2017-01-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/647503摘要：依據98 年2 月10 日召開之第182 次國科會委員會臨時提案，「生技製藥國家型科技計畫」與「基因體醫學國家型科技計畫」應進行資源整合，以避免基礎建設的重複配置；計畫並應朝產業化方向加強。經過多次協調討論會，整合後之計畫確定為「生技醫藥國家型科技計畫」，將自100 年起施行，並暫訂期程為六年（民國100 年至105 年）。本計畫擬訂了六大主軸：研究群組，臨床前發展群組，臨床群組，資源中心，產業化推動暨國際合作組，倫理、法律、社會影響組；參與之部會院涵蓋科技部、經濟部、衛福部、原能會；執行機構包括：各大學院校、中央研究院、財團法人生物技術開發中心、財團法人國家衛生研究院、財團法人醫藥品查驗中心、各醫學中心及產業界。本計畫之總體規劃案已於行政院國家科學委員會第188 次委員會議中獲得通過，將以新藥及新醫材的探索為起點，協助建構國內研發機制、凝聚相關領域之專業知識與能力，加強垂直及橫向的溝通及資源整合，以發揮最佳效率。計畫辦公室之主要任務為聯繫、協調、整合計畫及管理、推動研發成果，並確保以上六大分組間、參與之部會間及執行本計畫項下之研究者間有良好的互動及執行成效，以達到本國家型計畫之目標。<br> Abstract: A 6‐year “National Research Program for Biopharmaceuticals (NRPB)” was launched in 2011, inresponse to the resolution of the 182nd National Science Council Committee Meeting, that“NSTPBP (National Science and Technology Program for Biotechnology and Pharmaceuticals) andNRPGM (National Research Program for Genomic Medicine) should merged together so as tointegrate and consolidate the existing domestic biomedical infrastructures, accelerate thecommercialization of innovative technologies, and strengthen the domestic biomedical industry”.The Program focuses on the R&D of new drugs/new reagents/new therapeutic strategies/newmedical devices in a product‐oriented approach. It aims at developing a fully‐integratedbiopharmaceutical pipeline, and at streamlining the operating system of preclinical testing and earlyclinical trials. By bringing “value identification” to “value creation”, the Program hopes to fulfill thevision of turning scientific concepts into products. The ultimate goal is to develop new therapiesfor disease prevention, diagnosis and treatment.The Program is composed of 6 major parts, i.e. Research Group, Preclinical Development Group,Clinical Group, Resource Center, Industrial Bridging & International Collaboration (IBIC) Group, and Ethical, Legal and Social Issues (ELSI) Group. It provides funding opportunities for product‐orientedresearch projects, translational medicine research projects, clinical trials and academia‐industrycollaboration projects. In addition to the funding mechanism, NRPB also provides essentialtechnical and consulting services to further support the technology/product development of thefunded projects. This includes preclinical testing services, incubating mechanisms for developingfrom hits to leads then to drug candidates, industrial bridging services (e.g. patent and marketinganalysis, technology commercialization), international collaboration services and ELSI services (i.e.to resolve ethical, legal and social issues that arises from conducting biomedical research).生物技術醫藥轉譯醫學研究臨床前試驗臨床試驗新藥開發產業化BiotechnologyPharmaceuticalsTranslational ResearchPreclinical TestingClinical TrialsNew Drus DevelopmentCommercialization