Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict Issuance of FDA Priority Review Vouchers over the Next Decade 英文参考文献.docVIP

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Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict Issuance of FDA Priority Review Vouchers over the Next Decade 英文参考文献.doc

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Analysis of Neglected Tropical Disease Drug and Vaccine Development Pipelines to Predict Issuance of FDA Priority Review Vouchers over the Next Decade 英文参考文献

PolicyPlatform AnalysisofNeglectedTropicalDiseaseDrugandVaccine DevelopmentPipelinestoPredictIssuanceofFDA PriorityReviewVouchersovertheNextDecade RiannaStefanakis*,AndrewS.Robertson,ElizabethL.Ponder,MelindaMoree BIOVenturesforGlobalHealth,SanFrancisco,California,UnitedStatesofAmerica The need for new drugs and vaccines for neglected tropical diseases (NTDs) is widely accepted [1]. Yet, encouraging pharmaceutical and biotechnology com- accelerated review? The lack of under- standing as to how many PRVs may be awarded in the future limits companies from predicting the potential value of a voucherthatmightbeearned. IdentificationofPRV-Eligible DrugsandVaccines To be eligible for a PRV, a drug or vaccineapplicationmustmeetthecriteria described in the FDA Draft Guidance for pany investment in developing these much-needed treatments remains a chal- lengeduetoalackofacommercialmarket drivingcompaniestopursueNTDprojects [2].Toaddressthischallenge,economists Ridley, Grabowski, and Moe at Duke University conceived of an incentive to encourageinvestmentinthedevelopment ofnewdrugsandvaccinesforNTDs:the Intheabsenceofatangibleexampleof a voucher’s market value, companies, the FDA, policymakers, and other program stakeholderscouldbenefitfromexamining NTD product pipelines, understanding whenthe nextPRV(s)are expected to be issued, and ultimately quantifying the supply side of the PRV market. In addition, it is unclear to global health stakeholders whether companies are ac- tivelypursuingPRV-eligibleproducts,and iftheyare,whetherthePRVincentivehas hadanimpactontheirmotivation[5,6]. Here,wepresentananalysisofthedrug and vaccine development pipeline to a) Industry: Vouchers Tropical Disease Priority Review [3]. Specifically, PRV-eligible products must be approved after the PRV program start date (September 27, 2007),mustbeforahumandrugapplica- tion submitted under section 505(b)(1) of the Act (for new chemical entities) or section 351 of the Public Health Service (PHS)