SELECTBIO Conferences Cell Therapy Asia 2018


Thursday, 6 December 2018


Conference Registration, Materials Pick-Up, Morning Coffee and Tea

Session: Conference Opening Session and Cell Therapy Update


Norio NakatsujiConference Chair

Conference Chairman Welcome and Opening Remarks and Introduction to the Cell Therapy Space, circa 2018
Norio Nakatsuji, Chief Advisor, Stem Cell & Device Laboratory, Inc. (SCAD); Professor Emeritus, Kyoto University, Japan


Yuzo TodaConference Chair

Conference Chairman Welcome and Opening Remarks and State of Regenerative Medicine Industry
Yuzo Toda, President, FIRM (Forum for Innovative Regenerative Medicine, Japan), Japan


Masayo TakahashiKeynote Presentation

Retinal Cell Therapy Using iPS Cells
Masayo Takahashi, Professor, RIKEN Center for Biosystems Dynamics Research, Japan

The first in man application of iPS-derived cells started in September 2014, targeted age-related macular degeneration (AMD).  AMD is caused by the senescence of retinal pigment epithelium (RPE), so that we aimed to replace damaged RPE with normal, young RPE made from iPS cells. We judged the outcome 1 year after the surgery. Primary endpoint was the safety, mainly the tumor formation and immune rejection. The grafted RPE cell sheet was not rejected nor made tumor after two years. The patient's visual acuity stabilized after the surgery whereas it deteriorated before surgery in spite of 13 times injection of anti-VEGF in the eye. Since autologous transplantation is time consuming and expensive, it is necessary to prepare allogeneic transplantation to establish a standard treatment. RPE cells are suitable for allogeneic transplantation because they suppress the activation of the T-cell. From in vitro and in vivo study, it is possible that the rejection is considerably suppressed by using the iPS cell with matched HLA. Our new protocol has accepted by ministry in Feb 2017. We are planning transplantation using allogeneic iPS-RPE cell suspension & sheet, and also autologous iPS-RPE. For the cell suspension transplantation we will not combine CNV removal and apply to milder cases than sheet transplantation. In Japan, pharmaceutical law has been changed and a new chapter for regenerative medicine was created for clinical trial. Also the separate law for safety of regenerative medicine for clinical research (study) was enforced in 2015. These laws made the suitable condition for the brand new field of regenerative medicine. We are making regenerative medicine in co-operation with ministry & academia.


Morning Tea Break and Networking with Exhibitors


Yoshitsugu ShitakaKeynote Presentation

Regenerative Medicine in Astellas
Yoshitsugu Shitaka, President, Astellas Institute for Regenerative Medicine, Japan

Astellas Institute for Regenerative Medicine (AIRM) was established in May 2016 following Astellas' acquisition of Ocata Therapeutics. AIRM is an indirect, wholly owned subsidiary of Astellas and serves as Astellas' global hub for RM and cell therapy in ophthalmology and other therapeutic areas that have few or no available treatment options.  The outline of Astellas RM will be reviewed in this presentation.


Industrialization of Regenerative Medicine - Standards are the Key
Tatsuo Heki, Senior Expert, Regenerative Medicine Division, Fujifilm Corporation, Japan


Networking Lunch in the Exhibit Hall

Session Title: Cellular Classes for Cell Therapy and Current Research


Hiromitsu NakauchiKeynote Presentation

Translating Stem Cell Research: Challenges At Front Line
Hiromitsu Nakauchi, Prof of Genetics, Institute of Stem Cell Biology and Regenerative Medicine, Stanford University School of Medicine Project Professor, The Institute of Medical Science, Division of Stem Cell Therapy, Distinguished Professor Unit, The University of Tokyo, United States of America

The recent development of induced pluripotent stem cell (iPSC) technology opened the way to regenerative medicine using a patient's own PSC-derived cells.  In this presentation, I describe some of our iPSC technology-based projects aiming at clinical use.


Derivation of Clinical-Grade hESC in Japan
Hirofumi Suemori, Associate Professor, Laboratory of Embryonic Stem Cell Research, Institute for Frontier Life and Medical Sciences, Kyoto University, Japan

After obtaining governmental permission to derive clinical-grade hESC lines in 2017, we have been trying to produce hESC in compliant with relevant regulations and guidelines. Progress of our project will be presented.


