identifyinghaypi

OMBNo.
0925-0001and0925-0002(Rev.
11/16ApprovedThrough10/31/2018)BIOGRAPHICALSKETCHProvidethefollowinginformationfortheSenior/keypersonnelandothersignificantcontributors.
Followthisformatforeachperson.
DONOTEXCEEDFIVEPAGES.
NAME:Levitt,JosephEeRACOMMONSUSERNAME(credential,e.
g.
,agencylogin):LEVITT.
JOSEPHPOSITIONTITLE:AssistantProfessorofMedicineEDUCATION/TRAINING(Beginwithbaccalaureateorotherinitialprofessionaleducation,suchasnursing,includepostdoctoraltrainingandresidencytrainingifapplicable.
Add/deleterowsasnecessary.
)INSTITUTIONANDLOCATIONDEGREE(ifapplicable)CompletionDateMM/YYYYFIELDOFSTUDYPomonaCollege,Claremont,CABA1993MolecularbiologyUniversityofMinnesotaSchoolofMedicineMinneapolis,MNMD1998MedicineStanfordUniversitySchoolofHealthResearchandPolicy,Stanford,CAMS2007ClinicalEpidemiologyA.
PersonalStatementIhaveextensiveexperienceconductingclinicaltrialsincritically-illpatients,andmorespecifically,inemergencydepartmentpatientsathigh-riskfortheacuterespiratorydistresssyndrome(ARDS).
I'vecompletedaK23Awardtargetingidentificationandtreatmentofpatientswithearlyacutelunginjury.
IdevelopedanEarlyAcuteLungInjury(EALI)scoretohelpidentifyat-riskpatients.
ElementsofthisscorehavebeenadoptedasenrollmentcriteriaforthisproposedphaseIIbclinicaltrial.
IalsorecentlycompletedthephaseIIaLungInjuryPreventionStudywithBudesonideandBetaAgonists(LIPS-B),whichdemonstratedthesafetyandpotentialefficacyofearlytreatmentwithaerosolizedbudesonideandformoterolforimprovingoxygenationinpatientsadmittedthroughtheemergencydepartmentathigh-riskforARDS.
Thistrialhasgreatlyinformedthedesignofthisproposal.
Iwasalsothesite-PIatStanfordfortherecentlycompletedNHLBI-fundedLungInjuryPreventionStudywithAspirin(LIPS-A)andIamcurrentlythesite-PIfortheNIH/NHLBIPETALNetworkandamemberoftheprotocolcommitteefortheupcomingVitaminDtoImproveOutcomesbyLeveragingEarlyTreatment(VIOLET)trial.
Thesetrialsrepresentaparadigmshifttowardearlieridentificationandtreatmentofpatientspriortoneedformechanicalventilation,whichIhavehelpedtolead.
Asaresultoftheseactivities,Ihaveextensiveexperiencewithclinicaltrialdesign,recruitmentandconsentofstudysubjects,andmaintainingbudgetaryandhumansubjectprotectioncompliancethatqualifytoserveasaContactPIforthisproposal.
FesticE,CarrGE,Cartin–CebaR,HindsRF,Banner–GoodspeedV,BansalV,AsuniAT,TalmorD,RajagopalanR,FrankRD,GajicO,MatthayMA,LevittJE.
RandomizedClinicalTrialofaCombinationofanInhaledCorticosteroidandBetaAgonistinPatientsatRiskofDevelopingtheAcuteRespiratoryDistressSyndrome.
CritCareMed.
2017May;45(5):798-805.
(PMCID:PMC5392150)LevittJE,CalfeeCS,GoldsteinBA,VojnikR,MatthayMA.
Earlyacutelunginjury:CriteriaforidentifyinglungInjurypriortotheneedformechanicalventilation.
CritCareMed2013Aug;41(8);1929-37.
PMCID:PMC3748809LiuKD,WilsonJG,ZhuoH,CaballeroL,McMillanML,FangX,CosgroveK,CalfeeCS,LeeJW,KangelarisKN,GottsJE,RogersAJ,LevittJE,Wiener-KronishJP,DelucchiKL,LeavittAD,McKennaDH,ThompsonBT,MatthayMA;DesignandimplementationoftheSTART(STemcellsforARDSTreatment)trial,aphase1/2trialofhumanmesenchymalstem/stromalcellsforthetreatmentofmoderate-severeacuterespiratorydistresssyndrome.
AnnIntensiveCare.
2014Jul3;4:22.
