Expanding a pharmaceutical business into Japan requires robust regulatory strategies, clinical trial execution, and market entry planning, all of which depend on collaboration with appropriate stakeholders. For overseas biotech firms, identifying these stakeholders and adapting information into a Japan-specific business plan is a significant challenge, often hindering market entry. This presentation introduces a new industry–government–academia collaborative initiative designed to overcome these barriers and support the successful launch of innovative biopharmaceutical ventures in Japan.

Patient centricity is widely discussed, yet hard to embed in everyday decisions. In this session, Abdul Mullick Ph.D., President & CEO of Kyowa Kirin, shares how a patient centric mindset is built into strategy, governance, quality, and long term investment. Anchored in “Vision 2030 and beyond,” he will highlight focused disease areas, innovative modalities, partnering approaches, and transformation through DX/AI—showing how trusted collaboration across the pharmaceutical value chain creates sustainable value.

Focus on investment in R&D and commercialization in Japan, a major global pharmaceutical market, continues as both established and emerging biopharma maintain focused on opportunities in Japan. Join IQVIA Japan as we provide insights into the future of the Japan pharmaceutical market and our Outlook to 2030.

The presentation will provide an overview of the state of the global biopharma pipeline as of early 2026, looking at key corporate players, therapeutic, disease and modality areas, drug targets, clinical phases and emerging broad trends. It will highlight key changes over the past year including shifting focus areas and the continued rapid emergence of innovation from China.

Drug discovery for malaria and neglected tropical diseases (NTDs) is an innovation activity as important as those for dementia and cancer. Our company receives support from domestic and international funds, including the GHIT Fund, and collaborates with world-class academia, research institutions, and non-profit product development partners (PDP). By bringing together outstanding ideas, cutting-edge technologies, and clinical development expertise, we are driving numerous drug discovery projects. In this presentation, I will introduce the history of our efforts spanning more than 20 years and the challenges we face today.

Amid ongoing shortages of generic drugs, which constitute the majority of established medicines, the government has designated a concentrated reform period, initiating a transformation of the industry structure. The first half explains the “New Consortium Concept” promoting manufacturing plant consolidation to move away from the urgent challenge of low-volume, high-variety production, and discusses improving sales forecast accuracy as well. The latter half introduces proposals for creating a new application category for improved existing drugs, aiming to revitalize the industry through innovation in modifying already approved active ingredients, using the United States as a model.

High level understanding of regulatory system globally

How to make product launch quicker using different regulatory strategies with case studies

The recent instability in pharmaceutical supply stems from medium-to-long-term challenges, including inefficient manufacturing systems within the generic drug industry. This instability has been exacerbated by various factors, such as infectious disease outbreaks and reduced supply volumes triggered by pharmaceutical companies violating the Pharmaceutical Affairs Law. Therefore, it is crucial to address not only the immediate supply concerns but also tackle these medium-to-long-term challenges. In this presentation, we will introduce the current state of pharmaceutical supply and the administrative measures taken thus far.

Currently in Japan, there are concerns about the decline in both drug discovery capabilities and market viability. Many Japanese companies struggle with pipeline expansion and domestic and business development domestically/globally, while efforts like industry-government-academia collaboration and open innovation have shown limited results. Additionally, geopolitical risks such as the rapid expansion of drug discovery in China and the introduction of new tariffs and drug pricing policies in the US have become apparent. In response, this presentation will consider 1) the potential for new business models in domestic pharmaceutical companies and, 2) strategies to enhance drug discovery capabilities. 

SHIONOGI, with 147 years of history, strengthens drug discovery while expanding into Healthcare as a Service through reforms for sustainable growth.

The Next Generation Medical Infrastructure Act was enacted to establish a framework for anonymizing medical data and promoting its utilization in medical research and development. In April 2024, the amended law came into effect, including the establishment of a new mechanisms for pseudonymized medical data and linked analysis with public databases.

As a related development, based on the "Priority Plan for the Advancement of a Digital Society", a study meeting was held to examine the overall picture (grand design) in order to promote the use of medical information. This seminar introduces the current situation and future prospects of the Next Generation Medical Infrastructure Act.

※This summary is a provisional translation.

The University of Tokyo Pandemic Preparedness, Infection, and Advanced Research Center (UTOPIA) launched on October 18, 2022 with the support of AMED-SCARDA. With a mission to protect people from infectious diseases and pandemics, UTOPIA brings together top researchers, transcending disciplinary boundaries, to advance infectious disease prevention and vaccine development.

In this session, we will consider whether the adoption of DCT (Decentralized Clinical Trials), a method used in clinical trials, can help reduce drug loss, and we will discuss the current state of DCT and its further implementation in Japan.

In Japan, the GMP standards for investigational drugs are legally distinct from those for approved pharmaceuticals and are separate from the GMP ministerial order. However, in Europe and the United States, they are regulated under a single standard: EU-GMP/cGMP. So, what are the differences, and what constitutes a globally applicable "GMP for investigational drugs"? This presentation provides an overview of investigational drugs, which are essential for pharmaceutical development from a quality perspective.

Regenerative medicine, as well as cell and gene therapy, represent cutting-edge fields in medical technology, greatly expanding the potential for patient treatment. Japan has strengths in research and development in these areas and is undertaking advanced initiatives. However, from the perspective of promoting this industry, there are various challenges. In this presentation, Mr.Nishio will introduce the challenges faced by this industry, the government's measures and achievements to date, and the future direction moving forward.

