Research and Development in Ophthalmology
Santen aims to reduce the loss of social and economic opportunities for people around the world due to eye conditions through the utilization of emerging technologies and drug discovery collaboration with its partner companies in ophthalmology, its specialized field.
- Principles for Research and Development
- Research Ethics and Respect for Human Rights
- Disclosure of Information about Clinical Trials
- Principles for Approaches toward Emerging Technologies
- Animal Welfare in Research and Development
Principles for Research and Development
Santen promotes Patient Centricity. We aim to provide truly valuable solutions to difficulties faced by patients through direct dialogues with them and patient organizations. We actively incorporate both internal and external technologies necessary to accomplish this aim into our research and development activities, in order to create new value in cooperation and collaboration with our partner companies.
In addition, we conduct research and development activities in compliance with the Japanese government's Ethical Guidelines for Medical and Health Research Involving Human Subjects, the Japanese Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms, and applicable cabinet orders, ministerial orders, and public notices. Valuing harmonious relationships with local communities, we also strive to foster their understanding of our research and development activities therein by concluding environmental conservation agreements, establishing environmental conservation plans, and implementing them.
Research Ethics and Respect for Human Rights
The company has established a Research Ethics Committee as a system to ensure that research on human subjects 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) , the Ministry of Health, Labour and Welfare (MHLW) and Ministry of Economy, Trade and Industry (METI) of Japan, and the like.
The Research Ethics Committee deliberates whether the appropriateness of research in ethical terms, including the protection of privacy of clinical 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 executive officer 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 trials, including ones conducted based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, we have patients participate as subjects in those trials of their own free will while fully informing them of the expected results and possible side effects, and obtaining their consent to ensure their safety. We also take necessary measures to protect the personal information of patients who participate in clinical trials as subjects.
Disclosure of Information about Clinical Trials
The company has established Quality Principle Policies and carries out clinical trials following the policies. To ensure the transparency of our clinical trials and fulfill our accountability to society, we disclose information about our clinical trials mainly on the websites of the organizations below.
Principles for Approaches toward Emerging Technologies
To provide patients with valuable solutions, the company actively incorporates emerging technologies-including cell therapy, gene therapy, and nanotechnology-into our research and development activities.
Cell therapy takes advantage of various functions of cells and uses engineered cells to treat diseases. In 2020, Santen acquired the rights to develop and market jCell(*) in Japan, Asia and Europe from jCyte, Inc. in the U.S. We will promote the development of jCell, which is expected to be a first-in-class treatment for retinitis pigmentosa, with the aim of establishing our presence in the segment of cell therapy treatments in the ophthalmic field.
- jCell: Cell therapy products with retinal progenitor cells as the main component
In gene therapy, gene of interest is administered into patients tissue to produce protein of interest and treat diseases by the protein function. Santen has been committed to the research and development of gene therapy through an industry-government-academia collaboration in establishing a research and development structure to provide patients with treatments as soon as possible. Through these efforts, we strive to enhance our in-house capability in this area.
Peptides and antibody drugs
Santen develops products that can meet unmet medical needs by actively incorporating into its research and development activities next-generation technologies, including peptide inhibitors, bispecific antibodies, and antibody-functionalized molecular complexes. We aim to further streamline our product supply and enhance product quality in this area in collaboration with our partner companies, including Contract Development and Manufacturing Organizations (CDMOs) and third-party logistics (3PL) providers.
In eye tissues, where various barriers exist, it is very important to efficiently deliver a necessary amount of drug to an intended target tissue. Santen is committed to developing drug delivery systems (DDSs) using nanoparticles made of biocompatible materials, such as various polymers and lipids, and nanocarriers, including microemulsions.
Animal Welfare in Research and Development
Testing with experimental animals to confirm the efficacy and safety of drug candidates are essential in research and development of pharmaceuticals. Santen respects the lives of laboratory animals, pays due consideration to animal welfare, and ensures an appropriate rearing environment. Furthermore, the Company practices the 4Rs-the globally advocated 3Rs plus another R: (1) Reduction of the number of animals used, (2) Replacement of animal testing with alternatives without using animals, (3) Refinement in the form of alleviating the animals' pain, and (4) Responsibility of those who conduct or outsource animal testing.
- Reduction: we minimize the number of animals used per group in each experiment at the time of screening, and reduce the number of animals in reserve.
- Replacement: we facilitate the replacement of animal testing with non-animal testing while ensuring the predictability of experiments by building new iPS cell-based and other assessment systems, and utilizing in vitro alternatives to animal testing.
- Refinement: we take care not to cause unnecessary pain to the animals by adopting appropriate pain reduction measures, including applying anesthesia, and setting humane endpoints for each experiment.
- Responsibility: As our responsibility as a company that conducts and outsources animal testing, we plan animal testing with respect for the above 3Rs in full consideration of the necessity of testing.
In addition, all animal-testing plans at Santen, including plans for experiments outsourced to external parties, are subject to evaluation by the Animal Testing Committee, which comprises (1) members with excellent expertise mainly in animal testing, (2) members with excellent expertise in laboratory animals, and (3) members with knowledge and experience in other fields. Furthermore, we have formulated in-house rules in conformity to the Japanese Act on Welfare and Management of Animals, the Japanese Ministry of the Environment's Standards for the Rearing and Storage of Laboratory Animals and the Alleviation of Their Pain, and the Basic Guidelines for Proper Conduct of Animal Testing and Related Activities at Organizations under the Jurisdiction of the Japanese Ministry of Health, Labour and Welfare.
We secure necessary rearing spaces for each animal species in consideration of animal welfare, and practice behavioral enrichment to lessen the animals' stress. To increase employees' knowledge and awareness of the welfare of laboratory animals, we have continued to provide all employees involved in animal testing with education and training every year and keep records thereof.
We also strive to ensure transparency concerning the appropriate operation of our animal testing facility in consideration of animal welfare and the appropriate planning and implementation of animal testing with respect for the above 4Rs. The Nara Research and Development Center, Santen's only animal testing facility, has been accredited as a compliant facility as a result of assessment by the Japan Pharmaceutical Information Center's Animal Testing Facility Accreditation Center, which carries out external inspections of animal testing facilities in terms of whether they conduct appropriate scientifically based animal testing in consideration of animal welfare.
Before outsourcing animal testing, we confirm that the counterpart research facilities have received third-party animal welfare accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) or the Japan Pharmaceutical Information Center's Animal Testing Facility Accreditation Center, and that the accreditation is still valid. When we outsource university or other research facilities without third-party accreditation, the Nara Research and Development Center's Animal Testing Committee examines whether the animal testing is appropriately planned from the perspective of animal welfare, before the testing is started.
The number of animals used for all in-house and outsourced animal experiments planned by the Nara Research and Development Center has been continuously monitored. Despite short-term fluctuations, the number has been declining from a long-term perspective as a result of animal testing planning based on the principles of the 4Rs.