PMCID:PMC4273700Liu,KD,LevittJE,ZhuoH,KalletRH,BradyS,SteingrubJ,TidswellM,SiegelMD,SotoG,PetersonMW,ChestnuttMS,PhillipsC,WeinackerA,ThompsonBT,EisnerMD,andMatthayMA.
RandomizedClinicalTrialofActivatedProteinCfortheTreatmentofAcuteLungInjury.
AmJRespirCritCareMed.
2008;178(6):618-23.
PMCID:PMC2542435B.
PositionsandHonorsPositionsandEmployment1998-1999InterninMedicine,UniversityofArizonaHealthScienceCenter,Tucson,AZ1999-2001ResidentinMedicine,UniversityofChicagoHospitals,Chicago,Illinois2001-2002ChiefMedicalResident,CookCountyHospital,Chicago,Illinois2002-2004Fellow-PulmonaryandCriticalCare,UniversityofChicagoHospitals,Chicago,Illinois2004-2005Fellow-PulmonaryandCriticalCare,StanfordHospitalsandClinics,Stanford,CA2005-2013InstructorofMedicine,StanfordUniversitySchoolofMedicine,Stanford,CA2010-AssociateProgramDirector,PulmonaryandCriticalCareMedicineFellowshipProgramStanfordUniversitySchoolofMedicine,Stanford,CA2013-AssistantProfessorofMedicine,StanfordUniversitySchoolofMedicine,Stanford,CA2015-ProgramDirector,PulmonaryandCriticalCareMedicineFellowshipProgramStanfordUniversitySchoolofMedicine,Stanford,CAOtherExperienceandProfessionalMemberships2010-Site-PrincipalInvestigator-NIH/NHLBIARDSNetworkStatinsforAcutelyInjuredLungsfromSepsis(SAILS)Protocol,StanfordUniversityMedicalCenter,Stanford,CA2012-15Member,YoungAcademiciansCommittee,CriticalCareAssemblyoftheAmericanThoracicSociety2012-Facilitator,AmericanThoracicSocietyInternationalConference2013-Site-PrincipalInvestigator-NIH/NHLBILungInjuryPreventionStudywithAspirin(LIPS-A),Site-StanfordUniversityMedicalCenter,Stanford,CA2014-Site-PrincipalInvestigator-NIH/NHLBITheEsophagealPressure-GuidedVentilation2(EPVent2)Trial,StanfordUniversityMedicalCenter,Stanford,CA2014-Site-PrincipalInvestigator-NIH/NHLBIAllogeneicHumanMesenchymalStemCellsfortheTreatmentofAcuteLungInjury,StanfordUniversityMedicalCenter,Stanford,CA2015-Site-PrincipalInvestigator-NIH/NHLBINetworkforthePreventionandEarlyTreatmentofAcuteLungInjury,StanfordUniversityMedicalCenter,Stanford,CA2015-Member,VIOLETProtocolCommitteeforNIHPETALNetwork2015-Member,AmericanThoracicSocietyCriticalCareAssemblyProgramCommittee2015-Member,AmericanThoracicSocietyProgramReviewSubcommitteeHonors2009-2015NHLBIK23AwardeeC.
ContributionstoScience1.
MyrecentacademicfocushasbeenonearlyidentificationandtreatmentofpatientsatriskforARDS.
I'vecompletedaK23MentoredAwardtargetingtheseaims.
Alongwithmymentor,Dr.
MichaelMatthay,andmyco-leadinvestigator,Dr.
EmirFestic,weidentifiedinhaledbetaagonistsandcorticosteroidsaspotentialtreatmentforpreventionofARDS.
InaphaseIIastudy(LIPS-B),weestablishedthefeasibilityandpotentialefficacyofcombinedaerosolizedbudesonideandformoterolforimprovingoxygenationinpatientsatriskforARDS.
ThisnovelstudyisthefirstclinicaltrialtodemonstrateapositivesignalforpreventionofARDS.
Also,consistentwithotherstudiesdemonstratingtheimportanceofinflammatoryanddirect-lunginjurysubgroupsinARDS,wefoundimprovementinoxygenationprimarilyamongapre-specifiedsubgroupofpatientswithpneumonia.
WhileARDShasbeenafocusofmyresearchcareertodate,myexperiencewithlunginjurypreventionstudieshasconfirmedthatARDSisachallengingdiagnosistoreliablyadjudicateinclinicaltrialsandmaynotbeapatient-centricoutcomerelativetoacutehypoxicrespiratoryfailure(ARF).
