THE HEART OF JAPAN'S PHARMA INDUSTRY

Opening remarks by Mr. Ichiro Fujikawa, Chairperson of JAPTA 

Presentations 13:30-15:00

1. "Measures to be Taken by Companies to Ensure Stable Supply of APIs” 

Prof. Osamu Hiruta,
Department of Quality Assurance/ Quality Control Research Laboratory,
Kumamoto Health Science University 

2. Recent Issues on Stable Supply of APIs in Europe 

Ms. Marieke van Dalen, Global Regulatory Specialist, Aspen Oss B.V. 

3. Recent Issues Following the Implementation of the Revised GMP Ministerial Ordinance

Mr. Masabumi Takahashi,
Research Specialist, Pharmaceutical Quality Control Division,
Pharmaceuticals and Medical Devices Agency (PMDA) 

4. Our Issues Regarding the Revised PMD Act and the Revised GMP

Ministerial Ordinance
JAPTA（TBD） 

Panel Discussion 15:00-15:30 

Panelists:
Speakers listed above, Coordinator: Chairperson of JAPTA

1) Overview of ICH Q13 guideline – Continuous manufacturing of drug substances and drug products

2) Overview of continuous manufacturing process for oral solid dosage form
 
3) Current progress and future perspective of continuous manufacturing for biopharmaceuticals

Speaker:
1) Mr. Yoshinori Kubodera, Senior Manager, CMC regulatory affairs dept. Chugai Pharmaceutical Co., Ltd.
2) Mr. Keiji Inoue, Group manager, CMCRA, GlaxoSmithKline
3) Mr. Akihiro Yanagita, Professional of Next Generation Manufacturing & Technology for Bio-Product, DAPI Process Development Dept. (Bio-Product), Chugai Pharmaceutical Co., Ltd.

One of the major causes of aging is the accumulation of inflammation-inducing cells such as senescent cells in various organs and tissues, causing chronic inflammation. In this presentation, I would like to outline the technology to selectively remove senescent cells from our body and discuss whether it is possible to control human aging and overcome various diseases in the future.

Speakers:
Mr. Makoto Nakanishi,Professor,Institute of Medical Science,University of Tokyo

The creation of antibodies that can potentially be used as drugs is extremely important in the development of Biopharmaceuticals,  but it is still difficult to produce antibodies with the desired functionality. We are developing technologies to create functional antibodies based on epitopes to which antibodies bind. In this presentation, we will introduce the platform technologies for selecting the antibodies with superior functions and show some examples of their application.

Speaker:
Mr. Haruhiko Kamada, Project Leader,Center for Drug Design Research, National Institute of Biomedical Innovation, Health and Nutrition

Pharmaceuticals are being developed in shorter development periods to achieve early approval and long-term profitability, and lower costs are also required. Flow technology is expected to be one of the solutions. This presentation will introduce what is expected of this technology from the viewpoint of pharmaceutical CMC development, as well as examples of research and manufacturing using our flow technology.

Speaker:
Mr. Kazuki Hashimoto, Director, Group I,Process R&D Labs.,Sumitomo Pharma Co.,Ltd

Though many case studies of process chemistry have been discussed so far, few ones of research management can be found in process development of drug substances. Based on Astellas’s case, I will try to discuss a research management in the process development in this lecture.

Speakers:
Mr. Shigeru Ieda, Director, Chemical and Biological Technology Labs., Astellas Pharma Inc.

Speakers:
Mr. Yasunori Abe, Research Scientist, API Process Development, Chemical Technology, Pharmaceutical Technology Division, Taiho Pharmaceutical Co., Ltd.

In order to provide our customers with even better products, we pursue to “Pure Chemistry,” = “make clean (synthesis),” “purify cleanly (refining),” and “provide clean (analysis)” in process design. We have been striving to create products based on the concept of "Pure Chemistry". This time, we would like tointroduce our process design, focusing on the part of “make clean(flow reaction)”.

Speaker:
Mr. Kazutaka Seki,Manager, Production Process Development Department Production Process Development, Operations Laboratory and Specialty Chemicals Division, FUJIFILM Wako Pure Chemical Corporation

Previously, small molecules played the leading role in chemically synthesized pharmaceuticals. However, we are now entering into a new era of multi-modality, where middle to large molecules such as oligonucleotides or peptides and chemically modified biopharmaceuticals such as ADC are quickly on the rise in the pharmaceutical industry. Our examples of pharmaceutical process development and strategy in such an era will be presented.