Driven by the advent of a super-aged society, advances in aging research, and the utilization of AI with multimodal data, the Longevity paradigm—diagnosing, predicting, and intervening in aging—is maturing into an industry and driving a paradigm shift in healthcare. We will introduce the impact of this momentum in the field of prevention, an area where traditional pharmaceutical companies have historically been less adept.

１．We are challenging ourselves to cultivate talent capable of contributing globally while maintaining our commitment to "manufacturing", through a cross-organizational approach to discussion and review organized by business and technical fields.

２．Creating video manuals as an effective means of developing human resources to solve the challenges facing the GE industry.

３．Specific examples of our approaches as a manufacturing supervisor in developing human resources through Quality Objectives will be presented.

４．Focusing on talent acquisition as the starting point of education, I will introduce unique methods to overcome low visibility and recruitment difficulties.

The environment surrounding drug discovery is at a major turning point. With advances in artificial intelligence and digital technology, industry-academia collaboration, and co-creation with ventures and startups becoming essential, ecosystem-based innovation holds the key. As a keynote topic of the “Drug Discovery Innovation Seminar”, this lecture will explore strategies and practical examples for reconstructing the future of drug discovery, from everyday innovation to moonshot ideas, with an eye toward the healthcare landscape required in the era of 100-year lifespans.

In recent years, nitrosamines and drug substance-related impurities (NDSRIs) present in pharmaceuticals have attracted global attention due to their potential carcinogenic risk, and stringent regulatory control is required. In this presentation, we will introduce key aspects of developing an LC-MS/MS-based analytical method targeting nine nitrosamine species. Furthermore, recent case studies on the analysis of NDSRIs will also be presented.

This presentation will organize key concepts in “data management” that are crucial for accelerating the practical application of academic drug discovery seeds. We will introduce our efforts to collect and evaluate reliable academic data, demonstrating that early adoption of TPP is beneficial not only for drug discovery startups but also for academic research.

This presentation provides an overview of ADAR-mediated A-to-I RNA editing using RNA-editing oligonucleotides (REO) and summarizes current efforts to develop RNA-editing therapeutics for genetic diseases. It also introduces the potential of RNA editing as a novel therapeutic concept and outlines its prospects for drug discovery applications, while offering perspectives on future directions for advancing this technology.

The National Instituteｓ of Biomedical Innovation, Health and Nutrition has launched a drug discovery platform initiative utilizing generative AI. This initiative aims to reduce the burden on healthcare providers while building mechanisms to realize personalized and optimized medicine. Specifically, it involves developing conversational systems for obtaining patient consent and explaining medical procedures, constructing a medical information database to collect clinical data in real time, and pursuing AI-driven patient stratification and prediction of drug efficacy and side effects as novel approaches to drug discovery. This presentation introduces these initiatives.

Genomic medicine, which provides personalized healthcare tailored to each individual's genomic information, has advanced significantly over the past two decades. This would be mainly caused by next-generation sequencers available in 2006. Its scope extends beyond hereditary diseases to encompass cancer, multifactorial diseases, and infectious diseases. This presentation will mainly focus on large-scale cancer research conducted in the presenter's laboratory, discussing the current state of genomic medicine and its future prospects.

Characterization of therapeutic antibodies and antibody–drug conjugates (ADCs) requires LC/MS-based analysis of amino acid sequences, post-translational modifications, and drug-to-antibody ratio (DAR). This presentation highlights recent applications utilizing next-generation LC/MS systems for detailed structural, functional insights and MAM (Malti-Attribute Method). Furthermore, following the release of USP1132.1, the importance of host cell protein (HCP) analysis in biopharmaceutical development has significantly increased. I demonstrate high-sensitivity, comprehensive LC/MS approaches for HCP identification and quantitation, showcasing application workflows.I demonstrate high-sensitivity, comprehensive LC/MS approaches for HCP identification and quantitation, showcasing application workflows.

The regulatory environment for regenerative medicine products is being improved year by year, and public information in Japan, the United States, and Europe is available from public information to promote and support systems to safely and quickly deliver innovative therapies to patients, as well as guidance essential for development. On the other hand, manufacturing and CMC practices are diverse and are the most pointed out areas in the marketing approval process to address modality-specific challenges. This section provides a bird's-eye view of these developments, issues related to manufacturing and CMC, and introduces learnings from public information.

Clinical applications of oligonucleotide and mRNA therapeutics have advanced rapidly in recent years, drawing attention as promising modalities for diseases and infections lacking effective treatments. These modalities allow API design based on target sequences and enable platform-based manufacturing and structural modalities, providing the advantage of remarkably rapid development. This presentation outlines current development trends for both modalities and introduces efforts related to quality and safety evaluation.

What will the pharmaceutical industry look like in the next 5 years? 

In this session, Citeline/Evaluate—drawing on over 30 years of experience supporting the pharmaceutical industry with data and consulting—will share strategic insights for navigating uncertainty, based on proprietary drug sales forecasts and deal intelligence. 

This presentation is designed not only for those responsible for corporate growth strategies, such as business development and strategic planning, but also for anyone who wants to stay ahead of key trends shaping the pharmaceutical landscape. 

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.

CORYNEX® is Ajinomoto Co., Inc.'s proprietary protein secretion production services using endotoxin-free microorganisms. It excels in producing high-purity, high-accumulation VHH 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.

This presentation will provide an overview of oligonucleotide synthesis strategies for the development of oligonucleotide therapeutics. A discussion of the latest trends, technologies and innovations in the oligonucleotide landscape, including new paradigms in oligonucleotide manufacturing, will also be presented.

