All things in nature have a reason for being.
Today’s common sense is not common sense tomorrow.

This is our motto.
Senju Pharmaceutical has unique research systems, such as international joint research and industry-academia joint research, and tackles research and development through a flexible concept without adhering to a conventional framework or stereotypes. Looking at the future and quickly developing safe drugs that are needed are our goals as well as our wishes.

Message from Research and Development Division

Executive Officer
General Manager of Research and Development Division
Takuro Sekiya

Hello everyone. We, in the Research and Development Division, are conducting research and development activities every day with the vision that “We continue to provide First in Class and Best in Class products that will be the first-line drugs for patients with eye diseases with the speed far ahead of all others.”
To achieve the goal of "the speed far ahead of all others," we are striving to achieve the shortest research and development period by increasing work efficiency through unconventional ideas and using our unique project management method based on our strong desire to "deliver drugs as quickly as possible to patients suffering from eye diseases."
"First in Class products" in our vision is defined as "groundbreaking products with excellent effects and safety achieved by the new mechanism of action." In other words, by creating a “First in Class product”, we provide a therapeutic drug for the first time for eye diseases for which there are no therapeutic drugs and also provide a sufficient effect for the first time in patients who could not obtain it in the area where therapeutic drugs are already available. On the other hand, "Best in Class products" are defined as "products with the best effect, safety, convenience, etc. compared to existing products." For example, creating products that have the same mechanism of action as existing drugs but that exhibit outstanding effects and safety owing to the characteristics of the compound, or transforming drugs to be injected into products such as eye drops that enable the treatment of diseases without harming the body.
To continuously create the above products, we are promoting various research with enthusiasm and excellence, from the perspective of pharmacology, and also from the perspectives of pharmacokinetics, toxicity, and formulation. For examples, we have prepared ocular disease models that enhance the accuracy of the prediction of effects in humans, developed screening technologies for locally applicable compounds to the eyes, and conducted formulation research that enables the appropriate delivery of drugs to target sites through innovative technologies.
Meanwhile, in clinical development, we execute excellent interventions by constructing an optimal clinical package based on sophisticated regulatory strategies while expanding the development regions in Japan and globally, so that we can quickly commercialize the development compounds we create from the above perspectives. In our company, the Research Center and the Development Department conduct operations at the same site. Therefore, we engage in R&D in an open environment.
Finally, patients suffer from ocular diseases worldwide. There are no borders for diseases and no borders in our research and development activities. We aim to launch products that can be “First in Class” and “Best in Class” in each region and conduct research and development activities every day, not only in Japan but also overseas. We will continue to develop products from the standpoint of patients without fear of changes and challenges.

  • Ocular Science Laboratory

    We established research sites in Japan (Kobe) and the U.S. (Oregon) to satisfy global unmet medical needs. With the cooperation of these bases, we identify genes, proteins, etc., related to the pathological mechanism of eye diseases. Based on the research results, we then create innovative development compounds (mainly small molecules and middle-sized molecules). In addition, when it is difficult for us alone to create development compounds with characteristics that we need immediately, we incorporate other companies' drug discovery technologies. To commercialize products as early as possible, we swiftly clear non-clinical studies through industry-government-academia collaborations and conduct early/exploratory clinical studies.

  • General Laboratory

    ■Pharmacological research
    We explore the pathological mechanisms by investigating medical and scientific information on each eye disease. Based on them, we plan highly valuable drug discovery research themes that meet unmet medical needs. In addition, to identify effective therapeutic drugs for specific eye diseases, we collect and thoroughly examine information on the mechanism of action of various molecules and compounds. The pharmacological actions of many candidate development compounds are evaluated using cultured cell/animal experiments that help us identify the development compounds and investigate their mechanisms of action and effects to predict their effects in humans. To this end, we always conduct drug discovery research using innovative technologies without adhering to conventional research and analysis methods.

    ■Toxicology research
    We evaluate the toxicity of development compounds for which efficacy has been confirmed. If toxicity is observed, we evaluate the degree and presence or absence of reversibility using innovative technology. Specifically, we perform in silico simulations of toxicity profiles, toxicity tests, and evaluations using cultured cells and animals. In addition, based on data and findings obtained from toxicity tests and clinical studies, we construct a data package for nonclinical toxicity tests while discussing and forming a consensus with regulatory authorities in each country.

