FDA Commissioner’s Fellowship Program Class of 2011

2

FDACommissioner’sFellowshipProgram

2011Fellows

Abrams,Barbara………………………………….10Alum,Absar…………………………………………11Anderson,Kimberly……………………………..12Ceric,Olgica………………………………………...13Chang,Cynthia……………………………………..14Clotilde,Laurie…………………………………….15Erkkila,Brian……………………………………...16Ghadiali,Ali iya…………………………………...17Haggart,Charles…………………………………..18Haque,Ahsanul……………………………………19Kang,Yanna………………………………………...20Kelly,Jennifer……………………………………...21Liu,Gumei…………………………………………...22Mahadevan,Gajendiran……………………….23Mendicino,Michael……………………………...24Meyer,Clark………………………………………..25

Momper,Jeremiah……………………………….26Nguyen,Anh………………………………………..27Pang,Li……………………………………………….28Park,Ji‐Young……………………………………..29Petrova,Katya…………………………………….30Rath,Prakash……………………………………...31Rout,Subrat………………………………………..32Schultz‐Kuszak,Kristin………………………..33Sheikh,Jalal………………………………………...34Swoboda,Jonathan……………………………...35Tan,Wendy………………………………………...36Yancy,Jacquline…………………………………..37Yang,Xiaoxia……………………………………….38Yoon,Diana………………………………………...39Zhao,Shifu…………………………………………..40

3

FDACommissioner’sFellowshipProgram

2011Preceptors

Alterman,Michail……………………….42Benton,Kimberly……………………….43Burckart, Gilbert………………………..44Chiesa, O. Alberto……………………….45Duraiswamy,Nandini…………………46Elkins, Karen………………………………47Fisher, Jeff………………………………….48Hartman,Gary…………………………….49Himathongkham,Sunee…………….. . 50Kase,Julie…………………………………..51Lin, Andrew………………………………..52Linder, Sean……………………………….53Luke,Markham…………………………..54Lyn‐Cook,Beverly…………………….. . 55Major, Marian…………………………….56Mans ield, Elizabeth and Serrano,Katherine,co‐preceptors………….. . 57McNamee,Scott………………………….58

Mirza, Tahseen…………………………..59Moynahan,Megan………………………60Pariser, Anne……………………………..61Reimschuessel, Renate……………… 62Richardson,Anita………………………63Schnackenberg,Laura………………..64Seyfert‐Margolis, Vicki…………….. . 65Shieh,Y. Carol………………………….. . 66Sudarsan,Sithu………………………….67Yeager, Phil……………………………….68Regenerative Medicine Project Preceptors: Dang,Jiyoung;Lee, Mark;Mallis, Elias;andOh,Steven…………….69‐72

4

FDACommissioner’sFellowshipProgram2011PreceptorsandFellowsProjectslistedbytheirReg-

ulatorySciencePriorityAreaFDA’sRegulatorySciencePriorityAreasarearticulatedintheStrategicPlanforAdvancingRegulatoryScienceatFDA. ModernizeToxicologytoEnhanceProductSafetyAnAssessmentoftheRisksAssociatedwithChildhoodExposuretoEnvironmentalTobaccoSmoke,byFellowBrianE.Erkkila,Ph.D.andPreceptorRaymondYeager,Ph.D.PharmacokineticModeling:PredictionandEvaluationofRouteDependentDosimetryofBi-sphenolAinRatsatDifferentDevelopmentStages,by Fellow Xiaoxia Yang, Ph.D. and Pre‐ceptorJeffreyFisher,Ph.D.Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient OutcomesDevelopmentalEffectsonWarfarinPharmacogenomicsinYoungPediatricPatients,by Fel‐lowJeremiahMomper,Pharm.D.,Ph.D.andPreceptorGilbertBurckart,Pharm.D.TheRoleofABC-DrugTransportersinChemoresistanceinPancreaticCancer:AssessingDrugSafetyandEf icacy,byFellowLiPang,M.D.andPreceptorBeverlyLyn‐Cook,Ph.D.ImprovementofHepatitisCVirus(HCV)VaccinesthroughPhenotypicT-cellAnalysisandPo-tencyAssayDevelopment,byFellowWendyTan,Ph.D.andMarianMajor,Ph.D.Support New Approaches to Improve Product Manufacturing and QualityDevelopmentofinvitroModelsforthePredictionofinvivoFoodEffectonDrugs,by FellowAhsanulHaque,RPh,Ph.D.,RACandPreceptorsTahseenMirza,Ph.D.andMansoorKhan,Ph.D.SciencePolicyandComplianceProgramRisk-ModelingRelatedtotheRegulationofHumanCells,Tissues,andCellularandTissue-BasedProducts(HCT/Ps),by Fellow Prakash Rath,Ph.D.andAnitaRichardson,M.A.S.,B.S.,M.T.(ASCP)ProteomicCharacterizationofMultipotentStromalCellsSeededonDifferentScaffoldstoUn-coverOsteogenicDifferentiationBiomarkers,by Fellow Kristin Schultz‐Kuszak, Ph.D. andPreceptorMichailAlterman,Ph.D.RapidMicrobiologicalMethods (RMM) for Sterility Testing of Cellular andGene TherapyProducts,byFellowJalalSheikh,Ph.D.andPreceptorKimberlyBenton,Ph.D.Ensure FDA Readiness to Evaluate Innovative Emerging TechnologiesDeveloping Guidance Documents for Research Use Only/Investigational Use Only Compo-nents in in-vitroDevicesandRisk-basedClassi icationofNovel in-vitroDevices, by FellowBarbaraDembyAbrams,M.D., J.D. andPreceptorsElizabethMans ield,Ph.D. andKathe‐rineSerrano,B.S.

5

FDACommissioner’sFellowshipProgram2011PreceptorsandFellowsProjectslistedbytheir

RegulatorySciencePriority Area,cont...

Cross-centerIdenti icationofStandardstoEnhancethePremarketReviewProcessforScaffold-basedProducts,suchasSurgicalMeshDevicesandCell-scaffoldEngineeredCombinationProducts,by Fel‐lowCynthia J. Chang,D.Phil. andPreceptorsStevenOh,Ph.D.,MarkH. Lee,Ph.D., JiyoungDang,Ph.D.,andEliasMallis,B.S.DetectionofShigaToxin-ProducingEscherichiacoli,byFellowLaurieM.Clotilde,Ph.D.andPrecep‐torAndrewLin,Ph.D.U.S.MedicalDevice Innovation (2000-2011):AnAnalysisofRegulatoryDecisionPointsandTotalTime-to-MarketforPMAandDeNovoDevices,byFellowCharlesHaggart,Ph.D.andPreceptorsMe‐ganMoynahan,Ph.D., MurraySheldon,M.D.andDayaRanamukhaarachchi,Ph.D.AdvancingRegulatoryScienceandInnovation inStemCellsandRegenerativeMedicine,by FellowMichael Mendicino, Ph.D. and Preceptors FrankWeichold, M.D. and Vicki Seyfert‐Margolis.Ph.D.(CBERMentors:SteveBauer,Ph.D.andKeithWonnacott,Ph.D.)ComputationalModelingofDevice,Tissue,andDevice-Tissue Interaction forDeviceEvaluation,byFellowClarkMeyer,Ph.D.andPreceptorNandiniDuraiswamy,Ph.D.GuidanceDevelopmentforFutureMedicalDevices,byFellowAnhNguyen,M.D.,MBAandPreceptorMarkhamLuke,M.D.,Ph.D.DevelopmentMethodologiesfortheCharacterizationofFDARegulatedLiposomalProducts,by Fel‐lowJi‐YoungPark,Ph.D.andPreceptorSeanW.Linder,Ph.D.DevelopmentandApplicationofLC-SPE-NMRMethodstoEvaluateBiomarkersofHepatotoxicity,byFellowKatyaPetrova,Ph.D.andPreceptorLauraSchnackenberg,Ph.D.DevelopmentofGuidance forDirect-to-Consumer (DTC)GeneticTesting: ARapidandSystematicApproachforDeterminingtheClinicalSigni icanceandValidityofAddingNewIntendedUsestoal-readyApproved/clearedDTCGeneticTests,by Fellow Jacquline AM Yancy, Ph.D. and ElizabethMans ield,Ph.D.andKatherineM.Serrano,B.S.OpportunitiesandChallengesofUsingStandardsforPremarketReviewofBoneRegenerativeMedi-cineProductsatCBERandCDRH,byFellowDianaM.YoonandPreceptors JiyoungM.Dang,Ph.D.,MarkH.Lee,Ph.D.,andEliasMallis,B.S.TheFDAPatient-CenteredOutcomesResearch(PCOR)PromotingPersonalizedMedicine,byFellowShifuZhao,Ph.D.andPreceptorsFrankWeichold,M.D.andVickiSeyfert‐Margolis.Ph.D.HarnessDiverseDatathroughInformationSciencestoImproveHealthOutcomesMedicalDeviceAdverseEventLabeling(MEDAL)–AnAutomatedTextMiningApproach,by FellowYannaS.Kang,Ph.D.andPreceptorsSithuSudarsan, Ph.D. andBrianFitzgerald,B.Sc.TheRoleofNaturalHistoryStudiesinDrugDevelopmentforRareDiseases,by Fellow Gumei Liu,Ph.DandPreceptorAnnePariser,M.D.

6

FDACommissioner’sFellowshipProgram2011PreceptorsandFellowsProjectslistedbytheirReg-

ulatorySciencePriorityArea,cont...

Implement a New Prevention-Focused Food Safety System to Protect Public HealthDevelopmentofaMethodtoConcentrateNorovirusinFoodsandEvaluationofCellCultureSystemforVirusPropagation,by Fellow Absar Alum, Ph.D. and Preceptor Y. Carol Shieh,Ph.D.RapidMolecularTypingofShigaToxin-ProducingEscherichiacoliUsingtheAutomatedDi-versiLabÔRepetitive-Sequence-BasedPCRSystem,byFellowKimberlyAnderson, Ph.D. andPreceptorSuneeHimathongkham,Ph.D.,D.V.M.,M.P.V.M.InvestigationofEtiologyofChickenJerkyTreatRelatedRenalFailureandFanconiSyndromeinDogs,byFellowOlgicaCeric,Ph.D.andPreceptorRenateReimschuessel,Ph.D.TheDevelopmentofaHighThroughputQuantitativeScreenforAdulterantsinDietarySup-plements,byFellowEricCheaandPreceptorArefEl‐Demerdash,Ph.D.RecommendationsforLaboratorySurveillanceandScreeningofPathogenicEscherichiacoliinFoodProductsUsingMolecularMethods, byFellowAli iyaH.Ghadiali,Ph.D.andPrecep‐torJuliaA.Kase,Ph.D.DeterminationofAntimicrobialDrugConcentrationsinIntestinalTissuesandDigestiveSe-cretions fromTreatedSteers.An InitialPhase toCorrelateAntimicrobialDrugConcentra-tionsinPlasmaandDigestiveSecretions,by Fellow GajendiranMahadevan, Ph.D. and Pre‐ceptorOscar(Alberto)Chiesa,D.V.M.,M.S.,Ph.D.DevelopmentofaLiquidMid-DensityMicroArrayAssayfortheDetectionofFood-BorneEn-tericVirusesusingLuminex®xMAPTMTechnology,by Fellow Subrat Rout, Ph.D. and GaryHartman,M.A.Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and SecurityTheEffectofExtremeWeatherEventson the IntegrityandSafetyofMedicalDevicesandGuidancetowardMitigatingFutureChallenges,by Fellow Jennifer Kelly, Ph.D. and ScottMcNamee.Ph.D.TheBiologicalRoleoftheCytokinep40inClearingChronicInfectionsCausedbyVaccinationwithFrancisellaTularensisLiveVaccineStrain(LVS),by Fellow Jonathan Swoboda andPreceptorKarenElkins,Ph.D.

7

CBERPreceptor FellowMichaelAlterman KristinSchultz‐KuszakKimberlyBenton JalalSheikhKarenElkins JonathanSwobodaMarianMajor WendyTanAnitaRichardson PrakashRathCDERPreceptor FellowGilbertBurckart JeremiahMomperTahseenMirzaandMansoorKhan AhsanulHaqueAnnePariser GumeiLiuCDRHPreceptor FellowNandiniDuraiswamy ClarkMeyerMarkhamLuke AnhNguyenElizabethMans ieldand JacqulineYancyandKatherineSerrano BarbaraAbramsScottMcNamee JenniferKelly

MeganMoynahan, MurraySheldon,andDayaRanamukhaarachchiCharlesHaggart

BrianFitzgeraldandSithuSudarsan YannaKangCFSANPreceptor FellowJulieKase Ali iyaGhadialiY.CarolShieh AbsarAlumCTPPreceptor FellowPhil(Raymond)Yeager BrianErkkila

FDACommissioner’sFellowshipProgram2011PreceptorsandFellowsbyCenter

8

CVMPreceptor FellowO.AlbertoChiesa GajendiranMahadevanRenateReimschuessel OlgicaCericNCTRPreceptor FellowJeffFisher XiaoxiaYangBeverlyLyn‐Cook LiPangLauraSchnackenberg KatyaPetrovaOCPreceptor FellowFrankWeicholdandVickiSeyfert‐Margolis MichaelMendicinoand ShifuZhaoORAPreceptor FellowGaryHartman(CA) SubratRoutSuneeHimathongkham(CA) KimberlyAndersonAndrewLin(CA) LaurieClotildeSeanLinder(AR) Ji‐YoungParkRegenerativeMedicineProjectPreceptor FellowEliasMallis, CynthiaChangandJiyoungDang, DianaYoonMarkLeeandStevenOh

FDACommissioner’sFellowshipProgram2011PreceptorsandFellowsbyCenter,cont...