Forge Biologics is a CDMO specializing in AAV manufacturing, backed by a highly skilled and experienced team. We offer a flexible and robust manufacturing platform utilizing proprietary cell and gene tools and high-yield media, providing integrated services from cell culture to purification and analytics. With large-scale production up to 5,000L, advanced process development, and strict quality control, we respond quickly to diverse needs in the gene therapy field.

Biotech investment is at a major turning point, driven by advances in AI-enabled drug discovery, academia-originated seeds, and increasingly diverse modalities. At the same time, the sector still faces significant challenges, including a tough funding environment, underdeveloped ecosystems, the so-called “100-oku-yen problem,” and a shortage of experienced management talent. This talk will review the latest global and Japanese trends and examine the current state and future direction of biotech startup investment.

We explore how to design the facility and process more resilient and future-proof. How is our weather changing? Does the weather change have more impact on CO2e than how the electricity is generated? Looking at the Tohoku Earthquake in 2011, we try to highlight the key consideration points using the BioSolve® Process (Biopharm® Services) and the Monoclonal Antibody process.

Amidst recent compliance issues and revised GMP regulations, trust between Marketing Authorization Holders (MAHs) and manufacturers is critical. This presentation explores a "Win-Win" GMP audit approach, covering key topics like biopharmaceuticals, recent global inspection findings, and Data Integrity. We will focus on moving beyond simply identifying deficiencies to using the audit as a tool that fosters effective communication and strengthens daily collaboration. We welcome the participation of professionals from MAHs, manufacturers, and all related fields to join this important discussion.

We will introduce our precious metal catalysts for fine chemical synthesis, focusing on CHOIS-5D for debenzylation and CPs-HP series for metal impurity removal. Please feel free to contact us after the presentation if interested.

The total synthesis of polycyclic natural products is challenging theme, such as the construction of the ring and the stereocontrol of functional groups. It is extremely interesting from the synthetic organic chemistry. In this presentation,some examples of total synthesis of polycyclic natural products, mainly terpenoids, that have been carried out in our laboratory will be introduced.

Achieving quality, safety, and efficiency in pharmaceutical manufacturing demands advanced process design and robust scale-up strategies. This presentation highlights JUZEN CHEMICAL’s approach to integrating batch and continuous manufacturing technologies, focusing on real-world scale-up case studies. Key topics include reaction control, equipment design, and regulatory compliance, as well as critical considerations when transitioning from batch to continuous processes. Through comparative analysis and practical insights, we will explore solutions to common challenges and discuss how these innovations can shape the future of CDMO operations.

How can process chemists design “synthesis processes” and connect them to production? This presentation will showcase examples of process optimization and scale-up at APAC manufacturing sites utilizing computer-assisted synthesis pathway design, proposing concrete solutions to achieve process shortening, stable supply, cost reduction, and improved sustainability.

This lecture presents our recent advances in an innovative approach to organic molecular transformations that integrate photoactivation, electrochemical synthesis, and machine learning to achieve both sustainability and strict reaction control. It highlights progress toward zero-waste reaction processes, optimization of reaction conditions using minimal training data, and emerging challenges in directly harnessing solar energy for organic synthesis. Their applications to the synthesis of chemical products will also be discussed.

Pharmaceutical Supply Chain Initiative (PSCI) is a global association with 85 big pharmaceutical companies across the world. It does audit, build capability and projects for suppliers and contracted manufactures on the domains of Environmental Health Safety, Ethics, and Human Rights. The presentation will brief how is the PSCI audit at a supplier site looks like. Which could be important information for a pharmaceutical company who wants to be a part of the supply chain of PSCI member company.

The CMC Research Dep. at Asahi Kasei Therapeutics tackles complex challenges through “collective intelligence,” integrating diverse expertise both inside and outside the company, with core strengths in drug substance, formulation, and analytical technologies. This time, we focus on process chemistry, introducing case studies on the process leading up to collaboration with contract partners, manufacturing strategies tailored to development stage objectives and cost optimization, production of highly potent compounds, and structure determination using innovative technologies.

Environmentally benign, cost-effective, and inherently safe manufacturing processes are essential for the sustainable growth of the chemical industry. Catalytic reactions and continuous-flow manufacturing have emerged as key strategies to achieve these objectives. This presentation will outline our catalyst development efforts, initiated with the ℓ-menthol process in 1983, and highlight recent advances in continuous-flow manufacturing.

Currently, global supply chains and manufacturing systems that can deal with pandemics and geopolitical risks are required for pharmaceutical supply. SHIONOGI has established a domestic production and supply system, focusing on infectious disease drugs, while also embarking on global responses. This presentation will introduce examples from SHIONOGI regarding the establishment of a short-term development and production system for COVID-19 treatment drugs, as well as the establishment of a stable supply system for antibiotics from the perspective of economic security.

Researchers in the API Research Group at CMC Laboratories inherit the principles of “Quality First” from Tanabe and “Safety First” from Mitsubishi, serving as designers of processes that support the entire API supply chain. From raw material sourcing to manufacturing and logistics, we pursue efficient and high-quality processes through collaboration with internal and external partners, guided by integrity and flexibility. This presentation will review 18 years of progress in process development and share future perspectives focused on next-generation technologies and sustainable supply.

Organocatalysts are excellent tools for large-scale synthesis because they do not require strict exclusion of water or oxygen, and they avoid metal contamination in final products. One-pot reactions, which carry out multiple transformations in a single vessel, also reduce purification time and waste. In this work, we describe our studies on efficient syntheses of pharmaceuticals and their intermediates using organocatalytic one-pot processes as key steps.

