Since aspirin was launched on the market in the late 19th century, epoch-making new drugs have been released one after another, targeting illnesses for which no treatment previously existed. Even today, many patients remain dissatisfied with the existing treatments for cancer and neuropsychiatric disorders, among others. Astellas provides value to society, and works to create innovative and extremely useful pharmaceuticals that meet the needs of such patients, with the aim of relieving people worldwide from suffering and contributing to the maintenance of good health. Thus, Astellas, as a research-oriented global pharmaceutical company, is making efforts to understand the mechanism behind illnesses and the causes of illnesses that remain unknown. In this way, we will continue working to pioneer new territory.

Priority therapeutic areas Urology Immunology & Infectious Disease Oncology Neuroscience DM complications & Metabolic Diseases	We have designated five medical fields as our priority therapeutic areas, taking into account the extent of unmet medical needs, future market growth potential, and feasibility. In the areas of Immunology and urology, we already hold a leading position worldwide in immunosuppressants for organ transplantation and the treatment of urinary disorders.

Exploratory research

This is the stage in which research is undertaken to discover or chemically create new substances which may serve as the seeds of future drugs through the examination of the mechanisms by which illness comes about and by studying the genes, proteins involved and so on for clues. Various chemical and physical processes and biotechnology are employed. Recently, methods using genome information (genetic data) have also been employed.

Optimization research	In exploratory research, compounds that have been discovered are evaluated in terms of their strength of efficacy, safety, metabolism, and physical properties, and after being evaluated with regard to numerous aspects, a selection is made. The stage of optimization research is primarily the phase for creating new drug candidate components suitable for new pharmaceutical products.

Non-clinical research	The efficacy and safety of candidate substances are examined using cultured cells and lab animals. Research is conducted on ADME (absorption, distribution, metabolism and excretion), and on stability and quality of the substances.

Clinical development

Efficacy and safety for human beings is assessed during this stage. Useful compounds become investigational new drugs (IND) at this stage. After receiving the informed consent of both healthy subjects and patients, clinical trials are cautiously conducted while checking safety. This is done in the following three stages: Phase I clinical trial: Safety, including side-effects, are checked on a small number of healthy volunteers Phase II clinical trial: Usage and dosage are examined while checking the efficacy and safety on a small number of patients Phase III clinical trial: Efficacy and safety are checked on a large number of patients

Consideration of human rights in R&D

Exploratory research and optimization research raises ethical concerns about collecting and managing information related to samples such as blood, tissue, and individual genetic information.

At Astellas, we have established an Ethics Review Board on Human Tissue Research based primarily on ethical guidelines for human genome/gene analysis research. This committee, which is made up of members of the general public and experts in various fields such as ethics, law, and the natural sciences, as well as our employees, deliberates on the ethical acceptability and scientific validity of the research, and then recommends appropriate action related to the analysis of human genome and tissue samples.

It is necessary to protect the personal information and human rights of patients when conducting clinical trials, postmarketing clinical trials and surveillance.

Astellas has established an In-house Institutional Review Board that includes outside doctors and lawyers. This board checks and monitors the ethical and scientific appropriateness of clinical trial plans.

Ethical considerations related to animal tests

The relevant authorities in every country require various tests to ensure the efficacy and safety of new pharmaceuticals before they can be launched, and, given the current state of scientific technology, it is impossible to conduct these tests without using animals. Astellas conducts these tests based on the highest legal and ethical standards. Along with setting policies on animal testing from a perspective of harmonizing the scientific and animal welfare points of view, the Animal Research Committee strictly examines the four R's: replacement (the possibility of replacing the animal test), reduction (reducing the number of animals used to a minimum), refinement (refining measures to eliminate unnecessary suffering of the animal), and responsibility (being responsible for sufficiently explaining the predictability and significance of the experiment). It then recommends whether to conduct animal testing or not.

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