9

FDACommissioner’sFellowshipProgram2011Fellows

10

Scienti icandProfessionalBackground2005‐2011Medical‐LegalConsultanttoFlorida’sDept.ofHealthintheareaofDisability DeterminationsandtoFlorida’sCourtSystemintheareasofGuardianship/ IncapacityandMentallyRetardedCriminalDefendants2002‐2005J.D.,FloridaStateCollegeofLaw1989‐2002PrivatePracticeofPrimaryCareClinicalPediatrics1986‐1989PediatricInternshipandResidencyatClevelandMetropolitanGeneral1981‐1986M.D.,BostonUniversitySchoolofMedicine1979‐1986B.A.inMedicalScience,BostonUniversityResearchInterestsMydiverse educational andprofessional experience enablesme tobridgedifferent ields. I amparticularlyinterestedinimprovingpublichealthpolicybyhelpinglegalprofessionalsunderstandmedical/scienti ic issues, helpingmedical/scienti ic professionals understand regulatory issues,andhelpingFDAstakeholdersandthepublicunderstandmedical,scienti ic,andregulatoryissues.Commissioner’sFellowshipProjectOverviewDevelopingGuidanceDocuments forResearchuseOnly/InvestigationalUseOnlyComponents in invitroDevicesandRisk-basedClassi icationofNovelinvitroDevicesRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologiesMyprojectispartofabroaderCDRHinitiativetodevelopgreatertransparencyinitsapproachtoregulatorydecisionmakingforproductapproval. Iwillbeworkingontwoguidancedocuments.The irstwillfocusontheappropriatepromotionandmarketingofresearchuseonlyandinvesti‐gationaluseonlycomponents.ThesecondwillinvolveexplaininghowFDAconsidersriskfornov‐el invitrodiagnostic(IVD)devices forthepurposeofdeviceclassi ication. Myprojectwillcon‐tributetotheFDA’smissionbyprovidinginformationtostakeholdersonFDA’sthinkingregardingIVDproducts. Providinggreater transparencyonhowCDRHmakes classi icationdecisionsandclarifyingtheappropriatepromotionandmarketingofproductsadvancesregulatoryscienceandbene itsthemanufacturersofmedicaldevices,thelaboratoriesandhealthcareproviderswhousethemedicaldevices,andthepublic.

BarbaraDembyAbrams,M.D.,J.D.

CenterforDevicesandRadiologicalHealth(CDRH)Of iceofInVitroDiagnostics

Preceptors:ElizabethMans ield,Ph.D.and

KatherineSerrano,B.S.

11

Scienti icandProfessionalBackgroundPh.D.―EnvironmentalMicrobiology―UniversityofArizona,2001FacultyResearchAssociate,2001‐2006NationalScienceFoundationWaterQualityCenteratArizonaStateUniversityAssistantProfessorResearch,2006‐2011Civil,EnvironmentalandSustainableEngineering,ArizonaStateUniversityResearchInterestsMyresearchinterestisintheareaofhealthrelatedenvironmentalmicrobiologywithprimaryfo‐cusonthesurvival,transport,andcontrolofmicrobialpathogensinvariousenvironmentalmatri‐cesspeci icallywaterandfood.Ihaveextensiveexperienceintheapplicationofcellcultureandmoleculartechniquesforthedetectionofpathogens. Rapidmethodsforthedetectionofpathogensinfoodandwater MethodsforconcentratingpathogensinfoodandwaterCommissioner’sFellowshipProjectOverviewDevelopmentofaMethodtoConcentrateNorovirusinFoodsandEvaluationofCellCultureSystemforVirusPropagationRegulatory Science Priority Area:ImplementaNewPrevention‐FocusedFoodSafetySystemtoProtectPublicHealthIntheUS,entericvirusesareresponsiblefor59%ofthetotalfoodbornegastroenteritisoutbreaks.Humannorovirusesareasigni icantcauseofviralgastroenteritisintheUSandaroundtheworld.Globally,morethan50%oftheviralgastroenteritisoutbreaksarecausedbyhumannoroviruses.Duetotheirhighlycontagiousnature,norovirusesareclassi iedascategoryBbiodefenseagent.Ef icientandrapidmethodsfortheconcentrationanddetectionofinfectiousvirusesinfoodsareanurgentneedundertheFDA’sfoodsafetymandate.Weplan todeveloparapidmethod thatcanbeperformed inaroutinemicrobiology laboratorysettingtoconcentrate lowlevelsofnorovirusesinvarietyof freshproducematrices. Inadditionweplantoevaluatevariousfactorsthatfacilitatenorovirusattachmentandinfectionofmammali‐ancellscultures.

AbsarAlum,Ph.D.

CenterforFoodSafetyandAppliedNutrition(CFSAN)FDAMoffettCenter,BedfordPark,IL

Preceptor:Y.CarolShieh,Ph.D.

12

Scienti icandProfessionalBackground2006‐2011 PostdoctoralFellow,LoyolaUniversityMedicalCenter,Maywood,IL Advisor:ProfessorTarunB.Patel2004‐2006 PostdoctoralFellow,Children’sMemorialResearchCenter,Chicago,IL Advisor:Dr.EricG.Bremer1998‐2004 GraduateStudent,TulaneUniversity,NewOrleans,LA Mentors:ProfessorYu‐TehLiandDr.Su‐ChenLiResearchInterests Developmentofrapidhigh‐throughputassaysfortheisolationandidenti icationofbacterial

foodbornepathogens Investigatethecontributionofstressinitiatedduringfoodprocessingontheactivationofbac‐

terialresistancegenes IsolationandcharacterizationofbiomedicallyusefulenzymesfrombacterialsourcesCommissioner’sFellowshipProjectOverviewRapidMolecularTypingofShigaToxin-ProducingEscherichiacoliUsingtheAutomatedDiversiLabÔRepetitive-Sequence-BasedPCRSystemRegulatory Science Priority Area:ImplementaNewPrevention‐FocusedFoodSafetySystemtoProtectPublicHealthThelengthoftimeinvestedinmicrobialsourcetrackingisakeyfactorintheabilityoffoodregula‐toryagenciestoassessfoodborneoutbreaksinreal‐time.Although,thediscriminatorypowerofPulsed FieldGel Electrophoresis (PFGE) formolecular subtyping iswell documented, the PFGEprocess is labor‐intensiveandtime‐consuming. RapidPCR‐basedtypingmethodsmayprovein‐valuabletoolsforcomplimentingthediscriminatorypowerofPFGE,andthereisgreatinterestinusingtheDiversiLabrep‐PCRsystemformicrobialgenotyping.ThegoalofthisCFPstudyistousetheDiversiLabsystemtocharacterizeabatteryofshigatoxin‐producingE.coli(STEC)isolatesanddeterminewhetherrep‐PCRcandifferentiatebetweenandamongknownPFGE‐subtypes.WewillnotonlyexaminethereproducibilityandtypingabilityoftheautomatedDiversiLabrep‐PCRsys‐temforSTEC,butalsocreatealibraryofrep‐PCRpatternsfromwell‐characterizedSTECisolates.Inadditiontothis,ourprojectwillassesstheDiversiLabrep‐PCRsystem’sabilitytodiscriminateamongSTECisolatesbycomparingresultstothoseobtainedwiththe‘goldstandard’PFGEmeth‐od.The indingsof thisprojectmay improve theabilityof regulatoryagencies todetectandre‐spondtofoodsafetyproblemsbyfacilitatingtheidenti icationofmicrobialcontaminantsduringoutbreaks.

KimberlyM.Anderson,Ph.D.

Of iceofRegulatoryAffairs(ORA)SanFranciscoDistrictOf ice,Alameda,CA

Preceptor:SuneeHimathongkham,Ph.D.,D.V.M.,M.P.V.M.

13

Scienti icandProfessionalBackground07/2006 Ph.D.UniversityofBelgrade,Serbia.FacultyofVeterinaryMedicine,Departmentof

FoodHygieneandTechnology.2004‐2006 ManagementRepresentative(QualityControlManager).VeterinarySpecialists

Institute“Pancevo”,Pancevo,Serbia.2000‐2006 Associate,Serology.VeterinarySpecialistsInstitute“Pancevo”,Pancevo,Serbia.07/2001 M.S.UniversityofBelgrade,Serbia.FacultyofVeterinaryMedicine,Departmentof

FoodHygieneandTechnology.1996‐2000 Associate,FoodLaboratory.VeterinarySpecialistsInstitute,“Pancevo”,Pancevo, Serbia.06/1996 B.S.UniversityofBelgrade,Serbia.FacultyofVeterinaryMedicine,Departmentof

FoodHygieneandTechnology.ResearchInterestsIhave10yearsofcombinedexperienceinveterinarydiagnosticsandfoodmicrobiology.MyMas‐ter’sthesisresearchinterestswererelatedtosensoryanalysesofchickenmeat.MyPh.D.researchwas focusedondeterminationof factorssigni icant forpresenceof arsenicandheavymetals insnail tissues. My recent research interests are related to investigating potential problemswithFDA/CVMregulatedproducts‐animalfoodsandanimaldrugs.Commissioner’sFellowshipProjectOverviewInvestigationofetiologyofChickenJerkyTreatRelatedRenalFailureandFanconiSyndromeinDogsRegulatory Science Priority Area:ImplementaNewPrevention‐FocusedFoodSafetySystemtoProtectPublicHealthInSeptemberof2007,FDAissuedacautionarywarningregardingchickenjerkyproductsimport‐edfromChinatoconsumers,andaPreliminaryAnimalHealthNoti icationinDecemberof2008.Thenumberofcomplaintsdroppedoffduring2009and2010,butin2011thereisanincreaseinthe number of complaints of dog illnesses associatedwith consumption of chicken jerky treats.Signs reported in the complaints includedecreased appetite; decreased activity; vomiting; diar‐rhea, sometimeswithblood; increasedwater consumptionand/or increasedurination. In somecases, blood tests indicate kidney failure (increased urea nitrogen and creatinine), occasionallycoupledwithFanconisyndrome(increasedurinaryglucosewithnormalbloodglucose).FDA, incollaborationwithseveralveterinarydiagnosticlaboratoriesintheU.S., isworkingtodeterminewhy theseproductsareassociatedwith illness indogs.Todate,despitechemicalandmicrobialtesting,scientistshavenotbeenabletodetermineade initivecauseforthereportedillnesses.Theobjectiveofourprojectistotestchickenjerkyproductsfocusingonagentsknowntocausekidneyfailure/Fanconisyndrome

OlgicaCeric,Ph.D.

CenterforVeterinaryMedicine(CVM)

Preceptor:RenateReimschuessel,Ph.D.

14

Scienti icandProfessionalBackground2011 D.Phil.OrthopaedicSurgery

UniversityofOxford&NationalInstitutesofHealth(NIH)collaborativeprogram2006 B.S.Bioengineering

RiceUniversity,Houston,TXResearchInterestsMy research background lies in tissue engineering and regenerativemedicine, with a focus onmusculoskeletalandorthopaedicapplications.Myscienti ic interestsalso includestemcellsanddifferentiation,three‐dimensionalcellculture,mechanobiology,andbiomaterials.Formydoctoralresearch,Iinvestigatedtheregenerativemechanismsbehindthesurgicalbonelengtheningproce‐dureofdistractionosteogenesis(DO),auniqueexampleoftheformationofnew,organizedtissuein adults caused bymechanical strain.Mywork involved amousemodel and an invitro three‐dimensionalcell‐scaffoldconstructmodeltoprovidebasicinformationabouthowcellsrespondtomechanobiologicalcuesintheirenvironment.

Commissioner’sFellowshipProjectOverviewCross-centerIdenti icationofStandardstoEnhancethePremarketReviewProcessforScaffold-basedProducts,suchasSurgicalMeshDevicesandCell-scaffoldEngineeredCombinationProductsRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologiesIntheevaluationofthesafetyandef icacyofamedicalproduct,preclinicaltestingisrequiredtodemonstratethattheproductwillperformappropriatelyintheclinicalsetting.Fordifferentprod‐ucts inasingleproductclass,manyperformancerequirementswillbethesame.Asaresult, thetest methods and requirements are often similar, and may be based on published consensusstandards, such as standard test methods. The objective of this project is to facilitate the pre‐marketevaluationofsurgicalmeshdevices,throughtheassessmentandpromotionofstandardsuseful to performance testing of these products. Because regenerativemedicine (RM) productsincludescaffoldcomponents thataresimilar inmaterialsand function tosurgicalmeshdevices,thisprojectwillhaveabroaderimpactinenhancingthepremarketevaluationprocessforscaffold‐basedRMproducts.

CynthiaJ.Chang,D.Phil.

