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Early Development / Clinical Operations are the departments in charge of generating clinical data, mainly in patients, during pharmaceutical research and development activities. These departments are responsible for planning and conducting clinical studies (clinical trials) intended to evaluate and confirm the efficacy and safety of investigational products in patients.

Overview

A new pharmaceutical product candidate selected based on the results of non-clinical studies is first investigated in a small number of healthy volunteers in Phase I clinical studies to evaluate the safety and pharmacokinetics in humans. If safety in humans is confirmed and the clinical dose is estimated based on pharmacokinetic data from Phase I studies, clinical studies in actual patients can be conducted.
Usually, safety and efficacy are evaluated and the optimal dosage and administration are investigated in the Phase II studies in patients. The results obtained in the Phase II studies are confirmed through comparisons with a control drug (an existing drug for the same indication or a placebo) in the Phase III studies.
In addition to conducting appropriate clinical studies in compliance with GCP* guidelines, Early Development / Clinical Operations are in charge of key tasks, such as evaluating the efficacy and safety data of new pharmaceutical products and their risks and benefits, which are the core data for applications for drug approval to be submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) and other regulatory authorities worldwide. Moreover, clinical studies are supported by patients providing voluntary consent for participation and cannot be conducted without the understanding and cooperation of physicians, nurses, pharmacists, laboratory technicians, and clinical research coordinators (CRCs) at medical institutions. For this reason, the team in charge of clinical development is always required to act responsibly to gain the trust of the parties involved in clinical studies.
Recently, we have also been conducting multi-national clinical trials that make it possible to apply for approval globally at almost the same time and, thus, we share information with overseas research and development divisions, collaborate with each of these divisions to ensure efficient research and development, and aim to deliver innovative new pharmaceutical products to patients around the world as early as possible.

*GCP (Good Clinical Practice)
The MHLW Ordinance on Good Clinical Practice. In conducting clinical studies (clinical trials), protecting study participants (human rights and safety) and ensuring the reliability of clinical study data (quality and results) are essential, and this is why "Good Clinical Practice (GCP)" was established

Structure of the departments

The division is divided into two departments according to therapeutic area to enhance global collaboration, flexibility and efficiency of resource management within clinical development functions, as well as to develop new pharmaceutical products in various therapeutic areas by increasing expertise.
Moreover, we have recently been involved in the development of Astellas’ Rx+ project, contributing to the creation of new healthcare solutions that go beyond pharmaceutical product development.

Early Development

From Phase 1 studies to eary Phase 2 studies (initial evaluation on whether investigational product shows expected safety and efficacy), and clinical pharmacology studies including Phase 1 healthy volunteer studies, drug-drug interaction study, clinical studies in patients with renal or hepatic impairment, etc.

Clinical Operations

Late Phase 2 studies and Phase 3 studies, and also all clinical studies in Rx+^® projects

A few words from the Department Head

The mission of pharmaceutical companies is to provide better pharmaceutical products to patients who are fighting diseases. Early Development and Clinical Operations are the departments in charge of the planning, design, and conduct of clinical studies at the final stage of new pharmaceutical product development, and this is where we realize that investigational products can help patients worldwide treat their diseases.
On the other hand, it is necessary to advance the clinical studies while sufficiently paying attention to safety and quality. Thus, each member is required to act based on high ethical standards and scientific grounds. It comes with heavy responsibilities, but is also a very rewarding job.
"Deliver much-needed medications to patients as early as possible"
"For the patients and for us"
These are the slogans we live by, and the principles that guide our daily challenges.
Our departments are global organization, so we are executing global clinical studies in collaboration with the EU/US and Asian colleagues. There are many opportunities to work with global roles and responsibilities. If you wish to contribute to the health of people around the world, are full of passion, want to be able to work actively in a global setting, and have a strong spirit for taking on challenges, we hope you will join us. We look forward to receiving your application.

The Program and Portfolio Management is a division that globally manages clinical development projects for new drug candidates from the company's own research institute, or partner companies or research institutions, to get approval in countries all over the world with the optimized clinical development strategy and plan. We contribute to making clinical development strategies and plans for development projects, and manage schedules, budgets, and risks through close communication and collaboration with key stakeholders in Japan, Asia, the United States, and Europe. We advance the development of new pharmaceutical products in an optimal way by timely capturing and reflecting changes in the environment surrounding individual development projects, as well as associated risks.

