2nd Regenerative Medicine Expo [TOKYO] Conference


Industry leaders address regenerative medicine technologies. CAR-T cell therapy, organ regeneration, iPS cells for disease modeling and drug discovery, etc. will be discussed.

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Keynote Session Pre-registration Required

RM-K November 25 (Wed) 15:30  -  17:00

The Leading Company's Challenge for the Future Regenerative Medicine

  • English / Japanese

Creation of Clinical Innovation with iPS Cells

Yasushi Kajii Head, T-CiRA Discovery, Takeda Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
iPS cells are being applied to various pharmaceutical researches including regenerative medicine. Takeda Pharmaceutical Company and Kyoto University Center for iPS Cell Research and Application (CiRA) conduct ten-year reverse-style Academia-Industry collaboration program (T-CiRA), where academic researchers visit Takeda to create clinical innovations.

<Speaker’s Profile>

Rohto Pharmaceutical's Challenges to Regenerative Medicine

Kunio Yamada Chairman & Chief Executive Officer, Rohto Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
It's been seven years since Rohto started R&D in regenerative medicine under our slogan, "contribute to everyone's health and beauty". Meanwhile, the healthcare environment has been dramatically changed. In this talk, our challenges on regenerative medicine with mesenchymal stem cells will be introduced.

<Speaker’s Profile>

Special Session

RM-S1 November 25 (Wed) 10:30  -  12:00
  • FREE / Pre-registration Required

Creating Platform to Foster Biotech Startups

  • English / Japanese

Ecosystem of Biotech Start-ups in COVID-19 Era:
Limits of the Existing Paradigm Revealed by COVID-19

Yuzo Toda Former Chairman, Forum for Innovative Regenerative Medicine

Detail & Speaker’s Profile

<Detail>
Ecosystem of biotech startups in the COVID-19 Era: Limits of the Existing Paradigm Unraveled by COVID-19
3 Paradigm shifts:
1. Transformation of Demands from Society (Era of Extreme Decentralization of Demands)
2. Game Change (Disruptive Transformation in Social Agendas and Realization Methods, Change of Leading Player)
3. Reconstruction of Ideal (Realization of Totally-optimized Society)

<Speaker’s Profile>
Yuzo Toda joined current Fuji Photo Film Co., Ltd. (currently FUJIFILM Corp.) in 1973. Worked as Director of Fuji Photo Film B.V. in Netherlands from 1993 to 2004.
After coming back to Japan, Toda launched healthcare business (cosmetics and supplement), pharmaceutical business, and regenerative medicine business. In June 2018, Toda retired from Senior Executive Vice President and CTO.
Chairman of the Forum for Innovative Regenerative Medicine (FIRM) from 2011 to 2019.
Participated in the Health/Medicine Strategy Office of the Cabinet Secretariat from 2013 to 2018.

How to Create a Robust Startup Ecosystem

Koshin Sekimizu, Ph.D. President and Chief Executive Officer, PROVIGATE, Inc.

Detail & Speaker’s Profile

<Detail>
There are about 40 listed biotechs in Japan, but none of them have given birth to a blockbuster yet, and this is a structural problem. The key to success lies in tackling global issues with combinations of Japan's unique business assets. A perspective will be shown.

<Speaker’s Profile>
 

Fujita Health University Newly Established Biotechs Start-up Company for Regenerative Medicine

Kuniaki Saito, Ph.D. Dean, School of Medical Sciences, Fujita Health University

Detail & Speaker’s Profile

<Detail>
Fujita Health University (FHU) support an innovative regenerative medicine by newly established biotechs start-up company. FHU also established CPC facilities and Bio-bank with database comprising personal medical record. These facilities can be used by institutional scientists and academic network as well as the industrial researches.

<Speaker’s Profile>
Dean, School of Medical Sciences, Fujita Health University
Professor Emeritus, Kyoto University

RM-S2 November 26 (Thu) 13:00  -  14:30
  • FREE / Pre-registration Required

The Front Line of CAR T-cell Therapy

  • English / Japanese

Current Update and Future Perspective of Novel CAR-T Cell Therapy

Koji Tamada, Ph.D. Professor and Chairman, Dept. of Immunology, Yamaguchi University Graduate School of Medicine

Detail & Speaker’s Profile

<Detail>
Cancer immunotherapy is currently attracting a great deal of attention and is expected to grow rapidly in the future. Recently, CAR-T and TCR-T cells, gene-modified immune cells whose ability to attack cancer is enhanced, have been studied, and clinical development by many bio-ventures and pharmaceutical companies is progressing. In this presentation, the current status, challenges, and future perspectives of the latest CAR-T cell therapy will be introduced.

<Speaker’s Profile>

Developing Non-viral CAR T-cell Therapy

Yozo Nakazawa, Ph.D. Professor and Chairman, Dept. of Pediatrics, Shinshu University School of Medicine

Detail & Speaker’s Profile

<Detail>
Non-viral gene-modification technology to generate CAR-T cells using piggyBac transposons are also known as "Faster, Cheaper, Safer, T-cell Engineering". More recently, we found piggyBac-based CAR T-cells functionally better. We are going to start the investigator-initiated clinical trials for hematological and solid neoplasms.

