In recent years, with the changing environment surrounding the pharmaceutical industry, various problems have been pointed out, such as the occurrence of drug lag/loss and concerns about stable supply. To address such problems, we have improved the operation of lots of regulatory systems based on the discussion on “Study Group on Pharmaceutical Regulations for Strengthening Drug Discovery and Ensuring Stable Supply”, and also proceed with the procedures to revise the Act on Ensuring Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc.

Although the market for generic drugs has expanded significantly as a result of government measures to promote their use, there is little prospect for significant market expansion in the future, although the government is on track to achieve its goals. Furthermore, the profitability of generic drugs has been declining significantly due to the lower NHI drug price ratio at the time of their initial listing on the market and the annual NHI price revisions. In response to this market environment, we would like to discuss the problems of the industry structure in the future.

My lecture outlins Japan's universal health care system and discusses the role that pharmaceutical play in it.In addition,I will describe the current situation of the pharmaceutical industry in Japan and recent trends in pharmaceutical policy.Based on these findings,I will present the direction that the pharmaceutical industry in Japan should aim for in the future.

A panel discussion will be held in which plant managers and managers of member companies of the JAPIA will introduce changes and challenges in the business environment, fostering a quality culture, the impact of the supply chain and responses, and safety education initiatives.

The discussion will be moderated by Mr. Satoru Shiratori,

President of Shiratori Pharmaceutical Co.,Ltd.

Obtaining peptides with high purity, which are attracting attention as next-generation drugs is considerably more difficult than small molecules. Everyone's heart is broken. We devised a plan to discuss this problem with players with different expertise and different approaches. Where will the efforts to bring together "upstream" and "downstream" technologies end up? In this seminar, professionals in organic synthesis or separation science will collude to break into "animal trail".

CUBIC is a tissue-clearing technique that uses safe, water-based reagents, enabling whole-organ transparency while preserving the fluorescence of proteins such as GFP. Cleared organs can undergo immunostaining and be imaged with light-sheet microscopy to obtain 3D datasets at single-cell resolution. This presentation will detail the methodology for whole-organ analysis using CUBIC and its applications in drug discovery.

At the frontline manufacturing sites, we are striving to deliver as many high-quality medicines as possible to patients, using “Kaizen” as a lever.

In addition, "manufacturing/factory DX" has been attracting attention recently, and it has overcome the GMP barrier and is gradually starting to see results.

On the other hand, we often hear people asking, "How do I actually do it?" "What's so great about DX?"

In this session, we will delve into the essence of DX, which we cannot hear about anymore, and explain how to utilize it in daily "kaizen".

Organic electrolysis is attracting attention as a means of achieving sustainable chemical production. Among these, solid-polymer electrolyte (SPE) electrolysis technology is attracting attention because it does not require electrolytes in solution and boasts a high energy conversion efficiency. In this presentation, we will introduce our recent results on organic electrolysis synthesis based on SPE electrolysis technology.

The market for biopharmaceuticals and regenerative medicine products has been rapidly expanding in recent years. To support the industry in Japan, the Ministry of Economy, Trade and Industry (METI) is promoting start-up companies, establishing manufacturing facilities, and developing manufacturing technologies. This presentation will offer a detailed explanation of these initiatives and their background, as well as discuss recent changes in the market environment and future policy directions.

Forge Biologics has built a company focused on providing end-to-end manufacturing services for Recombinant adeno-associated virus (rAAV) gene therapies utilizing a transient plasmid transfection process. In this seminar, we will describe how Forge is improving the accessibility of genetic medicines through better manufacturing by making molecular improvements, process improvements, building enhanced analytics, scaling up our reactors and purification systems, scaling out our facility to increase the number of cGMP suites, and providing integrated regulatory support. In 2023, Forge joined Ajinomoto Group, a global business investing in our long-term growth and vision of providing hope to patients suffering from genetic diseases.

According to the diversification of biopharmaceutic modalities in recent years, the market expectations for new chromatography technologies in downstream development are increasing day by day.

In this seminar, we will propose our solutions for biopharmaceutic purification, including introduction of Bio-Rad's chromatography media family and most newly developed mixed-mode resin.

In this seminar, we will introduce methods to simplify, optimize, and transform biopharmaceutical lab operations using Agilent Asset Performance Management and OPC UA automation to reduce ancillary tasks and focus on core activities.

Staple oligomer is a next-generation nucleic acid medicine technology that induce artificial G-quadruplex (G4) formation by specifically hybridizing to target mRNAs. This unique feature allows it to 'downregulate ' or 'upregulate ' protein expression levels according to therapeutic goals. Importantly, these effects are highly selective to the target gene, ensuring the safety and precision of the treatment. In this session, we will introduce an overview of Staple oligomer technology and its potential application in the treatment of rare diseases.

Our company collects and analyzes a wide range of data related to the pharmaceutical industry, providing essential insights for pharmaceutical companies and their manufacturing partners, CDMO firms, to make informed decisions regarding development and business strategies. In this seminar, we will present case studies analyzing trends in new drug development and market forecasts, with a focus on biologics—an area of shared interest for both pharmaceutical and CDMO companies—alongside the latest topics in pharmaceutical manufacturing.

We are developing highly scientific evidence-based therapies for refractory cancers (especially pancreatic cancer and small cell lung cancer) with a 5-year survival rate of less than 10%, using omics and data science. In this presentation, I will discuss the basic theory and the current development stage of new therapeutic approaches targeting pancreatic cancer (Pipeline 1: antibodies) and small cell lung cancer (Pipeline 2: small molecule compounds).

In this lecture, I will discuss how information science accelerates drug discovery, covering recent advancements from target identification to lead compound acquisition, optimization, and clinical trials. I will then present some of our recent research findings in an omnibus format, highlighting how small molecules, nucleic acids, peptides, and novel modalities are being developed. Finally, I will touch on initiatives aimed at fostering the next generation of drug discovery researchers and developers.

This session discusses the changes in drug modalities and its impact on the pharmaceuticals market. In addition to small molecule and antibody drugs, new modalities such as nucleic acid drugs, gene therapy, and cell therapy are emerging, and transforming the structure of the market. The impact of these changes on the pharmaceutical market in the future and the intensifying competitive environment due to the diversification of modalities will be discussed in depth.

In recent years, the diversity of drug modalities has led to an acceleration in the development of drugs with significantly different chemical structures and physicochemical properties. This has also led to a variety of formulation-related issues. Drug delivery system (DDS) has attracted attention as a solution to these issues. In this presentation, based on discussions at the APSTJ, the challenges and DDS-supported solutions for innovative pharmaceuticals will be discussed.