    ■Pharmacokinetic research
    After the development compound is administered to living bodies, we evaluate how it is absorbed, distributed to tissues, metabolized, and excreted. We evaluate the systemic and ocular pharmacokinetics of eye drops and intraocular injections. Pharmacokinetics is strongly associated with the efficacy and safety of drugs. We interpret the results of pharmacological and toxicity tests obtained from animal experiments based on pharmacokinetic data and use them to predict the effects and safety in humans.

    ■Pharmaceutical technology research
    Eye diseases develop in various locations from the anterior eye, such as the cornea and conjunctiva, to the posterior eye, such as the retina and choroid membrane. We are conducting pharmaceutical technology research to explore and determine the optimal combination of technologies (DDS – drug delivery system) that efficiently delivers drugs to sites associated with diseases and the development compounds. For the DDS technology, we use the new technology developed by our company, as well as the technology developed by other companies for other purposes.

    ■Formulation research
    We focus on improving the formulation properties of products under development and existing products and conduct research to design types and amounts of excipients to be combined while considering safety so that drugs can fully demonstrate their effects. Specifically, we aim to ensure the stability and durability of the effects of the products, reduce the side effects and administration burden of the products by making appropriate dosage forms and improving prescriptions, and achieve better medicinal tolerance in patients. In addition, we examine the manufacturing methods of drug products and investigational products in cooperation with our own production sites but also in contract manufacturing facilities.

    ■Analytical research
    We conduct research aiming at quality control to maintain the effects and safety by evaluating the characteristics of active ingredients and excipients of new and existing products. We obtain research data for the development of safe and effective pharmaceutical products by evaluating the purity, content, and stability of the drug substance. Similarly, we construct data packages that meet regulatory requirements for non-clinical studies, clinical studies, and approval applications. To ensure a stable supply of high-quality products, we conduct research that spans from manufacturing processes to the distribution of products.

  • Development Department

    Our mission is to implement optimal development programs, increase the probability of successful development, and launch new products worldwide as soon as possible. The Development Department is responsible for verifying the effects and safety of development compounds created by our laboratories, licensing-in compounds from other companies in clinical studies, and obtaining marketing approval as drugs. Several groups work together on a wide range of activities, from the planning of protocols to site management during clinical trials, data collection/analysis, and application for approval. After a clinical data package is prepared for each development compound and appropriate clinical studies are conducted, we analyze the obtained data and submit approval applications for marketing to the regulatory authorities in each country.

Senju Laboratory

  • The Kobe Innovative Center
  • Laboratories of Oregon, U.S.

R&D Principles

Senju Pharmaceutical Co., Ltd. is engaged with the appropriate conducting of animal experiments carried out in the process of developing new pharmaceutical products. We are mindful of the welfare of laboratory animals and comply with the “Act on Welfare and Management of Animals”, “Standards Relating to the Care and Keeping and Reducing Pain of Laboratory Animals” (Ministry of the Environment), “Guidelines for Proper Conduct of Animal Experiments” (Science Council of Japan) and “Fundamental Guidelines for Proper Conduct of Animal Experiment and related Activities in institutions under the jurisdiction of the Ministry of Health, Labour and Welfare” (Ministry of Health, Labour and Welfare). We are establishing and improving our compliance and management system on an ongoing basis. To this end, we have adopted the institutional regulation*1 that govern our relevant activities and set up the Institutional Animal Care and Use Committee to carry out stringent vetting and monitoring of laboratory animal experiments. We administer education and training to our researchers regarding legislation, government guidelines as well as ethical issues relating to animal experiments.
Our guiding principle is that by optimizing laboratory conditions as well as experiment methods and technology, we can minimize animal stress and obtain reliable data. Based on this premise, we plan and implement animal experiments. We adhere to the 3Rs*2 and further added the fourth pillar of Responsibility, referring to the corporate responsibility that a pharmaceutical company should uphold. To check that these principles are followed and actions properly conducted, the Institutional Animal Care and Use Committee conducts a self-audit at least once a year aiming for further improvements. Our research facility, the Kobe Innovative Center, has been accredited by AAALAC International*3, an international accrediting third-party body, since November 2020(continued in 2023).

*1　The institutional regulation ( PDF)

*2　The principles of the 3Rs

  • Replacement (switching to research that does not involve laboratory animal experiments)
  • Reduction (reducing the number of animals used in experiments)
  • Refinement (minimizing the pain and distress experienced by animals)

*3　A nonprofit international organization that promotes the humane treatment of animals in science through accreditation and assessment programs. The accreditation demonstrates our commitment to responsible animal care and use.