Sumitomo Dainippon Pharma Annual Report 2017

OthersPsychiatry &Neurologyapprox. 50%FY2017 (forecast)50.5 billion yenFY201647.1 billion yenFY201548.2 billion yenOncologyapprox. 30%Regenerativemedicine /Cell therapyapprox. 3%Sumitomo Dainippon Pharma recognizes that intellectual property is an essential part of the business development of a pharmaceutical company. In filing patent applications, we are building up a patent portfolio including not only substance patent applications but also patent applications that encompass uses, manufacturing processes and formulations to comprehensively protect our commercial and development products. In addition, we are working to address themes of intellectual property regarding the regenerative medicine/cell therapy field in order to promote the business.Clinical Studies Put the Human Rights of Subjects FirstIntellectual PropertyWe conduct human clinical studies required for new drug applications in accordance with the utmost consideration of the subjects’ human rights.Ethical Approach to Human Tissue ResearchThe Research Ethical Review Committee, part of the Corporate Regulatory Compliance & Quality Assurance Division, reviews the appropriateness of implementing research from the perspectives of the significance and necessity of research, the scientific rationality of plans, the provision of adequate prior explanations to donors of human tissues, etc. and the acquisition of consent based on free will (informed consent), rigorous protection of personal information and other points of view. We also disclose the Rules for the Research Ethics Investigation Committee, the composition of the committee members, and the content of the committee proceedings.Ethical Considerations in Animal ExperimentationIn animal experimentation, Sumitomo Dainippon Pharma follows in-house procedures that conform to Japan’s Act on Welfare and Management of Animals and the Basic Policies for the Conduct of Animal Experiments in Research Institutions under the jurisdiction of the Ministry of Health, Labour and Welfare. Our Institutional Animal Care and Use Committee carries out proper ethical review of all experimental protocols, including outsourced tests, in terms of the “3Rs” (“reduction” of the number of animals used, “replacement” with alternative testing methods, and “refinement” to relieve pain and suffering).Since clinical studies are conducted during the intermediate stages of confirming the efficacy (effectiveness) and safety (or side effects etc.) of drug candidates, our clinical studies follow such regulations as Japan’s ministerial ordinance on GCP (Good Clinical Practice), which was established to protect the human rights, maintain the safety and improve the welfare of subjects participating in studies.Consideration in clinical studiesTrends in R&D Costs (direct) & Allocation to Areas22Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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