<Speaker’s Profile>
2016-present, Professor & Chairman, Department of Pediatrics, Shinshu University School of Medicine. 2011-2016, Shinshu University Hospital. 2007-2009, R&D on piggyBac-based CAR-T cells, Baylor College of Medicine. 2004, Shinshu University Graduate School. 1996, Asahikawa Medical College.

RM-S3 November 26 (Thu) 15:30  -  17:00
  • FREE / Pre-registration Required

Cell Processing & Manufacturing: Effort to Overcome Challenges

  • English / Japanese

Novel Approach to Stabilize Cell Production by Considering Cell Manufacturability

Masahiro Kino-oka, Ph.D. Professor, Dept. of Biotechnology, Graduate School of Engineering, Osaka University

Detail & Speaker’s Profile

<Detail>
I will present the current situation of the cell manufacturing to contribute to regenerative medicine. Particularly, the elemental technologies to stabilize a process and the concepts for the process design based on the cell manufacturability as well as Quality by Design (QbD) will be introduced.

<Speaker’s Profile>

Takara Bio's Contract Development and Manufacturing Service of Regenerative Medicine

Hideto Chono, Ph.D. General Manager, Customer Service Dept., Takara Bio Inc.

Detail & Speaker’s Profile

<Detail>
Takara Bio has been promoting gene therapy clinical trials in both ex vivo and in vivo gene therapy. By providing our knowledge and expertise, we offer contract development and manufacture service to customers who aim to promote the gene and cell therapy worldwide.

<Speaker’s Profile>
Joined Takara in 1992, worked in gene therapy field including development of RetroNectin Method, viral vector technologies for cell and gene therapies. Promoted gene therapy clinical trial in US in 2012 in collaboration with University of Pennsylvania. In 2015, moved to the General Manager of viral vector manufacturing team and promoted viral vector manufacture both for our own program and contract manufacture service. In 2020, General Manager of Customer Service department and promoting contract development and manufacturing service for customers.

RM-S4 November 27 (Fri) 10:30  -  12:00
  • FREE / Pre-registration Required

Regulations and Issues for Developing Regenerative Medicine & Cell Therapy

  • English / Japanese

"Standardization of Cell Product and Integration of Manufacturing Data" Are Key Issues to Open Up a Global Market

Shin Kawamata, Ph.D. Director, Research & Development Center for Cell Therapy, Foundation for Biomedical Research and Innovation

Detail & Speaker’s Profile

<Detail>
Market of cell and gene therapy is still small and needs an international development schema, such as global supply chains and the international product specification to make this therapy sustainable. This seminar is introducing a new cell manufacturing method that can contribute to the standardization of products.

<Speaker’s Profile>
Studied medicine at medical school of Kobe University, Japan (1984-1990) and started his carrier as a medical doctor (hematology) and got PhD degree (1998). He developed various human leukemia models in SCID mice in his post doctoral period at Systemix Co. and Stanford University (1999-2001). His career at Foundation for Biomedical Research and Innovation (FBRI) in Kobe started in 2002 and became Director of R&D Center for Cell Therapy in 2015. His major research fields are cell biology of Pluripotent Stem Cell and hematopoietic cell differentiation.

Regulatory Landscape of Regenerative Medicine

Yoshiaki Maruyama, Ph.D. Review Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency

Detail & Speaker’s Profile

<Detail>
On November 2014, new regulatory framework was enacted, two laws known as the Act on the Safety of Regenerative Medicine and the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act. The presentation will give the key consideration for development of regenerative medicine from experiences of the PMDA in consultation and review.

<Speaker’s Profile>
I am currently a Review Director at the Office of Cellular and Tissue-based Products at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. In 2008, I joined PMDA as an officer in the Office of Compliance and Standards.

RM-S5 November 27 (Fri) 15:30  -  16:30
  • FREE / Pre-registration Required

Regenerative Medicine Innovation by a Young Pioneer

  • English / Japanese

Humanity in a Dish

Takanori Takebe, M.D. Ph.D. Professor, Institute of Research, Tokyo Medical and Dental University / Director, Communication Design Center, Yokohama City University

Detail & Speaker’s Profile

<Detail>
Human organoids are multicellular structures that can be derived from pluripotent stem cells. Here I will summarize how the next generation of organoids can be designed by utilizing an engineering-based narrative design, and discuss its promise and impact towards future clinical applications.

<Speaker’s Profile>

Concurrent Conferences Pre-registration Required

IPJ-K November 25 (Wed) 10:30  -  12:00

To Develop Innovative New Medicine: Actual Effort and Future Outlook

  • English / Japanese
Course Leader Hirofumi Takeuchi, Lab. of Advanced Pharmaceutical Process Engineering Emeritus Professor, Research Professor, Gifu Pharmaceutical University

Transforming Medicine-producing Industry into Comprehensive Healthcare Industry Using Ecosystem

Takuko Sawada Director of the Board, Executive Vice President, Head, Integrated Disease Care Div., Shionogi & Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Improvement in life style and societal supports can help overcome many diseases and sustain health more than medicinal treatment. Therapeutic computer/smartphone applications, artificial intelligence (AI) and virtual reality (VR) began to be applied in the field of medicine and healthcare. Academia-industry cooperation and collaboration amongst pharmaceutical and non-pharmaceutical businesses will enhance such endeavor.

