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INTERPHEX Week Japan Conference


Industry leaders speak at Conference. Pharma industry's hot topics including AI/IoT in pharma manufacturing, continuous manufacturing, CAR-T Therapy and CMC strategy, etc. will be addressed.

>>> Sessions listed here are all bilingual session with English & Japanese.
For the full program, please visit
https://www.interphex.jp/seminar/
(available only in Japanese)

Keynote Session Pre-registration Required

IPJ-K July 3 (Wed) 10:30  -  11:30

Japanese Pharmaceutical Industry -- What is the Key to Growth?

  • English / Japanese
Course Leader Hirofumi Takeuchi, Professor, Gifu Pharmaceutical University

The Astellas Vision for the Future of Healthcare

Yoshihiko Hatanaka Representative Director, Chairman of the Board, Astellas Pharma Inc.

Detail & Speaker’s Profile

<Detail>
Healthcare needs are drastically changing with economic and social structure transition due to aging.
Astellas strives to create medical solutions that provide value to society through new modality / technology and digital transformation, including cell therapy and digital health programs.

<Speaker’s Profile>
Yoshihiko Hatanaka
Representative Director, Chairman of the Board
Astellas Pharma Inc.

Yoshihiko Hatanaka became Astellas' Chairman of the Board in April 2018. Hatanaka served as the company's President and CEO from June 2011 to March 2018.
He joined the marketing organization of Fujisawa Pharmaceutical Co., Ltd. in 1980 and expanded his roles and responsibilities in Japan, the US and Europe. He became Fujisawa's Vice President of the Corporate Planning in 2003 and played a key role in the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. to form Astellas Pharma Inc. in 2005. He kept the senior level position under the new company. He assumed the roles of President and CEO of Astellas US LLC and Astellas Pharma US, Inc. in 2006, and Chief Financial Officer and Chief Strategy Officer of Astellas Pharma Inc. in 2009. He holds a bachelor's degree in Economics from Hitotsubashi Univercity, Tokyo, Japan

INTERPHEX JAPAN Conference

Special Session

IPJ-S1 July 4 (Thu) 9:30  -  11:00
  • FREE / Pre-registration Required

Next-generation Pharma Facilities with AI/IoT Technologies

  • English / Japanese
Course Leader Masao Nagao, Senior Director, Takeda Pharmaceutical Co., Ltd.
Sub Leader Koichi Usuda, Executive Manager, Engineering Dept., Head Office, Takenaka Corp.

Hitachi Social Innovation Solutions

Shinsuke Kataoka Dept. Manager, Social Innovation Business Div., Business Incubation and Development Div., Pharma and Medical Dept., Hitachi, Ltd.

Detail & Speaker’s Profile

<Detail>
With the evolution of technologies such as IoT and big data technology, innovation is occurring in various industries.
In the field of pharma industry, each company is working on IoT utilization. In this talk, I introduce examples that pharma companies visualized the manufacturing site using sensing and feedback technologies, and that they solved difficult problems by utilizing IoT and AI.

<Speaker’s Profile>

Introduction Example of Artificial Intelligence at Packaging Line for Line Clearance

Masahiro Kondo Associate Director, Pharmaceutical Technology, Technology Operations, Hikari Plant Global Manufacturing & Supply Japan, Takeda Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Takeda is driving innovation applying the latest digital technologies to our manufacturing sites/GEMBA. This time, we successfully developed a new inspection system utilizing artificial intelligence(AI) in collaboration with our vendor and we have started operation on a commercial packaging line as an "automatic line clearance check system". We will introduce this case with our story of development as an example.

<Speaker’s Profile>

IPJ-S2 July 4 (Thu) 12:00  -  13:30
  • FREE / Pre-registration Required

Key Issues to Make Pharma Facilities with IoT Technologies

  • English / Japanese

Steps at Factory IoT and Success Stories

Yoshikazu Kida President & CEO, FA Products Inc.

Detail & Speaker’s Profile

<Detail>
The need to convert to IoT in various industries has long been said for a long time. However, it is true that the manufacturing industry as a whole has not progressed to IoT. In this lecture, we will explain the cause and introduce the steps to make IoT a success, with concrete examples, focusing on the two main themes of "operation monitoring" and "predictive maintenance".

<Speaker’s Profile>

A Key Concept to Realize New Dimension Productivity "Autonomous Manufacturing"

Daisaku Kimura Director, IT Service Promotion Dept., Engineering Headquarters, Advanced Automation Company, Azbil Corp.

Detail & Speaker’s Profile

<Detail>
The four technologies (IoT, big data, AI, robots) that drive Industry4.0 bring irreversible and discontinuous paradigm shifts to manufacturing. The concept of "autonomous manufacturing" is a guide for overcoming this wave of reform and rebuilding manufacturing. We would like to introduce the "To be model" with a sense of realism unique to our company, which has been engaged in AI utilization in heavy and large manufacturing fields.

