Selection of cytotoxicity markers for the screening of new chemical entities in a pharmaceutical conWord格式.docx

Selection of cytotoxicity markers for the screening of new chemical entities in a pharmaceutical conWord格式.docx

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OriginalResearchArticle

EuropeanJournalofCancerSupplements

majorstepintargetedcancerdrugdiscoveryisdemonstrating‘proofofmechanism’.Tissuesamplesareanintegralpartofcurrentdrugdevelopment.AttheBiotherapyDevelopmentAssociationMeetinginMarch2007,thebenefitsandproblemsoftissuerelatedendpointinclusioninclinicaldrugdevelopmentwerediscussed;

Academic,RegulatoryAuthorityandPharmaceuticalIndustryrepresentationbeingpresent.

Itwasagreedthatthepublicsupportstheuseofhumantissueinresearch;

cooperationandcollaborationareessentialtoensurethattissuesamplesarecollectedandavailableforresearch;

tissuesamplingshouldbemandatoryforclinicaltrials;

andthattissueremainingfromdiagnostic,surgicalandclinicaltrialbasedsamplingshouldbemadeavailableforresearch.

Untilexistingornewtechnologiesprovideutilityforalternativesampling,accesstohumantissuesamplesofconsistentqualitywillunderpinthesuccessofcancerdrugpipelinesintheeraofmolecularbiologicalbiomarkersandpersonalisedmedicine.

ArticleOutline

1.Introduction

2.Baseline

3.Definitions

4.Infrastructureandcoordination

5.Tissuebanks

5.1.Benefitsofperformingbiopsiesinoncologyclinicaltrials

5.2.Issueswithperformingbiopsiesinoncologyclinicaltrials

6.Conclusion

Conflictofintereststatement

References

Thefutureofdrugdiscoveryanddevelopment:

Shiftingemphasistowardspersonalizedmedicine 

TechnologicalForecastingandSocialChange

Thedrugdiscoverysectorisbeingrevolutionizedbythecurrentrateofadvancesinthepublicandprivatehumangenomeprojectsandbythedevelopmentofnewtechnologiesforbiomarkertesting.Ineffect,asthegeneticrootsofdisease,diseaseprogressionandtreatmenteffectivenessareuncovered,thedemandforsophisticatedprognostic,diagnosticandmonitoringtestswillbeincreasing.Alreadythishasledtothedevelopmentofinnovativediagnosticsproductsmeetingthecriteriaofimprovedefficacyandsafetyaswellasbettercost-benefits.Inordertoachievetheultimategoalofamorepredictiveandpersonalizedmedicinerequiresthedrugdiscoveryindustrytoimplementmoresynergiesbetweenthetwoworldsofclinicalresearchanddiagnostics.Thetherapeuticsthatareenabledbythatstrategyareoftencalled“theranostics”—highlyspecificteststhatallowforthediagnosisofthedisease,buttoadministerthemostappropriatetreatmentregimen,andtomonitorapatient'

sresponsetotherapy.Biomarkerswillconstituteacriticalcomponentofthehealthcaredeliverysysteminordertodetect,diagnoseandmonitordiseasesandothermedicalconditionsaswellastoevaluatetreatmentoptionsandeffectiveness.Whilediagnosticbreakthroughstypicallyprecedetherapeuticadvances,thepresenceofnewtherapiescanstimulatethedemandfortesting.Themainquestionthatremainstobeansweredishowwillthebiomarkerparadigmaltersthesecompanies'

innovationandcommercializationstrategies.Whereasdevelopingdrugtargetsmayoffergreaterlong-termvalue,initialcommercialopportunitiesoftenariseindiagnostics.

2.Introductiontobiomarkers

3.Drugdiscoveryindustry:

Benefitsfrombiomarkerutilization

3.1.Diseaseunderstanding

3.2.Projectprioritizationthroughearlyattrition

3.3.Streamliningclinicaltrials

3.4.Reducingcostofdrugdevelopment

3.5.Speedingdrugdevelopment

3.6.Improveddecisionmaking

3.7.Avoidingadversedrugreactions（ADR）

3.8.Rationalizingdosingregimen

3.9.Drugrepositioning

4.Factorsinfluencingdevelopmentstrategiestoembracebiomarkers

4.1.Favourableregulatorycontext

4.2.Successinclinicallaboratory

4.2.1.Cancer

4.2.2.Infectiousdiseases

4.2.3.Pharmacogenomics

4.3.Technologicalchallengesremain

4.4.Complexity

4.5.Thequestforvalueremainstobedetermined

4.6.Nodominantdevelopmentmodelhasyetemerged

5.Theimpactofthefinancialcrisis

6.Concludingremarks

Vitae

Applicationoftoxicogenomictoolsinthedrugresearchanddevelopmentprocess 

ToxicologyLetters

Drug-resistanttuberculosisintheEuropeanUnion:

Opportunitiesandchallengesforcontrol 

Tuberculosis

Mathematicalmodellingandquantitativemethods 

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CurrentregulatorytoxicologyperspectivesonthedevelopmentofherbalmedicinestoprescriptiondrugproductsintheUnitedStates 

Toxicologicalstudiesc