<Speaker’s Profile>

To be announced shortly

Junya Kasamatsu, Ph.D. Director, Research and Development Div. Health Policy Bureau, Ministry of Health, Labour and Welfare

Detail & Speaker’s Profile

<Detail>

<Speaker’s Profile>

IPJ-S1 November 26 (Thu) 10:30  -  12:00
  • FREE / Pre-registration Required

Changing BCPs of Pharmaceutical Companies due to COVID-19: Preparing for Unseen Disaster

  • English / Japanese
Course Leader Susumu Kimura, Pharmaceutical Science & Technology Core Function Unit, Medicine Development Center President, Eisai Co., Ltd.
Sub Leader Koichi Usuda, Engineering Dept., Head Office Executive Manager, Takenaka Corp.

What Does BCP Mean to Pharmaceutical Companies Now?

Shunsuke Horii Partner, Health Industries Advisory, PwC Consulting LLC

Detail & Speaker’s Profile

<Detail>
It is imperative that pharmaceutical companies meet industry-specific requirements such as securing manufacturing and distribution of pharmaceuticals, protecting patient safety, and conducting clinical trials in any situation. In light of Covid-19 pandemic and its impacts, PwC will outline what Business Continuity Plans are necessary in this situation and similar events.

<Speaker’s Profile>

Post-COVID-19 Pharmaceutical Research Facilities and Factories

Akihiro Sugiuchi Group Leader, Business Risk Management Group, Engineering Dept. Head Office, Takenaka Corp.

Detail & Speaker’s Profile

<Detail>
Until now, major disasters have been turning points in reviewing measures for risk at facilities. In this lecture, BCM and disaster prevention measures at facilities will be organized, focusing on COVID-19, and based on the trend changes caused by COVID-19, we will propose the ideal way for resilient facilities in the future.

<Speaker’s Profile>
In March 1999, graduated from the Department of Architecture, Graduate School of Engineering, The University of Tokyo, and joined Takenaka Corporation. Mainly involved in the Engineering Department, engaged in planning, development, dissemination and deployment of analysis and countermeasure technology related to building safety. In charge of the development of earthquake countermeasure technology that can be implemented while the facility is operating. Since 2016, in charge of BCM/disaster countermeasures in general. As for technology development, involved in risk measures for bio-clean room experimental facilities. Currently, the main work is BCP/disaster countermeasure support for customers, which we deal with from the stage of policy and planning of countermeasures.

IPJ-S2 November 26 (Thu) 13:00  -  14:30
  • FREE / Pre-registration Required

SDGs/ESG Strategies by Leading Pharmaceutical/Cosmetics Companies

  • English / Japanese

Shionogi's Efforts towards Realization of a Sustainable Society

Yoshimasa Kyokawa Vice President, Corporate Communications Dept. and Corporate Secretariat, Corporate Strategy Div., Shionogi & Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Shionogi is dedicated to growing sustainably as a drug-discovery based pharmaceutical company contributing to the realization of a sustainable society by seeking to protect people worldwide from the threat of infectious diseases, to improve productivity and to extend healthy lifespan. This presentation will include key examples of the company's efforts.

<Speaker’s Profile>
After graduating from the Tokyo University of Agriculture and Technology with a Masters Degree in Agriculture in March 1994, Mr. Kyokawa joined Shionogi & Co., Ltd. After working as a researcher in Toxicological Chemistry in the Development Research Laboratory for 12 years, he led Strategic Research Planning for the Pharmaceutical Research Division for two years. In 2008, he moved to the Corporate Communications Department, and has been working for communications, primarily focusing on Investor Relations and ESG communication with external stakeholders, for 10 years. During that period, he served as the Manager of Corporate Communications and Investor Relations at the US subsidiary, Shionogi Inc., for two and a half years. He was appointed as the Head of Corporate Communications and Corporate Secretariat in April 2018.

What Is Kao's ESG Strategy to Achieve "ZERO Waste" ?

Manabu Shibata Director for ESG Action Management Group, ESG Promotion, Kao Corp.

Detail & Speaker’s Profile

<Detail>
I will introduce the Kao ESG strategy "Kirei-Lifestyle Plan" which announced in 2019 to realize the life that consumers hope. In addition, I will introduce Kao's strategy and examples of activities regarding "Zero Waste" , which is one of the key themes of priority initiatives.

<Speaker’s Profile>
  

IPJ-S3 November 26 (Thu) 15:30  -  17:00
  • FREE / Pre-registration Required

AI & Deep Learning: Innovation of Next-gen Pharmaceutical Factories

  • English / Japanese

Continuous Manufacturing, the Enabling Element for the Digital Pharma Initiative within the Framework of Industry 4.0

Richard Steiner Global CTC Sales Director, Continuous Technologies, Food & Healthcare Technologies, Pharma & Healthcare - Solid Dosage, GEA Group

Detail & Speaker’s Profile

<Detail>
Experts equalizing "Industry 4.0" foremost with the "Internet of Things" (IoT), whereas continuous processing itself is the enabling technology for real-time process data to run the IoT. This presentation will provide insights in the advanced process control strategy of the ConsiGma®4.0 portfolio.