<Speaker’s Profile>

IPJ-S3 July 4 (Thu) 14:30  -  16:00
  • FREE / Pre-registration Required

Validation -- Basic Concepts and Practical Examples

  • English / Japanese

Practical Approach to Cleaning Validation

Masaharu Miyajima Deputy General Manager, R&D Div., Director Research Dept., NanoCarrier Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Based on the latest trend, I will introduce how to handle critical tasks for implementation of cleaning validation, such as how to set residual limit, how to set hold time, sampling method, how to think about worst-case, in this presentation.

<Speaker’s Profile>

Key to Success in Construction and Qualification of Packaging Line

Hiroshi Hirasawa Representative Director, ease Ltd.

Detail & Speaker’s Profile

<Detail>
Key to successful qualification is that the system has been designed from a perspective of qualification. This can be assessed by functional risk assessment.
Taking example of pharmaceutical packaging line, specific ideas (traps in system design, qualification types etc..) will be presented.

<Speaker’s Profile>

IPJ-S4 July 5 (Fri) 9:30  -  11:00
  • FREE / Pre-registration Required

AI & Big Data Bring Innovation in Drug Discovery

  • English / Japanese
Course Leader Nobuya Hatta, Manager, IHI Corp.
Sub Leader Tadashi Hakomori, Vice President, Astellas Pharma Inc.

Enhancement of Drug Discovery Process by Using Simulation and AI: LINC Challenge

Teruki Honma Team Leader, Laboratory for Structure-based Molecular Design, RIKEN Center for Biosystems Dynamics Research

Detail & Speaker’s Profile

<Detail>
Expectations for AI drug discovery are increasing due to big data, computer performance, and innovation of learning technology such as Deep Learning. In this presentation, we will outline a new drug discovery process by using both simulation and AI, with examples of LINC.

<Speaker’s Profile>
Teruki Honma was received his Ph.D. in Science from Hokkaido University, Japan in 2001. He joined Banyu Tsukuba research institute in 1993 for promoting in silico drug discovery. He moved to Pfizer in 2004 and RIKEN in 2007. Since 2008, he has been in charge of the team leader of structure-based molecular design team in RIKEN and developed new technologies for in silico drug discovery.

DeNA Health Initiatives in Digital Space

Kuniaki Miyake Chief Medical Officer(CMO), DeNA Co., Ltd.

* Please note that the speaker has been changed because of an unavoidable reason.
[As of April 22nd, 2019]

Detail & Speaker’s Profile

<Detail>
DeNA's Healthcare Business utilizes engagement science honed in our Game and Sports Businesses to help people be healthy, and enjoy doing it. We will discuss our initiatives & failures to date, how we built this new business from the ground up, and our most recent initiatives.

<Speaker’s Profile>

IPJ-S5 July 5 (Fri) 12:00  -  13:30
  • FREE / Pre-registration Required

Plant Innovations by Leading Cosmetics and Detergent Manufacturers

  • English / Japanese

Applied Humanoid Robots for the Cosmetic Production in Shiseido

Takehisa Kobayashi Group Manager, Production Dept., Nasu Factory, Shiseido Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Cosmetic products have been tended to have the multiple-pieces production for decades.
It is like an art piece and the production requires delicate treatment, so it is hard to be automatized.
I am pleased to show you our challenge that Shiseido has been tackled with this issue by using humanoid robots.

<Speaker’s Profile>

Challenge for Human Resource Training at Global Mother Plant of Kao Corporation

Kaoru Matsushita Plant Manager, Wakayama Plant, Kao Corp.

Detail & Speaker’s Profile

<Detail>
Kao Corporation Wakayama Plant is responsible for the mission of human resource training and supply as global mother plant founded 76 years ago. Wakayama Plant has excellent systems of human resource training, such as Kao Techno School, Monozukuri Training Center and Interval training. Those will be presented.

<Speaker’s Profile>

Technical Session

IPJ-1 July 3 (Wed) 12:30  -  14:30
  • Pre-registration Required

Latest Trends of Japanese PIC/S GDP Guideline

  • English / Japanese
Course Leader Koichi Usuda, Executive Manager, Engineering Dept., Head Office, Takenaka Corp.
Sub Leader Kakuji Yoshihara, Vice President, Shionogi & Co., Ltd.

Overview and Key-points of Japanese GDP Guideline, and Pharmaceutical Companies' Challenge in Future

Yasuto Koyama Associate Director, Corporate Quality Assurance, Shionogi Pharma Co., Ltd.

Detail & Speaker’s Profile

<Detail>
A GDP guideline was newly issued in Japan by MHLW in the last December. The speaker of this session had worked for a MHLW's working team to establish the GDP guideline, and will explain an overview and key-points of the guideline based on this experience. Especially, challenges to be managed by pharmaceutical companies from now on will be focused.

