Microsoft Word - 加速藥物發展科技報導.doc

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1 略林年來例 1990 年 15 年臨 14% 降 8% 臨率 20%50% 臨 FDA 列了 FDA 率浪 FDA 立 (critical path initiative) 索 (exploratory IND) 臨 cgmp (cgmp during phase 1) (Continuous Marketing Application) 良理 (Good Review Management Principles) (Accelerated Approval) 行年見 FDA 臨略 I. FDA (1) (Critical Path Initiative): 2004 年 FDA Advancing America s Health. Advancing Medical Breakthroughs. (Critical Path) 參 FDA 來索勵率

2 (Toolkits) (biomarker) 臨力 FDA 參 FDA 行 taskforce( NCI )NCI/CMS (biomarker qualification) ( 例索臨 cgmp )(ECG 數錄 ) 年 3 爐列 (Critical Path Initiative Opportunity List) 率 FDA 六領更 - 來率利來量量量理理狀說年來例 (genomic, proteomic, metabolomic) 列力 FDA 數量療量 (safety markers)

3 療臨療療 (surrogate endpoints) 療臨更來臨不易 ( 例 ) 來臨 ( 例療 ) 若療療療量例療臨量例療臨來量療 (stratification) 更更年 3 Innovation Stagnation: Critical Path Opportunities List 列 33 臨療 beta (polymorphisms) 參列臨率 - 率臨臨療臨說臨不臨率 -: 數臨都不良

4 數例療量 / 度列 (active control) 累理數 (missing data) 量臨療療異臨來量療量狀列行臨率臨行數理臨率例數 (case report form) 利 - 數數量理數利力理量理理不良數更精更數館 (data libraries) 行行列臨利不類料歷 (historical control) 臨數見不良數臨

5 - 量理力例量不不良不良不良行不 (combination product) 例量 (drug-eluting stent) 量不列療奈列數例流行療流奈切更療來利數了不臨療來不療領利連 (PCR) 例利奈 DNA, RNA, 力 - 療數力例年益年療例療參料 :

6 Innovation Stagnation: Critical Path Opportunities List, U.S. Department of Health and Human Services, Food and Drug Administration, March Innovation Stagnation: Critical Path Opportunities Report, U.S. Department of Health and Human Services, Food and Drug Administration, March (2) 索 (Exploratory IND) 說 FDA 利行 1 臨 FDA 索參索 1 臨量索療量理量來索 1 臨索臨料 1 臨不索力臨索理量臨臨利索異 CMC 若 CMC 說索良 (GLP) 精神 FDA 索

7 參料 : Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), April 2005 (3) cgmp During Phase I 臨例臨 FDA 1991 年 (Guideline on the Preparation of Investigational New Drug Products) 論 FDA 2006 年臨 cgmp 若臨不臨 FDA 力臨立精錄數例量索 FDA 理參料 : Guidance for Industry: INDs Approaches to Complying with cgmp During Phase 1 Draft Guidance, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), January (4) (Continuous Marketing Application) 了

8 若 FDA 更更 FDA (continuous marketing application pilots) 兩 1 (Fast Track) FDA 臨 (End of Phase-2) (Pre-NDA/BLA) FDA 料 ( Reviewable Units) 料 6 (NDA) FDA (Discipline Review Letter) 2 FDA 立識行臨 (End of Phase-1) 臨 (clinical hold) 說 (milestones) FDA 行 2007 年 9 30 FDA 行立來行參料 : (5) 良理 (Good Review Management Principles) FDA 立良理精神 : 率 FDA 5 : (1) 料 (filing determination and review planning phase)(2) (review phase)(3)(advisory committee meeting phase)(4) 行 (action phase)(5) 行 (post-action phase) 見 (review milestones)fda FDA 連料更率 FDA 立 2. 力良理 FDA 2003 年 10 練立來 2007 年行參料 :

9 Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA Products, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), April (6) (Accelerated Approval) 例理臨益臨 (surrogate endpoint) 流療理理了不復臨量益臨益療行臨益臨益不連臨益 II. 臨不年來例不令力 (1)- 立臨

10 爲臨度力臨來立立療行 94 年立臨臨臨量立臨立臨力立臨臨度臨 (1) 臨 : 立立臨立臨 : () 立 ( 神 ) 立 () 臨臨 Translational Research 立立年臨臨拓臨 Investigator Initiated 臨立臨理 (SMO) 臨理理流立臨

11 立益臨 (2) 立臨 : 了臨理臨臨臨臨都臨療療年行 (3) 臨練 : 金理臨臨臨理來勵臨 4. (4) 立臨 : 94 年度 4 行 -- 立臨 : 精神臨老年行 CRIMS(Clinical Research Information System) ICH GCP(International Conference on Harmonization Good Clinical Practice)Clinical Trial Process 流臨料理 : 料理 CRIMS 行精神臨精神行立 TPRN (Taiwanese Psychiatric Research Network) SMO (Site Management Organization) 理立臨臨臨立力 / 料理 (CRISM) 參 (Reference Labs)CROSMO 精神老年神 () 切行行臨年領臨療

12 臨臨 Contract Research Organization, CRO 臨臨來立臨立參料 : (2) -Center for Drug Evaluation 行行金略臨量力立 95 年年 4 13 說烈年度 11 行陸

13 流了切 1. 利税度利識 2. 靈累利念勵例 3. 臨利行流理理念力領力例 4. (research)development 度勵臨臨 Unmet Medical needs Project management 行車 Milestone IND 不 Milestone 不 Unmet Medical needs 療 5. 例 1 臨利行行行 due diligence 不不立利 1Inventor-ship IP Estate 立, Freedom to Operate 利,,, 2 3Due Diligence Candidate 力 4: LeaderManagers & Management Team Technical Expert Team Rainmakers 立 (3) - 力年來

14 參力行利落落立索力說勵利力刺參聯行臨例立拓立力行數年力療糖尿神領 20 力行度來 1. 索念不不精神不不易 2. 臨力不力量益不 3. 臨不例臨臨度臨不 4. 不理落行率行行益不力率參料 :

15 理行林

臺灣地區的警察教育現況與展望

臺灣地區的警察教育現況與展望林行練若不益立理例年行立了更年年例理類行立立立力年 1 年立立立力年年年年精神倫理精神精神立識律行念識行行練練練理論令理歷落流度精立度理論 2 立理行度勵劣行行更年度勵見理力領論例狀狀論不狀理利行六量切力兩 3 理

Microsoft Word - 加速藥物發展 科技報導.doc

Microsoft Word - 加速藥物發展科技報導.doc