Chemists have traditionally relied on heuristic methods to interpret experimental results, but such approaches are limited in handling large and complex datasets. We developed a machine learning algorithm incorporating latent variables to predict relationships among substitution patterns and reaction yields with high accuracy. The predictions were experimentally validated, demonstrating consistently high yields. The latent variables captured key electronic features of the molecules and revealed hidden reaction pathways that cannot be directly observed experimentally. This approach enhances mechanistic understanding and provides a data driven framework for optimizing synthetic strategies in organic molecular design.

Prefilled syringe (PFS) formulations support home-based treatment and reduce healthcare workload, and their use is expanding across many therapeutics and vaccines. With the growing number of PFS products and increasingly diverse development needs—especially in biopharmaceuticals—greater innovation in device design is required. This seminar will present BD’s insights on US/EU PFS trends and introduce cutting-edge PFS technologies that expand formulation possibilities, including the BD DualInjection Valve & Syringe System and BD Neopak™ XtraFlow™. 

The manufacturing of regenerative medicines faces unique and complex challenges, requiring innovative technologies that enable true scalability, efficiency, and regulatory compliance.

This presentation will introduce the next generation of closed, automated, and industry ready equipment solutions designed to seamlessly support product pipelines and establish manufacturing models that reliably transition therapies from lab scale to commercial production.

Key topics will include:

· A novel, fully integrated cGMP manufacturing approach for commercial-scale cell-based therapies

· Advanced, efficient non-viral vector production and nanoencapsulation technologies that unlock new possibilities for modality development

These solutions represent significant steps in overcoming barriers in regenerative medicine manufacturing — paving the way toward scalable, efficient, and commercially viable production pathways for the therapies of tomorrow.

Nucleic acid and mRNA therapeutics have advanced rapidly with progress in nucleic acid chemistry and drug delivery systems (DDS). These developments have led to many approved products and active clinical trials. However, an important issue remains, especially in delivering these drugs to organs beyond the liver. Designing lipid nanoparticles (nano-DDS) that are optimized for specific organs is key to overcoming this issue. This lecture will introduce the basics of DDS in nucleic acid and mRNA drug development and highlight recent progress in extra-hepatic delivery.

New modalities offer promising approaches for diseases once difficult to treat, yet major challenges remain in developing suitable delivery methods. Recently, an inhaled protein formulation and an inhaled vaccine have been commercialized, and thus inhalable formulations are gaining attention as delivery options for new modalities. This lecture outlines recent research and trends in developing inhaled formulations for biopharmaceuticals.

In pharmaceutical formulation development, a formulation design is required that simultaneously optimizes efficacy, safety, quality, and convenience, based on the properties of the active pharmaceutical ingredient and the target product profile. However, it is challenging to achieve the desired formulation performance from the vast number of combinations of numerous excipients. This presentation will outline our research approach to address this difficulty by utilizing digital technologies, such as artificial intelligence (AI) and molecular simulation, to streamline and enhance the quality of formulation design. Furthermore, we will introduce the activities of the focus group on application of digital technologies on pharmaceutical sciences of The Academy of Pharmaceutical Science and Technology, Japan (APSTJ).

In recent years, various DDS technologies have been developed and applied clinically. In Japan, fundamental research on DDS formulations is active, yet few products originate domestically. To address this gap, the DDS Formulation Clinical Application Focus Group (DDS-FG) of the Japanese Society of Pharmaceutical Sciences has focused on challenges in translating research into clinical practice. This presentation will introduce DDS-FG activities and initiatives aimed at advancing DDS technologies and formulation development from Japan.

In this seminar, we will start by outlining the CDMO market landscape and key growth drivers, then take a deep dive into how strategic partnerships between CDMOs and sponsor companies create competitive advantage. 

To conclude, we will showcase how our CDMO Intelligence can help enhance partnering strategies. 

This session is designed not only for those involved in CDMO business strategy, but also for executives in corporate planning and business development at pharmaceutical companies, as well as investors. We look forward to your participation. 

Formosa Laboratories demonstrates that controlling the conjugation reaction between antibody and linker to achieve site-specific DAR2 or DAR4 ADCs reduces heterogeneity in the ADC platform without altering the antibody sequence through engineering or enzymatic reactions. This method simplifies the CMC process for ADC products and speeds up the production timeline toward clinical trials. 

In recent years, the diversification of drug modalities has made the improvement of oral absorption for various types of active pharmaceutical ingredients—such as peptides, antibodies, and nucleic acid-based therapeutics—an increasingly important pharmaceutical challenge. This presentation provides an overview, from the perspective of the Oral Absorption Focus Group, of the current landscape surrounding absorption enhancement technologies, advances in evaluation systems, and prediction of transmucosal absorption. Furthermore, we will discuss integrative approaches that bridge pharmacokinetics and pharmaceutical formulation development, and explore future prospects in this field.

This presentation is for companies aiming to accelerate development in the antibody and ADC space. We will introduce WuXi Biologics and XDC’s end-to-end integrated solutions, from early discovery to commercialization. Leveraging a global development framework and comprehensive capabilities in manufacturing, CMC, analytics, and regulatory affairs, we will discuss how our flexible, high-quality, and rapid solutions have helped biopharma and startups overcome key challenges—highlighted through case studies. 

Collaboration, both in Japan and internationally, is essential to solve challenges in pediatric drug development. In this brochure, we introduce three key activities of our Pediatric Formulation Focus Group (FG):

(1) gathering children’s opinions about medicines, (2) organizing ideas on the classification and naming of mini-tablet formulations, and (3) working together with the European Paediatric Formulation Initiative.