Overview

In order to deliver possible new pharmaceutical product candidate compounds and modalities to patients around the world as quickly as possible, we support the advancement of development projects as project managers in collaboration with various internal stakeholders including Early Development / Clinical Operations, Research, Pharmaceutical Technology, Commercial & Marketing, Medical Affairs, Regulatory Affairs, and Pharmacovigilance, and other internal stakeholders as well as external stakeholders.
The project manager gets involved in and contributes to making the clinical development strategy and plan for the clinical development projects as a member of the Global Development Project Team. The team considers strategies and plans from various perspectives addressing what package of clinical studies will be conducted based on patient population, geography and timing. The strategy and plans proposed by the team are implemented by the team as a development plan after internal governance approval.
In order to implement the development plan, it is necessary to appropriately manage the progress and budget. In general, any development project has the risk of not moving forward as expected and planned. Therefore, risk management is an important element for the smooth advancement of a project.
The Program and Portfolio Management works and collaborates with members of various divisions in various regions to appropriately and promptly advance development projects based on optimal development plans that align with development strategies, thereby contributing to the timely delivery of necessary medical care to patients.

Divison features

The Program and Portfolio Management consists of the following two functions:

Biopharma and Ophthalmology Development, Program and Portfolio Management

This group is responsible for the project management of development projects in areas other than oncology, such as Ophthalmology, Women's health, Urology, Immunology and transplantation, Cell & Gene Therapy.

Oncology Development, Biopharma and Ophthalmology Development, Program and Portfolio Management

This group is responsible for the project management of development projects in the oncology area.

A few words from the Division Head

Quantitative Sciences and Evidence Generation is in charge of the series of activities from clinical development planning to the development of clinical study protocols, design the case report forms and develop the database, data collection, cleaning and reviewing collected data, data processing for data analysis, data analyses, evaluation, and preparation of reports. In addition, we work to standardize statistical analysis plans, analysis datasets, and case report forms globally to support and promote each activity in clinical studies, as well as methods of globally managing clinical data, etc., and plan, maintain, and manage the tools used.

Overview

The activities of each group within the division are as follows:

Data Management (DM)

This group is in charge of designing and developing database for case report forms and eCOA, cleaning, reviewing and central monitoring of collected data, user account management, planning, maintenance, and management of clinical data management tools, global standardization of clinical study data (CDISC support), and quality control to ensure the quality and reliability of clinical data. These are highly important tasks in the quality control of clinical data globally as the data is one of the major assets of a pharmaceutical company. In October 2024, some data management-related tasks, such as database programming, were transferred to Clinical Data Enablement.

Clinical Biometrics (CB)

This group is responsible for the statistical issues associated with the design, conduct, analysis, evaluation, and reporting of clinical studies. In particular, making full use of statistical knowledge to scientifically develop study protocols, such as a review of designs and sample size calculations, is important to enable the rapid and efficient development of new pharmaceutical products and to collect data that enable clear decision making. It is also necessary to leverage real world data for clinical development. and to create valuable information via epidemiological viewpoint. In addition, when carrying out projects in collaboration with Europe, the United States, and Asia, highly specialized activities also include discussing the statistical analysis and exchange of data in consideration of cutting-edge knowledge and regulations.

Evidence Generation & Advanced Analytics (EGAA)

This group is responsible for providing support from statistical and epidemiological approaches in database studies, observational studies, and post-marketing clinical studies. The group's contributions include, Creation of evidence utilizing real world data, Support of collaborative research with universities and medical institutions as well as re-examination applications, for R&D, Medical Affairs, and Pharmacovigilance through statistical/scientifical expertise, in order to create back-up information for Development of new drug, Safety information /Pharmacoeconomics, Appropriate use of drug, in collaboration with Europe, the United States, and Asia.

Medical Writing Clinical, Transparency & Public Disclosure (MWCTPD)

This group is responsible for document production required for the development of pharmaceutical products and medical devices and for regulatory submissions. Specifically, we mainly prepare documents related to clinical studies, such as documents intended for submission to start clinical studies, clinical study protocols, Investigator's Brochures and clinical study reports, and documents for new drug application, and disclosure documents and information related to clinical studies for external experts and non-expert. We also prepare documents for post-marketing survey study and for clinical study information disclosure. These are highly specialized tasks to prepare accurate and scientifically valid documents to appropriately include necessary information in accordance with the type and purpose of the documents.