<Speaker’s Profile>

The Pursuit of the Suitable Pharmaceutical Products' Supply Chain for GDP

Yutaka Tateiwa Manager, Health care Business Group, NIPPON EXPRESS Co., Ltd.

Detail & Speaker’s Profile

<Detail>
It should be needed to identify risks on GDP and analyze current headache problems in logistics industry. Nippon Express analyze these risks and problems and introduce one of the optimized logistics solutions for GDP and consider the risks in future in pharmaceutical industry.

<Speaker’s Profile>

IPJ-2 July 3 (Wed) 12:30  -  14:30
  • Pre-registration Required

Continuous Manufacturing of Synthetic APIs -- Latest Case & Future Prospect

  • English / Japanese
Course Leader Tadashi Hakomori, Vice President, Astellas Pharma Inc.
Sub Leader Shinichiro Takahama, Executive Officer, Chief of Engineering Div., Taisei Corp.

Case Studies and Trends of API Continuous Synthesis in Pharmaceutical Companies

Masami Takayama Associate Principal Scientist, Research Management & Planning Office, Pharmaceutical Research Div., Shionogi & Co., Ltd.

Detail & Speaker’s Profile

<Detail>
In recent years, continuous manufacturing in the pharmaceutical industry has attracted attention not only in formulation but also in API manufacturing. I will explain the concept of continuous manufacturing in API (intermediate) synthesis using flow synthesis technology and introduce trends with case studies.

<Speaker’s Profile>

Roadmap for Practical Use of Continuous Manufacturing System "iFactory" by 2030

Takao Saito President, Takasago Chemical Corp. / Fellow, Takasago International Corp.

Detail & Speaker’s Profile

<Detail>
The current manufacturing model is collapsed already. By 2030, human power saving manufacturing more than 40% is needed. NEDO Program has been started aiming at innovation in the continuous flow manufacturing. This Business cooperation is introduced in this lecture.

<Speaker’s Profile>
He received Ph.D of engineering from Osaka University in 1996. He is a president of Takasago Chemical Corporation and a Board member of Flow Science and Technology consortium (FlowST).

IPJ-3 July 3 (Wed) 15:30  -  17:30
  • Pre-registration Required

Case Study : For Data Integrity

  • English / Japanese
Course Leader Kakuji Yoshihara, Vice President, Shionogi & Co., Ltd.
Sub Leader Nobuya Hatta, Manager, IHI Corp.

The Understanding and Readiness for Data Integrity from a Standpoint of the Regulated Company

Atsushi Oto Senior Manager, Quality Assurance Dept., Shionogi Pharma Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Data Integrity needs to be performed in GMP area, furthermore is more often inspected. This session will be explained about Data Integrity how realize the essence and how practice, along with implemental way for computerized systems from a standpoint of the regulated company based on experience in Shionogi & Co., Ltd.

<Speaker’s Profile>
I joined Shionogi & Co., Ltd as an engineer of electricity, instrumentation, and computerized system and had managed constructing manufacturing facility of pharmaceutical products, introducing of computerized system, and their project and validation. After that I belonged to IT strategy planning department and IT/computerized system Quality Assurance. Currently I belong to Corp. QA dept as GMP auditor and drive Data integrity and computerized system validation company-wide. And I moved Shionogi Pharma & Co., Ltd which newly established at April 2019.

Indispensable Data Integrity in the Practical Use of Big Data to Meet GxP in 5G Era Based on AI

Daikichiro Murakami Special Advisor, Hirabara Engineering Service Ltd.

Detail & Speaker’s Profile

<Detail>
The paradigm shift from human-oriented performance to machine-dependent one has recently been required as an indispensable matter even to the pharmaceutical industry.
An effective approach to this achievement is practical application of Artificial Intelligence, which should be based on the practical use of the enormous data accumulated. Those big data, however, are required to meet GxP.
In other words, the new system applied with 5th Generation, which will be available in 2020, should be adopted on the condition that the highest priority of Data Integrity required by the regulatory agencies should be given and recognized.
Nevertheless, how the pharmaceutical industry utilizes these rapid data communication and large-capacity data could be an urgent issue.
Thereupon, some noticeable points would be made on the basis of the latest trend in the European and American pharmaceutical industries.

<Speaker’s Profile>

IPJ-4 July 3 (Wed) 15:30  -  17:30
  • Pre-registration Required

Solid Preparation -- Continuous Production and Pharma Companies' Challenges

  • English / Japanese
Course Leader Susumu Natsuyama, President & CEO, Powrex Corp.
Sub Leader Itaru Kimura, Associate Executive Officer, General Manager, JGC Corp.

Perspectives on Continuous Manufacturing in Pharmaceutical Industry

Yasuhiro Matsui Associate Director, Formulation Reseach Group I, Formulation Research & Development Labs., Technology Research & Development, Sumitomo Dainippon Pharma Co., Ltd.