RegenerativeMedicineProjectCenterforDevicesandRadiologicalHealth(CDRH)

CenterforBiologicsEvaluationandResearch(CBER)

Preceptors:JiyoungM.Dang,Ph.D.(CDRH),MarkH.Lee,Ph.D.(CBER),and

EliasMallis,B.S.(CDRH)

15

Scienti icandProfessionalBackground2008‐2011 ResearchBiologist,USDA‐ARS2004‐2008 Ph.D.CellularandMolecularBiology,UniversityofNevada‐Reno2003‐2004 M.S.AnimalSciences,UniversityofNevada‐Reno1999‐2003 B.S.Biology,UniversityofNevada‐RenoResearchInterestsMycurrentresearchinterestsareintheareaofmicrobialfoodsafety,speci icallyfocusingonde‐veloping fasterdetectionmethods forShiga toxin‐producingEscherichiacoli (STEC).While Iwasat the USDA, I developed a macro‐ and microbead‐based immunoassay for detecting differentSTECserogroupsandtheirShigatoxinsinvariousfoodmatrices.Mydoctoralworkfocusedonex‐ploringtherelationshipbetweenSTECprevalenceandpre‐harvestcontrolmeasuresto improvesafetyof cattleand theirproducts, and identifying themolecularaspectsof the recoveredSTECisolates.Commissioner’sFellowshipProjectOverviewDetectionofShigaToxin-ProducingEscherichiacoli.Regulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologiesBecauseof the increaseofoutbreakscausedbynon‐O157Shiga toxin‐producingEscherichiacoli(STEC), facilitating and speeding the detection of those organisms in contaminated foods is be‐comingextremelyimportant. Therefore,weproposetocompareandimprovetheef iciencyofa10‐Plex PCR‐based Luminex assay (E.coliserogroups O26, O45, O91, O103, O111, O113, O121,O128,O145,andO157),a9‐PlexantibodybasedLuminexassay(Shiga toxins1and2[Stx1andStx2],E.coliserogroupsO26,O45,O103,O111,O121,O145, andO157), and anewlydevelopedagar(SHIBAM)tothemethodsusedintheFDA‐BacteriologicalAnalyticalManual(BAM;Chapter4a).ThesedifferentassayshavebeenpreviouslydevelopedbythePrincipalInvestigatorand/orherpreceptorandwillbefurthertestedinshreddedcheeseandsprouts.UsingtheLuminextech‐nologypresentmanyadvantages:1)Themultiplexedformat(upto100analytes)willsavetime,reagents,andtestsample;and2)ManyFoodandDrugAdministration(FDA),FoodSafetyandIn‐spection Service (FSIS), and Food EmergencyResponseNetwork (FERN) laboratories currentlyutilizetheLuminexplatformforotherassays.Thereforeourassaywouldbedirectlytransferableandimplementedbytheselaboratories.AlsoanagarcapableofmorerapidlydifferentiatingSTECfrombackgroundorganismswillshortentheisolationprocess.WewillalsoexplorethepossibilityofusingRamanspectral ingerprintingforrapididenti icationofbacterialisolates.

LaurieM.Clotilde,Ph.D.

Of iceofRegulatoryAffairs(ORA)SanFranciscoDistrictOf ice,Alameda,CA

Preceptor:AndrewLin,Ph.D.

16

Scienti icandProfessionalBackground2008‐2011 Post‐DoctoralAssociate,NationalInstitutesofHealth(NICHD)2007‐2008 Post‐DoctoralAssociate,UniversityofTexasHealthScienceCenteratSanAntonio

(UTHSCSA)2007 Ph.D.Neurobiology,UniversityofAlabamaatBirmingham2000 B.A.Neuroscience,TheJohnsHopkinsUniversityResearchInterestsMyresearchfocushasmainlybeenthestructure,functionandpharmacologyofneurotransmitterreceptors.Mygraduateworkfocusedonthebiophysicalmechanismbywhichpesticidesandoth‐ercompoundsmodulatenicotinicandGABAergicligand‐gatedionchannels.Whileapost‐doctoralassociateattheNIH,Ibroadenedmyscopetoexaminehowthisreceptormodulationin luencedinterneuronmigrationduringdevelopment.Ihopetobuilduponthismolecular,biophysicalanddevelopmental knowledgebase to further the scienti ic and regulatorymissionof theFoodandDrugAdministration.Commissioner’sFellowshipProjectOverviewAnAssessmentoftheRisksAssociatedwithChildhoodExposuretoEnvironmentalTobaccoSmokeRegulatory Science Priority Area:ModernizeToxicologytoEnhanceProductSafetyIn2009theFamilySmokingPreventionandTobaccoControlAct(TCA,2009)gavetheFoodandDrugAdministration(FDA)regulatoryauthorityover“themanufacture,distributionandmarket‐ingoftobaccoproductstoprotectpublichealth.”ThislegislationmandatesCTPtominimizetherisksassociatedwithtobaccoproductsinbothusersandnon‐users.Childrencompriseapopula‐tion particularly susceptible to the effects of second‐hand or “environmental tobaccosmoke”(ETS),andforthatreasonit isnecessarytoconductalifestage‐basedriskassessmentofETSconstituents.MyCFPprojectwillbetoconductariskassessmentofETSconstituentstodeter‐mine the nature and probability of adverse health effects in children. Prioritywill be given tothoseconstituentswhichhavebeendeemed“HarmfulorPotentiallyHarmful”byCTP,andtheas‐sessmentwillexaminerisksatseveraldevelopmentalstages(infant,child,adolescent).

BrianE.ErkkilaPh.D.

CenterforTobaccoProducts(CTP)Of iceofScience

Preceptor:RaymondYeager,Ph.D.

17

Scienti icandProfessionalBackground2005‐2009 PostdoctoralFellow,UniversityofMedicalandDentistryofNewJersey2001‐2005 Ph.D.VeterinaryPreventiveMedicine,TheOhioStateUniversity1998‐2001 ResearchCo‐ordinator,MedicalResearchCouncil,UnitedKingdomandSociety

forNatalEffectsonHealthinAdults,India1996‐1998 M.Sc.BiochemistryandClinicalNutrition,UniversityofMumbai,India1993‐1996 B.Sc.MicrobiologyandBiochemistry,UniversityofMumbai,IndiaResearchInterestsIntricaciesofbiologicalscienceanddiseasehavealwaysintriguedme.Thisinteresthasgrownintoadeeperappreciation for themany challenges that impact control anderadicationof infectiousdiseases.Iamexcitedattheprospectofusingrevolutionaryresearchandnewtechnologytointer‐veneandchangetheoutcomeof thediseases. I intendtopursueacareer inamulti‐disciplinaryandinteractivesettingwhereIwillhavetheopportunitytoapplymytraininginveterinarymedi‐cine,publichealth,geneticsandmolecularepidemiologyofbacterialpathogens.Myoverallcareerobjectiveistocontributetoabetterunderstandingofmolecularpathogenesisofinfectiousagents.My primary research interests include comparative genomics, high‐throughput genotyping, anddrugresistanceevolution.Ihaveovertenyearsofexperienceinbacterial ingerprinting,molecu‐larepidemiology,anddiagnosticsandtherapeuticsresearchrelatedtoemergingandbiodefensepathogens.Commissioner’sFellowshipProjectOverviewRecommendationsforLaboratorySurveillanceandScreeningofPathogenicEscherichiacoliinFoodProductsUsingMolecularMethods.Regulatory Science Priority Area:ImplementaNewPrevention‐FocusedFoodSafetySystemtoProtectPublicHealthIncidences of food borne outbreak caused by non‐O157 shiga toxin‐producing Escherichia coli(STEC)hasincreasedrecently.Sixserogroupshavebeenidenti iedasclinicallyprevalent.Howev‐er, other serotypes can and have caused severe illness. Currentmethods are unable to identifypathogenicnon‐O157STECduetolackofknowledgeaboutwhichvirulencefactors(inadditiontoshigatoxin)areessentialtomakeanSTECharmfultohumans.Toaddressthisproblem,wepro‐posetode inethegeneticcharacteristicsthataremostcommonlyassociatedwithhumandisease.The Food and Drug Administration (FDA) currently has no regulatory position to address thepresenceofnon‐O157strainsinfoods,mostlyduetothedif icultiesinassessingthepathogenicityoftheSTECfoundin foodproducts.ThisprojectwilladdresspartofthisobstaclebyidentifyingtheSTECgeneticpro ilethat ismost frequently linkedtohumanillnessandthereby,supportingtheFDA’scommitmenttoensuringthatAmerica’sfoodsupplycontinuestobeamongthesafestintheworld.

Ali iyaH.Ghadiali,Ph.D.

CenterforFoodSafetyandAppliedNutrition

Preceptor:JulieA.Kase,Ph.D.

18

Scienti icandProfessionalBackground2010‐2011 CVRCPostdoctoralFellow,UniversityofVirginia2010 Ph.D.BiomedicalEngineering,ColumbiaUniversity2005 M.S.BiomedicalEngineering,ColumbiaUniversity2003 B.S.BiomedicalEngineering,UniversityofWisconsin‐MadisonResearchInterestsMyprimaryscienti icinterestsarefocusedonstructural,metabolic,andfunctionalremodelingoftheheartinresponsetobothphysiologicandpathologicstimuli.Mydoctoralworkaimedtoiden‐tify both the speci icmechanical signals responsible for triggeringhypertrophic growth and re‐modelingof cardiacmuscle aswell as thedownstream transcriptional effects of an alteredme‐chanicalenvironment(e.g., stressandstrain).Mostrecently, Ibuiltgenome‐scalecomputationalmodelsofcardiacmetabolisminbothnormalandheartfailurestates.Acommonthemebetweenthesetwolinesofworkhasbeenaninterestinleveraginghigh‐throughput‘omicsdataandquanti‐tativemethodstounderstandthecomplexityofcardiacphysiology,biology,andmetabolism.Commissioner’sFellowshipProjectOverviewU.S.MedicalDeviceInnovation(2000-2011):AnAnalysisofRegulatoryDecisionPointsandTotalTime-to-MarketforPMAandDeNovoDevicesRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologies Medicaldeviceinnovationoccursrapidlyandcontinuously,withgreatpotentialtopositivelyim‐pactpublichealthintheUnitedStates.Whilemostinnovationisbroadlyincrementalinnature,animportantminority tendstopositivelydisrupt thestandardsofcare for treatinganddiagnosingdisease.Thefasterthatsafeandeffective,disruptiveinnovationsareapprovedforbroadclinicaluse,thesoonertheirpositiveeffectsonpublichealthwillberealized.ThedegreetowhichCDRHregulatory policies and processes either promote and/or inhibit this disruptive innovation hasbeenspeculateduponbyexternalstakeholders,buthasnotbeenmeasuredoranalyzedwithanyscienti icrigor.Thecentralaimofmyprojectistobuildaregulatoryhistoricaldatabaseofdisrup‐tivemedicaldeviceinnovationandanalyzethisdatasothatwemay1)gainagreaterunderstand‐ingofCDRH’spastregulatoryperformanceonthemostinnovativemedicaldevicesand2)identifythoseattributesofpremarketsubmissionsforinnovativedevicesthatexhibitadisproportionatelylargeimpactonthetotaltimefromFDA’s irstengagementwiththedevice(sponsor)tofullmar‐ketingapprovalofthedevice.IwillalsoattempttoquantifytheimpactofCDRHregulatorydeci‐sionmakingonmedicaldeviceinnovation.

CharlesHaggart,Ph.D.

CenterforDevicesandRadiologicalHealth(CDRH)

Preceptors:MurraySheldon,M.D.andDayaRanamukhaarachchi,Ph.D.

19

Scienti icandProfessionalBackground2002‐2011:LicensedPharmacist(Florida&Virginia)2000‐2001:Post‐doctoralAssociate,UniversityofFlorida,Gainesville,Florida1998‐2000:Post‐doctoralAssociate,VirginiaTech,Blacksburg,Virginia1994‐1998:Ph.D,Bio‐analyticalChemistry,CollegeofPharmacy,UniversityofGeorgia,Athens,Georgia

ResearchInterestsIdidmyPh.Dandpost‐doctoralresearchintheareasofanalyticalmethoddevelopmentandvali‐dationofsmallmoleculesusingHPLC/UV,CapillaryElectrophoresis,GC/MS,LC/MS/MSandsolidphaseextraction.Myresearchinterestsareinthefollowingareas‐

DeterminationofBio‐equivalencybetweenBrandandGenericdrugsCorrelationbetweenin-vitrodissolutionandin-vivoperformanceofdrugproductsDeveloptoolsandstandardstoaccelerategenericdrugapprovalsHarmonizationofRegulatoryguidancebetweenFDA,EMA,ICHandWHO

Commissioner’sFellowshipProjectOverviewDevelopmentofinvitroModelsforthePredictionofinvivoFoodEffectonDrugsRegulatory Science Priority Area:SupportNewApproachestoImproveProductManu‐facturingandQualityForsomedrugsespeciallythosebelongingtoBCSClass2andClass4,thebioavailability(ef icacy)andsafetymaybeimpactedduetotheco‐administrationoffood.Forexample,thebioavailabilityofa lowsolubility (lipophilic)drugmay increasesigni icantly if it isco‐administeredwitha fullfattymealasopposedtogivingthedrugonlywithwaterorlightmeal.Thesigni icanceoffoodef‐fectonthebioavailabilityofdrugsiswellrecognizedbycliniciansandit isstudiedveryearly inthedrugdevelopmentprocess.Theproject is aimedatdevelopingbio‐relevant invitromethodsalongwithphysiologicallybasedabsorptionmodelsbyutilizingGastroPlusTMsimulationsoftwareinthepredictionoffoodeffect.

