2015-05-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/704476摘要：「台灣臨床試驗生資生統中心、培訓中心與藥物基因體實驗室」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，過去三年半建立了參考實驗室，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。在過去的三年半中，PGLab 已有豐碩的執行績效。第一、PG Lab 已取得四項基因檢測的TAF ISO15189 醫學實驗室認證即將獲得免疫組織染色的認證；第二、服務量達11,024 件，總收入達新台幣108,857,000 元；第三、獲得一項美國專利和提出三項美國暫時專利申請；第四、PG Lab 主持人應科技部、工研院、超級育成中心等邀約至於國內外進行經驗分享與專家會議；第五、建立的兩項的產學合作研究及產業投資。在未來二年計畫中，PG Lab將以致力提高服務量、提升檢驗品質、增加技轉、研發新服務項目為宗旨，希望完成的目標，包括:第一、提供已建立且優化的基因檢測給使用者；第二、依臨床使用者要求，更新、擴充及客製化基因檢測項目平台，超越目前市售基因檢測套組；第三、提供以次世代定序儀發展的基因檢測平台來執行臨床試驗；第四、執行接單式高階人才培育計畫。除此之外，也接觸國際藥廠爭取成為這些藥廠認可的台灣參考實驗室。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 的新藥開發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 「Taiwan Clinical Trial Bioinformatics and Statistical Center, Training Center,and Pharmacogenomics Laboratory」(NTCRC) is to provide necessary support for clinicaltrials and translational medicine studies initiated by investigators of National ResearchProgram 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 standardgene tests and customized gene tests for PI-initiated clinical trials as well as requests fromNRPB R&D groups, NRPB core facilities and translational research groups. In the past 3.5years, we have fruitful achievements 1. PG Lab has been accredited as ISO15189 MedicalLaboratory by TAF (Taiwan Accreditation Foundation) for four genes testing already andIHC soon. 2. The total services are 11,024 cases with NT 108,857,000 income. 3. We obtainone US patent and fill three US provisional patents 4. PG Lab PI was invited by MOST,ITRI (Industrial Technology Research Institute) and SiiC (Supra Integration and IncubationCenter) to attend conference or advisory committee meeting to share the experience of genetesting. 5. We initiate two Academic-industry collaboration studies. In the coming two-yearproposal, PG Lab will devote to follow the guideline including: upgrade the test capacity,improve the quality of testing, and increase technical transfer and R&D for providing newservices. Under this guideline, we anticipate to achieve the following specific aims including:1. Provide the well-established gene tests. 2. Develop the customized gene tests based onPIs' requirement. 3. Provide NGS-based gene tests for clinical trials. 4. Execute theorder-taking leadership education for young talents. In addition, we contact withinternational pharma to recognize PG Lab as reference lab in Taiwan. After our efforts, weexpect that PG Lab can reach the objectives of resource center project to support and tospeed up the development of NRPB innovative drugs and BioTech inventions into successfulcommercial medical products through translational research and clinical trials.轉譯醫學參考實驗室臨床試驗產學合作研究Translational MedicineReference LabClinical TrailAcademic-industry Collaboration