The transfer of drugs into the brain is strictly limited due to the blood-brain barrier, formed by tight junctions between endothelial cells in the brain's capillaries, leading to delays in developing therapeutic agents for brain diseases. To address this issue, research on drug delivery system (DDS) for the brain has been advancing. In my talk, I would like to introduce DDS into the brain using microbubbles/ultrasound-mediated blood-brain barrier opening, which has gained attention in recent years, and discuss the potential applications of this approach for brain disease treatment.

In drug development, assessing the risk of drug-drug interactions (DDIs) involving ADME proteins is crucial to ensuring the safety of co-administered drugs. Among DDI mechanisms, the inhibition of drug transporters responsible for hepatic and renal elimination is particularly significant. Recently, endogenous biomarkers have gained attention as a non-invasive approach to detecting such inhibition in clinical studies without the need for probe drugs. Moreover, biomarker data can be leveraged for quantitative DDI predictions using physiologically based pharmacokinetic (PBPK) modeling. This presentation will focus on clinical data, showcasing case studies on biomarker utilization and its practical applications.

Prefilled syringe (PFS) formulations are widely used for vaccines and therapeutic drugs including autoimmune diseases, contributing to promoting home treatment and reducing the burden on healthcare workers.

In recent years, the number of PFS formulations has increased. However, with improvements in technologies and the diversifying needs, several evaluations, including compatibility between drug and syringe, usability, and risk management, are getting more necessary than ever before.

This seminar will present the latest developments and key insights into PFS development, based on BD’s extensive expertise.

Validation, a method for scientifically assuring the quality of pharmaceutical products, is explained from the following perspectives:

- The concept of packaging validation

- The relationship between the function of pharmaceutical packaging and validation

- How to proceed with qualification evaluation

- Types and key points of validation

The field of Advanced Therapy Medicinal Products (ATMPs) is at the forefront of modern medicine, offering groundbreaking treatments for a range of diseases, including genetic disorders, cancers, and degenerative conditions.
However, the production of ATMPs presents unique challenges that require novel technologies and innovative solutions to ensure scalability, efficiency, and regulatory compliance where currently used approaches, mostly lab derived, struggle.
The presentation will discuss the latest advancements in closed and automated equipment solutions to support vast ATMP product pipeline and establish manufacturing models for commercial scale.
Discussed technologies are:
Happy Cell Factory - New approach for commercial cGMP manufacturing of Cell & Gene Therapies at scale
baXeptic - From lab to production in aseptic IV bag fill and finish
Leon Nanodrugs - Non-viral vector manufacturing and nano-encapsulation in closed sterile system ready to fill

This presentation examines the pharmaceutical industry's environmental challenges, showcasing sustainable practices like energy efficiency and green chemistry through case studies. It explores innovations such as renewable energy systems, addressing regulatory pressures and strategies to overcome challenges. It concludes with future goals and actionable steps.

The pharmaeutical market continues to evolve, with increasing focus on innovation and patient outcomes. This includes a  shift in focus to specialty, biologics, rare disease, CAGT and other emerging areas. Pharmaceutical companies' ability to fully remain "in-house" or "go-it-alone" has become a challenge, with increasing shift in R&D and comercialization - to CDMO , in/out-licensing agreements, and other partnerships. Join IQVIA as we highlight key markets and trends in the developent and commercialization of pharmaceuticals

While the significance of Digital Transformation (DX) is acknowledged, many organizations encounter substantial challenges in its execution, often falling short of expected outcomes. This session will explore key barriers that impede DX progress, emphasizing the crucial role of cross-functional collaboration to streamline clinical development processes. It will also present practical case studies of integrating systems such as Study Start Up (SSU), Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT)/Randomization and Trial Supply Management (RTSM), and Electronic Data Capture (EDC), demonstrating how such integration can streamline and optimize clinical development processes and achieve successful DX.

We will present practical applications of Large Language Models (LLMs) and AI agents in life sciences research. From automated analysis of scientific papers and experimental data to streamlining drug discovery processes, we'll showcase successful implementations across research institutions. We'll demonstrate how RAG technology enables utilization of proprietary data, and how autonomous AI agents can execute complex research tasks, leading to significant reductions in R&D timelines and costs.

How should we deploy DX in our organizations?　 What is the best way to drive DX?  They would review current complicated business processes, create a DX roadmap that is valuable to customers, and implement it.  The first step in utilizing DX is to increase people's DX literacy while improving processes such as　DMAIC* method.  What are Digital Skill Standards, and DX promotion with examples of successes and failures will be presented.
*Define/Measure/Analyze/Improve/Control

As generative AI evolves, bringing new possibilities to the pharmaceutical industry, how can we harness this technology to drive innovation and create value? This session introduces initiatives from participating companies, exploring generative AI's potential for operational efficiency and value creation. We'll discuss challenges and solutions for company-wide implementation, along with prospects for cross-industry collaboration. By sharing insights from industry leaders and engaging in Q&A, we aim to accelerate digital transformation across the pharmaceutical sector. Join us to explore how generative AI is reshaping the future of pharmaceuticals and healthcare innovation.

A patient registry improves data consistency and quality by centrally managing patient data over a long period. This allows for more accurate evaluation of treatment effectiveness and the development of new therapies. Additionally, it is positioned as an important tool for providing real-world data, contributing to epidemiological research and the formulation of public health policies, thereby enabling the provision of more effective medical services. This time, we will introduce the features of the patient registry service that utilizes Hitachi's unique anonymization and pseudonymization technology for secure and safe personal information management.

Continuous-flow synthesis that uses channels instead of vessels as reactors has garnered much attention in recent years in the production of pharmaceuticals. Efficient identification of the optimal flow reaction conditions using artificial intelligence and machine learning technology has been widely studied in recent years. In this presentation, I would like to introduce the efforts in our group aimed at acquiring valuable chemical and process-related insights beyond just reducing time and labor using machine learning technology in continuous flow synthesis.

Inefficient marketing in the pharmaceutical industry is driving up drug prices and negatively impacting the entire healthcare system. InsighTCROSS^® leverages data science to reduce unnecessary costs while delivering effective e-marketing strategies. This innovative decision-making support service transforms how the industry approaches marketing. In this presentation, we will explore inefficient marketing from a physician’s perspective and demonstrate how InsighTCROSS^® can revolutionize the pharmaceutical industry.

Are you making good use of your company’s website? There are important points of creating a website　for doctors, patients, and general consumers. We introduce the following topics.

・Targeting

・Access and search from log data

・Promotion and disease awareness

・Return on investment (ROI) measurement

・Homepage content creation and analysis support

This explains approaches for developing AI agents that address pharmaceutical industry-specific regulations and requirements, along with methods for in-house development and operation, featuring examples across a broad value chain from R&D to sales. It covers specific use cases and their effects, including streamlining pharmaceutical research and development, analysis of clinical trial data, support for creating regulatory documentation, and optimization of sales activities.

