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こうきしどり
7 years ago
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1 Views and Actions OPIR

2 Points of View HS HS HS HS PMDA No

3 HS No H N HIT B No

4 WEB No HS GLP DPPSGLT No

5 No

6 Points of View No

7 Pharmaprojects HIV GlaxoSmithKline Pfizer Novartis No

8 HIV No

9 Genzyme Genesis Pharma Swedish Orphan No

10 Pfizer Novartis GlaxoSmithKline Roche sanofi aventis Johnson & Johnson Genzyme Merck & Co Merck KGaA Gilead Sciences Abbott Eli Lilly Pfizer GlaxoSmithKline Genesis Pharma sanofi aventis Swedish Orphan Merck & Co Roche Abbott IMS Health IMS World Review HIV No

11 Novartis Celgene Johnson & Johnson Alexion Celgene Cell Therapeutics Roche Allos Therapeutics Axcan Pharma SuperGen Amgen Bayer Biogen Idec Genzyme Roche Roche imatinib mesylate Bcr Abl tacrolimus thalidomide TNF α infliximab TNF α eculizumab α lenalidomide TNF α arsenic trioxide bosentan pralatrexate T porfimer sodium decitabine DNA filgrastim sorafenib tosylate rituximab CD B clofarabine DNA A interferon α a α interferon γ b γ No

12 No

13 Pfizer Roche Novartis Celgene Genzyme Pfizer Roche Novartis Amgen Celgene Genzyme sanofi aventis IMS Health IMS World Review Genesis Pharma Pfizer Johnson & Johnson Roche GlaxoSmithKline Ferrer Swedish Orphan No

14 M Johnson & Johnson Biogen Idec B Amgen Novartis Celgene Eli Lilly Roche Amgen Pfizer Novartis Celgene Bristol Myers Squibb Celgene Pharma Future No Genesis Pharma HIV HIV Pfizer Genzyme Novartis Roche α No

15 No

16 No

17 Swedish Orphan Genesis Pharm Recordati Pfizer GlaxoSmithKline Genzyme Roche sanofi aventis CSL Endo Pharmaceuticals Swedish Orphan Pfizer Genesis Pharma Orphan Australia Recordati sanofi aventis Bayer Paladin Labs IMS Health IMS World Review M Yeda Biogen Idec B Roche A Merck & Co GlaxoSmithKline HIV NPS Pharmaceuticals Genzyme Pfizer B Pfizer Roche Genzyme Genzyme Pharma Future No Genzyme Roche CSL No

18 HIV HIV HIV HIV HIV HIV HIV HIV HIV No

19 No

20 HIV HIV Novartis GlaxoSmithKline Eli Lilly No

21 Novartis Pfizer GlaxoSmithKline Merck KGaA Roche Eli Lilly Johnson & Johnson sanofi aventis IMS Health IMS World Review Pfizer GlaxoSmithKline Merck & Co sanofi aventis Abbott Bristol Myers Squibb Roche Swedish Orphan M Roche AstraZeneca Roche HER Roche Merck KGaA CDT mm AIDS Eli Lilly EGF Warner Chilcott Pfizer Roche Novartis Novartis HIV Abbott HIV Eli Lilly ZymoGenetics A B Eli Lilly Johnson & Johnson Novartis Novartis Pfizer Novo NordiskGH Talecris Biotherapeutics GlaxoSmithKline Merck & Co HIV Merck KGaA Gilead Sciences HIV Eli Lilly Pharma Future No HIV No

22 Nature Review HIV M Miles Braun et al Emergence of orphan drugs in the United States a quantitative assessment of the firstyears Nature Reviews Drug Discovery 9 β No

23 Points of View Kim UGT A HER HIV CD K ras ClinicalTrials gov biomarker http www fda gov ScienceResearch SpecialTopics CriticalPathInitiative default htm No NIHhttp www clinicaltrials gov first received ClinicalTrials gov ClinicalTrials gov JAPIC UMIN ClinicalTrials gov No

24 ClinicalTrials gov No

25 No SW Glickman et al Ethical and Scientific Implications of the Globalization of Clinical Research N Engl J Med No

26 NIH NIH EC No

27 FDA NIH FDA PhRMA The Biomarkers Consortium NIH NIH IMI Innovative Medicines Initiative EC EFPIA Joint Technology Initiative IMI EC EFPIA http www biomarkersconsortium org images stories docs adiponectin pr pdf NIH http report nih gov index aspxmarker or biomarker http www imi europa eu calls _en html http mhlw grants niph go jp http kaken nii ac jp PhRMA EFPIA No

28 Points of View Personalized Medicine No

29 QOL QOL Jain PharmaBiotech Jain PharmaBiotech Report HER Jain K KPersonalized Medicine Scientific and Commercial AspectsJain PharmaBiotech April HERhuman epidermal growth factor receptor type EGFR No

30 HER HER HER HER HER Bcr Abl CML Bcr Abl CML bcr abl CML K VKORC CYP C HERneu HER Bcr Abl VKORC CYP C Davis C Jet al The microeconomics of personalized medicine today s challenge and tomorrow s promise Nat Rev Drug Discov HER CML Bcr Abl breakpoint cluster region Abelson murine leukemia viral oncogene homolog bcr abl CML Chronic Myelogenous Leukemia VKORCvitamin K epoxide reductase complex subunit K K CYP Ccytochrome PC PC International Warfarin Pharmacogenetics ConsortiumEstimation of the Warfarin Dose with Clinical and Pharmacogenetic DataN Engl J Med No