<Speaker’s Profile>
Educated the University of Applied Sciences in Nuernberg and the FU University of Berlin and graduated as a Mechanical Engineer, MBM and MBA. In 2012 he joined GEA Pharma and is today as Global Sales Director for Continuous Processing Technologies. He contributed papers and chapters on many international conferences and scientific textbooks.

Deep Learning for Visual Inspection:
Implementation in Automated Inspection Machine under Production Conditions

Jose Zanardi, Ph.D. Senior Manager, AI Image processing technology, Pharma Inspection Div., Syntegon Technology K.K.

Detail & Speaker’s Profile

<Detail>
AI is now making its way into the visual inspection of injectable drugs, especially the products difficult to inspect. Utilizing AI algorithm in the image processing will enable automated inspection machines to achieve a desired outcome. This lecture will introduce our pilot project of Deep Learning application, including solutions to the challenge of validation.

<Speaker’s Profile>
Zanardi is Senior Manager at Bosch Packaging Technology, where he is responsible to oversee projects related to Deep Learning applied to automated vision inspection at the Center of Competence for Vision Technology, located in Japan. Previous to his present position, he was project manager for platform development of automated inspection machines, later on Manager of the R&D Department, and also responsible for vision technology applications in customer projects. He has a doctoral degree in materials science, with specialty in spectroscopic characterization of defects in semiconductor materials.

IPJ-S4 November 27 (Fri) 10:00  -  11:30
  • FREE / Pre-registration Required

Challenge for Production Innovation of Cosmetics

  • English / Japanese

Production Base Strategy of Shiseido:
Manufacturing System Set-up to Lead Cosmetic Industry

Shuji Hasegawa Nasu Factory General Manager, Shiseido Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Shiseido are currently developing a supply chain strategy from a global perspective in align with the company-wide marketing strategy, and aiming to create a flexible responsive system at each of our factories around the globe. We are going to introduce our production base strategy with the case of Nasu factory started up in 2019.

<Speaker’s Profile>

The New Challenges of Naris Cosmetics in Hyogo Factory:
Balancing of the Multi-specification Form and Labor Savings

Taro Onishi General Manager, Engineering Dept., Naris Cosmetics Co., Ltd.

Detail & Speaker’s Profile

<Detail>
The growing demand for diverse cosmetics including the finish of the product making it difficult to select suitable investment of equipment in the factory. I would like to introduce some of our challenges as the case studies for complying with a demand for diversity, the cost-effectiveness of investment, and stable production under such a trade-off situation.

<Speaker’s Profile>
After graduated from Okayama University of Science in 1990, Taro Onishi joined Naris Cosmetics Co., Ltd.. He was in charge of formulation development and developed many categories of new products. Since 1997, continuing with the development of the new product and managing the beauty cosmetics research and basic research of the cosmetics. In 2012, he was appointed as a manager of the Engineering Department to the present, after having experienced both architectural and equipment layout design of the Vietnam and the new Hyogo factories.

IPJ-S5 November 25 (Wed) 13:00  -  14:30
  • FREE / Pre-registration Required

Automation, IoT, and GDP: Evolving Logistics of Pharmaceuticals

  • English / Japanese

Utilizing IoT in Pharmaceutical Distribution:
Looking to Personalized Medicine Era

Yusuke Fukujin Representative Director & President, Alfresa Corp.

Detail & Speaker’s Profile

<Detail>
To be announced shortly

<Speaker’s Profile>

MEDIPAL's Business Continuity Plan and Advanced Logistics in Pharmaceutical Distribution

Masaaki Katano General Manager of Sales Div., SPLine Corp., MEDIPAL GROUP

Detail & Speaker’s Profile

<Detail>
The MEDIPAL Group, based on the management philosophy of "contributing to people's health and the advancement of society through creation of value in distribution," is building a distribution platform that accommodates to effective business continuity planning and the construction of logistics that supports various temperature ranges including products that require ultra-low temperature logistics, such as regenerative medicine.

<Speaker’s Profile>
April 2016, Manager of Business Development Division, MEDIPAL Group
April 2018, President and CEO of SPLine Corp.
December 2019, Director and General Manager of Sales Division of SPLine Corp.

In 2009, Mr. Katano was involved in the development of "Kanagawa ALC" the first high-performance logistics center in the MEDIPAL Group, and gained experience as a drug sales area manager for pharmaceuticals.
He then became a member of the distribution project of "TEMCELL® HS injection", a regenerative medicine product that was the first to be handled by a pharmaceutical wholesaler, in 2016, which helped him elevate to his current position in the company.

IPJ-S6 November 27 (Fri) 12:30  -  14:00
  • FREE / Pre-registration Required

Towards 80% Share of Generic Drugs: Current Situation and Future Outlook

  • English / Japanese

Current Status and Future Perspectives on Generic Drugs

Mitsuo Sawai Chairman, Sawai Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
In 2019, we commemorated 90 years since our founding. When generic drugs were virtually unknown, Sawai began persistently raising awareness. Moving forward, we will continue to help reduce the burdens placed on patients, improve convenience, and continue to contribute to healthcare financing by staying the course in the years to come.