Detail & Speaker’s Profile

<Detail>
In this session, I will address the control strategy of continuous manufacturing with the experience at Sumitomo Dainippon Pharma.

<Speaker’s Profile>

Process System Engineering Latest Trend- (Continuous Manufacturing/Chromatography/NIR)

Koji Muteki Senior Manager, Development & MFG Technical Services, Pfizer Global Supply Japan Inc.

Detail & Speaker’s Profile

<Detail>
The latest trend of Process System Engineering (PSE) at Pharmaceutical Development and Manufacturing is presented. Some application of continuous manufacturing, chromatography (HPLC, SFC) and PAT is described.

<Speaker’s Profile>

IPJ-5 July 4 (Thu) 9:30  -  11:30
  • Pre-registration Required

ICH Q13 & Q14

  • English / Japanese
Course Leader Kimiya Okazaki, Regulatory Intelligence, Associate Department Manager, GlaxoSmithKline K.K.
Sub Leader Shuichi Ando, Vice President, Daiichi Sankyo Co., Ltd.

ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products -Heading towards Implementation-

Yoshihiro Matsuda Senior Scientist (for Quality), Pharmaceuticals and Medical Devices Agency

Detail & Speaker’s Profile

<Detail>
ICH Q13 (Continuous Manufacturing of Drug Substances & Drug Products) was adopted in 2018, and the concept paper and business plan of ICH Q13 were also endorsed. In my presentation, I would like to introduce these documents and talk about the prospects for continuous manufacturing.

<Speaker’s Profile>

Opportunities Created by ICHQ14 Analytical Procedure Development Guideline

Yukio Hiyama Visiting Scientist, Div. of Drugs, National Institute of Health Sciences

Detail & Speaker’s Profile

<Detail>
Q2(R1) revision and Q14 (Analytical Development) will improve regulatory communication between industry and regulators and facilitate more efficient approval as well as post-approval change.

<Speaker’s Profile>
The speaker contributed ICHQ guideline development since 1990 when he was in industry. After joining NIHS, he participated in Q8, Q9, Q10 teams and conducted case study development for their implementation through the study groups.

IPJ-6 July 4 (Thu) 12:30  -  14:30
  • Pre-registration Required

Latest Case of Pharmaceutical Plant Engineering

  • English / Japanese
Course Leader Shinichiro Takahama, Executive Officer, Chief of Engineering Div., Taisei Corp.
Sub Leader Iwao Fusejima, President & COO, Freund Corp.

Regarding the Latest Plant for Sterile Products comply with PIC/s GMP

Masamichi Oishi Director, Production Headquarters, NISSIN PHARMACEUTICAL Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Nissin established the latest Sterile Plant comply with requirements of relevant regulations.
Plant details and technologies that follow the regulations, and the latest sterile technologies will be introduced.

<Speaker’s Profile>

Introduction of Daito's strategy for Highly Potent Compounds(HPC) and No.8 HPC Dosage Formulation Facility

Yoshinori Nakajima Director, Formulation manufacturing Production, Daito Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
We introduce development and production strategies of Daito for Highly Potent Compounds(HPC).
Secondly, we confirm how to proceed with design and note points of HPC facilities,Finally we will introduce containment measures, taking as an example No.8 HPC Dosage Formulation Facility completed in Dec.2018.

<Speaker’s Profile>

IPJ-7 July 4 (Thu) 12:30  -  14:30
  • Pre-registration Required

How to penetrate into China Market -- Regulations & Case Study

  • English /
    Chinese / Japanese
Course Leader Iwao Fusejima, President & COO, Freund Corp.
Sub Leader Tomoaki Kurosawa, Deputy Operations Director General Manager, Chiyoda Corp.

China Regulatory Reform on Generic Drug Quality Consistency Evaluation and Suggestions to Pass the Evaluation

Mufeng Xie Deputy Chief Pharmacist, Shanghai Institute for Food and Drug Control

Detail & Speaker’s Profile

<Detail>
One of the major regulatory reforms of China pharmaceutical products is the Quality Consistency Evaluation of Generic Drugs. The background of the Evaluation, with reference to the experience of Japan in 1990's will be briefly described. The critical issues about the Dissolution Profiles of the Evaluation will be discussed so that pharmaceutical companies can have better chance to pass the Evaluation will be suggested, based on the speaker's experience in both Japan and China. In addition, the speaker will introduce the related regulation law and whole procedure of drug registration application.

<Speaker’s Profile>
 

Key Points and Prospects for Japanese Pharmaceutical Companies' Entry into China and Collaboration with Chinese Companies

Shuji Morimoto President, MORIMOTO-PHARMA Co., Ltd.

Detail & Speaker’s Profile

<Detail>
China's pharmaceutical business has continued to grow rapidly, making sales about 1.5 times higher than those of Japan. I have been deeply involved in the pharmaceutical industry since 2000 when they were stationed at Takeda Pharmaceuticals' Tenjin Plant. This time, I would like to introduce scenarios and prospects for the entry into and collaboration with China to companies that will launch pharmaceutical-related businesses in China.

