Research and Development
The Santen Group continues to help enhance the quality of life of patients around the world through the research and development of appropriate products by taking advantage of today's leading-edge technology.
Research and Development of New Products Based on Medical Needs
Santen contributes to the enhancement of the quality of life of patients around the world by promoting research and development focused on the field of ophthalmology in order to speedily discover appropriate pharmaceuticals that fulfill the unmet needs of patients. Our efforts are particularly focused on the development of effective new medicine in the field of corneal and conjunctival epithelial disorders, for which treatments are still insufficient worldwide, and also in the fields of glaucoma and retinal disorders, which affect an increasing number of patients due to rapid aging, with the possibility of vision loss.
Click on the following link to view the conditions of product development.
Efforts to Accelerate Research and Development
New medicine must go through the stages of basic research, non-clinical trials, clinical trials, submissions of applications, and government reviews and approvals before the medicine become available to patients. Because clinical trials for verifying the efficacy and safety of medicine in humans are divided into three phases, long periods are needed from the start of basic research before the approvals of new medicine take place. To make our medicine available to patients as soon as possible, we conduct the following efforts:
Efforts in research
Efforts are being made for the speedy discovery of products by utilizing "Network Product Development," an approach of proactive use of compounds and technologies from outside the company to improve the probability of technical success, and "Translational Research," which is a kind of multi-disciplinary research that links basic research, clinical research, and medical care, utilizing research findings for effective and efficient practical applications to contribute to healthcare advancement.
Efforts in clinical development
Because adaptive design (Note) is recommended in the United States, some of the steps of clinical development can be eliminated. Furthermore, because we are able to flexibly exchange opinions with authorities concerning the balance of risks and treatment efficacy in our pipeline, it will be easier to determine the success or failure of our clinical development. For these reasons, our clinical development bases are located in the United States to accelerate global clinical development.
- Adaptive design: A clinical trial design that determines the method of changing trial characteristics based on the data being accumulated throughout the clinical trial without compromising the validity or integrity of the trial.
Efforts to Respect Human Rights in Research and Development
The Santen Group has established a Research Ethics Committee as a system to ensure that research using human biological samples are appropriately conducted in scientific and ethical terms in accordance with the purport of the Declaration of Helsinki developed by the World Medical Association, the Ethical Guidelines for Medical and Health Research Involving Human Subjects formulated by the Ministry of Education, Culture, Sports, Science and Technology (MEXT) and the Ministry of Health, Labour and Welfare (MHLW) of Japan, the Ethical Guidelines for Human Genome and Genetic Analysis Research formulated by MEXT, MHLW and the Ministry of Economy, Trade and Industry (METI), and the like.
The Research Ethics Committee deliberates whether the appropriateness of research in ethical terms, including the protection of privacy of trial participants and the validity of research contents, and the appropriateness of research in scientific terms is assured. To ensure that the deliberation is fairly conducted, the director in charge of compliance serves as the chairperson of the committee, and the committee members comprise employees as well as external members who are professionals in the medical or legal fields.
When we conduct clinical tests, we have patients participate as subjects in the tests of their free will, and fully inform them of the expected results and possible side effects, and obtain their consent, to ensure their safety. We also take necessary measures to protect the personal information of patients who participate in clinical tests as subjects.
Considerations for Animal Welfare in Research Activities
In pharmaceutical research and development, animal experiments need to be carried out to determine drug safety and efficacy. To respect the lives and welfare of animals used in our experiments, Santen observes the 4Rs in animal use: namely, "Reduction" in the number of animals used, "Replacement" of methods requiring the use of animals with alternative methods, "Refinement" of test procedures to minimize pain, and the "Responsibility" of testers and sponsors.
To ensure that the 4Rs are observed, Santen has established internal regulations based on the "Act on the Welfare and Management of Animals," "Standards relating to the care and management of laboratory animals and relief of pain," and "Basic guidelines on the implementation of animal experimentation in facilities under the control of the Ministry of Health, Labour and Welfare (MHLW) of Japan." Based on these regulations, we periodically confirm care conditions, and review all animal experiment plans including those outsourced to external testers at the "Animal Care and Use Committee " to ensure that minimal animal experiments approved by the laboratory director are conducted.
These efforts of Santen were assessed by the Center for Accreditation of Laboratory Animal Care and Use, Japan Health Sciences Foundation (JHSF CALAC) (Note) , and were certified as compliant.
- Center for Accreditation of Laboratory Animal Care and Use, Japan Health Sciences Foundation (JHSF CALAC): JHSF CALAC is an external body that assesses/verifies whether scientifically appropriate animal experiments are conducted, while at the same time promoting voluntary management of animal experiments from the viewpoint of animal care, in animal experiments conducted at facilities under the control of MHLW.