<Speaker’s Profile>

Generic Drugs: Promotion Made by the Government

Toshihiro Hayashi Director, Economic Affairs Div., Health Policy Bureau, Ministry of Health, Labour & Welfare

Detail & Speaker’s Profile

<Detail>
In the promotion of use of generic drugs, the ratio of generic drugs use in volume is aimed to reach 80% by September 2020 and various efforts have been made to achieve it. In this seminar, the presenter will overview the challenges in promoting the use of generic drugs, various efforts made to achieve the goal as well as the vision after achieving the 80% usage ratio.

<Speaker’s Profile>

BP-K November 25 (Wed) 13:00  -  14:30

Biopharmaceutical R&D Strategy of Global Biopharma Companies

  • English / Japanese

Global R&D Trend of Biologics from CDMO Viewpoint

Takatoshi Ishikawa Senior Executive Vice President, General Manager, Bio CDMO Div., Fujifilm Corp. / Director, Fujifilm Holdings Corp.

Detail & Speaker’s Profile

<Detail>
It's been 9 years since Fujifilm first started the Bio CDMO business. We will introduce our history and the current global activities in recombinant proteins, monoclonal antibodies, cell/gene therapy products and vaccines, and will share our views of the market trend in the Bio CDMO industry and of the latest global R&D trend in biologics, together with the recent countermeasures for COVID-19.

<Speaker’s Profile>
April 1978, Fuji Photo Film Co., Ltd.

June 2012, Director of FUJIFILM Holdings Corp.
Director, Corporate Vice President and General Manager of the Pharmaceutical Products Div. of FUJIFILM Corp.

June 2017, Director, Senior Vice President, and General Manager of Bio CDMO Div. In charge of Life Science Products Div. of FUJIFILM Corp.

June 2020, Director, Senior Executive Vice President and General Manager of Bio CDMO Div. of FUJIFILM Corp. Chief Life Science Officer
To the Present

R&D Strategy of Amgen under the Age of Rapid Scientific Progress

Izuru Miyoshi, Ph.D. Corporate Officer, Executive Medical Director, Amgen K.K.

Detail & Speaker’s Profile

<Detail>
To support Amgen's mission of serving patients, the R&D organization aims to discover, develop, and deliver transformative medicines that address the leading causes of death and disability, working to meet the needs of as many patients as possible. Amgen's scientific success has been rooted in a unique "triple threat" capability that includes world-class human genetics, a deep understanding of disease biology, and the molecular engineering expertise needed to design the right drug for the right target. Details will be discussed in the session.

<Speaker’s Profile>
Izuru Miyoshi MD, PhD is Corporate Officer, Executive Medical Director of Amgen K.K. since he joined in 2018.
Before joining Amgen, Dr. Miyoshi worked more than decade in research and development area in the pharmaceutical industry, National Center and PMDA. Dr. Miyoshi held various roles of increasing responsibility in medical affairs, clinical development and marketing in the industry. He earned medical degree and PhD from Hiroshima University School of Medicine and worked for Hiroshima University Hospital, National Kure Medical Center/Chugoku Cancer Center, PMDA, National Center of Neurology and Psychiatry in psychiatry, palliative medicine and basic/clinical research.

BP-S1 November 25 (Wed) 15:30  -  17:00
  • FREE / Pre-registration Required

Biopharmaceuticals & Digital Innovation Forefronts

  • English / Japanese

Bioproduction AI Management System by Using Convolutional Data

Ken Kasahara, Ph.D. Executive Officer, Tech & Biz Development Div., Chitose Laboratory Corp.

Detail & Speaker’s Profile

<Detail>
Chitose laboratory holds a novel CHO-MK strain, which is significantly more productive than conventional CHO-K1 strain. Currently, we are developing an AI system that learns time-series culture data from various sensors in order to manage bioproduction precisely. The system is also applicable to biopharmaceutical manufacturing processes.

<Speaker’s Profile>
- The University of Tokyo, Ph.D., Pharmacy, 2007
- Chitose Laboratory Corp., 2007
- Japan Microbiome Consortium, R&D Committee Chair, 2017
- Japan Microbiome Consortium, Steering Committee Vice-chair, 2018

Manufacture of Biologics in Future and Digital Solutions

Masato Takeuchi BP Sales & Project Manager Bioprocess Application Sales, Cytiva

Detail & Speaker’s Profile

<Detail>
Biopharma industry is rapidly changing and faces unique challenges, that requires productivity growth. Digital transformation has not been spread across the industry, and there is a room for improvement. In this session, how digital transformation enables productivity growth will be discussed.

<Speaker’s Profile>
  

BP-S2 November 26 (Thu) 10:30  -  12:00
  • FREE / Pre-registration Required

Biotech Start-ups: A New Way to Grow

  • English / Japanese
Chairperson Kiichi Kubota, Chairman, Representative Director, PeptiDream

The Challenge of a Gel Start-up Bringing Innovation to Hemostat

Kosuke Masui CEO, Gellycle Co., Ltd.