AhsanulHaque,RPh,Ph.D.,RAC

CenterforDrugEvaluationandResearch(CDER)DivisionofDrugProductQualityResearch

PreceptorsTahseenMirza,Ph.D.and Mansoor Khan, Ph.D.

20

Scienti icandProfessionalBackground2009‐2011PostdoctoralFellow,NationalInstitutesofHealth2009Ph.D.IntelligentSystems,UniversityofPittsburgh,Pennsylvania2003M.S.ComputerScience,NortheasternUniversity,China2000B.S.ComputerScience,NortheasternUniversity,ChinaResearchInterestsMygeneralresearchinterestsareinspatio‐temporaldataminingandtextmining.Inparticular,Iaminterestedinapplyingtechniquesfrommachinelearning,probabilisticmodeling,andBayesianstatisticstobiomedicalandhealthcare‐relatedresearch.AsaCommissioner’sFellow,IamexcitedtohavetheopportunitytoworkwithFDAscientiststoturntheFDA’svastvolumeofregulatorydataintoknowledgethatcanbeusedtoprotectandimprovepublichealth.Commissioner’sFellowshipProjectOverviewMedicalDeviceAdverseEventLabeling(MEDAL)–AnAutomatedTextMiningApproachRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologiesAnalysts at CDRH studyMedicalDeviceReports (MDRs),which are adverse event (AE) reportsrelatedtomedicaldevices,foridentifyingsafetysignals.ThesesignalscouldbedividedintotwocategoriesforanarbitrarydeviceD:(i)adeviationrelativetothehistoricalbaselinebehaviorbe‐tweenDandaknownAEassociatedwithit,e.g.,aspikeinthenumberofMDRsforDandaknownAEincomparisonwiththepast,and(ii)apreviouslyunknownAEassociatedwithD.To identify the twotypesofsafetysignalsdescribedabove,oneneeds to irstclassifyaMDRashavinginformationaboutaknowneventoranunknown,denovoevent,forD.Wede ineaknownadverse event and an unknown event associatedwithD as a labeledevent and anunlabeledevent, respectively.Wecall this classi icationprocessMedicalDeviceAdverseeventLabeling(MEDAL).AtpresentthereisnotoolthatisavailabletohelpanalyststodoMEDAL.Thisprocess,if donemanually, is labor‐intensive and time‐consuming because the number of documents re‐quiring study and analysis is increasing rapidly. Therefore, there is an urgent need to developtoolsforef icientlabeling.Usingtextminingtechniquesinformationrelatedtoadverseeventscanbeautomaticallyidenti iedfromexistingresourceslikepre‐marketsubmissions.Thisprojectaimstomakeuseofpre‐marketsubmissionstoidentifyknownadverseeventsaspro‐videdintheirwarnings,contra‐indications,precautions,etc.andusethatinformationasarefer‐ence to label incomingMDRs. In this study, Iwill explore different textmining techniques andbuildaframeworktoautomaticallyidentifyknownadverseevents.

YannaS.Kang,Ph.D.

CenterforDevicesandRadiologicalHealth(CDRH)

Preceptor:Brian Fitzgerald, B.Sc.

21

Scienti icandProfessionalBackground2009–2011NRCPostdoctoralFellow–PolymersDivision/MML/NIST2008–2009PostdoctoralResearchAssistant–PolymersDivision/MML/NIST2002–2008Ph.D.Chemistry–UniversityofNorthCarolina,ChapelHill1997–2002B.S.Chemistry,B.A.German–VirginiaPolytechnicInstituteandStateUniversityResearchInterestsMyprimaryresearchinterestshaveincludedpolymerandmaterialsscienceandtheirapplicationsinnanotechnologyandmedicine.Previousresearcheffortsfocusedoninvestigatingblockcopoly‐merthin ilmsandcontrollingtheirself‐assembly.These ilmscanbeutilizedfromtemplatingap‐plications used in themicroelectronics industry to directing the placement of nanoparticles forsmartcoatings. Inmypostdoctoralwork,compositionalandthermalgradienttechniqueshelpedinvestigatesurface&interfacial interactionsinrapidfashion.MyPhDthesisfocusedonthesyn‐thesis of novel luorinated elastomers and their utility to advance innovation for drug deliveryplatforms.Iutilizedthisplatformtofabricatemonodisperse,shapeandsizespeci icnanoparticlescomprisedofvariousproteins,enzymes,andantibodiesforpersonalizedmedicine.Commissioner’sFellowshipProjectOverviewTheEffectofExtremeWeatherEventsontheIntegrityandSafetyofMedicalDevicesandGuidancetowardMitigatingFutureChallengesRegulatory Science Priority Area:FacilitateDevelopmentofMedicalCountermeasurestoProtectAgainstThreatstoU.S.andGlobalHealthandSecurityThe21stcenturyhasbroughtonarecordnumberofextremeweathereventsincludinghurricanes,tsunamis,wild ires,andextreme loodingtonameafew.MyCFPprojectwillinvestigatetheef‐fectsextremeweathereventshaveontheintegrityandsafetyofmedicaldevices.Potentialimpli‐cations on medical devices will be examined throughout their manufacturing chain, transport,storage, and inal use. Along with the manufacturing chain, this project will explore extremeweatherconditions fromamaterials structure‐property relationshipaswellas fromthequalitysystemsprogramcurrentlyinplace. Identifyingandassessingrisksthatextremeweatherposesonmedical devices and distinguishing current standard testing will prove instrumental to thisproject.Thedevicespronetothemostriskundertheseconditionswillbeidenti ied. Publicandindustrialoutreachwillhelpshapeguidancedevelopedtomitigatefuturechallengesandrisksun‐dertheseextremeweatherevents.

JenniferKelly,Ph.D.

CenterofDevicesandRadiologicalHealth(CDRH)

Preceptor:ScottMcNamee,Ph.D.

22

Scienti icandProfessionalBackground2010‐2011 SeniorResearchAssociate,DukeUniversity2007‐2010 PostdoctoralAssociate,DukeUniversity2005‐2007 PostdoctoralScholar,UniversityofIowa2005 Ph.D.Neurobiology,UniversityofIowa1999 M.D.HarbinMedicalUniversity,ChinaResearchInterestsWithtraininginbothclinicalmedicineandbasicscience, Ihavealwaysbeeninterestedintreat‐ment development for unmetmedical needs. My previous research has focused on developingnovel therapies forcentralnervoussystemmanifestationsof raredisorders including lysosomalstoragediseases, spinocerebellar ataxia and epilepsy. I hope to parlaymy clinical andbasic re‐searchexperiencetoregulatorysciencewhileworkingatCDER.Commissioner’sFellowshipProjectOverviewTheRoleofNaturalHistoryStudiesinDrugDevelopmentforRareDiseasesRegulatory Science Priority Area:HarnessDiverseDatathroughInformationSciencestoImproveHealthOutcomesRarediseases(RD)haveconsiderableunmetmedicalneedsandfewofthemarewellunderstood.Anunderstandingofararedisease’snaturalhistory(NH)isanimportantelementforclinicaltrialdesignandoutcomeassessmentforRDproductdevelopment. Incontrasttomanycommondis‐eases, thereoften is littleexistingknowledgeon thediseasenaturalhistory formostRD,whichmakesNHstudiesofparticularvalueinthesupportofRDproductdevelopment. ThegoalofmyCFPprojectisthree‐fold:1)ToestablishaNHdatabaseformarketingapplicationsforrarediseas‐esreviewedbyCDERfrom2006to2011;2)ToidentifykeyfactorsinNHstudiesthatcontributeto the clinical drug development for rare diseases; 3) To develop a framework on how well‐conductedNHstudiesmayfacilitatedrugdevelopmentforrarediseases.

GumeiLiu,Ph.D.

CenterforDrugEvaluationandResearch(CDER)

Preceptor:AnnePariser,M.D.

23

Scienti icandProfessionalBackground2004‐2007SeniorResearchAssociate,VanderbiltUniversity,Nashville,TN.2000‐2004PostgraduateResearcher,UniversityofCalifornia,LosAngeles,CA.1998‐2000PostdoctoralResearchFellow,IndianaUniversitySchoolofMedicine,IN.1997‐1998ResearchAssociate,IndianInstituteofChemicalBiology,India.1996‐1997ResearchFellowshipfromInternationalBrainResearchOrganization1992‐1996SeniorResearchFellow,IndianInstituteofChemicalBiology,India.1990‐1992JuniorResearchFellow,JadavpurUniversity,India1989‐1990AnalyticalChemist,HealthLinePvt.Ltd.,Bangalore,India1998Ph.D.(Pharmacology),JadavpurUniversity,India1992MasterofPharmacy,JadavpurUniversity,India 1990BachelorofPharmacy,AnnamalaiUniversity,IndiaResearchInterestsFormorethanadecade,Ihavebeenworkingoninvitroandinvivosingleneuronrecordingsfromdiscretebrainregions(cortex,striatum,substantianigra)andlumbarspinalcordofvariousneu‐rodegenerativemovement/motordisorderssuchasParkinson’sdisease,Huntingtondisease,tar‐divedyskinesia,andstrokewithaprimaryfocusonneurophysiologyandneuropharmacology.Myresearchinterestalsoincludespharmacokineticandbiopharmaceuticalstudiesofpharmaceuticaldosageformsandlaser(infra‐red)stimulationofmammalianneuronaltissue.Commissioner’sFellowshipProjectOverviewDeterminationofAntimicrobialDrugConcentrations in IntestinalTissuesandDigestiveSecretionsfromTreatedSteers.AninitialphasetoCorrelateAntimicrobialDrugConcentrationsinPlasmaandDigestiveSecretions.Regulatory Science Priority Area:ImplementaNewPrevention‐FocusedFoodSafetySystemtoProtectPublicHealthMy fellowshipproject focuseson thedeterminationofantimicrobialsconcentrationof intestinaltissues and gastrointestinal luid secretions from the duodenum, jejunum, and ileum of antimicrobialtreatedsteersusingarapidandhighly‐sensitiveLiquidChromatography‐MassSpectroscopy/MassSpectroscopymethod.Antimicrobialshavebeen extensivelyused in food‐producing animals fornumber of purposes including growth promoters, therapeutics, prophylactic, andmetaphylaxis.Thismaypromotetheselectionofantimicrobialdrug‐resistantbacteriathatinturncouldpersistinfoodproductsandtheenvironment.Thelackofdatarevealingactualconcentrationsofantimi‐crobialswithintheintestinaltissue/ luidsthatisexposedtogut loraofanimalsandthedevelop‐mentofantimicrobialresistancewarrantedthispresentstudy.

GajendiranMahadevan,Ph.D.

CenterforVeterinaryMedicine(CVM)

Preceptor:Oscar(Alberto)Chiesa,D.V.M.,M.S.,Ph.D.

24

Scienti icandProfessionalBackgroundProfessional2011 R&DProgramManager,RegenerativeMedicine,AvitaMedicalLtd.,Northridge,CA2010‐2011 Scientist,Immunology/CellTherapy,Dept.ofRegenerativeMedicine,AthersysInc.,

andInvestigator,Biology/Immunology,NationalCenterforRegenerativeMedicine,Cleveland,OH

2009 Consultant,VTBusinessTechnologyCenter,Blacksburg,VA2006‐2010 SeniorResearchAssociate,Revivicor,Inc.,Blacksburg,VAEducation2007‐TBD M.B.A.(AACSBaccredited),RadfordUniversity,Radford,VA(part‐time)2003‐2006 StrategicTrainingPrograminRegenerativeMedicine‐Certi icate1999‐2006 Ph.D.,DepartmentofImmunology,UniversityofToronto,Toronto,Canada1995‐1999 B.Sc.(Honors),UniversityofToronto,Toronto,Canada;Specialist:MolecularGe‐

neticsandMolecularBiology/Major:HumanBiologyResearchInterestsMyresearchinterestsincludeautologous,allogeneic,and(GEanimal)xenogeneiccell,tissueandorgan transplantation, with a particular interest in adult stem cell therapies and RegenerativeMedicineCombinationProducts. These interestsweredevelopedduringmyPh.D. in transplantimmunology,amulti‐disciplinaryTrainingPrograminRegenerativeMedicine,and5+yearsinpri‐vateandinternationalpublicCompaniesintheRegenerativeMedicinespace,fromadultstemcell,isletandorgantransplantation,totissueengineeringandmedicaldevices. AttheFDA,Ihopetoutilizemyexpertiseinpolicyandreviewactivities,andleveragingresourcestopromote,andcon‐tributeto,FDAregulatoryscience.Commissioner’sFellowshipProjectOverviewAdvancingRegulatoryScienceandInnovationinStemCellsandRegenerativeMedicineRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologiesStemcell(SC)therapy,andRegenerativeMedicineCombinationProductsthatcontainstemcells,arepromisingtreatmentsfordiseasesandotherconditionswithunmetclinicalneed. Identi ica‐tionandcorrelationoftrendsandscienti icgapanalysesofadultmultipotentMesenchymalStro‐mal Cell (MSC) product characterizations (including biomarkers), and of other stem cell typesfromdifferentsources,willcontributetounderstandingthecurrentstate‐of‐the‐industry,andthemajorgapsinthe ield.TheseactivitieswillbementoredbyexpertsinCBEROCTGT,andwillin‐volve:i)reviewofSCINDs/IDEs/510(k)sanddatabasegeneration,ii)primaryliterature,andiii)CBERresearch(i.e.MSCConsortiumatNIH). Thisprovidesascienti icdata‐drivengroundworkforrecommendationsandnext‐stepsforhowthesegapsmaybeaddressedviaregulatorysciencetopredict,andassure, thesafetyandef icacy(qualityandpotency)ofstemcell‐basedproducts,suchas:i)regulatorysciencereviewarticles,ii)regulatorypolicyandstandardsdevelopment,iii)guidance for Sponsors, and iv) potential leveraging of resources fromwithin FDA and outsidestakeholders.