Early Onset Preeclampsia (EOPE) in a Model For Early Stage Human Placental Trophoblast
Toshihiko Ezashi, Research Associate Professor, The University of Missouri, United States of America


Neuromuscular Diseases: How Could Stem Cells Help?
Masatoshi Suzuki, Associate Professor, Department of Comparative Biosciences and Stem Cell & Regenerative Medicine Center, University of Wisconsin-Madison, United States of America

Neuromuscular diseases are caused by functional defects of skeletal muscles via muscle pathology or indirectly via the nervous system. Extensive studies have been performed to improve the outcomes of therapies; however, there is still a crucial need for effective treatments in order to counteract muscle degeneration and neuromuscular denervation in such conditions. Human pluripotent stem cells, such as embryonic stem cells and induced pluripotent stem (iPS) cells, have a great capacity to differentiate into skeletal muscle progenitor/stem cells (also known as myogenic progenitors) for use in treating and modeling neuromuscular diseases. This presentation summarizes current progress of stem cell applications for therapeutic development in neuromuscular diseases, specifically focusing on advantages and limitations of iPS cells.


Afternoon Coffee and Tea Break and Networking

Session Title: Multidisciplinary Research Update


Shoji TakeuchiKeynote Presentation

Cell Fiber Technology For 3D Tissue-on-a-Chip Application
Shoji Takeuchi, Professor, Center For International Research on Integrative Biomedical Systems (CIBiS), Institute of Industrial Science, The University of Tokyo, Japan

The talk describes a 3D cell culture method using core-shell hydrogel microfibers (cell fibers). The core is filled with cells and ECM proteins, and the shell is composed of calcium alginate. Since the core diameter is about 100 microns, oxygen and nutrients can be diffused into the central area of the 3D tissue; therefore this culture system allows us to culture the tissue for a long period without central necrosis. Using this culture system, fiber-based tissues such as blood vessels, nerves, and muscles can be formed with in the core. Here, I will discuss the application of the cell fiber technology for various tissue-on-a-chip studies including cardiac tissue, neuro-muscular junctions, and vascularized skin etc.


Keisuke GodaKeynote Presentation

High-Speed Imaging Meets Single-Cell Analysis
Keisuke Goda, Professor of Physical Chemistry, University of Tokyo, ImPACT Program Manager, Cabinet Office, Government of Japan, Japan

High-speed imaging is an indispensable tool in today's scientific research, industry, and energy as it enables blur-free observation and monitoring of fast transient dynamics. It is commonly used for various applications including sports, manufacturing, and fusion science in which slow-motion analysis is conducted to understand their dynamics. On the other hand, the past several years have seen another and radically new application of high-speed imaging, namely single-cell analysis - the study of individual biological cells among populations for identifying cell-to-cell differences and elucidating cellular heterogeneity invisible to population-averaged measurements. This exciting application has been made possible by exploiting high-speed imaging's capability of acquiring information-rich images at high frame rates to provide a snapshot library of numerous cells in a short duration of time (with one cell per frame). In this talk, I introduce the principles of several unique high-speed imaging methods for microscopy and their emerging application to large-scale single-cell analysis.


Networking Reception in the Exhibit Hall with Beer and Wine


Close of Day 1 of the Conference.

Friday, 7 December 2018


Morning Coffee, Tea, Breakfast Pastries and Networking in the Exhibit Hall

Session Title: 3D-Culture, Organoids, Microfluidics -- Technologies and Trends in Cell Therapy Research


Terry RissKeynote Presentation

Questions to Ask when Designing 3D Cell Culture Model Systems
Terry Riss, Global Strategic Marketing Manager Cell Health, Promega Corporation, United States of America

There continues to be a rapid expansion in the use of 3D cell culture model systems because they more closely represent the in vivo situation compared to culturing cells as a monolayer attached to plastic. There are many approaches classified as 3D culture models ranging from individual scaffold-free spheroids to human-on-a-chip and researchers soon become aware the models have vastly different requirements and there is no "one size fits all" approach. Selecting a 3D culture model that is "fit for purpose" involves several decisions and often results in a compromise between sample throughput and culture model complexity or cost. We will describe an overview of factors to consider when designing or selecting an appropriate 3D culture model addressing: sample size, scaffolds, culture medium, choice of assay methods, and reproducibility. Attendees should acquire an increased awareness of the range of available approaches and be able to use the information to design an appropriate 3D culture model.


