2014-05-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/659678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，過去兩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。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。在過去的兩年半中，PG Lab 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；第二、服務量達 6,421 件，總收入達新台幣 63,318,000 元；第三、獲得一項美國專利「以微核醣核酸 miR-141 為標的治療小 RNA 病毒感染」和提出一項美國專利申請「Use of MicroRNA-146a in the diagnosis, treatment and prevention of enterovirus 71」；第四、PG Lab 主持人應國科會、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。在未來三年計畫中，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、依臨床使用者要求，更新且擴充基因檢測項目平台，超越目前市售基因檢測套組；第二、研發融合基因突變檢測平台，以其日後提供服務；第三、發展免疫組織化學染色檢測，提供臨床分子病理檢驗；第四、充分促進產學合作，達成吸引產業界投資新台幣 10,000,000 以上目標；第五、與國內臨床試驗聯盟合作，成立專業多元臨床團隊。除此之外，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。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 「Taiwan Clinical Trial Bioinformatics and Statistical Center, Training Center, and Pharmacogenomics Laboratory」(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 2.5 years, we have fruitful achievements 1. PG Lab has been accredited for ISO15189 Medical Laboratory by TAF (Taiwan Accreditation Foundation) in four genes testing. 2. The total service are 6,421 cases with NT 63,318,000 income. 3. We got one US patent “Treating Picornavirus Infection by Targeting MicroRNA miR-141” and applied one US provisional patent “Use of MicroRNA-146a in the diagnosis, treatment and prevention of enterovirus 71＂. 4. PG Lab PI was invited by NSC, ITRI (Industrial Technology Research Institute) and SiiC (Supra Integration and Incubation Center) to attend conference or advisory committee meeting to share the experience of gene testing. In the coming three-year proposal, 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 new services. Under this guideline, we anticipate to achieve the following specific aims including: 1. Update and upgrade the gene testing platform better than commercial available kit according to clinical request. 2. Develop fusion gene mutation detection platform in nucleic acid level. 3. Develop Immunohistochemical assay for molecular pathological service. 4. Promote academic-industry cooperation and attract the investment from industries more than NT 1,000,000. 5. Cooperate with other clinical consortiums to from professional and diverse team work. In addition, we will contact with international pharma to recognize PG Lab as reference lab in Taiwan. 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.轉譯醫學參考實驗室藥物基因體臨床試驗產學合作Translational MedicineReference LabPharmacogenomicsAcademic-Industry CooperationClinical Trail