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1. 法規制度、品質、效率、人才與未來發展 2. 從華人族群 基因 、特有疾病到執行國際級 臨床認驗

兩岸臨床試驗利基與競爭力 ( 一 ). 1. 法規制度、品質、效率、人才與未來發展 2. 從華人族群 基因 、特有疾病到執行國際級 臨床認驗. 胡 幼 圃 特 聘 教 授 考試院考試委員 國防醫學院 / 台大醫學院 100.3.25. 內容. 1. 海峽兩岸醫藥衛生合作協議 2. 我們臨床試驗之現況 3. 華人族群基因 4. 華人特有疾病 5. 我們的利基合作進行國際級臨床試驗. 1. 海峽兩岸醫藥衛生合作協議. 海峽兩岸醫藥衛生合作協議. 第三章 醫藥品安全管理及研發 十、 合作範圍

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1. 法規制度、品質、效率、人才與未來發展 2. 從華人族群 基因 、特有疾病到執行國際級 臨床認驗

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  1. 兩岸臨床試驗利基與競爭力(一) 1.法規制度、品質、效率、人才與未來發展2.從華人族群基因、特有疾病到執行國際級 臨床認驗 胡 幼 圃 特 聘 教 授 考試院考試委員 國防醫學院/台大醫學院 100.3.25

  2. 內容 1.海峽兩岸醫藥衛生合作協議 2.我們臨床試驗之現況 3.華人族群基因 4.華人特有疾病 5.我們的利基合作進行國際級臨床試驗

  3. 1.海峽兩岸醫藥衛生合作協議

  4. 海峽兩岸醫藥衛生合作協議 第三章 醫藥品安全管理及研發 十、 合作範圍 本協議所稱醫藥品，指藥品、醫療器材、健康食品（保健食品）及化粧品，不包括中藥材。 雙方同意就兩岸醫藥品的非臨床檢測、臨床試驗、上市前審查、生產管理、上市後管理等制度規範，及技術標準、檢驗技術與其他相關事項，進行交流與合作。

  5. 十四、 臨床試驗合作 雙方同意就彼此臨床試驗的相關制度規範、執行機構及執行團隊的管理、受試者權益保障和臨床試驗計畫及試驗結果審核機制等，進行交流與合作。 在符合臨床試驗管理規範（GCP）標準下，以減少重複試驗為目標，優先以試點及專案方式，積極推動兩岸臨床試驗及醫藥品研發合作，並在此基礎上，探討逐步接受雙方執行的結果。

  6. 2.我們臨床試驗之現況

  7. Domestic trial vs multi-national trial

  8. Volume of Clinical Trials in Asia Pacific Region- Taiwan is a major site allocated by big pharma Data accessed from www.clinicaltrials.gov 2009

  9. Ranking of countries for Phase II-III industry sponsored trial sites

  10. NEW IND in Taiwan (1994-2009) Local Registration Trial IND New System Bridging study Evaluation GCP-Taiwan 628 Announcement SARS CDE established ↑Qualified Site

  11. Distribution of CT Phases (2009.1.1~9.30 IND 完成審查案件,共134件) P: protocol S: site

  12. 我國二十五年藥政風華 Milestone of Regulation in Taiwan CDE C.T. Guidance DSRB GLP ADR Center JIRB SRB C.T. Training Registration Trial 7.7公告 GMP 1982 1987 1993~ 1996 1998 BA/BE

  13. 我國二十五年藥政風華 Milestone of Regulation in Taiwan Race Disease PDT and Drug Act 藥品CGMP Bridging study C.T. Waiver GCRC 醫材GMP 醫材重新分類(class) Drug Relief cGTP Gene Therapy 籌備Taiwan FDA(第一次送行政院) Non-FSC TDRF Consultation window 2000 2001 2002 APEC (II) APEC(III) DIA 38th Annual Meeting APEC Network project