Leveraging over 30 years of experience in the fields of regenerative medicine and biopharmaceuticals, Takara Bio provides comprehensive one-stop support as a CRDMO—from basic research to manufacturing process development, production, and quality testing. In this presentation, we will introduce the various services offered at Takara Bio's Center for Gene and Cell Processing, a GMP/GCTP-compliant facility.

KANEKA is advancing sustainable and high‑efficiency manufacturing processes for pharmaceutical intermediates by integrating advanced AI capabilities with a proprietary enzyme engineering platform. By combining AI‑driven activity and selectivity prediction with experimental data, we are establishing a rapid and scalable approach for identifying and optimizing environmentally friendly enzymes. This presentation will highlight case studies involving chiral alcohol and chiral amine production, presenting the future direction of next‑generation process development.

Many global drug discovery companies take advantage of Australia as their early-stage clinical study destination.  We have clinical trials ecosystem that support a diverse range of needs from the sponsors with different stages.  In this seminar, we will discuss how you can engage with industry players to accelerate your early drug development in Australia.
 

*Japanese-English AI real-time translation subtitles available.
*Attendees must provide their own smartphones and earphones.

This seminar provides an overview of Vietnam’s growing pharmaceutical market, focusing on the regulatory framework and practical considerations for market entry. Drawing on hands-on experience with local regulatory practice and pharmaceutical M&A transactions, the session explores how companies can utilize acquisitions and partnerships to expand their presence in Vietnam. It also touches on the structure of pharmaceutical distribution, including hospitals and pharmacies, and highlights key legal and operational issues commonly faced by Japanese companies operating in the market.

With the depreciation of the yen, API costs from Europe have risen significantly, while prices in China and India are also increasing. At the same time, geopolitical risks are making supply disruptions a more serious concern. In addition, the implementation of Japan’s “stable supply essential medicines” framework is increasing the responsibility of procurement functions for stable sourcing.
In this session, we will examine how companies should assess API procurement risks and what decisions procurement functions need to make, while also providing insights for trading companies and domestic API manufacturers. 

Advances in machine learning centered on deep learning, the increasing performance of GPUs, the sophistication of information infrastructure, and the expanding utilization of big data have significantly heightened expectations for AI. I have promoted medical device development and drug discovery through AI analysis of medical big data, and has achieved multiple results implemented clinically after obtaining regulatory approval. This presentation will introduce these achievements and the latest technological and implementation status.

In pharmaceutical supply chain management (SCM), data utilization including “externally provided data” has been advanced, and SCM visibility and AI-enabled sales forecasting have been established to a practical level. However, challenges remain in data completeness and timeliness. Going forward, downstream data closer to patients will be complemented and enhanced through digital technologies. By redesigning the end‑to‑end pharmaceutical supply chain through improved forecasting and supply‑scheme optimization, we aim not only to drive broader transformation but also to ensure the stable and reliable delivery of the medicines patients need.

We welcome Mr. Sezaki from UCB Japan—who has led digital transformation across both domestic and global pharmaceutical organizations—as our panelist. Together, we will discuss how effective omnichannel operations can enable smoother, more meaningful communication with healthcare professionals. What barriers are preventing real progress in marketing strategy and MR activity transformation? Joined by our Web Director, who has extensive expertise in CRM technology, data strategy, and content design, we will explore practical, actionable solutions to bridge the gap between vision and reality. 

Pharmaceutical marketing is entering a new “ecosystem era,” where companies, physicians, and patients are increasingly connected through advancing technologies. This lecture provides a broad view of how IT, AI, and data are reshaping industry structures, outlining the future shift from SOV-based approaches to behavior change and ultimately ecosystem optimization. It then offers clear guidance on how pharmaceutical companies should position themselves within emerging ecosystems and what strategic choices they must make to succeed in this new landscape.

This session explores how AI drives digital transformation in the pharmaceutical industry, addressing process efficiency, 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 use of wearables (DHTs) in next-generation clinical trials faces two major barriers: technical challenges related to data validity (validation/data integrity), and organizational challenges in decision-making processes.

In this session, we will explore the latest regulatory trends from the FDA and EMA, along with real-world examples of adoption in key clinical endpoints. We will also discuss practical approaches to overcoming technical hurdles and provide actionable insights for accelerating internal decision-making.

Finally, we will present a roadmap for moving from potential to real-world implementation.

TriNetX is a global federated network connecting healthcare organizations and life sciences companies to accelerate the development of new therapies through research using real-world data (RWD). Leveraging RWD from 300 million patients and a cloud-based clinical research and trial platform, TriNetX enables real-world evidence generation and trial optimization. In Japan, the network is rapidly expanding with more participating institutions and accessible data.

To further advance digital transformation, a key challenge lies in how to safely and securely utilise personal and confidential information—such as research and development data and clinical data—within the healthcare and pharmaceutical sectors. This presentation will explain practical data utilisation approaches for pharmaceutical companies and healthcare organisations, drawing on leading European examples that achieve data sharing even under strict regulations. These approaches leverage Personalised Electronic Trusts (PETs) and digital IDs. 

The success of a new drug launch strategy depends on understanding the market as a structure. This session introduces an approach that integrates secondary research (RWD) with primary insights to frame the market through Why → Where → Who. As AI evolves, marketers and strategists must determine how to use AI effectively and where human judgment should guide decisions. I will share practical perspectives to support launch planning in this new era.

Electronic health records contain rich information not captured in claims data, including lab results, clinical notes, and physicians’ clinical judgments. TXP Medical structures these deep clinical data and, together with specialist physicians, supports study design and outcome definition to enable pharmaceutical companies to conduct high-precision and highly feasible database research. This approach accelerates real-world evidence generation and allows robust analysis across multiple diseases. In this session, we will introduce the new value created by combining deep EHR data with medical expertise. 