Detail & Speaker’s Profile

<Detail>
90% of Japanese biotech startups are in the red despite their disruptive technologies. In this talk, the speaker who had founded an IT startup and successfully monetized it, introduces our challenge to disrupt the conventional wisdom of biotech startups with the case of hemostat development.

<Speaker’s Profile>
The speaker is a serial entrepreneur. After he graduated from the University of Tokyo in 2010, he was hired by Leverages, and drove the growth from 2 billion yen to 10 billion yen during five years. In 2015, he founded a co-owned IT startup and turned black successfully. After that, he traveled around the world, and he founded Gellycle in 2018.

Aiming for Innovation in Developing Countries

Mari Sakoh Chief Executive Officer, miup Inc.

Detail & Speaker’s Profile

<Detail>
Medical/Pharmaceutical are some of the fields with many restrictions. Due to this on top of vested interests and fierce competitions, innovation such as digital transformation is difficult to occur. Because of the nature of untapped region for developing countries, we consider the possibility of innovation there.

<Speaker’s Profile>
    

Panel discussion

< Panelist >

Kosuke Masui
CEO,
Gellycle Co., Ltd. ×
< Panelist >

Mari Sakoh
Chief Executive Officer,
miup Inc. ×
< Moderator >

Kiichi Kubota
Chairman, Representative Director,
PeptiDream Inc.
BP-S3 November 26 (Thu) 13:00  -  14:30
  • FREE / Pre-registration Required

Exosome: Application for Drug Discovery & Medical Treatment

  • English / Japanese
Chairperson Masamichi Koike, Fellow, Head of Research Function Unit, Kyowa Kirin Co., Ltd.

Exosome Diagnostic and Therapeutic Approach

Takayuki Mizutani, Ph.D. CEO, Theoria Science Inc.

Detail & Speaker’s Profile

<Detail>
Almost all of cells releases characteristic exosomes, which contribute to their cell-cell communications. Therefore, cancer specific exosomes have the potential to become biomarkers, and new therapeutic targets for cancer patients. I introduce our diagnostic and therapeutic approaches to target the characteristic exosomes.

<Speaker’s Profile>

Cancer Exosomal Protein Signatures:
Mechanistic Insights and Biomarker Potential

Ayuko Hoshino Associate Professor, Tokyo Institute of Technology

Detail & Speaker’s Profile

<Detail>
Exosomes, nanosized vesicles mediating cell-cell communication, play roles in normal physiology and disease etiology. We utilized our proteomics data of over 400 human exosome samples and defined a panel of proteins that could define cancer, classify tumor types and determine future sites of metastasis.

<Speaker’s Profile>
 

BP-S4 November 27 (Fri) 13:00  -  14:30
  • FREE / Pre-registration Required

Latest World Trends of Biopharmaceutical CMO

  • English / Japanese
Chairperson Hisafumi Okabe, Executive Vice President, In charge of Translational Research and General Manager of Translational Research Div., Chugai Pharmaceutical Co., Ltd.

Managing Biologics Manufacturing Complexity

Uwe Buecheler, Ph.D. Head of Biopharma Business Unit, Boehringer Ingelheim Biopharmaceuticals GmbH

Detail & Speaker’s Profile

<Detail>
Diversity of biologics manufacturing needs is increasing, requiring broad capabilities and different manufacturing platforms. Boehringer Ingelheim is responding to current global capacity demands while managing diversity and complexity to ensure reliable supplies and serve patients' needs worldwide.

<Speaker’s Profile>
Dr. Uwe Bucheler is Head of Biopharma Business Unit of Boehringer Ingelheim and CEO of Boehringer Ingelheim Biopharmaceuticals GmbH, the group's contract manufacturing business arm.
He holds a PhD in Molecular Biology from University of Heidelberg and Cancer Research Center Heidelberg.
Since joining Boehringer Ingelheim, he held various senior management positions in biopharma regulatory affairs, quality & compliance and operations for more than 25 years.

Leading Technology Innovations to Expedite Global Biologics Development and Manufacturing

Weichang Zhou, Ph.D. Chief Technology Officer, Executive Vice President, Biologics Development and Manufacturing, WuXi Biologics Co., Ltd.

Detail & Speaker’s Profile

<Detail>
To further expedite global biologics development from discovery to commercialization, we have been driving innovations of state-of-the-art technology platforms. These innovations will be highlighted for improving development efficiencies and reducing timelines from DNA to IND from a typical duration of 18 months to 6 months or less, as well as for reducing the manufacturing costs by implementing the next generation integrated continuous bioprocessing with ultra-high productivity. Case studies to expedite development of neutralizing monoclonal antibodies against COVID-19, and complex biologics including bispecific antibodies and antibody drug conjugates will be discussed.

<Speaker’s Profile>
Dr. Zhou specializes in biologics manufacturing process development, scale-up, characterization, technology transfer, manufacturing and regulatory support.