MichaelMendicino,Ph.D.

Of iceoftheCommissioner,Of iceoftheChiefScientist,Of iceofRegulatoryScienceandInnovation

Preceptors:FrankWeichold,M.D.,Ph.D.and

VickiSeyfert‐Margolis ,Ph.D.

CBEROCTGTMentors:SteveBauer,Ph.D.andKeithWonnacott,Ph.D.

25

Scienti icandProfessionalBackground2011 Post‐doctoralresearcher,BiomedicalEngineering,TexasA&MUniversity2009‐2010 WhitakerScholar,Biomechanics,IRPHE,CentreNationaldelaRechercheScien‐

ti ique(CNRS),UMR6594,Marseille,France2009 Ph.D.BiomedicalEngineering,TexasA&MUniversity2003 Ethicon2002 B.S.BiomedicalEngineering,TexasA&MUniversityResearchInterestsI am interested incomputationalmodelingofmedicaldevices, speci icallydevice‐tissue interac‐tions,vascularbiomechanics,andremodeling.Mybackgroundisprimarilyincomputationalsolidmechanicsofsofttissueusing initeelementanalysis.Ialsohaveexperienceinexperimental luidmechanics(PIV)andexperimentalsolidmechanics(tissuepropertycharacterization,stereoscopicobservationofstrains). Mypreviousresearchwasparticularly focusedonvariedaspectsofab‐dominalaorticaneurysms(AAA).Commissioner’sFellowshipProjectOverviewComputationalModelingofDevice,Tissue,andDevice-tissueInteractionforDeviceEvaluationRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologiesThedetaileddevice‐tissue interactionbehaviorsofmanymedicaldevices(suchascoronaryandperipheralvascularstents,atrialseptaloccluders,biodegradablepolymerdevices,andtissueheartvalues)arecomplexandchallengingnon‐linearproblems.Computationalmodelingofthesecasescanprovideameanstopredictdeviceef icacyandassesslikelyfatiguelifeaswellasidentifypo‐tential failuremodes. Themodelsgeneratedarealsoameanstoconsiderawidevarietyofuseandtreatmentconditions.Fromthevariationsintheresults,onecanseetherelativeimportanceofthatvariation.Understandingtherelativeimportanceandin luenceofdifferentdevicedesign/selectioncanguidethedevelopmentofappropriatestandards,instructionsforuse,andtestmeth‐ods.Myprojectlooksatthestressesandstrainsproducedbydevice‐tissueinteractionforaspe‐ci iccondition‐devicecombination.Theprojectusespatientspeci icmodelsoftheanatomicalge‐ometryaswellasimaging‐basedreconstructionsofdeployeddevicestoaddressissuessurround‐ingappropriatedeviceusage,selection,andevaluation.

ClarkMeyer,Ph.D.

CenterforDevicesandRadiologicalHealth(CDRH)

Preceptor:NandiniDuraiswamy,Ph.D.

26

Scienti icandProfessionalBackground2006–2011 Clinicalpharmacist,UniversityofPittsburghMedicalCenter2011 Ph.D.,PharmaceuticalSciences,UniversityofPittsburgh2006 Pharm.D.,UniversityofPittsburgh ResearchInterestsClinical pharmacokinetics and pharmacodynamics; population pharmacokinetics; phar‐macogenomicsofdrugmetabolizingenzymesandtransporters;pediatricdrugdevelopment.CommissionersFellowshipProjectOverviewDevelopmentalEffectsonWarfarinPharmacogenomicsinYoungPediatricPatientsRegulatory Science Priority Area:StimulateInnovationinClinicalEvaluationsandPer‐sonalizedMedicinetoImproveProductDevelopmentandPatientOutcomesGeneticfactorsareimportantdeterminantsofintra‐individualvariabilityindrugdispositionandresponse. Inchildren,theinterpretationofapharmacogeneticeffectmaybecomplicatedbythedevelopment andmaturation ofmetabolic enzymes, transporters, and/or drug targets. This isparticularlytruewhentheontogenyofacomponentofdrugresponseisunknown,orwhenmulti‐pleindependentsystemsareinvolved.Therefore,thecurrentprojectisdesignedtoelucidatethecompetingeffectsofpharmacogeneticsandontogenyinchildren. Warfarinisanoralanticoagu‐lantusedforthepreventionofthromboemboliceventsinchildrenwithheartdisease,atrial ibril‐lation,andthromboembolicdisease. CYP2C9isapolymorphicallyexpressedenzymeinvolvedinwarfarinmetabolism,andvariantalleles(CYP2C9*2and*3) result inreducedclearance.Thisre‐duction leads to an increase in the anticoagulant effect and a decrease in the dose required tomaintain the INRwithin thetherapeuticrange.Additionally,mutations in thegenethatencodesthe vitamin K epoxide reductase enzyme complex (VKORC) lead towarfarin resistance and in‐creaseddoserequirements.Collectively,CYP2C9andVKORC1genotypesaccountfornearly50%ofthevariability inwarfarindoserequirements inadults. Thisprojectwill evaluate the impactofCYP2C9andVKORC1genevariantsonwarfarindoserequirementsinchildrenacrossthepediatricagecontinuum.Ultimately,adosingalgorithmwillbeconstructed,allowingfortheintegrationofpharmacogenomicadvancesintopediatriccare.

JeremiahMomper,Pharm.D.,Ph.D.

CenterforDrugEvaluationandResearch(CDER)Of iceofClinicalPharmacology

Preceptor:GilbertBurckart,Pharm.D.

27

Scienti icandProfessionalBackground FDACommissioner’sFellow 2011‐present UniversityofChicago‐BoothSchoolofBusiness 2009‐2011 MastersBusinessAdministration,ConcentrationinFinance UniversityofChicago‐SchoolofSocialServiceAdministration 2009‐2011 GraduatePrograminHealthAdministration&Policy AdventistHealthSystemsMidwest–HinsdaleHospital 2004‐2011 DivisionHeadofPediatricAnesthesia,CardiacAnesthesiologist HarvardMedicalSchool–MGH&Children’sHospitalBoston 2003‐2003 FellowshipinCardiovascularAnesthesia HarvardMedicalSchool‐MassachusettsGeneralHospital 2000‐2003 ResidencyinAnesthesia NewJerseyMedicalSchool–UniversityHospital 1999‐2000 InternshipinGeneralInternalMedicine UMDNJ–NewJerseyMedicalSchool 1992‐1999 7‐yearHonorsCombinedB.S./M.D.ProgramResearchInterestsMybackgroundisworkinhealthcareadministration,policy,andclinicalmedicine.Myresearchinterestsinvolvethede‐sign, development, and implementationofmedical devices used in surgery, critical care, and chronicdiseasemanage‐ment.Commissioner’sFellowshipProjectOverviewGuidanceDevelopmentforFutureMedicalDevicesRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmergingTechnologiesFDAhasanintegralroleinidentifyingandstructuringthepathwayoffuturehealthcaretechnologies,tobothprotectandpromotepublichealth. Myexperienceasbothamedicalof icerandasaCommissioner’s fellowatFDAhasfocusedonproductdevelopment,withinthepre‐marketmedicaldevicesarena. Thishasbeenaninvaluableopportunitytoobtainmultiplepro iciencies:1. WritingGuidancePoliciesforfuturemedicaldevicedesign2. MedicalDeviceReviewforPre‐IDE,IDE,510(k),PMA,andHDEapplications3. ClinicalconsultationbetweenFDACenters–CDERandCBER4. PrimaryInvestigatoraspartoftheFDACriticalPathInitiativeSimilartootherpartsof theAgency, theCenter forDevicesandRadiologicalHealth(CDRH)isacollaborativeenviron‐mentbetweenmultipledisciplinesthatservesasthenexusbetweenclinicalmedicine,basicscience,policy,andtechnolo‐gy.CDRHprotectsthehealthofthepublicbyassuringthesafetyandeffectivenessofmedicaldevicesandthesafetyofradiologicalproductsmarketedintheUnitedStates.Tofurthersafeguardthepublichealth,CDRHmonitorsmedicalde‐vicesandradiologicalproductswhile inuseforcontinuedsafetyanddisseminatesaccurate,science‐basedinformationabout the regulatedproducts.TheworkofCenterpromotes technologies that improvepublichealth,while constantlyadapting to themanychangeswithinhealthcare. Similar to theconsumer technology industry,medicaldeviceshaveashorterdevelopmentlifecycle.Thus,thereisahigh‐levelofrapidinnovationinthedevicepre‐marketspace.Theoppor‐tunitytobepartofanorganizationthatfacilitatestheevolutionofhealthcareproductsandservicesisbothaprivilegeandanimmenseresponsibility.

AnhNguyen,M.D.,MBA

CenterforDeviceEvaluationandRadiologicalHealth(CDRH)Of iceofDeviceEvaluation(ODE)

Preceptor:MarkhamLuke,M.D.,Ph.D.

28

Scienti icandProfessionalBackgroundAssistantprofessor Univ.ofArkansasforMedicalSciences,2011ResearchInstructor Univ.ofArkansasforMedicalSciences,2005‐2010SeniorResearchAssociate Univ.ofTexasMedicalBranchatGalveston,2004‐2005Post‐doctoralResearchAssociate MontrealHeartInstitute,Canada,2000‐2004VisitingScholar UniversityofMontreal,Canada,1998‐2000FellowinEndocrinology PekingUnionMedicalCollegeHospital,China,1996‐1998M.Sc. PekingUnionMedicalCollege,China,1996M.D. NorthChinaCoalMedicalCollege,China,1993ResearchInterests SiRNA/miRNA‐basedgenetherapy Pharmacogenomicsandpersonalizedmedicine Transcriptionalandpost‐transcriptionalregulationofionchannelsanddrugtransportersin

cancerandcardiovasculardiseaseCommissioner’sFellowshipProjectOverviewTheRoleofABC-DrugTransportersinChemoresistanceinPancreaticCancer:AssessingDrugSafetyandEf icacyRegulatory Science Priority Area:StimulateInnovationinClinicalEvaluationsandPer‐sonalizedMedicinetoImproveProductDevelopmentandPatientOutcomesPancreatic cancer is one of the deadliestmalignancieswith verypoor prognosis. Because of nosymptomsornonspeci icandvariedsymptoms,pancreaticcancerisoftennotdiagnoseduntilitisadvanced.Chemotherapyisthemaintreatment,butduetochemoresistance,theef icacyofchem‐otherapyis limited.Ofthemanydifferent,unrelatedmechanisms,IamparticularlyinterestedinabnormalexpressionofATP‐bindingcassette(ABC)transporters,asthemultidrugef luxpumpsplayanimportantroleintheuptakeanddistributionoftherapeuticdrugs.MyprojectisaimedtodeterminewhetherabnormalexpressionofABCtransportersinpancreaticadenocarcinomacon‐tributestochemoresistanceandisassociatedwiththeprognosisofthedisease.UnderstandingthemolecularmechanismsinvolvedindrugresistanceisapplicabletotheoverallmissionofFDAinadvancingthepublichealth.Theresultsofthisstudywillaidinthefuturepracticeofutilizingper‐sonalizedmedicinetomakepancreaticcancerchemotherapymoreeffectiveandsafer.

LiPang,M.D.

NationalCenterforToxicologicalResearch(NCTR)

Preceptor:BeverlyLyn‐Cook,Ph.D.