This presentation introduces “QAI,” an AI-powered SaaS platform developed by a University of Tokyo–originated startup to support document-intensive workflows in the pharmaceutical and healthcare industries. Covering clinical development, regulatory affairs, quality assurance, manufacturing, marketing, and hospital operations, the session demonstrates how AI enables efficient document creation, review, search, training, and knowledge utilization through real-world use cases. It also discusses how large language models (LLMs) are transforming regulated industries and outlines future directions for AI adoption in pharmaceutical and healthcare domains.

As pharmaceutical companies advance their digital transformation, robust design and operation of digital disease awareness initiatives are becoming essential to delivering truly patient-centric care. This session will share insights from projects: Asahi Kasei Therapeutics Pharma’s osteoporosis program “honeken,” Kyowa Kirin’s FGF23-related hypophosphatemic rickets/osteomalacia project “Kurukotsu Hiroba,” and Vantive's chronic kidney disease platform “Toseki-Byoin.com.” Focusing on patient-journey–based information design and integration with hospital search services, we will highlight practical lessons and considerations for future initiatives.

Leveraging untapped unstructured data as a strategic asset is key to advancing pharmaceutical promotion. This session focuses on three types of unstructured data — promotional material review documents, MR activity reports, and electronic health records — and introduces practical AI solutions ready for immediate adoption: AI-powered material review (released as MIRAI Review), automated compliance checking with insight extraction from MR reports, and strategy development using qualitative EHR data. With unstructured data at the core, we present a concrete vision of promotional innovation that goes beyond operational efficiency.

This seminar provides a structured overview of the key perspectives that pharmaceutical companies should consider when evaluating Real-World Data (RWD) for utilization. Amid the growing diversity of RWD sources, we will explain how to identify the most suitable data for your objectives and how to effectively differentiate their use. From the standpoint of a health data science expert, the session will offer practical insights and actionable guidance for real-world application.

Pharmaceutical companies are increasingly leveraging data across multiple functions, including Medical Affairs, Marketing, and Clinical Development. However, differences in data definitions and intended use often create challenges for cross-functional collaboration and data integration.In this presentation, drawing on practical experience in data science and the utilization of patient and market data in the Japanese market, I will discuss key perspectives, common challenges, and real-world solutions for enabling effective cross-functional data utilization.

FRONTEO’s proprietary natural language processing AI engine, “KIBIT”, enables non-continuous discovery by identifying relationships that are not described in existing literature. This contrasts with conventional continuous discovery methods that rely on direct, sequential connections. Building upon this unique capability, we have developed the “Drug Discovery AI Factory (DDAIF)”—a comprehensive solution designed to support the identification of highly novel drug targets and indications (DR, LCM) and the others. In this presentation, we will provide an overview of the DDAIF solution and share findings from an in vitro study that utilized DDAIF to identify novel therapeutic targets for pancreatic cancer.

A new healthcare‑focused advertising network launched in April 2026, introducing a fresh approach to long‑standing challenges in the industry. Traditional models have struggled with limited transparency, unclear measurement, and restricted choices for both advertisers and media. This new platform uses AI and a secure data clean‑room environment to create a safer, more accountable way for physicians, patients, companies, and media partners to connect.

In this session, we will explore how the network is redefining the future of healthcare advertising and share perspectives on the ongoing work of the industry consortium involved in the initiative. Ideal for teams looking to elevate their AI‑driven omnichannel strategies.

Advances in pharmaceuticals have expanded treatment options even in the field of rare diseases. However, due to the very nature of rare diseases, it is often difficult for individual clinical settings to fully grasp the overall picture of the diagnostic process and post-diagnosis treatment. In this lecture, using several rare diseases as examples, we provide an overview of the patient journey—including the periods before and after diagnosis—through the use of real-world data (RWD), and organize the associated disease burden. We will share the significance of utilizing RWD in the rare disease field and discuss its implications for drug development and evidence generation.

This session demonstrates how AI Agents can accelerate research and decision-making in Life Sciences through a live demo of Patsnap’s Eureka Life Science. The presentation covers practical use cases including competitive intelligence, patent analysis, lead compound evaluation, antibody–antigen analysis, and Markush candidate generation. By showcasing a data-driven, AI-powered workflow, the session highlights how researchers and strategists can rapidly gain actionable insights and streamline complex analyses across the drug discovery process.

This presentation introduces an approach that enhances the precision and efficiency of MR activities by combining dynamic targeting—powered by machinelearning–based data accumulation and analysis to recommend the optimal frequency and timing of engagements for each healthcare professional—with an AI Agent that integrates internal and external information to reduce search time and improve the quality of medical information provision by MRs. 

The pharmaceutical industry is moving beyond isolated AI pilots toward AI-first transformation that redefines operations, organizations, and workforce models. This session provides an end-to-end view of AI adoption across the pharma value chain, including drug discovery, development, PV, MA, and corporate functions. Based on industry-wide insights and IBM’s Client Zero experience, where IBM applies AI to its own operations, the speaker presents practical and executable approaches for moving from vision toward execution.

In pharmaceutical manufacturing process development, there has been growing attention in recent years toward approaches utilizing Modeling & Simulation (M&S), with expectations for shortening development periods and improving process robustness. In this presentation, we will introduce case studies of M&S applications to therapeutic antibody process development at our company, and report on enhanced understanding of bioprocess and improved development efficiency through integrated use of machine learning and mechanistic models.

