Views and Actions OPIR
Points of View HS HS HS HS PMDA No
HS No H N HIT B No
WEB No HS GLP DPPSGLT No
No
Points of View No
Pharmaprojects HIV GlaxoSmithKline Pfizer Novartis No
HIV No
Genzyme Genesis Pharma Swedish Orphan No
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
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
No
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
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
No
No
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
HIV HIV HIV HIV HIV HIV HIV HIV HIV No
No
HIV HIV Novartis GlaxoSmithKline Eli Lilly No
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
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
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
ClinicalTrials gov No
No SW Glickman et al Ethical and Scientific Implications of the Globalization of Clinical Research N Engl J Med No
NIH NIH EC No
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
Points of View Personalized Medicine No
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
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
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
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
FDA NIH FDA NIH NIH FDA DNA DNA Hamburg M ACollins F SThe Path to Personalized Medicine N Engl J Med No
Points of View IMS Japan JPM No
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
ATC yes A L ATC No
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
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
ATC ATC No
IMS Japan JPM No
IMS Japan JPM ATC ATC ATC ARB C C ATC ATC No
Points of View No Pfizer Novartis sanofi aventis Roche Glaxo SmithKline GSKAstraZeneca Merck & CoJohnson & Johnson J&JEli Lilly Bristol Myers Squibb BMS No
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
M&A M&A No
OECD No OECD No
GSK Strategy for Science Technology & Innovation PhD IP No
pt pt pt pt pt No
No
Points of View GDP The World Bank World Development Indicators The World Bank World Development Indicators No
IMS Health IMS World Review No No
No
No
No
Points of View principal agent Iizuka Iizuka T Experts agency problems Evidence from the prescription drug market in Japan RAND Journal of Economics No
Iizuka Iizuka t t Rt t t R R R R R No
R R R R R Iizuka No
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
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
R No
Clinical Development and Review Times of New Drugs in JapanUpdate Drug Information Assosiation DPC DPC No No
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
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