31 FDA FDA FDA DNA DNA DNA CCR Your doctor will do a blood test to see if you have been CCR HIV infected with CCRtropic HIV before prescribing SELZENTRY for you EGFR HERneu Patients enrolled in the clinical studies were required to EGFR have immuno histochemical evidence of positive EGFR expression using the DakoCytomation EGFR pharmdx TM test kit Detection of HER protein overexpression is necessary HER for selection of patients appropriate for HERCEPTIN therapy HERCEPTIN HER should be used in patients whose tu- mors have been evaluated with an assay validated to predict HER protein overexpression HER Dasatinib is indicated for the treatment of adults with Philadelphia chromosome positive acute lymphoblastic leukemia Ph ALL with resistance or intolerance to prior therapy FDA Food and Drug Administration FDA http www fda gov Drugs ScienceResearch ResearchAreas Pharmacogenetics ucmhtm RequiredRecommendedInformation Only vol No

32 DNA PubMed Genomic and Personalized Medicine Act of NIH FDA vol pharmacogenomics OR epigenetics OR transcriptome OR proteomics OR metabonomics OR bioinformatics OR systems biology NIH National Institutes of Health No

33 FDA NIH FDA NIH NIH FDA DNA DNA Hamburg M ACollins F SThe Path to Personalized Medicine N Engl J Med No

34 Points of View IMS Japan JPM No

35 ATC it Σ β kit k ATC yes Σ βl ATCit l it it α i α t ε it itα i α tε it ATC ATC No

36 ATC yes A L ATC No

37 ATC R D N B M S A D N C B G A J G A N R T A A S N R C No

38 jt jt jt jt jt jt jt β jt β jt β jt β jt jt jt jt yes α j α t ε jt jtα j α t ε it tt R t t t No

39 ATC ATC No

40 IMS Japan JPM No

41 IMS Japan JPM ATC ATC ATC ARB C C ATC ATC No

42 Points of View No Pfizer Novartis sanofi aventis Roche Glaxo SmithKline GSKAstraZeneca Merck & CoJohnson & Johnson J&JEli Lilly Bristol Myers Squibb BMS No

43 J&J Puerto Rico and Ireland operations Research and orphan drug tax credits International subsidiaries excluding Ireland Pfizer Earnings Taxed at other than U S statutory rate U S research tax credit and manufacturing deduction GSK R & D credits Roche Novartis Effect of tax credits and allowances sanofi aventis Impact of reduced rate income tax on royalties in France AstraZeneca Differences in effective overseas tax rates Merck & Co Foreign earnings BMS Foreign tax effect of operetions in Ireland Puerto Rico and Switzerland U S Federal research and development tax credit Eli Lilly International operetions including Puerto Rico Genaral business credits average expected tax rate Roche Non taxable income non deductible expenses No

44 M&A M&A No

45 OECD No OECD No

46 GSK Strategy for Science Technology & Innovation PhD IP No

47 pt pt pt pt pt No

48 No

49 Points of View GDP The World Bank World Development Indicators The World Bank World Development Indicators No

50 IMS Health IMS World Review No No

51 No

52 No

53 No

54 Points of View principal agent Iizuka Iizuka T Experts agency problems Evidence from the prescription drug market in Japan RAND Journal of Economics No

55 Iizuka Iizuka t t Rt t t R R R R R No

56 R R R R R Iizuka No

57 IMS Japan JPM PubMed Iizuka discrete choice model ATC HPPI nested logit model outside market ijt t max j J Vijt βσ k x jktβk α p R jt γ Mjt ξ jt ε ijt i j t j V x p R M ξ ε j δ δ j βσ k x jkβk α p R j γ Mj ξ j nested logit model Berry ln sj ln s βσ k x jkβk α p R j γ Mj σ ln sj g ξ j δ sj j s outside market sj g j g δ outside market outside market outside market WITS outside market outside market nested logit model Berry S Estimating discrete choice models of product differentiation RAND Journal of Economics No

58 ln sjt Log ln s t Log outside market share ln sj g Log of g IMS JapanKK IMS JPM PubMed Iizuka U ln sj g yes yes R squared ln sj g No

59 R No

60 Clinical Development and Review Times of New Drugs in JapanUpdate Drug Information Assosiation DPC DPC No No

61 PHARM TECH JAPAN Vol No Clinical Development and Review Times for New Drugs in Japan Associated Factors Clinical Pharmacology & Therapeuticsadvance online publicationaugust No OPIR CRO SMO No

62 OPIR Office of Pharmaceutical Industry Research TEL FAX http www jpma or jp opir

政策研ニュースNo27

政策研ニュースNo27 Views and Actions Points of View IMS World Review IMS Health Pfizer Johnson & Johnson Merck & Co Abbott Eli Lilly Amgen Wyeth Bristol Myers Squibb Schering Plough ForestBaxterMylanGlaxoSmithKline Novartis