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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 Development, 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 - Vice President of Operations, 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 Development, 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
Info
Manufacturing and Process Development Strategies – Novel Technologies for Efficient Scale Up and Scale Out
Streamlining the Cell Therapy Workflow with Silicon Chip Technology
  • Kristi Valentine - Senior Business Development Manager, IMEC

A major hurdle to scale up the market of cell therapies is the cost and complexity of the workflow. We propose a novel approach based on a standardised workflow which will be easy to use, reliable and reproducible. Using silicon chip technology, fully integrated solutions can be built, combining microfluidics, photonics-based biosensors, PCR, and single cell manipulation.

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, Ph.D 官建村 - EVP/ COO & CTO, GenomeFrontier Therapeutics, Inc.
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 - Vice President of Operations, 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
T-cell engineering: Driving automation towards commercialization
  • Dr. Silvio Weber - Group Leader, Cellular Therapy Industrial Process Development, Miltenyi Biotec GmbH
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
ISCT Process and Product Development Subcommittee Co-Chair Presentation: 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
Info
Reducing the Cost of Manufacturing – Costs of Goods Calculations, Automation and Robotics
An End-to-End Solution for Large Scale Viral Vectors and Cells Manufacturing for Therapeutic Use
  • Dr. Rachel Legmann - Senior PD lab manager, Pall Corporation

With several recent FDA approvals and a strong drug pipeline, the gene therapy market is providing new hope for patients. As demand for these new therapies increases, a robust and scalable manufacturing process is critical. We will present three case studies which illustrates the challenges and progress to scale up the viral vector manufacturing production of AAV, lentivirus and adenovirus.

15:30 - 16:00 30 mins
Afternoon Coffee
16:00 - 16:30 30 mins
Info
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
  •    Case study
16:30 - 17:00 30 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.

17:00 - 17:30 30 mins
Info
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.
  • 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