2013-05-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/660819摘要：國家轉譯醫學與臨床試驗資源中心(NTCRC)的任務是為執行生技醫藥國家型計畫(NRPB)臨床試驗與轉譯醫學研究提供必要的協助，其中，子計畫三(TR6-3)藥物基因 體實驗室(PG Lab)是一個目標導向的參考實驗室。為符合 NRPB 計畫的研究人員的需 求，我們於兩年前建立了參考實驗室，為研究者發起的臨床試驗和其他從事轉譯醫學 研究的同仁提供標準與客製化的基因檢測服務。此參考實驗室的目標有二，第一、提 供常規基因檢測服務：PG Lab 將為從事新藥、新體外試劑或新醫療儀器確效評估的 NRPB 研究者提供與優化常規基因檢測。第二、依照使用者的需求提供客製化服務： PG Lab 將為研究人員研發新的基因檢測平台。在過去的一年中，PG Lab 已有豐碩的 執行績效。第一、PG Lab 已經過 TAF ISO15189 的醫學實驗室認證。第二、服務收入 達新台幣 36,928,000 元。第三、申請了兩項專利，「分枝桿菌的鑒定與抗藥性判定的快 速篩檢方法」與「以微核醣核酸 miR-141 為標的治療小 RNA 病毒感染」。第四，基亞 生物科技股份有限公司投資新台幣 100 萬進行合作研究。第五、PG Lab 主持人應國科 會至中國大陸與菲律賓進行海峽兩邊會談，分享參考實驗室的經驗。在第三年的計畫 中，PG Lab 將致力於提高服務量、增加技轉與研發新服務項目。我們將拜訪 NRPB clinical consortiums 與 R&D 群組中對新疾病標記研發與基因檢測有興趣的研究者， 也會接觸國際藥廠爭取成為這些藥廠認可的台灣參考實驗室。為提升台灣的生技產業 與增加技轉的機會，我們將與台灣生技業提出產學合作計畫。經過本計畫的努力，我 們預期 PG Lab 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: The mission of National Translational Medicine and Clinical Trial Resource Center (NTCRC) is to provide necessary support for clinical trials and translational medicine studies initiated by investigators of National Research Program for Biopharmaceuticals (NRPB). The component project 3 (TR6-3), Pharmacogenomics Lab (PG Lab) of NTCRC, is a direction-oriented reference laboratory. To meet the needs of NRPB researchers we have established PG Lab to provide the standard gene tests and customized gene tests for PI-initiated clinical trials as well as requests from NRPB R&D groups, NRPB core facilities and translational research groups. The specific aims of PG Lab are: First, providing the well-established gene tests: we provide and optimize the well-established gene tests for NRPB researches focusing on assessment of new drug/medical device efficacy, evaluation of new IVD (in vitro diagnosis kit) accuracy, and so on. Second, developing the customized gene tests based on users’ request: we will develop the new assays for currently unavailable gene tests for evaluation of new drug targets, new therapeutic manipulations, new IVD and so on. In the past year, we have fruitful achievements 1. PG Lab has been accredited for ISO15189 Medical Laboratory by TAF (Taiwan Accreditation Foundation). 2. The service income is NT 36,928,000. 3. We filed two patents, Method for Multiplex Detection of A Target Drug-resistant Mycobacterium Tuberculosis and Treating Picornavirus Infection by Targeting MicroRNA miR-141. 4. NT 1,000,000 funded by Medigen Biotechnology Corp for collaboration. 5. PG Lab PI was invited by NSC to China and Philippine to introduce this reference lab. In the third year proposal, we will be devoted to promoting service, increasing the technology transfer and developing new services. We will visit NRPB PIs of disease-specific consortiums and R&D groups who are interested on discovery of new disease biomarkers or gene tests and contact with international pharma to strive as reference lab in Taiwan. To help the upgrade of Taiwan BioTech companies and to increase technology transfer we will collaborate with Taiwan BioTech to initiate Industry-Academia Collaborative Research Projects. After our efforts, we expect that PG Lab can reach the OBJECTIVES of resource center project to support and to speed up the development of NRPB innovative drugs and BioTech inventions into successful commercial medical products through translational research and clinical trials.轉譯醫學新藥開發體外試劑臨床試驗Translational MedicineDevelopment of New DrugIVDClinical Trail