Speaker:
Mr. Yoshitaka Nakamura,Vice President,Process Technology Research Laboratories, Pharmaceutical Technology Division,Daiichi Sankyo Co., Ltd.

Many enantiopure drugs contain a hydrogen atom at the stereoselective center. As this hydrogen atom can be introduced into appropriate unsaturated precursors by hydrogenation, asymmetric hydrogenation is of particular importance.

Speaker:
Mr. Masatoshi Yamada, Director,CMC R&D Division, SPERA PHARMA, Inc.

In recent years, with the progress of basic research in the life science field, substances and drug targets that have not been used as drugs in the past are now being utilized. These are attracting attention as a new drug discovery modality. This presentation will focus on oligonucleotide therapeutics among the new drug discovery modalities, and in addition, will give an outlook on future pharmaceuticals.

Speaker:
Ms. Yuko Ito, Senior Research Fellow/ Group Leader of foresightCenter for S&T Foresight and IndicatorsNational Institute of Science and Technology Policy (NISTEP)

In this presentation, I would like to introduce the construction of a small molecule compound library based on rigid cage-like scaffolds, which allows substituents to be precisely arranged three-dimensionally with respect to the target protein, to achieve structural diversity in the compound library. Furthermore, I would also like to present the "SAR Matrix" and "SAR Transfer" methods for prediction of side chain structures using ChEMBL databases.

Speakers:
Mr. Hiroyuki Nakamura, Professor, Laboratory for Chemistry and Life Science, Institute of Innovative Research, Tokyo Institute of Technology

In the early CNS drug development stages, it is necessary to estimate the extent to which candidate drugs reach the human brain. We have been developing human blood-brain barrier models in order to evaluate drug penetration property to the brain. In this presentation, we will introduce the current status and future perspectives of the BBB models.

Speakers:
Mr. Tomomi Furihata, Professor, Laboratory of Clinical Pharmacy Experimental Therapeutics, School of Pharmacy Tokyo University of Pharmacy and Life Sciences

Antibody drugs have developed rapidly since 2000 and have grown to more than half of the biopharmaceutical market in Japan. However, the rise of next-generation antibodies is expected amid the need for various further improvements. In this lecture, I will introduce the prospects for the use of single-domain antibody molecules ticketed in camelids as candidates for next-generation antibodies in pharmaceuticals.

Speaker:
Mr. Masayuki Tsuchiya, Member of the Board,Executive Vice President of Drug Research & Development,Epsilon Molecular Engineering, Inc.

Have you looked beyond CSR in your quest to achieve sustainability? Intangible assets are swiftly gaining recognition as a primary source of competitive advantage for companies, with key advantages derived from human capital, intellectual property and predictions of future competitiveness. In this seminar, EY Japan’s CPAs and sustainability experts will guide participants through a discussion of key concepts pharmaceutical companies should incorporate into their sustainability programs.

Speaker:
Mr. Yusuke Tsuruta, Senior Manager, Division 4, Ernst & Young ShinNihon LLC
Mr. Takayuki Nakatsukasa, Principal, Climate Change and Sustainability Services Public Cluster, Ernst & Young ShinNihon LLC
Mr. Go Yoshizawa, Manager, Climate Change and Sustainability Services,Ernst & Young ShinNihon LLC

In this seminar, I will explain about an open research publication model, F1000, which we describe as "Beyond Open Access". F1000 publication model is supporting many global funders and institutions including Bill & Melinda Gates Foundation. I’ll explore the publication process that ensures transparency of peer review process and quality of papers, while at the same time enables speedy publication as required during pandemic.

Speaker:
Ms. Tomoko Yamanojo Childress, Business Development Manager, Academic and Corporate Sales, Taylor & Francis Group

Introducing business transformation support for pharmaceutical companies, focusing on acceleration of drug discovery research, fulfillment and enrichment of new targets / themes made possible by FRONTEO Drug Discovery Best Known Method, a proprietary natural language AI drug discovery solution asset.

Speaker:
Mr. Nobuya Nakano, General Manager, Lifescience AI Business Division, FRONTEO, Inc.

DX has long been a hot topic. Although challenges to reach the final goal remain, it’s imperative to simply get started and initiating the journey has become easier with Aktana’s solutions. What are the secrets to reskilling and adapting your company to the new environment and what are the pitfalls that everyone falls into? Please join us to learn more.

