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TianZhou
1st
ORISEfellowatFDA,OfficeofGenericDrugs,Division
ofQuantitativeMethodsandModeling
WashingtonD.C.MetroArea
Pharmaceuticals
Current
FDA,OfficeofGenericDrugs,DivisionofQuantitativeMethods
andModeling
Previous
FDA,OfficeofClinicalPharmacology,UniversityofPittsburgh,
SchoolofPharmacy,NanjingUniversityStateKeyLaboratory
ofPharmaceuticalBiotechnology
Education
UniversityofPittsburgh
358
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MinluHu
ResearchIntern,atVertex
Pharmaceuticals
LianMa
Email
adzhou2008@gmail.com
Linkedin
WeChat
https://www.linkedin.com/in/tianzhou2015
PharmacometricsRevieweratFDA
YanWang
StaffFellowatFDA
Tian
LiangZhao
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Background
Experience
ORISEPostdoctoralFellow
FDA,OfficeofGenericDrugs,DivisionofQuantitativeMethodsandModeling
Director,DivsionofQuantitative
MethodsandModeling,OGD/ORS
GraceYan
SeniorClinicalPharmacology
RevieweratFDA
XuyangSong
ClinicalPharmacokineticistat
AstraZeneca
NanZhang
ORISEFellowatFDA
June2015Present(7months) | SilverSpring,MD
PopulationPK/PDmodelingtofacilitateclinicaldevelopmentofinhaledasthmaproducts
ChaoLiu
PharmacometricsRevieweratUS
FoodandDrugAdministration
ORISEPostdoctoralFellow
FDA,OfficeofClinicalPharmacology
XuYuan
February2015May2015(4months) | SilverSpring,MD
ORISEFellowatFDA,Divisionof
Pharmacometrics,OfficeofClinical
Pharmacology
Summary:Investigatingtransportermediateddrugdruginteractionstofacilitatenewdrugdevelopment
andtoimprovepharmacotherapy
PengDuan
FDABiopharmaceuticsReviewer
1.Evaluatetheroleoftransportersinantiviraldrugdevelopment(Pgp,OATPs):evaluatetheabilityof
quantitativemetricsinpredictinginvivotransporterinhibitionbyantiviraldrugs.Thesemetricsare
outlinedintheinhibitordecisiontreesofFDA2012DDIguidanceandITCwhitepaper.
2.EvaluatethePgpdecisiontreeusingdatafromrecentlyapprovednewmolecularentities(NMEs)
(20112015):evaluatetheabilityofdifferentmetricsinpredictinginvivoPgpinhibitionbyNMEs.These
metricsareoutlinedinthePgpinhibitordecisiontreeofFDAguidanceandITCwhitepaper.
InCommonwithTian
Tian
3.Harmonizedrugdruginteractioninformationacrossprescribinginformation(labels):Developa
workflowtoidentifyandcorrecterrors/discrepanciesinDDIrelatedlabelinglanguageforallapproved
drugs,anddevelopastrategytopreventsuchdiscrepanciesfromhappeningagaininfuture.Current
focusisonthediscrepanciesbetweenantiviraldrugs(perpetrators),nonantiviraldrugs(victims),and
DDIguidance.
GraduateStudentResearcher
UniversityofPittsburgh,SchoolofPharmacy
June2011January2015(3years8months) | Pittsburgh,PA
Summary:Researchonthecriticalissuesinvolvedinbenchtobedsidedevelopmentoftopical
antiretroviraldrugproducts(microbicides)forthepreventionofsexuallytransmittedinfections
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1.PatientrelatedfactorsthatinfluenceantiretroviralPK/PD
ExaminedthemRNAexpressionofeffluxtransporters,uptaketransporters,andnuclearreceptorsin
thecervicovaginalandcolorectaltissuesofhumanandanimalmodels(macaque,rabbit,mouse),andin
celllinesderivedfromcervicovaginaltissuesorimmunesystemdeterminedtheproteinlocalizationof
selecttransportersinthecervicovaginalandcolorectaltissuesofhuman,macaque,rabbitandmouse
examinedtheeffectofmenstrualcycle,contraceptives,andinflammatorycytokinesontransporter
expressionincervicovaginaltissues,colorectumandimmunecells
Examinedtheroleofselecttransportersinantiretroviraldrugpharmacokineticsincervicovaginal
tissuesandimmunecells
Helpedcolleaguesinevaluatingtheexpression,function,andregulationofdrugmetabolizingenzymes
(CYPs,UGTs,nucleotidephosphorylatingenzymes)intransmissionrelatedtissuesandcells
Analyzeddata,preparedmanuscripts,progressreports,SOPs,andgrantproposals
Mentoredgraduateandundergraduatestudentsinwritingreviewpapersandexecutingexperiments.