<Speaker’s Profile>

Key Consideration and Trend for Regulation in China

Yuko Kikuchi Senior Director, Eisai Co., Ltd.

* Please note that the number of speakers have changed from 2 to 3. [As of April 24th, 2019]

Detail & Speaker’s Profile

<Detail>
China is a very attractive country for Pharmaceutical industries also. However, key consideration for regulatory information and information of current actual operation for drastic current regulatory change is very limited. Speaker will make presentation for key consideration of regulatory information, impact after joining ICH and what you need to know about China today.

<Speaker’s Profile>

IPJ-8 July 4 (Thu) 15:30  -  17:30
  • Pre-registration Required

Chugai's and Daiichi Sankyo's Examples -- Manufacturing Equipment for High Potency Drugs and Antibody APIs

  • English / Japanese
Course Leader Itaru Kimura, Associate Executive Officer, General Manager, JGC Corp.
Sub Leader Susumu Natsuyama, President & CEO, Powrex Corp.

Facility Concept of Fujieda Plant to Prevent from Worker's Health Hazard and Cross-contamination between Multi-product

Masami Teshirogi  , Fujieda Plant Technical Planning And Cooperation Group, Chugai Pharma Manufacturing Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Fujieda factory's containment concept of solid formulation building and examples of its introduction are reported.

<Speaker’s Profile>
April 1989 Joined Chugai Pharmaceutical. Since joining Kamakura Plant has been involved in the production of solid formulations and later development. Participated in the design project of the Fujieda Plant Solid Drug Building in 2005, from the design to the launch, to the present. Participate in the expansion project of the solid drug building from 2015.

Single-use Technology Integration in Monoclonal Antibody Manufacturing

Koichi Nonaka Vice President, Biologics Div., Biologics Technology Research Labs., Daiichi Sankyo Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Biologics/monoclonal antibodies, which hold a top-ranking position in pharmaceuticals sales, have been manufactured by CHO cells. To provide a drug substance with higher efficiency, it is important to achieve not only host-vector and manufacturing technique developments but also high-speed change-over of manufacturing line. Some examples of single-use technology integration will be introduced in this session.

<Speaker’s Profile>
After graduating Kyushu University in March, 1992, KN joined Sankyo Co., Ltd. in April, 1992. Daiichi Sankyo original host-vector systems have been developed in his group and applied to manufacture a drug substance and the related proteins in a field of therapeutic biologics. KN is strongly focusing on the strategy for development of biologics manufacturing process and drug substance provision.

IPJ-9 July 4 (Thu) 15:30  -  17:30
  • Pre-registration Required

Manufacturing and Quality Evaluation of Biopharmaceuticals

  • English / Japanese
Course Leader Akiko Koga, Dept. Manager, Chugai Pharmaceutical Co., Ltd.
Sub Leader Susumu Kimura, Executive Director, Eisai Co., Ltd.

Issues and Approaches in Biopharmaceuticals Production

Yutaka Osawa Vice President Head Production Div., Director of the Board, Managing Executive Officer,, Kyowa Hakko Kirin Co., Ltd.

Detail & Speaker’s Profile

<Detail>
It is important to develop processes for stable and efficient production of high-quality biopharmaceutical products. In our understanding, there are issues in the production process and facility for antibody drugs. I will provide some approaches to solve them, including continuous manufacturing and application of single use system.

<Speaker’s Profile>

Introduction for Bio-product's Control Strategy Based on QbD Approach

Junichi Shoji Group Manager, Quality Development Dept., Bio-product Analysis 2G, Chugai Pharma Manufacturing Co., Ltd.

Detail & Speaker’s Profile

<Detail>
For the development of bio-product medicines, it is important to establish robust control strategy based on deep understanding of critical quality attribute and manufacturing process. This session introduces each step to establish control strategy using actual experience upon bio-product development.

<Speaker’s Profile>

IPJ-10 July 5 (Fri) 9:30  -  11:30
  • Pre-registration Required

Continuous Production of Biopharmaceuticals -- Latest Trends in Domestic/Overseas Manufacturers

  • English / Japanese
Course Leader Tomoaki Kurosawa, Deputy Operations Director General Manager, Chiyoda Corp.
Sub Leader Akiko Koga, Dept. Manager, Chugai Pharmaceutical Co., Ltd.

Continuous Manufacturing for Biologics in Japan - Past and Future 

Takeshi Omasa Professor, Graduate School of Engineering, Osaka University / Visiting Professor , Tokushima University / Kobe University

Detail & Speaker’s Profile

<Detail>
In this presentation, I will introduce the progress of continuous manufacturing and related area for biologics in Japan and discuss the future aspects.

