Sumitomo Dainippon Pharma Annual Report 2017
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Research & Development• Accelerating late-stage clinical development productsUnder our ONE TEAM operating structure for the Global Clinical Development linking our Japan and U.S. units, we are conducting efficient development focused on late-stage clinical development products to obtain fast approval.Seeking rapid development and approval for our late-stage pipeline• Allocate research resources to the focus therapeutic areas (Psychiatry & Neurology, and Oncology) and new therapeutic areasWe are focusing our research activities in areas of significant unmet medical needs, Psychiatry & Neurology and Oncology. We are also dedicating our research effort to new areas such as the Regenerative Medicine and Cell Therapy field, and disease fields where no approved drugs exist.• Ensuring “POC* First” to quickly confirm drug concepts in humansWe are applying translational research to bridge basic research to clinical studies. One such activity is to evaluate the same biomarkers in non-clinical and clinical studies, in order to predict clinically effective dose ranges and demonstrate clear POC at earlier clinical phases. Additionally, we are making efforts in repositioning/repurposing the drugs or drug candidates whose safety has been confirmed in humans, to other therapeutic indications.• Drug discovery leveraging our strengths; Accelerating external collaborationsWe are applying leading-edge technologies in drug discovery, such as using in-silico methods for drug design, using iPS cells to confirm efficacy/safety, and using disease-specific iPS derived cells to clarify the mechanisms of disease. We are working further to incorporate leading-edge technologies from external collaborations and strengthen our drug discovery activities.Boost drug discovery research activity to create novel differentiated drug candidatesBasic StrategyWe are maintaining aggressiveresearch & development investmentin particular for late-stagedevelopment productsEngaged in drug discovery research to continuously create innovative drug candidates based on cutting-edge technologies, we are not limiting our research activities to internal technologies and talents but are aggressively promoting external collaborations with academic institutions and biotech companies having innovative technologies.In April 2016, we started the second phase of the Kyoto University and Sumitomo Dainippon Pharma Joint Research Project (DSK Project), aiming to discover innovative anti-cancer drugs. Additionally, we signed several contracts for joint research collaborations under the “PRISM” framework, our open innovation program, which we ran again in fiscal 2016.Actively collaborating with external research institutionsIn order to strengthen our drug discovery activities, we are operating early/late research stages with different management philosophies and processes.Early-stage research mimics start-up biotech-style approach, to maximize individual talents and creativity. Late-stage research emphasizes organizational and team strengths, and collaboration across multiple functions such as clinical research, CMC*, and regulatory affairs to proceed toward early approvals. Additionally, from April 2016 we established a PC (Professional Contributor) job title as part of our emphasis on individual specialization and career paths for employees aspiring to make a difference.R&D organizational structure supporting active drug discovery research* CMC: An abbreviation of Chemistry (characteristics analysis) of active ingredients/formulations, Manufacturing, and Controls (quality control). CMC refers to parts of the company involved with pharmaceutical manufacturing and quality during the process of applications for approval.DCI: DSP Cancer InstituteDSK: Kyoto University and Sumitomo Dainippon Pharma Joint Research ProjectDRD: Drug Research DivisionRACMO: Regenerative & Cellular Medicine OfficeOncology AreaPsychiatry & Neurology AreaOsakaToleroU.S.RACMOKobeSunovionU.S.SumitomoPharma(China Suzhou)BostonBiomedicalU.S.DSKDCIDRDJohns Hopkins UniversitySharp Edge LabsKyoto UniversityREMIGES VenturesJCR PharmaBioElectronAfraxisPsychoGenicsExscientiaRIKENKeio UniversityKyoto UniversityCiRA* Proof of Concept (POC): confirmation of expected safety and efficacy in humansSumitomoDainippon PharmaR&D Sites (including Alliances)Hub & Spoke, Central & Satellite System19Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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