Insmed, the company in the market to launch new drug for the treatment of pulmonary MAC disease in 2021, is promoting the “Patient First Project. This presentation will introduce the significance of working on “Patient First” with patients' voices as the starting point, advanced activities to analyze patients' voices to discover insights through the use of generative AI, and future prospects.

For those who are looking for new information dissemination strategies to improve sales of pharmaceutical formulations. This presentation will explain how to effectively deliver information to physicians who are eager to learn by using a SlideShare service where physicians create and share content themselves. We will demonstrate the effectiveness of SlideShare as a quick and easy alternative to webinars and provide specific strategies to meet the needs of physicians with shrinking time.

Momentum in drug discovery.

Momentum Bio is a newly established company that provides low-cost, high-quality contract drug discovery services to support physicians and scientists in their research, from assay establishment to data analysis. In addition to preclinical studies, we also provide an assay system start-up and optimization. We are particularly strong in pathogen-based assays. In this presentation, we will introduce our vision and the services we provide, including contract research and scientific research consultation.

Surgical medical professionals struggle with long working hours due to non-core tasks and analog information transmission reliant on hospital PC environments. This lecture explores how cloud solutions, including LLM utilization, can enhance efficiency by streamlining non-core tasks and enabling asynchronous communication. Additionally, digitizing unstructured data opens new possibilities for utilizing perioperative treatment data. By leveraging these innovations, we can improve workflow efficiency, reduce burdens on medical professionals, and unlock new insights for perioperative care. This session will provide a forward-looking perspective on medical DX and its impact on surgical workflows.

Electroencephalography (EEG) has long been limited to specific diagnostic support due to challenges in signal accuracy and clinical validation, despite its potential in disease diagnosis, treatment, and drug development. However, advances in device precision, miniaturization, and AI-driven analytical techniques are now expanding its clinical applications. EEG is emerging as a valuable digital biomarker for diagnostics support and a tool for therapeutic interventions. In this talk, I will discuss the current state of EEG applications, its role in biomarker development, and future prospects for broader clinical and pharmaceutical use.

ETQ Reliance is a cloud QMS application that has been adopted by over 100 life science companies globally and over 600 companies in other industries combined. We will be introduced along with practical examples of how many companies have digitized their closed-loop QMS processes from deviations to CAPAs, changes/procedure revisions and training, and audits, all while complying with regulations.

We collaborate with 7 universities and national hospitals to analyze real-time data from 60,000 images and 50,000 reviews posted on the "Atopiyo" app for atopic dermatitis patients. By leveraging AI image analysis for digital biomarkers and natural language processing for patient stratification, we facilitate personalized medicine. Additionally, we visualize the timing of new medication switches and symptom changes and promote disease awareness through the patient platform.

This seminar will introduce SG4D10B, the world's largest molecular-specialized AI developed by SyntheticGestalt. This model revolutionizes drug discovery by utilizing 4-dimensional information based on 10 billion compound data. We will explain the background of the foundation model's development, technical challenges, and differentiation points from other models. We will also share the mechanism that enables high-accuracy predictions with small datasets, achievements in balancing activity, safety, and synthesizability, and present specific applications in the drug discovery process.

Medridge co. “Practical application of single cell isolation system and drug discovery support”

Cancer organoids can be grown with high efficiency from patient-derived tumor tissues, potentially enabling patient-specific drug testing and the development of individualized treatment regimens. Circulating tumor cells (CTCs), one of the biomarkers for liquid biopsies, which can be obtained from peripheral blood in a minimally invasive and repeated manner. However, a special method that can detect and collect CTCs is required as there are only a few CTCs among millions of other blood cells. In this lecture, we will introduce a cell isolation system that extracts live CTCs at the single cell level from patient blood and its application to drug discovery support.

BioCMOS Co. Ltd. “Environmental and medical application of semiconductor LSI”

R&D has been developed to utilize semiconductor LSIs for environmental and medical applications. BioCMOS Co. Ltd. has brought biomedical biosensor chips to the market, demonstrating 2-dimensional image of biomolecules and bio-interactions, based on the electrochemical detection of potential, current, and impedance. These chips are used as a research tool at several laboratories, although there are several issues to be overcome to be used by medical institutions. Such issues will be discussed, in addition to future prospect to realize ‘chemistry integrated circuit’ where two completely different fields, material chemistry and semiconductor technology, are merged.

Medridge co.  “Practical application of single cell isolation system and drug discovery support”

Quastella Inc. “Revolutionizing human-driven evaluation in cell culture!

The AI-powered cell quality evaluation system “Cytometa””

Quastella Inc. provides Cytometa, an AI-based quality evaluation system using cell image analysis. By simply uploading microscope images of MSCs, iPS cells and others, you can easily access analysis reports, including evaluations of growth potential and colony comparison.

Cytometa solves the problems of qualitative evaluation and inter-rater variability, enabling standardized evaluation methods through quantitative analysis.

With an aging population, passing down technical skills is becoming a major challenge. Video manuals are seen as a solution, but busy workloads make creation difficult. In this session, we will introduce ways to utilize video manuals with minimal effort using the latest technologies such as AI and eye tracking. Learn practical methods and take away key insights to drive skill transfer in your organization.

Using API-related data including MF registrations, CPHI exhibition data, and generic manufacturers' country of origin disclosures, we will examine Japan's current position and challenges in the global market. Furthermore, we will discuss Japan's unique quality standards and small-volume procurement practices, and propose solutions to achieve true stability in pharmaceutical supply chains.

The ASEAN region is poised for growth in the pharmaceutical sector due to rising populations and economic expansion. However, challenges such as complex legal frameworks, underdeveloped pharmaceutical regulations in some areas, and frequent updates to laws and regulations hinder market entry. This presentation provides an overview of pharmaceutical laws, regulations, and drug registration processes in ASEAN countries. It aims to offer valuable insights into regulatory issues and key points to note, supporting companies seeking success in this evolving market as well as to facilitate strategic decision-making for businesses targeting the ASEAN pharmaceutical market by addressing these challenges.