<Speaker’s Profile>
PhD Osaka U (Eng,1992), Assit Prof (1992), Assoc Prof. (2005) in Osaka U, Prof in Tokushima U (2015), Prof in Osaka U (2015) President of JAACT, Division head in Biochemical Eng. Div. in SCEJ

Current State of Integrated Continuous Biomanufacturing

Veena Warikoo Head, Single Use Technology, Pharma Technical Operations, F.Hoffmann-La Roche Ltd.

Detail & Speaker’s Profile

<Detail>
Recently, continuous processing is being leveraged by biopharmaceutical industry to establish lean, fully automated and agile manufacturing. There are industry wide efforts to address gaps in both technology and regulatory guidelines.

<Speaker’s Profile>
Dr. Veena Warikoo has 20 years of experience in innovation, process development, manufacturing and organizational management. She was been involved in the development of an innovative end-to-end, integrated biomanufacturing platform.

IPJ-11 July 5 (Fri) 12:30  -  14:30
  • Pre-registration Required

For Productivity Improvement

  • English / Japanese
Course Leader Shuichi Ando, Vice President, Daiichi Sankyo Co., Ltd.
Sub Leader Masao Nagao, Senior Director, Takeda Pharmaceutical Co., Ltd.

Operational Excellence 2.0

Tsuyoshi Sato Head, Operational Excellence Osaka Palant Japan, Global Manufacturing & Supply Japan, Takeda Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
IE, QC and TPM in Japan have become global common language as "Lean Six Sigma", and deployed as "operational excellence" in pharmaceutical industry.
What is required for "operational excellence" and where will it go in the future?
We introduce our company's activities which combined Japan's strengths and Global trend, and predict its trend.

<Speaker’s Profile>

Pharmaceutical Process Systems Engineering and Decision Support

Hirokazu Sugiyama Associate Professor, Dep. of Chemical Syste, Engineering, Graduate School of Engineering, The University of Tokyo

Detail & Speaker’s Profile

<Detail>
This talk will introduce latest research achievements (e.g., continuous manufacturing, single-use, production data utilization) of pharmaceutical process systems engineering that the presenter is conducting, and discuss the role of the research in decision-support towards productivity improvement.

<Speaker’s Profile>

IPJ-12 July 5 (Fri) 12:30  -  14:30
  • Pre-registration Required

Current Status of Nucleic Acid-based Drug R&D and Forefront of CMC

  • English / Japanese
Course Leader Susumu Kimura, Executive Director, Eisai Co., Ltd.
Sub Leader Kimiya Okazaki, Regulatory Intelligence, Associate Department Manager, GlaxoSmithKline K.K.

Current Status of Development of Oligonucleotide Therapeutics

Takao Inoue Chief of Lab., Laboratory of Oligonucleotide therapeutics, Div. of Molecular Target and Gene Therapy Products, National Institute of Health Sciences

Detail & Speaker’s Profile

<Detail>
Oligonucleotide therapeutics have been developed extensively over the past several decades and are emerging as the third platform after small molecules and biologics for drug development. In this meeting, I would like to talk about the development trends for oligonucleotide therapeutics and discuss quality and safety evaluation of oligonucleotide therapeutics.

<Speaker’s Profile>

Production Engineering and Quality Control of Oligonucleotide Drug Substances

Hirokazu Nankai General Manager, Research & Development Div., Ajinomoto Bio-Pharma Services / GeneDesign, Inc.

Detail & Speaker’s Profile

<Detail>
We produce oligonucleotides by solid-phase synthesis.
In cooperation with Ajinomoto Co., Inc. which commercializes liquid-phase synthesis (AJIPHASE), we can consistently contract from small quantity to mass production.
I will talk about the manufacturing and quality control of oligonucleotides.

<Speaker’s Profile>

BioPharma Expo Conference

Keynote Session Pre-registration Required

* Please note that the session is rescheduled to 13:00 – 14:30. [May 22, 2019]

BP-K
July 3 (Wed) 13:00  -  14:30

Japanese Biopharmaceutical Industry's Steps for Growth -- Japanese Companies' Challenges and Future Perspective

  • English / Japanese

Evolution of Biotechnology and Creation of Innovation in Medicine

Hisafumi Okabe Executive Vice President, Research, Translational Research, General Manager of Translational Research Div., Chugai Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Recent progress in biotechnologies has brought rapid evolution of existing biologics as well as development of new modalities. In this session, I will talk about the evolution of therapeutic antibodies and emerging new modalities, and also touch on industry-academia collaboration to accelerate the innovation.

<Speaker’s Profile>
Education: Institute of Medical Science, The University of Tokyo, Faculty of Science, Tohoku University(Ph.D.).
Professional career: Researcher at Metropolitan Institute of Medical Science, Postdoc at Yale University, Researcher at Nippon Roche Research Center, Executive Vice President, Head of Research and Translational Research at Chugai Pharmaceutical Co., Ltd.

