How do you bridge your product?
  • Tech transfer with regards to comparability?
  • Case study
17:30 - 17:35 5 mins
Chairperson’s Closing Remarks
17:35 - 19:35 120 mins
Networking Drinks and Evening Social Event