Opening remarks

Mr. Toshihiko Miyajima, Managing director, FPMAJ

Part1: Key note session

Keynote Session 1: 『Current status of Indonesian pharmaceutical business and possibilities and challenges in collaboration with Japanese companies』

Mr. F. Tirto Koesnadi, President, GP Farmasi Indonesia

Dr. Matthew Yap, Vice President, PT. MERSIFARMA TIRMAKU MERCUSANA

Keynote Session 2: 『Indonesia's Healthcare Situation and Health Policy – Opportunities for Japanese Pharmaceutical Companies』

Mr. Masahiro Sasaki, JICA Expert assigned to MINISTRY OF HEALTH REPUBLIC OF INDONESIA

Keynote Session 3: 『Reflections After Three Assignments in Indonesia』

Mr. Masanobu Kumada, Asia and Europe Business Department, Mitsubishi Tanabe Pharma Corporation

(Former Chairman of the Indonesian Pharmaceutical Association)   

Part2: Panel session

Moderator:

Mr. Yasuhiro Sensho, Coordinator of FPMAJ

Panelist:

Mr. Masahiro Sasaki, JICA Expert assigned to MINISTRY OF HEALTH REPUBLIC OF INDONESIA

Mr. Masanobu Kumada, Mitsubishi Tanabe Pharma Corporation

Mr. Hayato Ishida, Pharmaceuticals and Medical Devices Agency (PMDA)

Mr. Tetsuya Yamamoto, PT Otsuka Indonesia(PTOI)

----------------------------------------------------------------------------------------

Main Moderator：Mr. Mikiya Takeuchi, Chairman, FPMAJ

Although stakeholders are increasingly aware of the importance of a stable supply of APIs, several issues in pharmaceutical regulation remain unresolved. This symposium will therefore provide an opportunity to consider current issues and desirable ways forward through presentations and discussions by a representative of generic MAH, an European regulatory affairs consultant and Japanese government officials.

The global biopharma R&D environment continues to be highly dynamic amid the world's ongoing shift into a post-pandemic environment and all the changes that COVID-19 brought to the sector. This graphical-based presentation will identify and analyse the major trends in global biopharma R&D over the 12-month period ended early 2025, identifying key areas of research, changes in the rankings of major companies and diseases, emerging technologies, rare disease activity and much more. Join for invaluable insights into this key area of activity.

1. This process seminar is supported by the Japanse Society for Process Chemistry (JSPC).  JSPC started 25 years ago.  In this lecture, history, current situation, and future of process chemistry of Japan and JSPS.

2. The sustainability of peptide manufacturing is challenging in Europe and the US. The environmental impact of liquid-phase synthesis (LPPS) is much lower than that of solid-phase synthesis, but the process development in LPPS is time- and labor-intensive. Our novel and flexible LPPS strategies have greener properties and allow short-term route construction. In this presentation, we will give an overview of the new LPPS method and discuss the sustainability of peptide production.

The importance of process R&D in pharmaceutical industries remains unchanged during current environmental transformation where the increase of complexity of candidate molecules as well as their competition in the development needs to be welcomed.  The aim of this lecture is to introduce some examples in which process chemistry played a critical role through new drug development.

In recent years, oligonucleotide therapeutics have rapidly expanded, with diverse modalities such as antisense, siRNA, and mRNA advancing in therapeutic applications. Sumitomo Chemical is leveraging its accumulated assets in small molecule API to advance the manufacturing and development of oligonucleotide for therapeutics use. Among these efforts, particular attention has been given to the production of guide RNA for genome editing therapies, which has recently garnered significant attention. This presentation will focus on our initiatives in GMP manufacturing of guide RNA, which is considered chemically challenging to produce.

In recent years, drug candidate compounds have become more diverse and complex, requiring significant time and cost for process development. The development competition is intensifying, and there is a growing demand for increased speed. Pharmaceutical companies need to develop manufacturing processes for active pharmaceutical ingredients (APIs) that overcome the challenges of establishing safe processes, improving productivity, and reducing environmental impact.

Inthis presentation, we will introduce Ono Pharmaceutical's API process development strategy, examples of our technological developments, and our future perspectives.

In our laboratory, we have developed heterogeneous platinum group catalysts and applied them to functional group selective catalytic reduction reactions, and we have developed new heterogeneous catalytic reduction catalysts that are functional group selective and applied them to organic synthesis reactions other than catalytic reduction and deuterium labeling reactions. More recently, we have developed research on heterogeneous catalytic reactions that combine new devices and energy, as well as environmentally benign synthetic methods and methods for the production, transportation, and storage of decarbonized fuels. We will present an overview of this work.

mRNA is a new drug modality that was developed for the first time as a vaccine against COVID-19. Based on active development of technologies such as mRNA design manufacturing, and DDS, mRNA is expected not only for infectious disease vaccines, but also for cancer vaccines and therapeutic agents. In this presentation, I would like to introduce various studies for mRNA drug development, especially for disease treatment, and discuss the future perspective of the mRNA therapeutics.

Metagen Therapeutics is a biotech developing innovative medical cares and drugs utilizing human stool-derived gut microbiota. We are currently working on treatments for ulcerative colitis, immuno-oncology, and Parkinson’s disease. This presentation will provide an overview of the development process of the gut microbiota-based therapeutic "MGT-006" for ulcerative colitis, along with evidence of its efficacy and safety demonstrated through clinical trials. Additionally, the latest updates on the establishment of a stool supply chain and interactions with regulatory authorities in various countries will be shared.

Nucleic acid medicines are being actively developed worldwide, and as development progresses, their functions and structures are diversifying. At Ajinomoto Bio-Pharma Services, GeneDesign, as an oligonucleotide CDMO, we are undertaking various initiatives to accommodate these diverse modalities. In this seminar, we will introduce some of these efforts, including the synthesis of siRNA and long-chain RNA using enzyme ligation methods, as well as antibody conjugation using AJICAP® technology.

Antibody-drug conjugate (ADC) is one of the hottest modalities in the pharmaceutical field today. ADCs consist of three components: an antibody delivering the drug to the target site, a small molecule drug as the active agent, and a linker connecting antibody and small molecule. It is essential for CMC quality evaluation research to combine various analytical techniques to accomplish stable supply. This presentation will provide an overview of the analytical evaluation techniques for ADC quality evaluation research and the current status of the analytical instruments used for this purpose. Finally Agilent will introduce the latest application of ADC using HPLC and LC/MS.

1. This presentation will provide an overview of the latest technologies and developments in the field of oligonucleotide therapeutics. It will also provide an overview of the delivery challenge of oligonucleotide therapeutics and current progress in the field.

2. Xencor has created a growing set of bispecific antibodies, using principles of avidity-driven selectivity to improve therapeutic index. Building on these modalities are additional efforts to explore T cell costimulation via signal 2 to potentiate anti-tumor activity of T cells.

Nucleic acid therapeutics have been continuously approved and are maturing into a practical stage. However, only one Japan-originated drug has been approved so far. To bridge the gap between Japan's strengths in nucleic acid chemistry and the realization of drug discovery, Luxna Biotech has successfully developed the LuxiAP® platform, based on artificial nucleic acid technologies originating from Osaka University. This platform holds promise for high safety and efficacy in the central nervous system field. In this presentation, we will introduce the current state of the nucleic acid pharmaceutical industry in Japan and the progress of our development, and discuss the prospects for nucleic acid drug discovery originating from Japan.