Clinical Data Enablement (CDE)

This group was launched in April 2023 with SMEs in data management and statistical analysis solutions, and in October 2024 some data management-related tasks, such as database programming, were added. SMEs have the vision to drive optimal use of systems and data flow, drive innovation, further automation, adoption of AI solutions.

Department features

There are five groups in Quantitative Sciences and Evidence Generation: DM, CB, EGAA, MWCTPD and CDE. These groups are in charge of an important part of the operations in clinical studies; to plan, conduct, evaluate, and report.
In addition to responsibilities in clinical studies, DM, CB and EGAA are in charge of standardizing various documents, process, clinical data and analysis data globally. MW uses a globally document management system to create and manage documents using a global standard format and writing guides created for each document type. Quantitative Sciences and Evidence Generation is working globally in collaboration between regions.

Message from the Division

EDTS Clinical Pharmacology develops and implements early clinical development strategies and clinical pharmacology study plans, develops translational research plan, plan the strategic use of biomarkers, develop companion diagnostics and conducts Modeling & Simulation of study data (Model Informed Drug Development), to optimize the dosage and administration of pharmaceutical product candidates and make early informed decision for projects.

Overview

Early Development (Clinical Pharmacology Function)
ED Clinical Pharmacology develops and implements early clinical development strategies and clinical pharmacology study plans, develops translational research plan, plan the strategic use of biomarkers, develop companion diagnostics and conducts Modeling & Simulation of study data (Model Informed Drug Development), to optimize the dosage and administration of pharmaceutical product candidates and make early informed decision for projects.
ED Clinical Pharmacology is composed of the following groups

Clinical Pharmacology: Develop a clinical pharmacology strategy for oncology project, non-oncology project and cell/gene therapy project.

Translational Medicine: Develop plan and conduct translational medicine in collaboration with non-clinical research group and utilize the strategic application of biomarker research.

Precision Medicine: Develop plan for companion diagnostics for personalized medicine.

Machine Learning & PBPK: Conduct PBPK（Physiological based Pharmacokinetic） modeling and implement new computational technology (Artificial Intelligence and Machine Learning) for MIDD.

Pharmacometrics: Conduct and plan Population Pharmacokinetics/Pharmacodynamics analysis for dose optimization and develop MIDD.

Department features

EDTS is the hybrid organization which consists both Non-clinical research function and clinial function. Early Development Clinical Pharmacolgy is a global organization mainly in the US and Japan that contributed to drug research and development under the leadership of the global EDTS head. Various clinical pharmacology studies are conducted in the most appropriate region. On the other hand, the output from clinical pharmacology should be consistent and standardized across regions. For this reason, the members of EDTS Clinical Pharmacology are always working globally beyond regions.

Message from the Division

Site Activation & Late-Stage Site Monitoring supports the mission of providing dynamic clinical services support, industry expertise, and global leadership for late-stage clinical trial operations that allows Astellas portfolio teams to deliver more value to patients.

Overview

Site Activation & Late-Stage Site Monitoring is a new division in Astellas. The Feasibility group lead by the Feasibility Lead works with the clinical operations team to develop an optimal country and site strategy by identifying where studies would be best conducted identifying where potential patients live and identifying the right sites to meet the study objectives. The Study Start-Up (SSU) group lead by the SSU Manager drives Study Start-Up activities from site selection through site activation. The Site Contract, Budget and Payment group work in coordination with the SSU group to expedite sites to site activation. The Clinical Site Manager (CSM) group is responsible for defining and executing the site monitoring study strategy. The CSM is the primary point of contact for the site, fostering strong relationships. The CSM also interact with study team members to provide site specific perspectives where needed.

Department features

All members in Site Activation & Late-Stage Site Monitoring work as one team through the site selection process to the end of study conduct. We are also contributing the improvement of study quality, efficient start up timelines, and optimization of costs. The locations of team members are spread globally to effectively support trial execution while maximizing efficiencies. Each CSM acts as primary local contact for assigned sites for specific trials, trying to build and maintain long-term professional relationship with Clinical Investigators and sites.

Message from the Division