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May 18, 2011 Herng-Der Chern, M.D., Ph.D. Distinguished Research Fellow Center for Drug Evaluation (CDE), Chinese Taipe

May 18, 2011 Herng-Der Chern, M.D., Ph.D. Distinguished Research Fellow Center for Drug Evaluation (CDE), Chinese Taipei. Early Introduction for Top 20 US Market New Drugs Table. Unpublished Data compiled by Joseph Lee, CDE, 2010 Aug.

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May 18, 2011 Herng-Der Chern, M.D., Ph.D. Distinguished Research Fellow Center for Drug Evaluation (CDE), Chinese Taipe

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  1. May 18, 2011 Herng-Der Chern, M.D., Ph.D. Distinguished Research Fellow Center for Drug Evaluation (CDE), Chinese Taipei

  2. Early Introduction for Top 20 US Market New Drugs Table Unpublished Data compiled by Joseph Lee, CDE, 2010 Aug. www.diahome.org

  3. Expand Regulatory Cooperation and Advance Regulatory Convergence – Proposed by 2011 APEC Hosting Country USA • New drug development and registration is regulatory intensive business across the region • “Partnership in Harmonization” of regulatory convergence can minimize trade cost, bureaucratic inefficiencies and non-tariff barriers • Promote public health with cheaper, faster, easier drug development and registration www.diahome.org

  4. APEC Network under ISTWGsince 1999 and APEC BRP since 2011 (2004) (2002, 2006) Chinese Taipei(2000, 2001, 2003, 2005, 2007, 2008, 2009, 2011) Partnership in Harmonization with ICH Best Regulatory Practice 4 www.diahome.org

  5. “APEC Network of Pharmaceutical Regulatory Science-Theme and Topics Clinical Trial Level of Emphasis Bridging Study Global Drug Development Harmonization Initiative ICH GCG APEC LSIF ASEAN EAPRS RA update 0 2010 2011 2000 2002 2004 2006 2007 2008 2009 Year www.diahome.org

  6. Intrinsic Extrinsic Genetic Physiological and pathological conditions Environmental Gender Race Genetic polymorphism Genetic diseases Age (Children-elderly) Liver Kidney Cardiovascular functions Diseases Climate Sunlight Pollution Culture Socioeconomic status Educational status Language Medical practice Disease definition/diagnostic Therapeutic approach Drug compliance Regulatory practice/GCP Methodology/Endpoints Heighe Bodyweight ADME Receptor sensitivity Smoking Alcohol Food habits Stress Classification of intrinsic and extrinsic ethnic factors www.diahome.org

  7. Pharmacogenetic Consideration of “Race” Appearance of race determined by a few genes Extrinsic factors are more important than intrinsic factors Genetic distance has major branches corresponding to major racial groups Intra-ethnic differences is greater than inter-ethnic mean difference Genetically, Asian can be barely categorized as “Southern Asian” and “Northern Asian” using Yang-Tze Riveras nature border www.diahome.org

  8. Genetic Distance of Southern vs Northern Asian Lin,et al. Tissue Antigens 2001, 27:192-199 www.diahome.org

  9. Ethnic Group Not defined by “race”, or “citizenship” Defined by “Drug characteristics” and “Target patient population” Epidemiology: incidence, etiology, nature course, prognosis, response to other medications with similar mechanism China composed of Southern, Northern Asian and some minority races www.diahome.org

  10. Working Definition of Ethnic Sensitivity for ICH-E5 (Bridging Study Evaluation) D  I = C D : Drug Characteristics I : Epidemiology of “Indication” C : Clinical impact based on risk – benefit approach www.diahome.org

  11. Association of HLA-B*1502 with CBZ-induced SJS/TEN in different populations. Country/ Major 1502 SJS/TEN Region Population a.f. Association Taiwan Han-Chinese 5.9 Strong Hong Kong Han-Chinese 10.2 Strong Thailand Thai 8.5 Strong China Southern Han-Chinese 7.1 Strong China Northern Han-Chinese 1.9 NA Japan Japanese 0.1 No Korea Korean 0.2 No Germany European 0 No France European 0 No

  12. Challenge in Oncology Trials Cancer-mutation spectrum and frequency may have ethnic sensitivity, e.g. NSCLC & Irresa Medical practice in diagnosis, standard therapy, best supportive care may be different e.g. HCC & Nexavar Philosophy to death may be different – die in ICU, general ward, hospice, home, resuscitate or not may affect “overall survival” Different epidemiology for common cancers: HCC, Gastric Ca., Cervical Ca., NPC,…. 12

  13. Sorafenib data from Asian vs Caucasian: different severity of liver cancer patients 13

  14. Sorafenib data from China vs Korea and Chinese Taipei-Medical Practice vs Genetics 14

  15. Examples of Ethnic Sensitivities www.diahome.org

  16. Bridging Study Evaluation for Ethnicity • Checking list and flow chart for BSE • Consider all factors in totality • Clinical impact is the key • In general, accept all Asian data as good reference • 60% NME considered ethnic insensitive www.diahome.org

  17. Build up Regulatory Infrastructure – New IND from 1994~2010 Local Registration Trial Bridging Study Evaluation 200 189 187 162 173 GCP-Taiwan 138 150 131 130 116 IND New System 106 Protocol No. Phase I~III 100 95 SARS 115 87 100 Phase IV 74 66 90 63 Qualified Site 81 67 67 66 62 50 35 21 16 CDE established 12 16 14 6 5 4 4 14 3 0 10' 94' 98' 04' 96' 00' 06' 09' 02' 08' Year www.diahome.org

  18. Drug Price Incentive for C.T. Conduct 2010 BNHI announced 10% drug price mark up for clinical trial conduct in Taiwan (draft Ph.I: 10 cases, Ph.II: 20 cases, Ph.III 80 cases)-give incentive in stead of administrative requirement 18 www.diahome.org

  19. 2010.8.18 Clinical Trials Notification 19 Plateau on C.T., need more early trials Reviewers overloading CTN route, no science review in general If join MRCT with IND reviewed by one of 10 reference countries (26/138,19%),  efficiency (predictable, save 21 days),  early trials (25% to 50%) www.diahome.org

  20. CTN案現況(2010. 8. 18~2011.3.31) Sponsor’s Time 6.27 days for Non-CTN IND 20

  21. CTN Cases Characteristics Ph. I 1, Ph. II 12, Ph. III 13 cases, from 10 Big Pharma and 1 domestic companies Indication: Cancer 11, DM 5, Hepatitis 3, Psoriasis 2, CV1,Asthma 1, Depression1, Eye 1, Orphan Drug 1 cases. Asian Countries Involved: Japan 9, Korea12,China 4, Hong Kong 9 No question asked, no disapproval, no case considered as high risk 21

  22. 2011-12 APEC “Best Regulatory Practice” Led by Taiwan • Project supported by Canada, China, Indonesia, Korea, Malaysia, Mexico, Peru, Philippine, Thailand, USA • Good Review Practice Workshop for Drug and Device, Taipei, Oct. 11-15, 2011 • APEC PER Scheme for exchange of Pharmaceutical Evaluation Report with consent from the license holder • Ethnic sensitivity will be emphasized for regulatory convergence www.diahome.org

  23. Regulatory Convergence for Ethnicity Consideration : Regression Towards the Mean 2011 Regulatory Science/SGDDP Regulatory Convergence 2000 High Low Ethnic Sensitivity /Market Size Japan EMA US ASEAN Rest of World Korea China Taiwan www.diahome.org

  24. Thank you for your attention www.diahome.org 24

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