A New Era of Clinical Drug Development in China

Yuyan Jin, Ph.D. Leader, Site Head of Pharmaceutical Sciences Shanghai, Roche Pharma Research & Early Development, Roche Innovation Center Shanghai, Roche R&D Center (China) Ltd.

Detail & Speaker’s Profile

<Detail>
Once significantly behind, China begins to close the innovative drug development gap by a series of sweeping regulatory reforms. The presentation will provide an overview of changes in clinical development in China and its potential profound impact on global drug development environment.

<Speaker’s Profile>
Yuyan Jin is the site head of pharmaceutical sciences in China. The function of Pharmaceutical Sciences in China focuses on clinical pharmacology, drug metabolism, toxicology, bioanalytics, and biomarker development to enable drug discovery and development from early to late stages. Yuyan joined Roche in Jan 2013 and has supported global and China development of multiple early and late stage programs. Before joining Roche, she was a Project Clinical Pharmacologist at Pfizer US with a focus on CNS drug development after two-year Critical Path fellowship at US FDA. Yuyan has a BSc In Biopharmaceutics, a MSc in Pharmaceutics from China Pharmaceutical University, and a PhD in quantitative clinical pharmacology from the University of Pittsburgh.

PRD-K November 27 (Fri) 10:30  -  12:00

Open Innovation in the New Era of Pharmaceutical Industry

  • English / Japanese

Toward the Building of a Drug Discovery Ecosystem

George Nakayama President, Japan Pharmaceutical Manufacturers Association

Detail & Speaker’s Profile

<Detail>
Innovation in the life sciences creates innovative new drugs. These new drugs will extend the nation's healthy lives and enable the economy to grow as well. And it creates a positive cycle that leads to the next innovation. In this presentation, I will talk about what we need to do to build "a drug discovery ecosystem" to lead to this innovation.

<Speaker’s Profile>

Co-creation of Innovation in Drug Discovery Research and Digital Transformation

Shunichi Takahashi, Ph.D. Director, Head of Open Innovation Center Japan, Bayer Yakuhin, Ltd.

Detail & Speaker’s Profile

<Detail>
In recent years, the progress of basic research, the development of drug discovery technology, and the diversification of modalities have led to active efforts of open innovation by pharmaceutical companies. In this session, a wide range of Bayer's open innovation activities will be introduced.

<Speaker’s Profile>

PRD-S1 November 25 (Wed) 10:30  -  12:00
  • FREE / Pre-registration Required

AI & Quantum Computing Technologies: Future of Drug Discovery Research

  • English / Japanese

Re-energising Small Molecule Drug Discovery by Artificial Intelligence

Daisuke Tanaka, Ph.D. Representative Director, Exscientia K.K.

Detail & Speaker’s Profile

<Detail>
It has been widely understood or accepted by pharma industry that the hit-to-candidate exploratory phase in drug discovery requires 5 years of time and 2500 of test compounds to deliver a clinical candidate. Exscientia is the world-leading AI drug discovery company who directly challenges this industry's preconception.

<Speaker’s Profile>
Daisuke started his pharma industry career at Dainippon Pharma (now Sumitomo Dainippon Pharma) in 1993 as a medicinal chemist. After 25-year experience at the same company he moved to Exscientia Ltd. On the establishment of Exscientia KK, a Japanese subsidiary of Exscientia, he became the representative director of the company.

Toward Practical Use of Quantum Computer in Drug Discovery

Ryuji Tanimura, Ph.D. Senior Molecular Designer, Head of Digital Life Science Group, Pharmaceutical Research Labs., Toray Industries, Inc.

Detail & Speaker’s Profile

<Detail>
Quantum computers, whose development is accelerating rapidly in recent years, among them, annealing machines that specialize in combinatorial optimization processing, have begun to be used in various field, so I tried using it. In this seminar, I would like to talk about the results, the technical issues and future prospects.

<Speaker’s Profile>

PRD-S2 November 25 (Wed) 13:00  -  14:30
  • FREE / Pre-registration Required

Nucleic Acid Pharmaceuticals: Key Points for Practical Use

  • English / Japanese

Development of Exon Skipping Therapy for Duchenne Muscular Dystrophy

Yoshitsugu Aoki, Ph.D. Director (Head of Dept.), Dept. of Molecular Therapy, National Institute of Neuroscience, National Center of Neurology and Psychiatry (NCNP)

Detail & Speaker’s Profile

<Detail>
Duchenne muscular dystrophy (DMD), mainly caused by a frameshift mutation in the DMD gene, is fatal, inherited progressive muscle degenerative disorder. Very recently, an antisense oligonucleotide drug, viltolarsen, for the treatment of DMD in patients amenable to skipping exon 53, has been approved in Japan.

<Speaker’s Profile>
Yoshitsugu Aoki, MD, PhD graduated in Medicine from the University of Tohoku, Japan in 2001, working in clinical Neurology and became a consultant neurologist in 2008 before gaining a doctorate in System Neuroscience in 2011 from Tokyo Medical and Dental University Graduate School (TMDU), Japan. Dr. Aoki joined Prof. Matthew JA Wood's laboratory at the University of Oxford in 2012. His achievements on the development of oligonucleotide treatment for neuromuscular diseases have been endorsed by the Royal Society of the UK as of Exceptional Promise in 2013 and have prepared him to serve as a member of Congregation and a Senior Research Scientist, Faculty of Physiological Sciences, University of Oxford in 2014. He is currently the Director, Department of Molecular Therapy and the head of dystrophic dog facility, National Institute of Neuroscience, National Center of Neurology and Psychiatry (NCNP). Dr. Aoki also holds the rank as Adjunct Professor at TMDU, Tokyo University of Agriculture and Technology, and Waseda University.

