2011-05-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/659711摘要：轉譯醫學可以加速將基礎研究的成果應用於臨床，最終可以達到生技產業升級的目的。在過去九年間，基因體醫學國家型科技計畫和生技製藥國家型科技計畫不僅深耕了基礎醫學，更累積了相當豐碩的研發成果。臺灣大學轉譯醫學資源中心整合型計畫第二子計畫-轉譯核心實驗室(TLC)是一個目標導向的參考實驗室計畫，本實驗室會為生技醫藥國家型計畫(NRPB)向下研究人員所發起的臨床試驗計畫與轉譯醫學研究提供基因檢測服務，以期加速新基因檢測或新藥的研發。同時，也為新藥標的、新體外試劑或是小型醫療儀器開發基因檢測平台。然而，這些基因檢測都將申請ISO17025或ISO15189 及TAF 的認證。為了滿足NRPB 的需求，TLC 將提供兩種不同層次的服務。第一種是常規服務，包括：檢體處理、基因突變偵測、病原體鑑定/抗藥性分析、單核苷酸多型性分型、基因/微核醣核酸表現測定。第一種是客製化服務，依照NRPB的研究人員需求，TLC 設計並優化特定的基因檢測。而TLC 發展基因檢測的優先順序為-第一、國際間公認的疾病基因標的，可供疾病的鑑定、病患預後的評估、個人化醫療的決策、新藥開發與評估等。第二、NRPB 研究人員的研究發現且具申請專利潛力的疾病基因標的。第三、NRPB 研究人員的研究發現且具商品化價值的疾病基因標的。經過本計畫的努力，我們預期TLC 將可達成本整合型計畫的目標-藉由轉譯醫學研究與臨床試驗計畫，將可加速NRPB 開發的新藥與生技發明成功地商品化成為醫療產品的速度。<br> Abstract: Translational Medicine can efficiently promote the transformation from valuable findingsof basic research to clinical applications and finally lead the upgrade of Biotech. Duringthe past nine years, National Research Grogram for Genomic Medicine (NRPGM)NSTP/Biotechnology and Pharmaceuticals (NSTPBP) not only strengthen the basis ofmedical science but also accumulate a lot of fruitful achievements. The mission ofTranslational Medicine Resource Center at National Taiwan University (TMRC-NTU) isto provide necessary support for clinical trials and translational medicine studies initiatedby investigators of National Research Program for Biopharmaceuticals (NRPB). Thecomponent project 2, Translational Core Laboratories (TCL), of TMRC-NTU is adirection-oriented reference laboratory which provides the gene tests for NRPBinvestigator-initiated clinical trials or translational research and facilitates thedevelopment of gene tests or new biomarkers, new gene targets for drug development andin vitro diagnosis (IVD) kits as well as small medical devices. All of gene tests will becertificated by ISO 17025 (or ISO 15189) and TAF (Taiwan Accreditation Foundation).To meet the requests from NRPB, TCL will provide two kinds of services, one is regularservice including sample preparation, gene mutation detection, pathogenidentification/drug resistance, SNP genotyping and gene/microRNA expression measureand the other one is customized service by which we will design and optimize theparticular gene tests based on NRPB investigator’s request. The priority of gene testsestablished by TCL is according to the following order. First, the well-known targetswhich acts as biomarkers for disease identification, prognosis, prediction of treatment andpersonalized therapy as well as new drug development and evaluation. Second, the genescharacterized by NRPB investigators can be patented. Third, the genes characterized byNRPB investigators have commercial potential. After our efforts, we expect that TLC canreach the OBJECT of this general project- to support and speed up the development ofNRPB innovative drugs and biotech inventions into successful commercial medicalproducts through translational research and clinical trials.轉譯醫學新藥標的體外試劑臨床試驗Translational Medicine，Target of New DrugIVDClinical Trail