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12/2/2015

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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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connections

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Connected19hoursago

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ContactInfo

friends

MinluHu
ResearchIntern,atVertex
Pharmaceuticals

LianMa
Email

adzhou2008@gmail.com

Linkedin
WeChat

https://www.linkedin.com/in/tianzhou2015

PharmacometricsRevieweratFDA

YanWang
StaffFellowatFDA

Tian

LiangZhao
Editthiscontactinfo

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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