AGC's Challenge to Raise Japan's Competitiveness in Biopharmaceuticals

Hideyuki Kurata GM of Technology General Div., Senior Executive Officer, AGC Inc.

Detail & Speaker’s Profile

<Detail>
AGC's brand statement, "Your Dreams, Our Challenge" stands for our determination to bring to life the dreams that lay beyond everyone's thoughts, building a reliable partnership with our customers.
This session will introduce the role and mission of CDMOs in the biopharmaceutical industry in Japan, and AGC's past and present commitments.

<Speaker’s Profile>
 

Special Session

BP-S2 July 4 (Thu) 10:30  -  12:00
  • FREE / Pre-registration Required

New Nucleic Acid-based Drugs : Drug Discovery & Clinical Application

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

Clinical Application of Nucleic Acid Therapy

Masahiko Kuroda Professor and Chair, Dept. of Molecular Pathology, Tokyo Medical University

Detail & Speaker’s Profile

<Detail>
Nucleic acid therapy are highly attracting great attention. It is highly safe, inexpensive and mass producible, and it is also an attractive tool from the viewpoint of medical economics. In this presentation, I would like to outline the current state of nucleic acid drug development from both the basic and clinical aspects.

<Speaker’s Profile>

RNA as a Target

Mads Aaboe Jensen External Innovation Officer, RNA Molecule Research, Roche Pharma Research & Early Development, Roche Innovation Center Copenhagen A/S

Detail & Speaker’s Profile

<Detail>
RNA molecules are essential for cellular information transfer as they encode proteins and regulate gene expression. Numerous RNAs have been implicated in human diseases. Targeting these RNAs with either oligonucleotides or small molecules provides an opportunity to therapeutically modulate numerous cellular processes.

<Speaker’s Profile>
Mads holds a position as External Innovation Officer at Roche Innovation Center Copenhagen, where he is responsible for scouting and assessment of external opportunities related to nucleic acid based therapies. Prior to this, he was leading a RNA research team with activities in the field of early drug discovery and external innovation. Over the course of his career, Mads has led over 7 RNA therapeutic discovery projects and numerous technology innovation projects which have yielded over 10 patents and patent applications.

PharmaLab JAPAN Conference

Keynote Session Pre-registration Required

PRD-K July 3 (Wed) 10:30  -  12:00

For Innovative Drug R&D

  • English / Japanese

Mission of AMED: Global Data Sharing

Makoto Suematsu President, Japan Agency for Medical Research and Development

Detail & Speaker’s Profile

<Detail>
AMED has chosen a field of rare and undiagnosed diseases to tackle with a number of obstacles including "Balkanization" of mindsets among researchers. Solving Balkanization gives a clue to fast-track implementation of outcomes among all other fields of medical researches. I would present an overview of our missions and visions.

<Speaker’s Profile>

Creating an Innovation Hotspot in Life Science in Japan

Toshio Fujimoto General Manager, Shonan Health Innovation Park, Takeda Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
Takeda Pharmaceuticals opened a state-of-the-art research facility in Shonan, as a center of open innovation in April, 2018. The new research park aims to create an ecosystem in which researchers with diverse backgrounds will translate cutting-edge science into innovative solutions for the benefit of patients.

<Speaker’s Profile>
not required

Special Session

PRD-S4 July 5 (Fri) 14:30  -  16:25
  • FREE / Pre-registration Required

Gene Therapy -- Challenges for Next-generation Drug Discovery

  • English / Japanese

Gene Therapy -- Expectation and Reality

Mitsuru Miyata Executive Leader Writer, Nikkei Business Publications, Inc. / President, Miyata Institute of Technologies, MIT

Detail & Speaker’s Profile

<Detail>
A great progress has been made in commercialization of gene therapies. "Zolgensma" by Novartis from Switzerland was approved in US and is expected to be the world's first blockbuster for gene therapy. "Zolgensma" is now being reviewed in Japan as well. There is no doubt that gene therapies will make a huge impact in our country in a near future. Here, we discuss the requirements for gene therapy to be a pillar of the pharmaceutical industry's profits and its pitfalls.

<Speaker’s Profile>
 

Gene Therapy for Neuropathic Pain: Clinical and Commercial Implications

Sunyoung Kim CEO, Helixmith Co., Ltd. (formerly: ViroMed Co., Ltd.)

Detail & Speaker’s Profile

<Detail>
The world's first Phase III clinical study, using plasmid gene therapy, for treating severe neuropathic pain is nearing completion in the USA. I will discuss the scientific rationale and early clinical results with VM202, and if available, either topline results or blinded efficacy and safety from our Phase III study.

<Speaker’s Profile>
- Sunyoung Kim, DPhil, founder and current CEO of Helixmith Co., Ltd.
- Highly regarded as a successful entrepreneurial scientist, Dr. Kim served on the Seoul National University faculty (1992-2018) after serving as an assistant professor at Harvard Medical School (1990-1992).
- Helixmith today is the global leader in the area of plasmid DNA-based gene therapy with focus on neurological and cardiovascular diseases.