In the first part of this session, we address the ongoing challenges in pharmaceutical marketing, where essential medical information does not always reach physicians in a timely or effective manner. As physicians increasingly curate trusted, high-quality information from digital platforms and academic meetings, the role of reliable medical information channels has become more critical than ever. In the second part, we introduce InsighTCROSS, an AI-driven system designed to optimise sales and marketing activities. We also present its latest feature, EarlyScripters, which enhances the system’s ability to detect, characterise, and understand influential early adopters, enabling more targeted and efficient engagement strategies.

Patient information searches have become widely dispersed, spanning search engines, generative AI, social media searches, and medical Q&A platforms. Amid this shift, disease awareness sites must evolve beyond mere “web pages” to become more easily discoverable by patients. This seminar will introduce the latest practical strategies, covering AI-era optimized content design, digital pathways tailored to the patient journey, and initiatives connecting AI search. 

Driving behavioral change requires identifying a doctor's "decision-making points" in clinical settings. This session reveals insights from the slide viewing logs of 74,000 physicians, visualizing the unconscious information-seeking process often missed by traditional surveys. We analyze how clinical questions are resolved in real-time. Attendees will learn methods to significantly improve product launch accuracy by utilizing unbiased, real-world behavioral data to uncover deep insights into physician psychology.

FPT Software develops medical systems globally from its Vietnam base, serving North America, the EU, and ASEAN countries. We address differences in national medical reimbursement and insurance systems, while also considering global medical data standardization. Our expertise covers a wide range: from medical device software and real-world data platforms to both SaMD and non-SaMD development. We also present cutting-edge case studies in generative AI applications for healthcare. These experiences demonstrate our ability to deliver advanced, compliant healthcare solutions tailored to various international regulatory and market requirements.

In this session, we will present methods for the safe and secure enterprise adoption of AI and AI agents, alongside the latest use cases. We plan to introduce examples across several key business areas, including R&D, quality control for regulatory compliance, and general administrative operations. 

We provide an integrated solution that accelerates the entire process of physician behavior change—from awareness to prescription—and visualizes its outcomes. By understanding each physician's status at every stage of behavior change, identifying bottlenecks, and delivering relevant information, we build a system that streamlines the physician's decision-making process. Our solution accurately captures the transformation process—which was difficult to grasp with conventional approaches—enabling us to visualize effectiveness and improve reproducibility.

NEC leverages its long-standing expertise in medical data and AI technologies, cultivated through years of engagement with healthcare institutions, to develop services that enable more efficient drug discovery, clinical development, and clinical trials.
In this session, NEC will present its initiatives toward building a clinical trial ecosystem through the use of real-world data (RWD). Additionally, Professor Asano from Osaka University Hospital will discuss the social challenges surrounding clinical trials and outline the future vision to be pursued.

"SaaS is Dead" — We have entered the era of the "Agentic Enterprise," where AI no longer just manages data but autonomously reasons and takes action. In this session, we will explore how Salesforce "Agentforce" is revolutionizing the Life Sciences industry. From empowering MRs with AI-driven decision-making to elevating patient support to new heights, we will showcase the next-generation life sciences business model powered by AI agents. Join us as we define the new frontier of Pharma DX in 2026 and propose strategies for driving authentic value creation.

As safety management across the drug lifecycle gains importance, PV teams face challenges such as talent development, diverse information sources, manual workloads, and increasingly complex evaluation and prediction. This presentation introduces two solutions to improve safety-data quality: (1) AE BridgeX, which automatically converts diverse unstructured data into E2b format; and (2) PV Virtual Assistant, which leverages the safety database as a knowledge base to support case search, summarization, and review—explained together with practical usage scenarios.

Even when patients receive information, their behavior often doesn’t change. Many patient-engagement and screening initiatives face this challenge. This session introduces an approach that uses PHR-based interventions and real-world data to quantify behavior change. By visualizing shifts in consultation and prescription rates, opportunities for improvement become clear. A disciplined process of forming hypotheses, validating with data, and refining actions—a scientific discipline for continuous improvement—can elevate patient-engagement and screening initiatives to the next stage.

In pharmaceutical marketing, rapid response to customer needs and strict adherence to legal requirements are essential. This session introduces the latest trends and practical applications of AI-driven content creation. AI enables faster, more cost-efficient production and validation of materials while maintaining regulatory compliance. We will demonstrate how AI streamlines workflows, accelerates content volume, and supports tasks such as format transformation and segmentation-specific variations. These approaches help establish competitive product advantages by improving both speed and quality. 

In 2026, competitive advantage depends on integrating AI into education. We share case studies of AI Roleplay using the latest LLM technology. Unlike traditional scenarios, we verify the learning effects of natural dialogue and instant feedback. We discuss the "AI x Human" hybrid training model that maximizes sales power while reducing workload, along with implementation tips. 

Maximizing product value requires genuine improvement in patient experience. In this session, we will introduce a new support model for pharmaceutical companies through the collaboration between LunaLuna, a women-centered platform with over 22 million downloads, and Pharumo, which connects with more than 10,000 pharmacies. Leveraging these strong platforms, we will discuss how to engage with patients in their daily lives and drive meaningful adherence and appropriate use—presenting concrete approaches for next-generation, accompanied marketing.

Omnichannel has become a core strategy in pharmaceutical marketing, yet few organizations can clearly explain how their initiatives influence physicians’ prescribing decisions. This presentation argues that the real challenge lies in confusing customer touchpoint optimization with decision-making design. Drawing on examples of treatment dilemmas in oncology and rare diseases, it explores how prescribing decisions are shaped under clinical uncertainty. Reinterpreting Rita McGrath’s arena theory for healthcare, the session proposes a strategic shift—from competing across channels to competing in the “Decision Arena,” where treatment choices are ultimately made.