We provide comprehensive solutions for pharmaceutical companies, leveraging our expertise in pharmaceuticals and medical devices. Our capabilities include:
- Development of drug-compatible devices
- Advanced manufacturing for combination products
- CDMO services from clinical trials to commercial production
Explore our CDMO expertise, including Pre-fillable syringes and Intradermal delivery devices.

Elixirgen Scientific Japan, with over 600 manufacturing achievements, offers innovative solutions in mRNA production. This presentation highlights our approach to delivering high-quality and flexible services, including purification techniques, process optimization, and scalable solutions from small-scale production to cGMP-compliant clinical manufacturing.

OLIC(Thailand) is the largest CDMO in Southeast Asia. We provide CDMO services from formulation development, clinical trial manufacturing to commercial production. We have more than 30 partners in the world and our products are exported to over 30 countries.　Our presentation includes advantages of Thailand, our services, strengths and track record for Japanese pharmaceutical companies.

This seminar focuses on business opportunities for Japanese companies in India's rapidly growing healthcare market. India has one of the world's largest medical demands, with strong growth in advanced care, digital health, and medical devices. We will invite key public and private sector figures from India’s healthcare industry and showcase successful Japanese companies, sharing market entry strategies and challenges. The seminar also provides networking opportunities to foster Japan-India partnerships and introduces available support programs. It offers valuable insights and connections for companies exploring expansion into the Indian market.

This presentation will explain how SaaS and AI can be effectively applied in pharmaceutical commercial operations to:
1. Reduce content creation costs and lead times
2. Expand physician coverage and improve detailing
3. Strengthen compliance with AI-driven solutions

This session will provide the latest information on the utilization of Google Cloud's AI and Generative AI in the pharmaceutical industry, particularly in the drug discovery research domain. Additionally, we will feature a customer case study with Daiichi Sankyo Co., Ltd., discussing their utilization of Google Cloud as a data analytics platform.

In this seminar, we will introduce effective channel utilization strategies to enhance customer engagement, as well as discuss the ideal approach to managing the human capital of sales organizations. We will dive deep into how to intervene based on performance and skill data to improve the current state and generate results. This is a valuable opportunity to explore performance management strategies in business. We look forward to your participation.

In order to achieve Patient Centricity, it is essential to gain a full picture of the treatment and understand the insights of doctors and patients.

Patient Journey Visualizer can view electronic medical record data for up to 1000 cases and analyze the background of treatment choices.

TalkAId is a role-play system for MR that utilizes the generative AI and supports skill-improvement through real-world dialogue and feedback.

We will also provide an update of Webinar on the process from hypothesis-making to implementation of a patient-centric product strategy.

Based on the latest trends in the 2025 health tech and digital health industry, we will explain the role and case studies of disease awareness projects. Specific examples include Asahi Kasei Pharma's "Honeken" project to prevent osteoporosis, Kyowa Kirin's "Kurukotsu Hiroba" project to raise awareness of rare disease, and Medicon's (Becton Dickinson Group) project to raise awareness of inguinal hernia.

The utilization of new metrics generated from digital data is anticipated in the future development of therapeutic apps and new treatment solutions. In this lecture, we will introduce efforts to develop diagnostic programs, medical devices, and treatment solutions utilizing digital biomarkers as indicators, constructed through the accumulation and analysis of long-term data obtained from general wearable devices such as Fitbit and Apple Watch, and their implementation in society. Additionally, we will discuss the practical hurdles and challenges faced in the development of Software as a Medical Device (SaMD), along with our company's achievements in this area.

KIBIT is an AI excels at discovering hidden relationships not documented in the literature. FRONTEO's AI drug discovery support service, "Drug Discovery AI Factory," utilizes KIBIT to identify highly novel target molecules that could not be found previously, and to propose new indications along with supporting hypotheses. This seminar will feature insights from our algorithm developers, showcasing innovative outputs that enable greater efficiency, accelerated timelines, and improved probability of success in drug discovery.

A new era is dawning in clinical trial design. Innovative methods utilizing AI and automation are emerging to simplify trial complexity, reduce patient burden, and achieve cost savings. This approach allows pharmaceutical companies to optimize trial design while maintaining scientific rigor, enabling faster trial execution and economic benefits. We will discuss the paradigm shift brought about by efficient trial design based on digitized data.

This seminar will explore using real-world data (RWD), such as acute care data and electronic medical records, for database research, patient journey mapping, and clinical trial support in acute care, oncology, and rare diseases. Additionally, we will discuss the application of generative AI in healthcare, offering insights into the current state and future outlook of data-driven medicine.

"Evolving PHR accelerates new drug development"
Discover how the epilepsy-focused PHR "nanacara" and the electronic prescription record "harmo" by CMIC Group shape a patient-centered future in clinical development. Through case studies of PHR utilization in clinical trials for refractory epilepsy and patient support models using real-time prescription data, we will delve into how responsive patient support and needs-based insights from PHR can transform and accelerate the path to new therapies.

FPT Software’s development centers in Ho Chi Minh City and Tokyo have established a system to undertake development for digital health and medical device vendors, with a QMS framework certified under ISO 13485. We provide examples ranging from traditional medical device software to medical AI and cutting-edge SaMD/non-SaMD.

CAS, the scientific knowledge management divisions of the American Chemical Society, is expanding its business into the life sciences, building on its track record in data curation and harmonization and in delivering discovery tools and services for researchers. The new CAS BioFinder Discovery Platform™ centralizes experimental data and domain knowledge essential for drug discovery and combines them with predictive capabilities. Authoritative characterization of small molecules and biologics, unambiguous target identification, and normalization of measurement values, assay details, and data sources, enable an informed and accelerated preclinical discovery.

Many companies can track increased MR activities through SFA systems, but it's challenging to assess whether these activities' quality has improved and translates into actual performance gains. We introduce a new platform focused on MR enablement. By providing high-quality training opportunities, it visualizes improvements in each MR's capabilities through scoring, supporting enhanced performance. 

Our company is developing a wireless implantable brain-computer interface (wiBCI) based on research from Osaka University. The wiBCI involves implanting a small EEG device in the skull through surgery, enabling control of devices like PCs with thought alone, and supporting or restoring bodily and communication functions lost due to severe neurological disorders. In this presentation, we will discuss the development status, as well as the database creation of intracranial EEG data and potential applications in bio-sensing devices and new drug development.

Oral care and understanding the condition of the oral cavity in daily life is very important for maintaining oral function, which is essential for maintaining overall health. Therefore, we are challenging to provide a new self-care method and to collecting oral data with Oral care robot 「g.eN」 for new healthcare solution.

Several pharmaceutical companies have announced that a treatment for the preclinical stage of Alzheimer's disease will be available in a few years. Identifying people who currently have no subjective symptoms and consider themselves “healthy” during the preclinical phase of the disease is expected to be a very difficult task, as it will require screening many subjects. We will discuss how MIG thinks the AD prevention-treatment environment should be established and aim to realize it.