Research Process on Drug Delivery System for Nucleic Acid Therapeutics

Hiroshi Ishihara, Ph.D. Senior Principal Scientist, Modality Development, Pharmaceutical Science and Technology Core Function Unit, Medicine Development Center, Eisai Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Research and Development of nucleic acid therapeutics are accelerated as modalities that can selectively control the expression of target proteins. In this presentation, the research process of drug discovery and development process on nucleic acid therapeutics and their drug delivery systems will be outlined.

<Speaker’s Profile>
Dr. Hiroshi Ishihara is Senior Principal Researcher of Modality Development Section at Eisai. He has various experiences on pharmaceutical research over 25 years in CMC section including research and development of nanomedicines such as liposomes and lipid nanoparticles in the pharmaceutical industry.

PRD-S3 November 26 (Thu) 16:00  -  17:00
  • FREE / Pre-registration Required

Drug Developer of "AVIGAN" Addresses the Importance of Drugs for Infections

  • English / Japanese

Development of Favipiravir

Kimiyasu Shiraki, Ph.D. Vice President, Professor, Senri Kinran University

Detail & Speaker’s Profile

<Detail>
The development of favipiravir, a therapeutic drug for COVID-19, and its mechanism of action, and its characteristics as an antiviral drug are introduced in this presentation.

<Speaker’s Profile>
Professor Kimiyasu Shiraki graduated Osaka University, School of Medicine, started virus research at Osaka University, Pennsylvania State University, and became the professor at University of Toyama and developed favipiravir with Toyama Chemical Co., Ltd.

PRD-S4 November 27 (Fri) 13:00  -  14:30
  • FREE / Pre-registration Required

Forefront of Next-gen Nano-DDS Formulations for Clinical Application

  • English / Japanese

Clinical Development of Liposomal Drugs in FUJIFILM Corp.

Kiyohito Takada Senior Manager, Pharmaceutical Products Div., FUJIFILM Corp. / Deputy General Manager Development Div., FUJIFILM Toyama Chemical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
We have started U.S. Phase I clinical trials of anti-cancer agent FF-10832 (liposomal gemcitabine) and FF-10850 (liposomal topotecan). I would like to focus my talk on preclinical/clinical interim results of these pipelines and the new manufacturing facility of liposomal drugs.

<Speaker’s Profile>

Clinical Development of Micellar Nanoparticles

Tetsuhito Matsuyama President and CEO, NanoCarrier Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Micellar nanoparticles have superior characteristics that can carry the highly toxic drug such as the anticancer agent into the desired tissue safely and effectively. In this talk, we will introduce pipelines under clinical development.

<Speaker’s Profile>

PRD-S5 November 27 (Fri) 15:30  -  16:30
  • FREE / Pre-registration Required

Precision Medicine: Towards the Realization

  • English / Japanese

Konica Minolta Approaches to Precision Medicine through Quantitative Analysis

Hidenori Seshimo Vice President, Pharma Service Unit, KONICA MINOLTA PRECISION MEDICINE JAPAN, Inc.

Detail & Speaker’s Profile

<Detail>
Konica Minolta helps pharmaceutical companies to save time and cost for discovery and development of new therapeutics to realize the personalized medicine. We introduce our approaches to precision medicine through our cutting-edge technologies as to high-sensitive and quantitative detection of target proteins or medicines, and image analysis provided by Invicro, LLC., our group company.

<Speaker’s Profile>

Takatoshi Kaya, Ph.D. Manager, Clinical Services, R&D Div., Precision Medicine Business Operations, Precision Medicine Business Unit, Healthcare Business Headquarters, KONICA MINOLTA, Inc.

Detail & Speaker’s Profile

<Detail>
Konica Minolta helps pharmaceutical companies to save time and cost for discovery and development of new therapeutics to realize the personalized medicine. We introduce our approaches to precision medicine through our cutting-edge technologies as to high-sensitive and quantitative detection of target proteins or medicines, and image analysis provided by Invicro, LLC., our group company.

<Speaker’s Profile>

Masaru Takahashi, Ph.D. Manager, R&D Planning, R&D Div., Precision Medicine Business Operations, Precision Medicine Business Unit, Healthcare Business Headquarters, KONICA MINOLTA, Inc.

Detail & Speaker’s Profile

<Detail>
Konica Minolta helps pharmaceutical companies to save time and cost for discovery and development of new therapeutics to realize the personalized medicine. We introduce our approaches to precision medicine through our cutting-edge technologies as to high-sensitive and quantitative detection of target proteins or medicines, and image analysis provided by Invicro, LLC., our group company.

<Speaker’s Profile>

<Concurrent Conference>