Promoting digital transformation (DX) in pharmaceutical R&D, which involves complex and diverse processes, is of critical importance. Based on our recent survey of pharmaceutical companies in Japan, this presentation examines the current state, challenges, and expectations surrounding DX in R&D. While there are high expectations for shortening development timelines and improving productivity, issues such as cross-departmental collaboration, data governance, and AI expertise remain. We present these findings alongside an analysis of the required human capabilities, and explore the potential of DX to drive further evolution and new value creation in pharmaceutical R&D.

We have shifted from acquiring real-world data (RWD) to selecting and mastering its use. Drug discovery, clinical development, commercial operations, business development... How is the value of real-world data being generated across the pharmaceutical value chain? As AI technology advances, we also want to consider the role of human expertise within this landscape.

In the pharmaceutical industry, real-world data are increasingly used across a wide range of activities, including drug discovery and evidence generation. In this presentation, I will introduce how real-world data are leveraged in dementia, one of Eisai’s key therapeutic areas, and demonstrate how data science can contribute to advancing dementia research.

Antaa fosters a culture where doctors support each other under the mission "Connecting Medicine, Connecting Lives." This session explores this high-energy community of 74,000 physicians and our data vision integrating learning with practice through JMDC collaboration. We propose a next-generation marketing model that moves beyond one-way information delivery. Learn how to co-create value as a true partner in clinical learning, supporting the ecosystem while driving meaningful engagement.

Utilizing unstructured text data, such as inquiry records and daily reports, has long challenged pharmaceutical companies. Yet, these sources conceal the "true voices" of doctors and patients—critical for understanding treatment needs and improving QOL.

This seminar explores cutting-edge methods for mining actionable insights from massive text datasets, illustrated by real-world case studies. Join us to learn practical approaches that transform tacit knowledge into explicit strategies, ultimately driving true Patient Centricity.

Epistra has supported over 60 experimental optimization projects for pharmaceutical and biotech companies using its proprietary AI solution, Epistra Accelerate. This presentation covers real-world achievements including world-class yields in microbial fermentation and the impact of autonomous experimentation systems combining AI and robotics on cell manufacturing for regenerative medicine. We also discuss future directions including the AI Custom Media Development Service co-created with Shimadzu Group. 

In recent years, the importance of data integrity and ALCOA+ has become increasingly recognized, but are these principles fully ensured for the analytical instrument data you currently manage? This presentation explains the advantages of a cloud archive solution that is easy to implement and offers a high cost-benefit ratio, along with how our services can help you take the first step toward deployment.

Utilizing Generative AI for commercial function is the biggest challenge for all pharmaceutical companies. In this session, Generative AI for omnichannel management will be discussed to maximize return on investment for omnichannel.

In this session, we will introduce a new business model that is transforming the way medical information is delivered through the role of the “Digital Communicator” at Novartis. Against the backdrop of changing physician behaviors and evolving market structures, we will share how Novartis has shifted toward a customer experience–driven approach. The presentation will highlight the evolution of organization, processes, and talent, as well as key learnings gained through practical implementation of this model. 

Mediwill, the organizer of disease awareness initiatives and the Pharma Innovation EXPO, presents a session examining the future of digital marketing in the generative AI-driven DX era. This session engages attendees in exploring disease awareness case studies, including osteoporosis, dialysis for kidney failure, and rare diseases, alongside the latest DX solutions highlighted by Expo exhibitors. Participants will gain insights into emerging trends and strategic opportunities for leveraging digital marketing to drive innovation and enhance healthcare communication.

From "Task-Burdened MR" to "Next-Generation AI-Powered MR."
We reveal the system behind "Complete Elimination of MR Administrative Work" — now adopted by 720 companies, including major pharmaceutical firms.
By reducing to zero the time spent on arranging meetings, catering, and expense reporting, our approach frees MRs to leverage AI Agents where it matters most.
Learn how AI — trained on CRM data and the thinking patterns of top-performing MRs —instantly generates sophisticated detailing strategies and Q&A responses tailored to each physician's needs.
We unveil the full picture of sales efficiency transformation that the field has been waiting for, backed by real-world success stories.

While the importance of medical–dental collaboration is widely recognized, in practice it often falls short due to operational barriers such as time-consuming processes of creating referral letters, sending them, and confirming receipt.

In this session, we will introduce a new collaboration platform that enables the entire workflow—from issuing referral letters to sending and confirming receipt—to be completed online with a single click. By minimizing the administrative burden on both physicians and dentists, this solution facilitates seamless information sharing and supports continuous, integrated patient care. Real-world use cases will also be presented to illustrate how the platform can be effectively implemented.

This presentation explores how to integrate "real intentions" from the medical field into business strategy. We introduce a method combining insights　from active physicians with strategic perspectives from healthcare marketing experts. By visualizing "clinical reality"—structural challenges and latent needs invisible to quantitative research—we go beyond simple data collection. Through a "resolution-enhancement process" that links insights directly to concrete actions and outcomes, we support high-precision decision-making in uncertain market environments.

This seminar introduces the renewable energy group procurement program that BCG is implementing globally under the SMI Health Systems Task Force. In Japan, the program aggregates electricity demand across multiple healthcare companies and leverages additionality-based procurement schemes such as PPAs, renewable energy plans, and certificates.

Through group negotiation and scale advantages, participating companies have achieved up to nearly 20% cost reductions compared to individual procurement. The initiative also engages suppliers in the joint procurement framework to accelerate Scope 3 decarbonization, ultimately enhancing sustainability performance and strengthening long-term corporate value.