Speakers:
Mr. Robert Willson, General Manager, Sales,Aktana International LLC

The biopharmaceutical industry is making remarkable progress in delivering life-saving and life-changing medicines to patients around the world. This presentation will outline the need to build a robust global drug discovery ecosystem with cycles of R&D/start-up, regulatory harmonization, and evaluation of innovation to achieve medical advances.

Speaker:
Mr. Hans Klemm, PhRMA Japan Representative, Pharmaceutical Research and Manufacturers of America

Takeda has transformed into a global, science driven, digital biopharmaceutical company and has accelerated our competitiveness over the past several years. Our global footprint, robust financial position, balanced portfolio and diverse talent gives us the scale needed to bring innovative medicines to patients around the world.

Our purpose to create better health for people and brighter future for the world is the core foundation of our global growth strategy, and will help us create value for the future. Our values of Takeda-ism, brought to life through actions based on patient, trust, reputation and business, in that order, guide everything we do.

For us to make more meaningful impact on patients and society, we are committed to develop and launch life-transforming medicines globally, lead the new era of data and digital technology, create an exceptional experience for our people, and build a better planet for future generations.

Speakers:
Mr. Christophe Weber, Representative Director President & CEO, Takeda Pharmaceutical Company Limited

-Introduction of the ISPE Japan Affiliate
-The presentation will explain the trends of the health authorities in Japan, the U.S., and Europe in response to the shortage of drug supply, a serious social problem worldwide, and introduce the programs proposed by ISPE in collaboration with FDA and EMA to solve the issues of quality culture, quality system, and supply chain, which are important factors in drug shortages, and to achieve sustainable GMP compliance.

Speakers:
Mr. Junya Souma, Vice-Chair, ISPE Japan Affiliate
Ms. Ayako Nakajima, CEO, Q&EHS Solutions Corporation

Speaker:
Mr. Ian Haydock, Editor-In-Chief, APAC, Insights, Citeline (Norstella group)

Since 2020, there have been repeated cases of voluntary recalls and administrative penalties due to GMP violations at pharmaceutical manufacturing facilities. I would like to summarize what happened in these cases and why they could not be avoided, and consider what pharmaceutical manufacturing facilities should do.

Speaker:
Mr. Kazuhiko Arai, Representative, C&J

Cancer has a diverse molecular background, including types of genetic mutations, which results in different mode of progression, available molecular targeted therapies, and their efficacy from individual to individual. Since clinical application of liquid biopsy technologies to diagnose the molecular biological information that defines such diversity for personalized cancer care is accelerating, here I would like to share some examples and future prospects.

Speakers:
Mr. Koji Ueda, Project Leader, Cancer Precision Medicine Center, Japanese Foundation for Cancer Research

Under the initiatives of accelerating translational research, it has become possible to carry out drug development widely in academia from "manufacturing", non-clinical trials, to investigator-initiated clinical trials. On the other hand, the essential role of academia in drug creation, such as basic research such as elucidation of disease pathology and exploratory investigator-initiated clinical trials, is also becoming important. Open innovation across interdisciplinary fields such as chemistry, biology, and information engineering is essential.

Speakers:
Mr. Toshio Miyata, Professor,Molecular Medicine and Therapy, School of Medicine Tohoku University

The ratio of biosimilars to marketed biopharmaceuticals in Japan is low, and the replacement of original biopharmaceuticals with biosimilars is not progressing.

The government is promoting support for the development of biosimilars as a measure to reduce medical costs, but on the other hand, it is also taking measures to approve “bio-same” and stifle the development of biosimilars. Are biosimilars unnecessary in Japan? We would like to reconsider what should be done from the standpoints of both companies and patients.

Speaker:
Mr. Motoyoshi Okamura, President,Pharmatelier Inc.

What you develop the robust purification processes by combining some chromatography media effectively has been one of the key factors to achieve the projects in success at the manufacturing scale for the biotherapeutic drugs.In this presentation, we would like to introduce you some case studies and our Bio-Rad’s process chromatography solutions.

Speakers:
Mr. Hiroaki Hamana, Senior Specialist,Life Science, Process Chromatography Unit, Bio-Rad Laboratories
Mr. Koji Nakamura, Manager, Life Science, Process Chromatography Unit, Bio-Rad Laboratories

Minaris Regenerative Medicine is a contract development and manufacturing organization (CDMO) for regenerative medicine products with manufacturing sites in Japan, the U.S., and Europe, and offers process development, clinical and commercial manufacturing for cell and gene therapy products.

In the presentation, we will introduce global trends in the regenerative medicine (cell and gene therapy) industry, current challenges and our business.