Creation of Functional Tissue with a Novel 3D Printing Technology
Shizuka Akieda, Chief Executive Officer, Cyfuse Biomedical K.K., Japan

Cyfuse is a regenerative medicine start-up focused on creation of functional 3D tissues and organs. The proprietary "Kenzan method" skewers multiple cellular aggregates with fine needles until cells fuse entirely in a few days. Our Bio 3D Printer, "Regenova" automated this skewering process and is designed to help researchers try various cell populations and culture conditions to discover a protocol of manufacturing functional organs. The system was launched commercially in Japan and US. The examples of cellular products include Blood Vessels, Peripheral Nerve Regeneration, and functional liver for drug discovery. Further applications with neural cells and cardiomyocytes are currently being explored by Japanese and US academia.


GE Healthcare Life SciencesGenerating Models of Human Liver by 3D Bioprinting
William G Whitford, Strategic Solutions Leader Bioprocess, GE Healthcare Life Sciences

A demonstration of the bioprintability of human liver ECM using such commercially available products as CELLINK HEP X™ bioink to support human hepatic cell maintenance in the modeling of liver fibrosis in vitro is presented.


Morning Coffee and Tea Break and Networking with Exhibitors


Biophysical Approaches To Organoid Fabrication
Kennedy Okeyo, Senior Lecturer, Institute for Frontier Life and Medical Sciences, Kyoto University, Japan

Organoid generation by biochemical induction strategies faces scalability challenges owing to cost implications stemming from the use of costly reagents. On the other hand, biophysical techniques relying on modulating the cell culture milieu to induce self-assembly, direct differentiation, and, ultimately, organoid formation presents a viable alternative approach with ease of scalability, higher reproducibility and cost effectiveness. Here, we introduce such a biophysical technique, namely, the mesh culture technique, and demonstrate its potential in directing self-assembly and differentiation of stem cells. Ongoing efforts to integrate this technology with microfluidics to realize organoid-on-a-chip system for drug assay and biological studies will be presented.


Networking Lunch


Kunihiko SuzukiKeynote Presentation

How to Regulate Unproven Cellular Therapies, Beyond "Right to Try"
Kunihiko Suzuki, Vice Chairman & Member of the Board, Medinet Co. Ltd., Vice Chair, Forum for Innovative Regenerative Medicine (FIRM), Japan

There are some movement recently in regulation for so-called "unproven cellular therapies" (UCT)/"unregulated market product", which private hospitals/clinics may provide medical care/medical treatment to patients. According to the report (Cell Stem Cell 19, August 4, 2016 Elvsevier Inc.), there are 570 clinics which offer stem cell interventions to the public without any market authorization as a product from FDA.  In addition, in November last year, FDA published 4 Guidances for HCTPs, which seem to put on target towards UCTs and gave warning letters to the clinics in California and also Miami, FL.  However, at the same time, "Right to try" bills are under lots of discussions among the various parties. In general, there has been no specific regulation to control the activities of medical care/medical treatment by medical doctors/dental doctors before Japan introduced "The Act on the Safety of Regenerative Medicine" (ASRM).  With the new regulation in Japan, we can reach to the statistics of clinics/hospitals which involve care/treatment with non market-authorized products by MHLW/PMDA and/or the details of such medical care/medical treatment. It is worthwhile for everyone in this space to learn benefit/outcome/limitation on ASRM to bring cutting-edge medical technologies with safe and efficacious manner to the patients. Hope Japanese regulatory framework will be the pilot model for the regulations of other countries in future.


Michael BennettKeynote Presentation

Commercialization of Cell Therapies - Laboratory to Bedside
Michael Bennett, Director of Business Development, Cell and Gene Therapy Catapult, United Kingdom

There are many teams of scientists working diligently in the broad field of regenerative medicine.  The goal of much of this work is to create new medicines that have the potential to cure debilitating diseases that conventional small molecule medicines cannot.  In my presentation I will discuss some of the challenges facing us all within regenerative medicine and some of the solutions that the cell and gene therapy catapult has seen implemented around the world to assist the commercialisation of promising laboratory science through pre-clinical testing, clinical trial and to the patient bedside.


Panel Discussion with Coffee and Tea Served

Panel Discussion: Future View, Challenges and Opportunities in the Cellular Therapy Field
Session Chair: Norio Nakatsuji, Chief Advisor, Stem Cell & Device Laboratory, Inc. (SCAD); Professor Emeritus, Kyoto University, Japan


Close of Conference.

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