The Open Innovation Venture Creation Council (JOIC), in collaboration with the New Energy and Industrial Technology Development Organisation (NEDO), organises pitch events by start-ups.

This year's event is positioned as a special Dream Pitch, where three start-up companies, each operating under the theme of ‘DX in the pharmaceutical industry’, will introduce their latest technological services

・NEDO

・AMI Inc.“Auscultation DX - Evaluation of cardiac disease by ultra-auscultation during the drug development phase”

・CaTe inc.“Research and development of programme medical devices to improve cardiac disease”

・Boston Medical Sciences, Inc.　“AI technology for laxative-free endoscopy - the AIM4CRC laxative-free virtual endoscopy system”

・NEDO×AMI×CaTe×Boston Medical Sciences　 “NEDO×Speaking Startups Talk Session - What kind of matching do startups expect?

At our company, we utilize CPS (Cyber-Physical System) to solve on-site issues faced by our customers based on movement data of "people, things, goods (commercial distribution), money, business, energy," etc. We support our customers in promoting their digital business by maximizing investment effectiveness.

In this lecture, we will introduce our company overview, business overview, usage examples, and future development based on our track record in pharmaceutical companies.

This session explores how AI drives digital transformation in the pharmaceutical industry, addressing process effi ciency, reducing reliance on individual expertise, and alleviating workloads. Learn actionable insights and real-world examples to revolutionize manufacturing while maintaining safety and quality standards.

The need for DX has long been advocated, but full-scale initiatives have yet to be implemented, and there are many misconceptions such as DX = D, X is suddenly a new business, and the cost-effectiveness of DX is calculated in man-days only. The president of the Manufacturing DX Association will talk about the misconceptions and traps to avoid in order to achieve results with DX.

Then, as one concrete example for success, we will tell you about a new method of inventory management using digital technology and case studies from the chemical and pharmaceutical industries on the subject of the Smart Mat Cloud, which uses IoT weighing scales to DX inventory management.

With women playing an increasingly important role in the pharmaceutical industry every year, there is a need for networking opportunities for women beyond company boundaries for the exchange of information. CPHI Women, now in its eighth edition, is a support project to respond to such calls.

In the first part of the panel discussion, a moderator with a wealth of experience in human resources in the pharmaceutical and medical device industries will be invited to talk to the two panellists, who are currently working in human resources at pharmaceutical companies, about the current state of women's activities in the pharmaceutical industry.

What has been done in the last five years? What are the recent examples of career paths for women? What systems would you like to introduce in the future...?

To think about my own career in the future. To think about introducing a new system in your company. We look forward to your participation.

Chugai Pharmaceutical, a research-based pharmaceutical company, is approaching its centennial in 2025. With a robust business model based on a strategic alliance with Roche, as its business foundation, Chugai pursues a technology-driven drug discovery approach. In addition to small molecule and antibody drugs, Chugai is also venturing into the new field of mid-size molecule drugs. This presentation will outline Chugai's drug discovery and manufacturing strategies, highlighting key initiatives. Additionally, it will share the company's vision for the future of healthcare, emphasizing co-creation with diverse stakeholders.

Drug loss in Japan is a social issue, partly due to Japan losing its appeal as a venue for new drug development amid global trends. CROs are tackling this challenge, aiming to help Japan regain its leadership in drug development. This presentation outlines specific strategies and the future outlook for the CRO industry.

India has become one of the prominent forces in global CDMO industry for development and manufacturing new drugs worldwide.  A presenter himself having over 20+ years of experience in process development and manufacturing intermediate and active NCE in small molecule space, he will present the challenges and mitigations during the scale up through introducing the CDMO case studies in India.   While there is relatively few CDMO cases yet between Japan and India, audience would be able to capture the attractiveness and ways of working with CDMO from India through this presentation.  

This presentation explores how AI can enhance pharmaceutical reaction analysis and process design. It highlights the development of models for commonly used reactions in drug synthesis, the identification of design spaces, and disturbance analysis for process control applications. The talk also covers a data-driven exploration aimed at automating the extraction of reaction mechanisms from time-series concentration data in chemical reactions, alongside the construction of corresponding physical models. By leveraging digital technologies to reduce experiments, Auxilart aims to contribute to faster and more efficient drug development.

On-demand production is changing the traditional production model by offering flexibility, efficiency, immediacy, and cost-effectiveness. This presentation will discuss Japan's progress at this time in the tipping-point to on-demand, decentralized, clone modular facilities, and remote continuous manufacturing for pharmaceuticals and fine chemicals.It will provide a better understanding of what can be done through these types of manufacturing methods in the current dynamic market environment.

Interest in RNA that takes three-dimensional structures is growing as a new potential drug targets in pharmaceutical development. However, structural information about RNA, is currently very limited. This presentation provides an overview of structural analysis that combine cryo-electron microscopy, nuclear magnetic resonance, and in silico computational methods to elucidate the three-dimensional structures and dynamic interactions of RNA targets and RNA complexes.

Gene therapy products, expected to treat intractable diseases, are increasing in number both domestically and internationally. However, they face many issues before launching, including safety, cost, and regulations. Therefore, it is necessary to establish advanced quality systems and manufacture better products appropriately. Although gene therapy is still in its developmental stages, solving these challenges in the future is expected to benefit more patients. This presentation will explain these challenges and prospects.

Bio and drug discovery startups play a central role in the creation of innovative new modalities. As these new modalities emerge in the market, they can form large markets and bring about dramatic changes to existing industry structures. Particularly in the field of biopharmaceuticals, including antibody drugs, substantial investments in production facilities are required, which in turn promotes horizontal division of labor and the growth of bio CDMOs (Contract Development and Manufacturing Organizations). This presentation will focus on startups and outline how they will impact the entire industry in the future.

CORYNEX® is Ajinomoto Co., Inc.'s proprietary protein secretion production technology using endotoxin-free microorganisms. It excels in producing high-purity, high-accumulation VHH, antibody-like proteins, and long-chain peptides, significantly improving productivity and reducing environmental impact compared to traditional platforms. Additionally, we have developed technology to incorporate non-natural amino acids.
 This presentation will introduce our one-stop-shop service, from strain construction to process development and GMP manufacturing.

We will introduce the LC/MS system required for the characterization of mAb therapeutics, consists of 1290 BioLC, 6545XT QTOF-MS, ExD cell, MassHunter BioConfirm software, and the AssayMap Bravo pipetting robot that automates sample preparation.

Ministry of Health, Labour and Welfare (MHLW) is promoting policies to promote medical startups that will play a role in maintaining and improving the health of the Japanese people and raising the level of medical care worldwide, based on the “Startup Development Five-year Plan” and other policies formulated to foster startups through the concerted efforts of the entire government. In this presentation, we will introduce measures to strengthen Japan's drug discovery capabilities, with a focus on measures to support startups and to build a global drug discovery ecosystem.