Speakers:
Mr. Hiroto Bando, CEO,Minaris Regenerative Medicine CO., Ltd.

1) Oligonucleotide therapeutics that are currently attracting attention: the attractiveness of antisense oligonucleotide
 
2) Progress in drug development of antisense oligonucleotides based on artificial nucleic acid by Luxna Biotech
 
3) Accelerate R&D and market launch of nucleic acid drugs by automating and efficient purification and HPLC analysis

1) Oligonucleotide therapeutics, such as antisense oligonucleotide and siRNA, are a promising class of drugs that can modulate the expression levels of target RNA. In addition, they can be produced by chemical synthesis, enabling rapid candidate discovery. In this symposium, I would like to introduce the basics of oligonucleotide therapeutics especially focusing on antisense oligonucleotide.
 
2) Luxna Biotech is a biotech company that aims at clinical application of antisense drugs. We have established drug discovery platform, Luxna’s XNA incorporated Antisense Platform, LuxiAPTM, consisting of artificial nucleic acids invented by Osaka University. Luxna Biotech is conducting joint drug discovery with pharmaceutical companies, technology licensing, and in-house drug development. In this seminar, I will discuss research results for linking university-developed technologies to drug discovery and share the possibilities of this field.

Speaker:
1) Mr. Takao Yamaguchi, Associate Professor,Graduate School of Pharmaceutical Sciences,Osaka University
2) Mr. Hideaki Sato, President CEO, Luxna Biotech Co., Ltd.
3) Mr. Hiroshi Sezaki, Application specialist, LC・LC/MS Group, Agilent Technologies Japan, Ltd.

Electro-Osmosis pump can provide high back pressure from the moment it is driven. We develop medical devices using this pump. I would like to inform you of the current progress and potential.

Speaker:
Mr. Hidenori Nakamura, Founder & CEO, atDose Co., Ltd.

The present work summarizes the thermal impact on the formulation during the blow fill seal process and how it can be minimized. Based on fundamental trials from bench and production equipment with integrated in-line temperature measurement, the impact of different process parameters was investigated to identify the major parameters. It could be verified that the maximum formulation temperature can be hold below approx. 30 °C during the filling and sealing process even for filling volumes below 1 ml.Through this presentation, the gained process understanding enables the aseptic packaging of temperature sensitive formulations like biologics with the blow fill seal technology.

Speakers:
Mr. Cornel Eberle, Area Sales Manager, Rommlag Sales, Rommelag AG

Dry powder inhalers (DPIs) have been used to treat asthma and Chronic Obstructive Pulmonary Disease (COPD) for almost half a century. All inhalers on the market or in the development distinguish significantly in terms of powder fill weight, container closure system and manufacturing technologies. The originators developed diverse dry powder inhalation technologies and thereby created a high entrance barrier for the generic companies to follow. In contrast to the local treatment of pulmonary diseases, aerosol inhalation for treatment of systemic diseases is a novel therapeutic approach. This will be used as alternatives to parenteral delivery for drug doses of the order of milligrams or less. In this presentation we will explore the current worldwide activities of aerosol inhalation for treatment of systemic diseases.

Speakers:
Mr. Marco Laackmann, Sales Director, Inhalation Technologies,Harro Höfliger Verpackungsmaschinen GmbH

The covid-19 pandemic has had devastating effects on global health, education, and economies. On the other hand, it made us the success of mRNA vaccines and an accelerate of other RNSA-enabled treatments where mRNA-loaded lipid nanoparticles (LNPs) are used as new therapeutic drug products. We will introduce the current worldwide activities on LNP based medicines and the option for practical manufacturing like LNP encapsulation and filling in this presentation.

Speakers:
Mr. Julian Grossmann, Sales Manager, Aseptic Technologie, Harro Höfliger Verpackungsmaschinen GmbH

Recent years, Container Closure Integrity Testing required for drug containers, including pre-filled syringes, has been changing from a qualitative test method to a quantitative one. This seminar will introduce the definition of CCIT and recent trends in regulatory based on the FDA, as well as the characteristics of various test methods.

Improving operational efficiency, reliability and comfort is a challenge for laboratories. SDMS digitizes everything from the start of lab work to reporting results and data management and enables remote operation from home to the lab. We will report on a new SDMS that embodies operational efficiency, reliability including data integrity, and work-life balance with customer case studies.

Speaker:
Mr. Toshikazu Kobayashi, Lab Informatics Group, Agilent Technologies