29

Scienti icandProfessionalBackground2008‐2011Post‐DoctoralAssociate,RadiationOncology,DukeUniversity,NC2006‐2008Post‐DoctoralAssociate,SchoolofPharmacy,UniversityofNorthCarolinaatChapelHill,NC2005‐2006Post‐DoctoralAssociate,Chemistry,UniversityofNorthCarolinaatChapelHill,NC2005Ph.D.ChemicalEngineering,YonseiUniversity,Korea1999M.S.ChemicalEngineering,YonseiUniversity,Korea1996B.S.ChemicalEngineering,UniversityofSeoul,KoreaResearchInterestsMycurrentresearchinterestsarethedevelopmentanddiscoveryofadrug/genedeliverysystemusingliposomalnanoparticlesforcancertherapy.Theseinterestsinclude:1)formulationoflipo‐somalnanoparticlescomposedof lipidsandsiRNA,whichdueto theirsizeareable tocross thebloodbrainbarrier(BBB),and2)developmentofnovelthermosensitiveliposomescontainingan‐ticancerpharmaceuticals,MRIcontrastagents,DNA/siRNA,proteins,and/orpeptides3)designoftargetedliposomaldrugswithsite‐speci icaf inity.Myultimategoalsaretoimprovecurrentdrugdeliverysystem(DDS) in termsofdrugtransportanddrugrelease in tumor,andtodesignDDSthatenhancesef icacyofdrugagainsttumors,andtostudyphysicochemicalpropertiesthataffectDDSinphysiologicalenvironment.Commissioner’sFellowshipProjectOverviewDevelopmentMethodologiesfortheCharacterizationofFDARegulatedLiposomalProducts.Regulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologiesNanotechnologyisthecontrolandmanipulationofmaterialswithonesizedimension(lengthorwidth)betweenapproximately1‐100nm.Thistechnologyisanemergingscience,whichisnowbeingutilizedwithinmultipleproductclassi icationsregulatedbytheFDA.Onekeyutilizationofnanotechnology is thecreationof liposomalproducts. Liposomesaregenerallyde inedasengi‐neeredvesicleswhicharecomposedofalipidbasedbilayer.Thesevesiclesareusedasadeliverycarrierforvarioustherapeuticagents(i.e.pharmaceuticalanddietarysupplements).TheOf iceofRegulatoryAffairs(ORA)currentlylacksvalidatedmethodsforthecharacterizationofthephysico‐chemical properties of commercially available liposomal products. Our project will focus onbridgingthisknowledgegaptoensurethatweareabletoful illourmissionofprotectingandpro‐motingpublichealththroughregulatoryscience.

Ji‐YoungPark,Ph.D.

Of iceofRegulatoryAffairs(ORA)Jefferson,AR

Preceptor:SeanW.Linder,Ph.D.

30

Scienti icandProfessionalBackground

2004‐2011 PostdoctoralResearchAssociate,VanderbiltUniversity2003‐2004 AssistantProfessor,So iaUniversity,Bulgaria2000‐2003 SeniorExpert,ExecutiveEnvironmentalAgency,So ia,Bulgaria1992‐1995 ResearchAssistant,BulgarianAcademyofSciences,InstituteofOrganicChemistry,

So ia,Bulgaria2004 Ph.D. in Technology of Fine Organic Synthesis and Biochemical Synthesis, So ia

University,Bulgaria1992 M.S.inChemistryandPhysics,So iaUniversity,Bulgaria

ResearchInterests

Overtheyears,Ihaveacquiredextensiveresearchexperienceinchemicaltoxicology,environmen‐tal analytical chemistry andorganic synthesis of potential targetmolecules formedical applica‐tions.Asapostdoctoralfellow,IhavehadtheopportunitytoworkonseveralprojectsfocusedonDNAadductsarisingfromreactiveoxygenspeciesandfromtheirreactionswithlipids.TheuseofvariousmodernmassspectrometryandNMRtechniqueshasbeenanintegralpartofmyresearch.DuringmypostdoctoralfellowshipatVanderbiltUniversity,Idevelopedaninterestinthemecha‐nism by which modi ied nucleosides are generated and the re‐arrangements of DNA adducts.Thesemechanistic studies involved trapping andanalysisof intermediates, usingboth chemicalandspectroscopicmethods.

Commissioner’sFellowshipProjectOverviewDevelopmentandApplicationofLC-SPE-NMRMethodstoEvaluateBiomarkersofHepatotoxicityRegulatory Science Priority Area:EnsureFDAReadinesstoEvaluateInnovativeEmerg‐ingTechnologies

Hepatotoxicity isa commoncomplication indrugdevelopmentandoneof themainreasons forwithdrawal of FDA‐approved drugs from the market. The most common used biomarkers forhepatotoxicity, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), are goodmarkersofdamagebutarenotalwayselevated.Morespeci icbiomarkersofliverinjurymayben‐e itpublichealthbyremovingsuspectcompoundearlierinthedevelopmentprocess.Biomarkersarealsoneededthatcanpredictpotentialliverdamageandindicaterecoveryafteratoxicinsult.The objective of this study is to develop ametabolomic approach to identify more speci ic bi‐omarkersofhepatotoxicityinlivertissueandbio luidsfromratsexposedtowell‐knownhepato‐toxicants. LC‐NMR‐basedmethodswill be developed for detection of targetedmetabolites sus‐pectedtobealteredfollowingahepatotoxicinsultinlivertissuefromratsexposedtoacetamino‐phen,whichiscommonlyusedanalgesicdrugandcarbontetrachloride,whichisusedasanindus‐trialcompound. Bothcompoundsareknowntoinduceliverinjuryandthisstudyaimstoprovethattheobservedbiomarkersaretheresultoflivernecrosiscausedbytheseknownhepatotoxi‐cants.Theexpectationisthattheidenti iedmetabolitescanbetranslatedtohumansandprovidebetterpredictionand identi icationof liverdamagedue toexposure (inadvertentor chronic) tohepatotoxicxenobiotics.

KatyaPetrova,Ph.D.

NationalCenterforToxicologicalResearch(NCTR)

Preceptor:LauraSchnackenberg,Ph.D.

31

Scienti icandProfessionalBackground2010‐2011 PostdoctoralFellowship,Neurology,JohnsHopkinsSchoolofMedicine

andKennedyKriegerResearchInstitute2009 Ph.D.BiologicalSciences,UniversityofMissouri‐Columbia2004 M.S.CellandMolecularBiology,UniversityofArkansas‐Fayetteville2002 B.S.Zoology,UniversityofArkansas‐FayettevilleResearchInterestsMyinterestsare focusedonthedecisionmakingprocessesattheforefrontoftranslationalresearchforadvancingcellular‐basedtherapiesandproductdevelopment,i.e.,theregulatoryaspectsinvolvedintransitioningbenchdiscoveriestotheclinicalsetting.DuringmyPh.D.studiesIidenti iedandchar‐acterizedbraintumorstem/initiatingcellsusingnext‐generationepigeneticandgenetictechnologies,andmypostdoctoralstudiesinvolvedinvestigatingtheanti‐tumoreffectsoftyrosinekinaseinhibitortherapiesthattargetgliomastem/initiatingcellsinvivo.TheCommissionersFellowshipProgrampro‐videsanopportunitytolearnaboutFDA’sguidingprinciplesandregulatorysciencepoliciessurround‐ingbiologics,andmoreimportantlytheregulationoftranslationalsciencewithrespecttocomplianceandful illingFDA’smissionofprotectingthepublichealth.Commissioner’sFellowshipProjectOverviewSciencePolicyandComplianceProgramRisk-ModelingRelatedtotheRegulationofHumanCells,Tissues,andCellularandTissue-BasedProducts(HCT/Ps)Regulatory Science Priority Area: Support New Approaches to Improve Product Manufacturing and QualityEnsuringthatmanufacturerscomplywithfoodanddruglawsisanessentialroleoftheAgency,andthepremiseofthisregulatoryproject.ThisprojectisdesignedtoassisttheOf iceofComplianceandBiologicsQuality(OCBQ)intheirroleofensuringthequalityofhumancells,tissuesandcellularandtissuebasedproducts(HCT/Ps)thathaveuniqueregulationspromulgatedundersection361of thePublicHealthServiceAct(referredtoasSection361HCT/Ps).Theoverallgoalofthisprojectistoin‐creasethesafetyofSection361HCT/Psbycreatingaguidancedocumentandrisk‐basedcompliancetool to help prevent the introduction, transmission, and spread of communicable disease transmis‐sion,whichareconsistentwithdevelopingtheAgency’sregulatoryscienceprograms.The irstpartofthisprojectwillbetocreateaguidancedocument for industrythataddressesreportingproceduresforbiologicalproductdeviations(errorsandaccidentsinmanufacturing,donortesting,facilities,etc.)forSection361HCT/Ps.ExamplesofSection361HCT/Psincludebone, ligaments,skin,duramater,hematopoietic stem/progenitor cells, oocytes, andembryos that areminimallymanipulated and in‐tended forhomologoususe,amongstadditional criteria.Theotherportionof thisprojectwillbe tocreatearisk‐basedassessmenttooltoassistwithprioritizinginspectionsofregisteredestablishmentsthatmanufactureSection361HCT/Ps.This toolwillanalyzethevastamountsof informationOCBQreceiveseveryyearsuchasinspectionreports,summaries,recalls,adversereactionreports,deviationreports,complaints,etc.,tocomeupwithariskrankingforestablishments.Thisrankingwillbeuti‐lizedtodirectthebestuseofOCBQ’sinspectionalresourcestohigh‐riskestablishmentsthatwilllikelyyieldthegreatestpublichealthimpact.

PrakashRath,Ph.D.

CenterforBiologicsEvaluationandResearch(CBER)

Preceptor:AnitaRichardson,M.A.S.,B.S.,M.T.(ASCP)

32

Scienti icandProfessionalBackground2009‐2011 PostdoctoralFellow,CenterforAdvanceDrugResearch,SRI

International,Harrisonburg,VA2008‐2007 PostdoctoralFellow,UniversityofMaryland,CollegePark2002‐2007 PhD,Virology,UniversityofMaryland,CollegePark1999‐2001 MVSc,AnimalBiotechnology,IndianVeterinaryResearchInstitute,

India1992‐1998 BVSc&AH,OrissaUniversityofAgriculture&Technology,IndiaResearchInterestsIobtainedmyMasterdegreeandPh.D.inthe ieldofvirology.DuringmypostdoctoraltrainingIhaveworkedonsmallmoleculescreening forpotential targetagainstDenguevirus.Someofmypreviousworkhasinvolvedstudyingmolecularbasisofpathogenesis,reversegeneticsofnegativestrandRNAvirusesandscreeningofsmallmoleculeagainstRNAviruses.Mycurrentresearchin‐terest includes developing detectionmethod for enteric viruses causing food borne illness andlearningregulatoryaspectsatFDA.Commissioner’sFellowshipProjectOverviewDevelopmentofaLiquidMid-densityMicroArrayAssayfortheDetectionofFood-borneEntericvi-rusesusingLuminex®xMAPTMTechnologyRegulatory Science Priority Area:Implement a New Prevention-Focused Food Safety System to Protect Public HealthHepatitisEisaliverdiseasecausedbytheHepatitisEvirus(HEV).HEVinfectioniswidespreadinthedevelopingworldandusuallyresultsinaself‐limited,acuteillness. Inthecurrentclimateofglobalization,foodbornehepatitisEoutbreakcanoccurduetoimportationofcontaminatedfoodfromendemiccountries.TitleIIofthe2011FoodSafetiesandModernizationAct(FSMA)outlinestheFDA’scommitmenttoreducefoodsafetythreatsbyredirectingtheagency’sfocusfromoneoftheresponsetooneoftheprevention.BydetectingtheHEVinfoodsamplesatanearlystage,thenumberof food‐borneoutbreakscanbeminimized.WearedevelopingaRT‐PCRbasedassaytodetectHEVgenomefromfoodsamplesanduseittodevelopaliquidmid‐densitymicroarrayassayusingLuminex®xMAPTMtechnology.However,developmentof thisnewassayneedstobevali‐datedbeforethe implementation inreference laboratories. Furthermore,ouraimis tocombinethisassaymethodwithotherLuminex®xMAPTMbasedassaystodevelopamultiplexassaythatcandetectNorovirusandHepatitisAVirusandHEVinasingletubefromfoodsamples.

SubratN.Rout,Ph.D.

Of iceofRegulatoryAffairsSanFranciscoDistrictOf ice

Alameda,CA

Preceptor:GaryHartman,M.A.

33

Scienti icandProfessionalBackground2009‐2011 IRTAPostdoctoralResearchFellowattheNationalInstituteonDrugAbuse2009PhD AnalyticalChemistry,UniversityofMichigan2005MS UniversityofMichigan2003BA LawrenceUniversityResearchInterestsMyresearchinterestslieinthedevelopmentandapplicationofanalyticalchemistryandbiochemi‐calmethodstoelucidatephysiologicalandpathologicalpathwaysrelevantforpublichealth.Asananalytical chemist I always enjoy the challenge of looking for the proverbial needle in the hay‐stack.InmygraduateandpostgraduateworkIstudiedtwodifferentneurochemicalsystems:theinteractionsbetweendopaminergicandestrogensignalingthatpromotesusceptibilitytodrugad‐dictionandtheopioidsignalingnetworkswhichinducewithdrawalsymptoms.Bothpursuitsuti‐lizedinvivomicrodialysiscoupledtocapillaryelectrophoresisorHPLC.WorkingattheNationalInstitute on Drug Abuse solidi ied my interest in doing research that directly bene its publichealth.IlookforwardtolearningmoreaboutregulatoryscienceintheCommissioner’sfellowshipprogramaswellasexpandingmyskillsettoincludeproteinanalysisandmassspectrometry.Commissioner’sFellowshipProjectOverviewProteomicCharacterizationofMultipotentStromalCellsSeededonDifferentScaffoldstoUncoverOsteogenicDifferentiationBiomarkersRegulatory Science Priority Area:Support New Approaches to Improve Product Manufac-turing and QualityMultipotentstromalcells(MSCs)havegarneredalotofattentioninthe ieldofregenerativemedi‐cine due to their low immunogenicity and immunomodulatory properties. MSCs are effectivetreatments inanimalmodelsofavarietyofailments includingcardiac,spinal,andbonetrauma.Spurredbythesepromisingpreclinicalresults,anumberofINDapplicationshavebeen iledwithCBER.AcquiringFDAapprovalofthesenewtherapiesiscomplexbecausetherearefewhistoricalcharacterizationassaystoworkwith.Thesechallengespromptedtheformationofaresearchcon‐sortiumwithinOCTGTwhosegoalistodevelopaquantitativeandqualitativeassaytosystemical‐lyidentifybiomarkerswhichwillpredicttheinvivoperformanceoftransplantedMSCs.Aspartofthis consortium,my researchproject is to analyze theproteomeofMSCs culturedunder condi‐tionsthatpromoteosteogenicdifferentiationtouncoverspeci icbiomarkers indicativeofosteo‐blastdevelopment. IwillcomparetheMSCproteomeofcellsculturedwithosteogenicchemicalsupplementsona latsurfacetoMSCsculturedona3Dpolymericscaffoldthatinducesosteogenicdifferentiation. Both Electrospray andMatrix Assisted Laser Desorption Ionizationmass spec‐trometrymethodswillbeutilizedtocharacterizetheMSCdifferentiationproteome.