At last year's Drug Discovery Ecosystem Summit, the government positioned the biopharmaceutical industry as a key industry and stepped up its support. Currently, the number of university-launched startups is increasing, and their growth is being supported by matching funds from METI. However, few of them have been able to form corporate partnerships or obtain private funding, and even fewer have the potential to expand their business globally. This lecture will examine the challenges and solutions for Japan to once again become the land of drug discovery.

In recent years, the combination of platform technologies such as antibody drugs and regenerative/cell therapies with multi-omics analysis has been driving the diversification and efficiency of pharmaceutical development. Academia and venture companies are increasingly pursuing open innovation, achieving Proof of Concept (PoC) and aiming to license out to manufacturing and marketing firms. The National Cancer Center is strengthening support for domestic and international researchers and companies, focusing on exit strategies such as "Clinical Marketing" and entrepreneurship support, with the goal of fostering innovation and advancing the commercialization of new technologies.

The following will be briefly discussed.
(1) Halogen-containing polymers, which have been widely used, need to be examined in relation to PPWR.
(2) Significance and current status of standardization of PTP dimensions and shape
(3) Status of improvement in usability (ease of opening and prevention of accidental ingestion) due to the aging of the population
(4) Others

This presenter started liposomal research for gene therapy in 1994 when he was in Daiichi Pharmaceutical Co., Ltd., and in the field of nucleic acids delivery 26 original scientific papers and 9 basic patents have been published. Thirty years have passed, and APIs have been changed from plasmid DNA to siRNA and mRNA. Lipid nanoparticles (LNP) are necessary for the development of the above nucleic acid medicines. In this presentation the past and the present of LNP research will be introduced, and the future of LNP research including exosome research will be discussed.

Increasing demands on quality control in pharmaceutical solid dose production leads to the use of continuous in-line inspection systems.  The CU-120 imspection machine from Pharma Technology is capable to measure up to 120.000 tablets per hour for the following CQA's: mass, dimensions,  API fraction, water content, Content Uniformity, assay and porosity. The machine can be used for product development, process control and supports Real Time Release.

Nucleic acids and genes are attracting attention as new drug modalities, and R&D on them is being actively conducted around the world. One of the technologies that holds the key to the success of nucleic acid and gene drug development is drug delivery system (DDS). As DDS technology advances, including lipid nanoparticle (LNP) technology, which has contributed to the practical use of mRNA vaccines, the development of nucleic acid and gene drugs will make great progress. Here, I will provide an overview of recent trends in nucleic acid and gene drug development, focusing on DDS technology. I will also introduce the efforts of the Nucleic Acid and Gene Medicine Focus Group of The Academy of Pharmaceutical Science and Technology, Japan.

Drug-device combination products (DDCPs) that involve peptides are gaining prominence in the pharmaceutical and biotechnology sectors due to their potential to enhance drug delivery, improve patient compliance, and enable more effective treatment. They offer innovative solutions for the challenges of peptide delivery, improving both the therapeutic potential of peptides and the overall patient experience. These products typically consist of a drug (the peptide) and a device that aids in the administration or delivery of the drug. Biocon’s involvement in the peptide sector is a part of a broader strategy to make treatments more accessible and affordable while focusing on high-quality standards in the production of peptides and related therapies

In August 2021, the Japanese GMP Ordinance was revised, increasing the requirements for QA work, and the time has come when QA work is dramatically required in terms of both quality and quantity. With the increase in the manufacture of new fields such as biopharmaceuticals, it is necessary for manufacturers to ensure quality throughout the lifecycle and to make continuous improvements through appropriate collaboration with CDMOs, etc., as appropriate, with a focus on QA. This presentation will explain the current QA systems required, including recent case studies.

Outsourcing of development and manufacturing of biopharmaceuticals has been popular. However, with the emergence of new modalities such as mRNA vaccines and ADCs, CDMOs are increasingly required to provide new manufacturing and quality control services. What will be required of biopharmaceutical CDMOs in the future? The current status of biopharmaceutical CDMOs and the challenges of outsourcing will be outlined.

Mr. Akhil Ravi

Chief Executive Officer (CEO)

Aurigene Pharmaceutical Services Limited

One of the issues to expand the potential of mRNA therapeutics is lipid nanoparticles (LNPs) for mRNA delivery. We have obtained proprietary ionizable lipids through in vivo screening and evaluated their application to LNPs. Some of them showed high activity for RNA delivery and low toxicity, and others have showed potential for extrahepatic delivery.
In this presentation, we will introduce the features and applications of LNPs using our proprietary ionizable lipids and one-stop CDMO services from mRNA to LNPs to meet customers’ needs for mRNA therapeutics.

Oligonucleotide synthesis via flow chemistry is an ideal method for producing oligonucleotides and can address scalability challenges of conventional solid-phase synthesis. Unfortunately, to date, flow chemistry for nucleotide synthesis has only been applied to synthesize trimer nucleotides, and there is a strong demand to extend the application of flow chemistry to the production of longer oligonucleotide APIs. We have recently succeeded in large scale synthesis of 10-mer phosphoramidites, termed Blockmer™, as raw materials for liquid-phase oligonucleotide synthesis. Using the Blockmer™, we have achieved a one-step elongation to a 24-mer oligonucleotide with in-line deprotection.

In this presentation, we will discuss the details of the oligonucleotide synthesis by flow chemistry in liquid phase using Blockmer™ and our progress toward continuous production of oligonucleotide.

Presentation focuses on ScinoPharm's advanced peptide manufacturing capabilities, highlighting technologies designed to address diverse client development needs while enabling scalable, high-quality production across both drug substances and drug products. ScinoPharm employs robust solutions such as solid-phase peptide synthesis, continuous purification processes, lyophilization, and spray drying for peptide drug substances, as well as fill-finish services in pre-filled syringes/cartridges and in-house assembly for peptide drug products. ScinoPharm is empowered to efficiently and precisely tackle complex manufacturing challenges, advancing cost-effective and environmentally sustainable practices. A snapshot demonstrates why ScinoPharm is a tailored, trusted partner for clients seeking reliable and scalable peptide manufacturing expertise.

With the evolution of AI and the decline of productive population, more and more companies and organizations are changing their perspective from “adding AI” to “starting with AI”. In this presentation, we will introduce examples of initiatives such as accelerating drug discovery using biomedical foundation model, streamlining clinical trials by incorporating RWD such as electronic medical records and generative AI, turning factories into smart factories using digital technologies, and using generative AI to detect adverse events and support early detection of patients with rare diseases.