Therefore,IhaveshiftedfocusfrompreventionofARDSinunselectedat-riskpatientstopreventionofARFinhypoxemicpatientswithseverepneumonia.
Ianticipatethiswillbeanimportantsteptowardreducingheterogeneityamongbothtrialsubjectsandendpoints,thusimprovingtheabilityoffutureclinicaltrialstoidentifypositivetreatmenteffectsinthisrealm.
a.
FesticE,CarrGE,Cartin–CebaR,HindsRF,Banner–GoodspeedV,BansalV,AsuniAT,TalmorD,RajagopalanR,FrankRD,GajicO,MatthayMA,LevittJE.
RandomizedClinicalTrialofaCombinationofanInhaledCorticosteroidandBetaAgonistinPatientsatRiskofDevelopingtheAcuteRespiratoryDistressSyndrome.
CritCareMed.
2017May;45(5):798-805.
(PMCID:PMC5392150)CritCareMedicne(inpress)b.
LevittJE,GouldMK,WareLB,MatthayMA.
PathogeneticandPrognosticValueofBiomarkersinAcuteLungInjury.
JIntensiveCareMed2009;24(3):151-67.
Review.
PMID:19282296.
c.
FesticE,Ortiz-DiazE,LeeA,LiG,KorDJ,AdebolaA,AkcaO,HothJ,LevittJE,CarterR,GajicO;UnitedStatesCriticalIllnessandInjuryTrialsGroup:LungInjuryPreventionStudyInvestigators(USCIITG-LIPS).
Prehospitaluseofinhaledsteroidsandincidenceofacutelunginjuryamongpatientsatrisk.
JCritCare.
2013Dec;28(6):985-91.
PMCID:PMC4219561d.
LevittJE,MatthayMA.
ClinicalReview:EarlyTreatmentofAcuteLungInjury:ParadigmShifttowardPreventionandTreatmentPriortoRespiratoryFailure.
CritCare2012,16:223.
PMCID:PMC35805962.
ARDScontinuestobeamajorcauseofmorbidityandmortalityincriticallyillpatients.
IhaveanactiveresearchinterestinimprovingthetreatmentofARDS.
Ihavebeenasite-principalinvestigatoronnumerousclinicaltrialsaspartoftheNIHARDSNetworkandnowthenewlyformedPETALNetwork,aswellasDr.
Matthay'songoingtrialofmesenchymalstemcellsforthetreatmentofARDS,asoutlinedabove.
Iamalsothesite-PIforthephaseIIbEsophagealPressure-GuidedVentilation2(EPVent2)Trial,whichistestingtheuseofanesophagealballoontoadjustpositiveend-expiratorypressure(PEEP)todesiredtranspulmonarypressures.
IamalsointerestedinnovelsubphenotypingofARDStobetteridentifypatientswiththehighestARDS-specificmortalitywhoaremostlikelytobenefitfromtargetedtherapies.
Aspreparationforthisongoingresearch,IhavepublishedmultiplereviewarticlesontheuseofbiologicmarkersforidentificationandphenotypingofpatientswithARDS.
a.
LevittJE,RogersAJ.
ProteomicsintheAcuteRespiratoryDistressSyndrome:currentknowledgeandimplicationsfordrugdevelopment.
ExpertReviewofProteomics.
2016,13(5):457-69.
PMID27031735.
b.
SweattAJandLevittJE.
EvolvingEpidemiologyandDefinitionsoftheAcuteRespiratoryDistressSyndromeandEarlyAcuteLungInjury.
ClinChestMed35(2014)609–624.
Review.
PMID:25453413c.
AgrawalA,ZhuoH,BradyS,LevittJ,SteingrubJ,SiegelMD,SotoG,PetersonMW,ChesnuttMS,MatthayMA,LiuKD.
PathogeneticandpredictivevalueofbiomarkersinpatientswithALIandlowerseverityofillness:resultsfromtwoclinicaltrials.
AmJPhysiolLungCellMolPhysiol2012;303(8):L634-9.
PMCID:PMC3469636d.
LevittJE,Bedi,HCalfeeC,GouldMK,MatthayMA.
IdentificationofEarlyAcuteLungInjuryatInitialEvaluationinanAcuteCareSettingPriortotheOnsetofRespiratoryFailure.
Chest2009;135(4):936-43.
PMCID:PMC27583053.
Qualitymetricsareanimportantcomponentofassessingandimprovingqualityofhealthcare.
However,metricsmayalsohaveunintendedconsequences.