  14. Results of GCP Inspection

  15. 3.華人族群基因

  16. Age Body weight Gender Genotype Organ dysfunction Diet Drug interactions Food interactions Herbal products Smoking habit Working Definition of Special Populations Intrinsic Factors Extrinsic Factors Adapted from ICH Guideline E5: Ethnic Factors inthe Acceptability of Foreign Clinical Data, 1998

  17. PK/PD/PG for Drug Response NEJM 348;6, 2003

  18. Pharmacogenetic Assessment • Ultimate goal of drug development – providing safe therapies with meaningful clinical benefit • Most promising impact of genomics – applying biomarkers to inform therapeutic decisions Drug – Gene Interactions  Optimal Dosing

  19. We Can and Should Do Better Finding the Optimal Dose FDA Critical Path Document: Challenges the traditional drug development process ~ 1 in 4 approved drugs undergoes relabeling because of inadequate dosing FDA White Paper, Challenge and Opportunity on the Critical Path to New Medical Products, 2004

  20. Result #1: Unpredictable Variability in Efficacy Spear et al. Trends in Molecular Medicine, 7:201 (2001).

  21. 1. Assement of Phase I and II Enzyme SNPs Affect Pharmacokinetic Parameters

  22. Summary of SNPs • Total Single Nucleotide Polymorphisms (SNP): 96 SNPs of 8 metabolic enzymes • CYP2A6: 13 SNPs • CYP2C9: 11 SNPs • CYP2C19: 14 SNPs • CYP2D6: 25 SNPs • CYP2E1: 5 SNPs • CYP3A4: 13 SNPs • CYP3A5: 11 SNPs • UGT2B7: 4 SNPs

  23. 2. Assess the effects of phase I and II metabolic enzyme SNPs in drug metabolism (PK parameters)

  24. Acknowledgement • NDMC • 胡幼圃, Ph.D. • 熊正輝, Ph.D. • 中研院 • 陳垣崇,所長,Ph.D. • 王慧虹, Ph.D. • Clinical trial volunteers • PK analysis teams • CRO -佳生、明生、世宬、昌達、美時

  25. 4.華人特有疾病

  26. 華人特有疾病-肝病PK in Special Population美國FDA推薦之肝功能測定新法 Galactose Single Point(GSP) method

  27. Guidance for Industry Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling 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) May 2003 Clinical Pharmacology

  28. Quantitative Marker of Liver Residual Function - GSP • Galactose Single Point (GSP) status • US FDA Guidance • ROC DOH Guidance • Text Book • GSP method • GSP application

  29. 肝功能不全病患的藥動學試驗基準 －臨床試驗設計、數據分析以及對劑量調整與標示的影響 GUIDANCE FOR PHARMACOKINETICS IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION: STUDY DESIGN, DATA ANALYSIS, AND IMPACT ON DOSING AND LABELING 行 政 院 衛 生 署 中華民國九十年七月

  30. Galactose Single Point (GSP) Method • IV infused 0.5g/kg of galactose, and measuring whole blood (collected by dry filter papers) galactose concentration enzymatically at 60 minutes later

  31. GSP Sampling

  32. GSP Method Recent Application in Medical Centers of R.O.C. • Diagnostic Drug: Galactose injection(干能糖,衛署藥製字第046996號) • Medical Centers: NTUH(台大)、TSGH(三總)、TVGH(榮總)、CGMH(長庚)、CTH(耕莘) …: 23 hospitals and clinics • Subjects: 766 (Chronic hepatitis: 58; Cirrhosis: 24; Hepatocellular Carcinoma: 66; Liver normal: 618) • The GSP values were significantly different between patients with various liver function

  33. Hu OYP, Tang HS and Sheeng TY, J Pharm Sci 1995;84:111-4

  34. 兩岸華人臨床試驗之利基 1.共同族群基因-例如CYP Enzymes 2.共同特有疾病-例如肝病 3.優質卓越的臨床試驗設施，人才制度 經驗及廣大市場 4.建構兩岸臨床研究合作機制

  35. Thank you for your attention!

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