Digital health will play a major role in future medical care. Artificial intelligence and new modalities are also developing. However, we need a vision of what we can achieve with digital health. First, we will take a bird's-eye view of medical care and consider the healthcare and/or patient journey and digital health. Another important method is the “backcasting approach”, which starts defining a desirable future and works backwards. I will give you tips on how to make digital technology valuable.

In this seminar, we will introduce "QAI," an AI SaaS developed by a startup from the Matsuo Lab at the University of Tokyo, designed to enhance the efficiency of quality assurance operations. We will discuss how AI can be utilized in document creation, review, search, and training, as well as explore the impact of large language models on business processes in the pharmaceutical industry and future developments.

Life Sciences Cloud, designed for the life sciences industry, shows how the combination of data and autonomous AI can shape the future, with a clear demonstration. By bringing together both internal and third-party data in Salesforce and securely connecting it to autonomous AI, this solution allows better data usage in various situations, helping businesses grow.

In specialty fields, including rare diseases and oncology, the low frequency of encounters in clinical settings poses significant diagnostic and treatment challenges for physicians. The traditional push-based information delivery method requires transformation. This seminar will delve into the challenges from a physician's perspective, explore their realities, and highlight Medii's effective initiatives and achievements in addressing these issues.

As physicians' information-gathering trends continue to evolve, effective digital content design has become essential for driving omnichannel marketing. In this seminar, we will revisit the role of digital content in omnichannel marketing and provide concrete insights into key aspects of content planning and creation, including theme setting, expression techniques, and lead flow design.

This seminar explores the keys to improving operational efficiency and quality in the healthcare industry by examining successful AI utilization cases from other sectors. We will analyze the transformations AI has brought to various industries and consider how these advancements can be applied to healthcare. This seminar is ideal for those interested in enhancing efficiency and improving quality and services through data utilization. Join us to learn about the latest AI trends and gain practical insights to help solve challenges and drive business improvements in your organization.

The characteristics of RWD (Real World Data) and examples of its use will be presented, explaining how a data-driven approach can bring new value to everything from Research and Development to marketing and patient support. It also examines points to note and future prospects for data utilisation, and explores the possibilities for data-driven healthcare.

❛B3❜ is Hitachi's analysis technology that offers accurate analysis result and can explain result evidence, and is used by various companies, research institutions and testing services.

Hitachi will introduce the case studies and the cloud-based ❛B3 Analytics❜.

It has been a year since the work style reform for doctors began, and the opportunities and time for MRs (Medical Representatives) to meet with doctors have decreased. The era where results could be achieved solely through the efforts of MRs has come to an end, and we are transitioning to an era where digital tools, such as CRM, should be utilized to enhance meeting capabilities. In this seminar, we will re-examine the usefulness of CRM and introduce one of our comprehensive MR support measures: 'a system that integrates internal and external data into CRM and visualizes it in an easy-to-understand manner tailored to the doctors being met with.

Delirium is a consciousness disorder that frequently occurs in the elderly. It can lead to a decline in patients' physical and cognitive functions, increase the risk of dementia, and impose a greater workload on healthcare professionals. Additionally, it contributes to prolonged hospital stays and rising medical costs. Amid these challenges, advancements in AI technology have recently led to the emergence of innovative delirium prediction methods worldwide. This lecture will provide an overview of the latest trends in AI-driven delirium management.

The use of AI is inevitable in innovations in the health tech sector, such as medical DX, wearable devices and digital therapies, and the key is how effectively we leverage the information from precedent case studies. In this presentation, multiple sources of information, including media and reports, will be collected and analyzed across the board to explore specific actions that will lead directly to new businesses, including precedent cases and discovery of potential needs.

Implementing Beyond the Pill requires personalized support based on individual patient data, aligning with the Patient Journey. BiPSEE, recognized by Japan's MHLW as a Priority Review Item for SaMD and selected by NEDO as a Deep-Tech Startup, develops VRx for depression treatment, a metaverse for return-to-work support, and an AI agent for drug adherence and side effect management. We are advancing commercialization in collaboration with partner companies.

PharmaX operates an online pharmacy called “YOJO,” serving as a personal pharmacist for customers. This AI-driven system routes 80% of user interactions through an AI agent that consults a pharmacist for confirmation or updates when needed. In this talk, we’ll explain the AI agent framework developed by PharmaX and discuss how AI-powered solutions will shape the future of the medical and healthcare industries.

At TechFamily Inc., we specialize in AI development and are exploring the potential of AI avatars as next-generation conversational interfaces in healthcare industry.
In this session, we will share real-world implementation examples and collaborative models with partner companies, highlighting how AI avatars can enhance user experience and support seamless integration in healthcare environments.

In 2025, Japan faces a super-aging society, while the world enters the AI agent era. Each year, millions of medical papers are published, and AI is accelerating the explosion of medical information. Can traditional human-based dissemination ensure fair and up-to-date pharmaceutical information? AI can transform data into various formats, and pharmaceuticals are essentially "chemicals + information." Now is the time to establish a new system where everyone, especially healthcare professionals, can access scientifically reliable drug information. The future of medicine depends on how we integrate AI to ensure transparency, accessibility, and fairness in pharmaceutical knowledge sharing.

Currently, the drug shortage continues , and one of the reasons for this is the increasing complexity of the supply chain. Pharmaceutical companies continue to increase the number of products , and are switching to outsourced manufacturing. “Resilire” is a cloud system that visualizes the supply chain and makes supply chain management operations more efficient. It is used by over 30 pharmaceutical companies, supporting their stable supply.

In response to the distribution needs of the Japanese pharmaceutical market, we, as a CDMO, support the development of supply chain systems tailored to the specific needs of both domestic and international pharmaceutical companies from multiple perspectives.
We will introduce our expanded contract operations for high-demand biopharmaceuticals, enhanced support for 3PL functions, and assistance for market entry in Japan aimed at reducing drug loss through our partnership with the Suzuken Group and EPS. Additionally, we will highlight the establishment of an Asian Hub through our GATEWAY to ASIA® service.

“The Self-imposed Standard of GMP for Pharmaceutical Excipients” was developed by IPEC Japan in 2016. After that、data integrity and other items have become necessary for GMP management of pharmaceutical excipients, and ”The Joint IPEC-PQG Good Manufacturing Practice Guide for Excipients” developed by IPEC Federation was revised in 2022. Now we are currently working on revising “The Self-imposed Standard of GMP for Pharmaceutical Excipients” based on this guide to incorporate the above. We will introduce some of the contents of the revision.

Drawing on 17 years of API procurement experience, this presentation offers practical approaches for pharmaceutical buyers and trading companies to effectively utilize expos in building partnerships with key manufacturers. We will explore specific methods for relationship building through expo communications, with special focus on crucial elements for successful collaboration with Indian and Chinese manufacturers.