Public-private partnerships as driving forces in the quest for innovative medicines 英文参考文献.docVIP

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2017-05-13 发布于上海
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Public-private partnerships as driving forces in the quest for innovative medicines 英文参考文献.doc

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Public-private partnerships as driving forces in the quest for innovative medicines 英文参考文献

Goldmanetal.ClinicalandTranslationalMedicine2013,2:2 /content/2/1/2 EDITORIAL OpenAccess Public-privatepartnershipsasdrivingforcesin thequestforinnovativemedicines MichelGoldman1*,CarolynCompton2andBarbaraBMittleman3 Abstract Background:Despiteprogressintranslationalresearch,wearestillfallingshortindevelopingtheinnovative medicinesrequiredtoaddressmajorpublichealthneeds.Furthermore,thefailurerate,time,andcostrequiredfor registrationofanewdrugarepushingtheeconomicsoftheindustrytothebreakingpoint.Newmodelsofdrug developmentbasedoncollaborativeendeavoursarebadlyneededtoimprovethisdiresituation. Findings:In2004,theUSFoodandDrugAdministration(FDA)introducedtheCriticalPathInitiativewiththeintent ofmodernizingdrugdevelopmentbyimplementingpublic-privatepartnerships(PPP)tosharedata,expertise,and resources.InresponsetoFDA’sinitiative,inthefollowingyearthenon-profitCriticalPathInstitute(C-Path)was formed.Atthesametime,theNationalInstitutesofHealth(NIH)Public-PrivatePartnershipprogramwas established.InEurope,theInnovativeMedicinesInitiative(IMI)supportedjointlybytheEuropeanUnionandthe EuropeanFederationofPharmaceuticalIndustriesandAssociationswaslaunchedin2008.Theseindependent effortshaveacommonlong-termobjective,namelytofacilitatetheemergenceofinnovativemedicinesby developingnewtoolsfordrugdiscovery,newindicatorsfordrugefficacyorsafety,andnewapproachesforpatient stratification.Herein,wepresentevidencethatPPPalreadyexertapositiveimpactonthedrugdevelopment process. Conclusions:Public-privatepartnershipsrepresentattractivemeanstoleverageresourcesdispersedacrossindustry, academia,andvoluntaryhealthorganizationsinordertoaddressmultiplechallengesofdrugdevelopmentinan eraofconstrainedresourcesandincreasedregulatorypressure. Keywords:Drugdevelopment,Drugefficacy,Drugsafety,Pre-competitiveresearch,Knowledgemanagement, Public-privatepartnership,Datasharing,Regulators,Standards Overcominghurdlesthroughpre-competitive research someofthesehurdlesbybringingtogetherpharmaceutical companies,