KristinSchultz‐Kuszak,Ph.D.

CenterforBiologicEvaluationandResearch(CBER)

Preceptor:MichailAlterman,Ph.D.

34

Scienti icandProfessionalBackground M.ScinMolecularBiology(1995):InstituteofMolecularBiologyandBiotechnology,FreeUniversityofBrussels

(VUB),Belgium. PhDinMolecularmicrobiology(1999):FacultyofScience,VUB,Belgium. Post‐doctoralFellowship(1999‐2004):CenterforVaccineDevelopment,UniversityofMaryland,Baltimore(UMB),

Maryland. Facultymember(2004‐2008):SchoolofMedicine,UMB,Baltimore,Maryland. SeniorMicrobiologist(2008‐2010):BaxterBioscienceInc. InternationalQA/QCCoordinator(2011):JohnsHopkinsUniversity,Baltimore,Maryland.ResearchInterestsIamaclinicalmicrobiologistandmolecularbiologistbytraining,educationandexperienceandhavebeenworkinginvariousmicrobiologydisciplines.IworkedfortheclinicallaboratorieswhereIwasinvolvedinallstagesoftestingbio‐logicalspecimensincludingsampleprocessingtoreleasingresultsforpatientscare.Ididmypost‐doctoraltrainingonbacterialpathogenesisresearchandmoleculardiagnosticsattheCenterforVaccineDevelopment(CVD)attheUniver‐sityofMaryland,Baltimore.IjoinedinaVaccineManufacturingPlantofBaxterBioscienceIncasaseniormicrobiolo‐gistinitsQC/QAmicrobiologydepartmentandservedfortwoyearsuntiltheplantmovedtooverseas.Later,IjoinedintheDepartmentofPathologyatJohnsHopkinsUniversity,BaltimoreasanInternationalQA/QCQualityCoordinatorforClinicallaboratorieswherethegroupoverseesandmonitoringthequalitysystemofabout170clinicallabsworldwidebyfollowingGCLPandCLSI/CLIAregulations.Duringmytenureinpharmaceuticalindustryandinthequalitysystems,Icameacrosslotsoffederalandinternationalregulations.IamfascinatedwithFDA’sregulationswhichensurethebestproductsandethicalservicesforthepublichealthwithintheUSandoverseasbyensuringthesafety,accuracyandef i‐cacy.Iwouldliketoinvestmyexperienceinthetranslationalresearchwhichwillprovidebene itforthepublichealthoftheUSandoverseas.FDAisanidealplacewhichharmonizestheapplicationoftranslationalresearchguidedbyethi‐calregulationsandensurestheprotectionofpublichealthoftheAmericancommunity.TheFDACommissioner’sFel‐lowship trainingwill provide a unique opportunity to learnmore about FDA rules and regulations; in‐depthunder‐standingofthesciencebehindregulatoryreviewsandprovidesauniqueopportunitytocompleteresearchprojectsofimportantpublichealthissues.Commissioner’sFellowshipProjectOverviewRapidMicrobiologicalMethods(RMM)forSterilityTestingofCellularandGeneTherapyProductsRegulatory Science Priority Area:Support New Approaches to Improve Product Manufacturing and Quality SterilityisacommonaspectofensuringthesafetyofBiologicalProducts.FDAregulationsrequirethatthesterilityofeachlotofeachproduct,withtheexceptionofcertainproducts,bedemonstratedbytheperformanceofprescribedste‐rilitytests.Manufacturersofinnovativeproducts,suchascellandgenetherapyproducts,aswellasmanufacturersofcurrentlyapprovedproducts,maybene it fromsterilitytestmethodswithrapidandadvanceddetectioncapabilities.Mostcell andgene therapyproductsareadministered topatientsbeforeresults fromstandard14daysterility tests(requiredby21CodeofFederalRegulations610.12)areavailable.TheCFRmethodreliesonmanually inspectingatde inedintervalswhetherbacterialculturemediathathasbeeninoculatedwithproductappearscontaminated.Instru‐mentsdevelopedbyindustryhaveautomatedthereadingofsterilitycultures,potentiallyallowingformoresensitiveandrapidmethodsofproductcontamination,andwithlessoperator intervention. SomeexamplesofnovelmethodswiththepotentialtodetectviablemicroorganismsincludetheAdenosineTriphosphate(ATP)bioluminescence,chemi‐luminescence,andcarbondioxideheadspacemeasurement. Undertheregulationssponsorsareallowedtousesuchalternatemethods for sterilitydetermination, however, theymustdemonstrate equivalency of the alternatemethodwith theCFRmethod.Unfortunately,nocomprehensivecomparisonof theserapidmicrobiologicalmethods (RMMs)exists.

JalalSheikh,Ph.D.

DivisionofCellandGeneTherapyOf iceofCellular,Tissue,andGeneTherapy

CenterforBiologicsEvaluationandResearch(CBER)

Preceptor:KimberlyBenton,Ph.D.

35

Scienti icandProfessionalBackground B.Sc.withhonorsfromBrownUniversity,Biochemistry,ProvidenceRhodeIsland(1999‐2003) MAfromHarvardUniversity,ChemicalBiology,Cambridge,Massachusetts(2004‐2005) Ph.D.fromHarvardUniversity,ChemicalBiology,Cambridge,Massachusetts(2004‐2009) Post‐doctoralexperiencefromTheScrippsResearchInstitute,ChemicalBiology,LaJolla,California (2009‐2011) ResearchInterestsMyresearchinterestisinthe ieldofdrugdiscoverywithintheareasofinfectiousdiseaseandregenera‐tivemedicine.FormyPh.D.andpost‐doctoraltraining,Ifocusedonhigh‐throughputscreeningtoidentifynovelcompoundstargetingS.aureusandtoinduceproliferationinterminallydifferentiatedcellsforcell‐based therapies. I am currentlyworking as a Commissioner’s Fellow in the lab of Dr. Karen Elkins inCBER.Myprojectfocusesonunderstandinghost‐pathogeninteractionsforF.tularensis.Commissioner’sFellowshipProjectOverviewTheBiologicalRoleoftheCytokinep40inClearingChronicInfectionsCausedbyVaccinationwithFrancisellaTularensisLiveVaccineStrain(LVS)Regulatory Science Priority Area:Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and SecurityPreviously,theElkinslabhasshownthatmicede icientinthep40subunitofIL‐12exhibitachronicinfec‐tionwhenvaccinatedwiththeLiveVaccineStrain(LVS)oftheintracellularbacteriumFrancisellatularen-sis, while thewild type controlmice completely clear the vaccinating infection. This defect cannot bereadilyattributedtothefunctionsofp40aspartofeitherIL‐12orIL‐23heterodimers.Thep40proteinisalsoproducedandsecretedinvivoinrelativelylargeamountsasahomodimer(p402),whichcanblockthebindingofIL‐12(p70)toitsreceptor,buttheinvivofunctionofthehomodimerformremainselusive.Wearethereforeinterestedinevaluatingnovelbiologicalrolesthep40subunitplaysduringvaccinationwiththis live attenuated bacterial strain, including clearance. Using a combination of tissue sectioning andlowcytometrywithisolatedcells,wewillexaminethelocalizationandexpressionofp40inLVS‐infectedEYFPp40transgenicmiceovertime;inthesemice,cells(notablyDCsandmacrophages)thatproducep40canbedetectedbyexpressionofYFP.Similarly,todetermineuniquesitesofp40expression,relativep40geneexpressioninselectedtissuesandcells(asdirectedbyresultsofp40proteinexpressionusingtrans‐genicmice)willbedeterminedandcomparedtotherelativeexpressionofthep35chainofIL‐12andthep19chainofIL‐23.BecauseTlymphocytefunctioniscriticaltoclearanceofFrancisella,therelativeTcellfunctionoflymphocytesfromspleens,livers,andlungsofLVS‐immuneWT,p40KO,andp35KOmicewillbe compared. Further, LVS‐immune cells restimulated by invitro co‐culturewith LVS‐infectedmacro‐phages will be recovered and compared for relative expression of a large panel of immunologically‐relatedgenesbyqRT‐PCR.ExperiencetodateindicatesthatchronicLVSinfectioninp40KOmicedrivescontinuedproductionofmanypro‐in lammatorycytokines,andpresumablyactivation‐relatedmolecules;thereforeweexpectmanyentitieswillbeupregulatedincellsfromLVS‐infectedp40KOmicecomparedtocellsfromLVS‐infectedWTmice.Takentogether,thisworkwillprovideabetterunderstandingofthebiologicalroleof p40duringinvivo clearanceofinfectionswithintracellularbacteriaandsuccessfulvac‐cinationwithliveattenuatedvaccinestrains,asexempli iedbyF.tularensisLVS.

JonathanSwoboda,Ph.D.

CenterforBiologicEvaluationandResearch(CBER)

Preceptor:KarenElkins,Ph.D.

36

Scienti icandProfessionalBackground2007‐2011 PostdoctoralResearchFellow,EmoryVaccineCenter,EmoryUniversity2006‐2007 PostdoctoralResearchFellow,CentersforDiseasePreventionandControl2001‐2006 Ph.D.BiologicalSciences(Virology),WesternMichiganUniversity1998‐2001 B.Sc.BiomedicalSciences,WesternMichiganUniversityResearchInterestsMyresearchinterestsareintheareasofcellularimmunityinducedduringvaccinationsorexpo‐suretopathogens.Primarily,IuseFACS(Fluorescence‐activatedCellSorting)tocharacterizetheantigen‐speci icTcellpopulationsduringimmuneinductiontoassesstheirphenotypicandfunc‐tionalcharacteristicsandwhethertheybecomelong‐livedmemorycells toconfer futureprotec‐tionagainstre‐infectionbythesamepathogenorintendedpathogen,inthecaseofvaccination.IamespeciallyexcitedtobeabletoexpandmyexperienceandinterestsinthecapacityofaCom‐missioner’s Fellow to conduct research and reviewwork in vaccines that are sorely needed toeradicatesomechronicdiseasesthathavenotyetanyvaccinesavailable.Commissioner’sFellowshipProjectOverviewImprovementofHepatitisCVirus (HCV)Vaccines throughPhenotypicT-cellAnalysisandPotencyAssayDevelopmentRegulatory Science Priority Area:StimulateInnovationinClinicalEvaluationsandPer‐sonalizedMedicinetoImproveProductDevelopmentandPatientOutcomesHCVinfectionisoneofthemanychronicdiseasesforwhichthereisnoeffectiveprophylacticvac‐cineavailable.ThegoalofmyprojectistoidentifyandcharacterizeHCVantigen‐speci icTcellstounderstandthephenotypesandfunctionalqualityoftheseTcells followingvaccinationwithre‐combinantvaccines.AsecondarygoaloftheprojectistodevelopaFACS‐basedpotencyassaytoshowconsistentimmunogenicityofT‐cell‐targetingvaccinesforclinicaltrialproductionandlongtermmanufacturing.Together,theseresultswillimpartvaluableknowledgeaboutthedifferentTcellphenotypesinducedbydifferentvectorsandprovidevaluableguidanceforfuturevaccinede‐velopment.TheFACS‐basedassaywillenableconsistentdeterminationofthepotencyofeachvac‐cinefromlot‐to‐lotduringmassproductiontoensurepublicsafety.ThisknowledgewillprovidefundamentalandessentialinformationforregulatoryreviewsofT‐cellbasedvaccineapplications.

WendyTan,Ph.D.

CenterforBiologicsEvaluationandResearch(CBER)

Preceptor:MarianMajor,Ph.D.