IhaveanalyzedtheimpactofimplementationoftheLungAllocationScore(LAS)andincreasedscrutinyofthe1-yearsurvivalmetricfollowinglungtransplantation.
Wefoundthat,while1-yearsurvivalisunchangedpostimplementationoftheLAS,resourceutilizationhasincreased,survivalbeyond1yearhasdecreased,andasignificantincreaseinmortalityoccursimmediatelyafter1yearsuggestingthatphysiciansmaynowbecommittingdisproportionateresourcestopreservetheircenter's1-yearmortalitystatistics.
a.
MaxwellBG/LevittJE,GoldsteinBA,MooneyJJ,NicollsMR,ZamoraM,ValentineV,Weill,DhillonGS;ImpactoftheLungAllocationScoreonSurvivalbeyondOneYearpostLungTransplantation.
AmJTransplant.
2014Oct;2288-94.
PMCID:PMC4428280b.
MaxwellBG,MooneyJJ,LeePH,LevittJE,ChhatwaniL,NicollsMR,ZamoraMR,ValentineV,WeillD,DhillonGS.
Increasedresourceuseinlungtransplantadmissionsinthelungallocationscoreera.
AmJRespirCritCareMed.
2015Feb1;191(3):302-8.
PMCID:PMC4351576.
CompletelistofPublishedWorkinMyBibliography:http://www.
ncbi.
nlm.
nih.
gov/sites/myncbi/joseph.
levitt.
1/bibliography/40871347/public/sort=date&direction=ascendingD.
AdditionalInformation:ResearchSupportand/orScholasticPerformanceOngoingResearchSupportU01HL123004(MatthayPI)04/01/2014-03/31/20210.
48CMNIH/NHLBINetworkforthePreventionandEarlTreatmentofAcuteLungInjury(PETAL)Totestnewtherapeuticstrategiesfortheearlytreatmentandpreventionoftheacuterespiratorydistresssyndrome(ARDS)inPhaseIIItrialsinmultiplemedicalcenters5U01HL123004-02(MatthayPI)11/01/2015-04/30/20190.
84calendarNIH/NHLBIReevaluationofSystemicEarlyneuromuscularblockade(ROSE)PhaseIIIclinicaltrialwithinPETALNetworkofearlyuseofneuromuscularblockadeforthetreatmentofmoderatetosevereARDSRole:Site-PIU01-HL108724(TalmorPI)5/11/2014–4/30/20160.
36CMNIH/NHLBITheEsophagealPressure-GuidedVentilation2(EPVent2)TrialPhaseIIbclinicaltrialofesophagealpressuremeasuredguidedpositiveend-expiratorypressure(PEEP)inpatientswithmoderatetosevereacuterespiratorydistresssyndrome(ARDS)Role:Site-PICompletedResearchSupportU01HL1087137/01/2013–present1.
2CMNIH/NHLBISubcontractfromUCSF(MatthayPI)AllogeneicHumanMesenchymalStemCellsfortheTreatmentofAcuteLungInjuryThisisaphaseI/IIclinicaltrialtestthevalueofhumanmesenchymalstemcellsforthetreatmentofmoderatetosevereacuterespiratorydistresssyndrome(ARDS)inhumans.
Role:Site-PIK23HL091334(LevittPI)7/01/2009–11/30/20148.
0CMNIH/NHLBIEarlyAcuteLungInjury(EALI):AProspectiveEvaluationPriortoRespiratoryFailureThegoalistoidentifyAcuteLungInjurypriortoneedformechanicalventilationandestablishevidence-basedcriteriaforadefinitionofEarlyAcuteLungInjurytoallowenrollmentofsubjectsinarandomizedcontroltrialofaerosolizedalbuterolpriortoprogressiontoacutelunginjury.
Role:PI(Mentor:Matthay)N01HR056166Levitt(SitePI)7/1/2010–6/30/2014NIH/NHLBIClinicalResearchNetworkfortheTreatmentofAcuteLungInjury(ALI)andAcuteRespiratoryDistressSyndrome(ARDS)(contractfromNHLBI)(N01)TotestnewtherapeuticstrategiesforARDSinPhaseIItrialsinmultiplemedicalcenters.
Role:Site-PIU01HL108712(GajicPI)7/01/2013–8/31/20141.
2CMNIH/NHLBILungInjuryPreventionStudywithAspirin(LIPS-A)Role:Site-PINovelphaseIImulticenterclinicaltrialtargetingthepreventionofAcuteLungInjuryinhigh-riskpatientswithaspirin.
Role:Site-PI