2.FormulationrelatedfactorsthatinfluenceantiretroviralPK/PD
Developedandevaluatedavaginalfilmcontaininganaminoglycosideantibiotic(Tobramycin),which
couldreawakentheproductionofasilencedantiviralpeptideretrocyclininhumancells,coordinatedthe
PK,safety,andefficacyevaluationsofthefilmproductsincelllinesormacaques
Participatedinastudyevaluatingtheeffectofcommonlyusedformulationexcipientsontheepithelial
permeability,integrity,andtenofovirPK/PDinhumanectocervicaltissueexplantmodelofHIV1
infection.
1
SkillorExpertise
2
Languages
1
Cause
GraduateStudentResearcher
UniversityofPittsburgh,SchoolofPharmacy
August2008May2011(2years10months) | Pittsburgh,PA
Summary:Addressingcriticalissuesintheadvancementofanonviralgenetherapytechnologyfrom
smallanimalmodelstopatients
Majorproject:Identifiedhostfactorsthatinfluenceplasmiddeliveryefficiencyandtransgeneprotein
production,tooptimizetheeffectivenessandsafetyofhydrodynamicgenedelivery(HGD)forliver
basedgenetherapy.Myworkincluded:
EvaluatedtheeffectivenessandsafetyofusingHGDforhepaticgenedeliveryinrats
Testedtheinfluenceofpathophysiologicalfactors(liverfibrosis,species,age)onthekineticsof
transgeneproteinlevelsinplasmaandliver,usingratsandmiceasresearchmodels
Examinedthedifferentialpatternsofepigeneticcontroloftransgeneexpressioninmouseandratliver,
asapotentialmechanismunderlyingtheinterspeciesdifferenceinthekineticsoftransgeneprotein
levelsbetweenmiceandrats
Examinedtheeffectofliverdiseaserelatedcytokines(ILsandIFNs)onthepersistencyoftransgene
expressioninmouseliver
Analyzeddataandpreparedmanuscripts.
Graduatestudentresearcher
NanjingUniversityStateKeyLaboratoryofPharmaceuticalBiotechnology
September2005July2008(2years11months) | Nanjing,China
Majorproject:GeneticallymodifythemarinefungusPhomaherbarumYS4108towardbetterproductivity
ofanantitumorpolysaccharideYCP
ClonedGAPDHandactinpromotersfromthefungus,andconstructedreporterplasmidsforthe
developmentofagenetransformationplatformthatcanbeusedforgeneticmodification
ClonedthefulllengthcDNAofkeyenzymesinvolvedinthebiosynthesisofYCPpolysaccharide,
includingUDPglucosepyrophosphorylase(UGPase)andUDPglucose6dehydrogenase(UGDH)
Constructedexpressionvectors,expressedUGPaseinE.coliandUGDHinP.pastoris,and
characterizedthebiochemicalpropertiesofthepurifiedrecombinantUGDH
Analyzeddataandpreparedmanuscripts.
Skills
TopSkills
4
Drugpermeability
TEERmeasurement
Effluxratio
CellCulture
WesternBlotting
Rodenthandling
HPLCUV,LCMS/MS
Formulation
Histologicalstaining...
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Topicalfilmandgel
Tianalsoknowsabout...
1
UssingChamber
RNA/gDNA/plasmid...
ELISA
IACUCprotocolwriting
MolecularCloning
FranzCell
Plasmidconstruction
Recombinantprotein...
1
2
qRTPCR
SDSPAGE
Grantwriting
SOPwriting
AnimalModels
1
1
Progressreport...
Biotechnology
Courses
UniversityofPittsburgh
DrugDevelopment2(PharmDcourse,focusingonclinicalpharmacokinetics)
DrugDevelopment3(PharmDcourse,focusingonpharmaceuticsanddosageforms)
PharmacologyandTherapeutics
FoundationsinPharmaceuticalScience
PharmaceuticalAnalysis
AdvancedPharmacokinetics
TopicsinBiopharmaceuticsandPharmacokinetics
AdvancesinPharmaceuticalSciences
PharmaceuticalSciencesSeminar
StatisticalMethods
EssentialsofCompetitiveGrantWriting
TeachMetoTeachYou(graduatecourse,focusingonteachingmethodologies)
Education
UniversityofPittsburgh
DoctorofPhilosophy(PhD),Pharmaceutics(drugformulation,transportersand
metabolizingenzymes)
20112014
12courses,including:
UniversityofPittsburgh
MasterofScience(M.S.),Pharmaceutics(genetherapy)
20082011
NanjingUniversity,StateKeyLaboratoryofPharmaceutical
Biotechnology
MasterofScience(MS),MicrobiologyandBiopharmaceutics
20052008
ChinaPharmaceuticalUniversity
BS,Biotechnology(biologicsandpharmaceuticalbiotechnology)
20012005
HighSchoolAffiliatedtoNanjingNormalUniversity(NSFZ)
19982001
Languages
English
Chinese
Fullprofessionalproficiency
Nativeorbilingualproficiency
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VolunteerExperience&Causes
CausesTiancaresabout:
Environment
Health
HumanRights
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