Development and Commercialization of Gene Therapy: Focusing on CAR-T Cell Therapy

Keiya Ozawa Professor Emeritus and Visiting Professor of the Div. of Immuno-Gene & Cell Therapy (Takara Bio), School of Medicine, Jichi Medical University

Detail & Speaker’s Profile

<Detail>
Gene therapy has revived. Hematopoietic stem cell gene therapy became safer. AAV vector gene therapy is effective in neurological diseases, eye diseases, and hemophilia. As for cancer gene therapy, development of CAR-T/TCR-T cell therapy is remarkable. Application of genome editing technology is also rapidly progressing.

<Speaker’s Profile>
Keiya Ozawa received his M.D. from University of Tokyo in 1977 and his Ph.D. from University of Tokyo in 1984. He studied at NIH, USA as a Fogarty Fellow (1985-87). In 1994 he became Professor of Jichi Medical School. In 2014 he became Hospital Director of The Institute of Medical Science, The University of Tokyo (IMSUT) and Professor of the Division of Genetic Therapeutics, The Advanced Clinical Research Center, IMSUT. In 2018, he became Professor Emeritus and Visiting Professor of the Division of Immuno-Gene & Cell Therapy (Takara Bio), Jichi Medical University.

in-PHARMA JAPAN Conference

Special Session

PI-S1 July 3 (Wed) 13:00  -  14:00
  • FREE / Pre-registration Required

The Challenges for Global Procurement of Drug Substance (API)

  • English / Japanese
Kazuhito Takahashi President & CEO, Pharma Planning Co., Ltd.

Detail & Speaker’s Profile

<Detail>
The age of 80% share of generic drugs (in the drug market) is coming, and drug substances (APIs) for generic drugs is getting more globally procured. In my talk, some issues in the global procurement of APIs will be presented with examples to find clues to solving problems in the procurement of APIs.

<Speaker’s Profile>

PI-S2 July 4 (Thu) 13:00  -  14:00
  • FREE / Pre-registration Required

Challenging for Development and Manufacturing of Next Generation Chemical APIs

  • English / Japanese
Kenji Maeda Deputy Dept. Manager, API Process Development Dept. (Chemical Technology), Pharmaceutical Technology Div., Chugai Pharmaceutical Co., Ltd.

Detail & Speaker’s Profile

<Detail>
"Small molecule" APIs are getting expanded to "Large sized Small molecule", "High-potent Small molecule" and also "Middle molecule" APIs. Our challenges for such kind of next generation APIs will be presented.

<Speaker’s Profile>

PI-S3 July 5 (Fri) 13:00  -  14:00
  • FREE / Pre-registration Required

Process Chemistry in Drug Development

  • English / Japanese
Mikio Sasaki Senior Director, Process Chemistry Research & Development Labs., Sumitomo Dainippon Pharma Co., Ltd.

Detail & Speaker’s Profile

<Detail>
In this seminar, I will introduce case studies and research at Sumitomo Dainippon Pharma on the roles and recent trends of process chemistry required for drug development.

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Exhibitors' Presentation Free / No Registration Required

Exhibitors will give presentations about the latest products/technologies.

>> Program

No registration required.
Please go to the venue (inside exhibition hall) directly.
Please note that some presentations might be given only in Japanese.

Concurrent Conference Pre-registration Required

RM-K July 4 (Thu) 13:00  -  14:30

Future Medical Care & Drug Development with Regenerative Medicine

  • English / Japanese

Development of Chimeric Antigen Receptor T-cell Treatment in Novartis

Tohru Hirose Director, Div.Head, Japan Development, Novartis Pharma K.K.

Detail & Speaker’s Profile

<Detail>
The development of Chimeric Antigen Receptor T-cell (CAR-T) treatment, CTL019: tisagenlecleucel, a cellular therapy consisting of autologous T cells transduced with an anti-CD19 chimeric antigen receptor for the patients with relapsed or refractory CD19 positive Acute Lymphoblastic Leukemia and Diffused Large B Cell Lymphoma.

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iPSCs-based Regenerative Medicine and Drug Development

Hideyuki Okano Dean, Keio University Graduate School of Medicine/ Professor, Dept. of Physiology, Keio University School of Medicine

Detail & Speaker’s Profile

<Detail>
There is increasing interest in regenerative medicine and drug development as medical application of iPSCs-technology. Here, I will talk about clinical trials of our iPSCs-based cell therapy for spinal cord injury and patients-based drug development for ALS.

<Speaker’s Profile>
Hideyuki Okano received M.D. in Physiology from Keio University in 1983. He held post doctoral position in Johns Hopkins University School of Medicine. He was appointed full professors at Keio University Medical School in 2001 as a full professor of Physiology.

<Concurrent Conference>