37

Scienti icandProfessionalBackgroundSr.Scientist,ResearchandDevelopment,CanonUSLifeSciences,2007‐2011PostDoctoralScientist‐CanonUSLifeSciences,Rockville,MD,2006‐2007Ph.D.inMicrobiology,MolecularBiologyconcentration,HowardUniversity,2006B.S.inBiology,VirginiaUnionUniversity,2001ResearchInterestsIhavehadaninterestinhealthdisparitiesamongminoritygroups.Mydoctoralresearchinvolvedinvestigating matrix proteins and their involvement in metastasis of breast cancer in AfricanAmericanandCaucasianwomen. Duringmypost‐doctoral fellowship, Iparticipated inavalida‐tionprojectwithCanonUSLifeSciences,theDepartmentofHomelandSecurity,UniversityofMar‐ylandatCollegePark,andTheInstituteforGenomicResearchonvalidatinganewbioinformaticspipeline of microbial genomes to ascertain the sensitivity and speci icity in differentiating be‐tweenspeciesofbacteriaparticularlyagentsofhealthconsequences.Mycurrentinterestsareinunderstandingtheregulatorypoliciesrelatedtoinvitrodiagnosticsandmedicaldevicedevelop‐ment.Commissioner’sFellowshipProjectOverviewDevelopmentofGuidanceforDirect-to-Consumer(DTC)GeneticTesting:ARapidandSystematicApproachforDeterminingtheClinicalSigni icanceandValidityofAddingNewIntendedUsestoal-readyApproved/clearedDTCGeneticTests.Regulatory Science Priority Area:Ensure FDA Readiness to Evaluate Innovative Emerging TechnologiesCurrently,DirecttoConsumergenetictesting(DTC)isanareaofregulatoryconcerntoFDA.DTCgenetic testsare testsoffereddirectly toconsumers(mostofwhomarehealthy)withoutadoc‐tor’sprescription, andgenerallyencompassmultiple testsand interpretations forgeneticvaria‐tions.Mostofthegeneticvariationsthatarereportedhaveclinicalimplications.Thismodelhascreatedmuchdiscussionaroundpublichealthandothersocial/legal/ethicalconcerns.Theprima‐rygoalofmyproject is todeveloprecommendationsfordeterminingwhennewscienti ic infor‐mationcanreasonablysupportadditionalDTCtestofferings togetherwithanalreadyapprovedtestsystem.

JacqulineAMYancy,Ph.D.

CenterforDevicesandRadiologicalHealth(CDRH)Of iceofInVitroDiagnosticDeviceEvaluationandSafety

Preceptors:ElizabethMans ield,Ph.D.andKatherineSerrano,B.S.

38

Scienti icandProfessionalBackground2009‐2011 ResearchAssociate/Scientist,TheOhioStateUniversity2006‐2009 PostdoctoralFellow,KansasUniversityMedicalCenter2007Ph.D. Pharmaceutics,NationalUniversityofSingapore,Singapore2002M.S. PharmaceuticalAnalysis,NationalInstituteforFoodandDrugControl,China1999B.S. Pharmacy,WestChinaUniversityofMedicalSciences,ChinaResearchInterestsThroughmyeducationalandprofessionalexperience,Ihaveacquiredin‐depthknowledgeinpre‐clinicalandclinicalpharmacokineticsandpharmacodynamics.Ihaveworkedondrugmetabolism,drugtransport,drug‐druginteractionandpharmacokineticmodeling.Mycurrentresearchinter‐estsinvolvethedevelopmentanduseofphysiologicallybasedpharmacokineticmodelstounder‐standkeyfactorscontributingtoBisphenolAdosimetry.Commissioner’sFellowshipProjectOverviewPharmacokineticModeling:PredictionandEvaluationofRouteDependentDosimetryofBisphenolAinRatsatDifferentDevelopmentStagesRegulatory Science Priority Area:ModernizeToxicologytoEnhanceProductSafetyPharmacokineticsofbisphenolA(BPA)hasbeencharacterizedinlaboratoryanimalsandhumans.Tofacilitatetheextrapolationofanimaltoxicity indingstohumansandassisttheinterpretationofhumanBPAbiomonitoring, thequantitativecomparisonofBPAdosimetrybetweenanimalsandhumans iswarranted.Myproject is todevelopa suiteofphysiologicallybasedpharmacokineticmodels(PBPK)topredictinternaldosesforbothaglyconeandconjugatedformsofBPAinratsatdifferentreproductivestages.Thesemodelswillbeusedforthe90‐dayand2‐yearNationalTest‐ingProgramtoxicitystudieswithBPAatNCTR.TheaccomplishmentofthisprojectcanbedirectlyrelatedtothecontrolofpublichealthrisksposedbyBPA,andhelpprovidecriticalinformationforFDAtomakesciencebasedregulatorydecisionsregardingtheuseofBPA.

XiaoxiaYang,Ph.D.

NationalCenterforToxicologicalResearch(NCTR)

Preceptor:JeffreyFisher,Ph.D.

39

Scienti icandProfessionalBackground2009‐2011 PostdoctoralResearchFellow,RiceUniversity2003‐2008 Ph.D.ChemicalEngineering,UniversityofMaryland1999‐2003 B.S.BiomedicalEngineeringandB.S.ChemicalEngineering,CarnegieMellon UniversityResearchInterestsMyareaofexpertiseisinthe ieldoftissueengineeringwithaconcentrationinorthopedictissues.MyPh.D.researchfocusedontissueengineeringstrategiesforcartilage,morespeci icallyinvesti‐gatingtheeffectofconstructproperties,suchascell tocellcontacts,biomaterials,matrices,andproteins,onchondrocytegeneexpression.Mypostdoctoralresearchinvestigatedthemechanicalpropertiesofsyntheticpolymersforpotentialapplicationinloadbearingbonedefectsaswellascontrollingthedeliveryofgrowthfactorstoaidinboneregeneration.Commissioner’sFellowshipProjectOverviewOpportunitiesandChallengesofUsingStandardsforPremarketReviewofBoneRegenerativeMedi-cineProductsatCBERandCDRHRegulatory Science Priority Area:Ensure FDA Readiness to Evaluate Innovative Emerging TechnologiesThe ieldoftissueengineering/regenerativemedicine(TE/RM)isprovidingthebiomedicalcom‐munitywithinnovativetreatmentoptionstomeetunmetneedsacrossawiderangeofclinicalin‐dications.Forbonereplacementandregeneration,avarietyofTE/RMapproachesarecurrentlyused, includingbiologics,devices, tissues,drugsandcombinationproducts.TE/RMproductsareevaluatedunderestablishedregulatorypathwaysattheFDA.Factorssuchasthecomposition,un‐derstandingofmechanismofactionandintendeduseoftheproductareconsideredindetermin‐ingwhetherbonehealingTE/RMproductsarereviewedprimarilyatCBER,CDERorCDRH.Stand‐ardsdevelopedbyStandardDevelopingOrganizations(SDOs)suchasAmericanSocietyofTestingand Materials (ASTM), International Organization for Standardization (ISO) and United StatesPharmacopeialConvention(USP)facilitateevaluationoftheseproducts.Forexamplewhenfocus‐ingonnon‐clinicalstudies,standardscanprovideknowledgethat isbene icial inassaydevelop‐ment,manufacturingprocess,andanimalstudies).Asstandardstypicallyarewrittentoaddressageneralorspeci icpurposeandthecontentcanbede initiveorbroad,identi icationofpertinentinformationforaspeci icapplicationisimportant.Therefore,thegoalofthisprojectistodeter‐minehowstandardscanbemosteffectivelyutilizedtoaidintheevaluationofnon‐clinicalaspectsofboneTE/RMproductsatCBERandCDRH.

DianaM.Yoon,Ph.D.

CenterforBiologicsEvaluationandResearch(CBER)andCenterforDevicesandRadiologicalHealth(CDRH)

Preceptors:JiyoungM.Dang,Ph.D.,MarkH.Lee,Ph.D.,and

EliasMallis,B.S.

40

Scienti ic&ProfessionalBackground

2006‐2011 Sr.ClinicalDataManager,Allergan2004‐2006 Manager,ClinicalDataOperations,TouchstoneResearch2002‐2004 ClinicalDataManager,NabiBiopharmaceuticals2001‐2002 DataValidationProgrammer,CatoResearch2000‐2001 SASProgrammerAnalyst,Westat1988‐1994 PlantProtection,QuarantineandPesticideAgency,Jiangxi,China

2000 Ph.D.Entomology,WestVirginiaUniversity1988 M.S.InsectEcology,FujianAgriculturalUniversity,China1985 B.S.PlantProtectionScience,JiangxiAgriculturalUniversity,China ResearchInterests

Myearlyresearchexperiencewasfocusedonplanthealth, involvingeffectivemonitoring, forecastingandmanagementofplantepidemicstoensuresafeandsustainablefoodproductionandminimalimpactontheenvironment.Mygraduateworkfocusedoneriophyoidmitesasspecialvectorsofplantvirusdiseasesanddiscoveredhundredsofmitespeciesnewtoscience.AfterreceivingmyPH.D.,Imovedintotheareasofhealthcareandclinicalresearch,speci icallyprotocolde‐sign,datamanagementandanalysis.Currentlymyareasof focusare:policiesandpracticesprovidingforoptimalclinicaltrialef iciencyanddataquality;innovativetrialdesign,dataanalysisandreviewmethodol‐ogiesandtoolssupportingeffectiveidenti icationofclinicalandscienti icevidence.Commissioner’sFellowshipProjectOverviewTheFDAPatient-CenteredOutcomesResearch(PCOR)PromotingPersonalizedMedicineRegulatory Science Priority Area:Ensure FDA Readiness to Evaluate Innovative Emerging Technolo-giesFDAhaslongseenacriticalneedinupgradingitscapacityineffectiveandef icientmanagementandanaly‐sisoftheclinicaltrialdataitreceives.TheFDAPCORprojectdirectlyaddressessuchaneedintwomajorfronts:

Standardizationandintegrationoflegacysubmissiondata:clinicaldatafromselectedgroupsofstudiesacrossCBER,CDERandCDRHwillbetransformedandpopulatedintoFDA’scentralizedstudydatare‐positorythatiscurrentlybeingbuilt.SuchaneffortwillpavetheroadtosuccessforFDA’sfuturedataconversiontasksaswellasnewdatasubmissionsbysponsors.

PCORpilotstudiesusingFDAandexternaldatasources:theresearcheffortsareexpectedtoprovidean‐swerstoimportantscienti icandregulatoryquestionsofinterestconcerningpatientoutcomesandtrialdesignstrategies.Inaddition,thecollectiveexperienceoftheFDAPCORprojectwillhelpfurtherde inedataacquisitionrequirementsandbestpracticesrelevanttoclinicalstudiesinspeci ictherapeuticareas.

ShifuZhao,Ph.D.

Of iceoftheCommissioner(OC)

Preceptors:FrankWeichold,M.DandVickiSeyfert‐Margolis.Ph.D.

41

FDACommissioner’sFellowshipProgram2011Preceptors

42

BackgroundB.S.–OrganicChemistry,MoscowLomonosovInstituteofFineChemicalTechnology.M.S.–BioorganicChemistry,MoscowLomonosovInstituteofFineChemicalTechnology.Ph.D.–Biochemistry,RussianStateMedicalUniversity,Moscow,Russia.FDAExperience–5yearsResearchInterestsThedevelopment andavailabilityof “‐omics” technologieshasmovedanalytical research to theforefrontofbiomedicalsciencesanditisimperativethatpromising indingsaretranslatedrapidlyintonewapproachesandstrategiesforproductdevelopment.Ourworkre lectsthatpathbyde‐velopingnewstate‐of‐the‐artmassspectrometry‐basedproteomicapproachfortestingofbiologi‐calproductsqualityandidentity.Biologicproductsarederivedfromlivingsourcesandrepresentmixturesof proteins, carbohydrates, lipids andotherbiomoleculesof enormous analytical com‐plexity.Themajorphysical‐chemicalfeaturethatcanbemeasuredforallcomponentsofbiologicalmixturesanduniquelyidentifyanddistinguishthemismolecularmass.Massspectrometry‐basedproteomicsistheleadingtechnologyfortherapidanalysisofcomplexproteinmixtures.Thistech‐nologyprovidesmeansforconcomitantanalysisofallcomponentsofbiologicalproducts.Thegoalof this researchprogram is todevelop, evaluate andadaptmass spectrometry‐basedproteomictechniques for qualitative and quantitative analytical testing of cells, cell‐derived products, andvaccines.

MichailA.Alterman,Ph.D.

Of iceofCellular,Tissue,andGeneTherapiesCenterforBiologicsEvaluationandResearch(CBER)

NIHCampus,Bethesda,MD

43

BackgroundPh.D.–MicrobiologyFDAExperience–10yearsResearchInterestsSterilityisacommonaspectofensuringthesafetyofBiologicalProducts.FDAregulationsrequirethatthesterilityofeachlotofeachproduct,withtheexceptionofcertainproducts,bedemonstrat‐edbytheperformanceofprescribedsterilitytests.Manufacturersofinnovativeproducts,suchascell and gene therapy products, aswell asmanufacturers of currently approved products,maybene it fromsterilitytestmethodswithrapidandadvanceddetectioncapabilities.Mostcellandgenetherapyproductsareadministeredtopatientsbeforeresultsfromstandard14daysterilitytests(requiredby21CodeofFederalRegulations610.12)areavailable.TheCFRmethodreliesonmanuallyinspectingatde inedintervalswhetherbacterialculturemediathathasbeeninoculatedwithproductappearscontaminated.Instrumentsdevelopedbyindustryhaveautomatedtheread‐ingofsterilitycultures,potentiallyallowingformoresensitiveandrapidmethodsofproductcon‐tamination,andwithlessoperatorintervention.Someexamplesofnovelmethodswiththepoten‐tialtodetectviablemicroorganismsincludetheAdenosineTriphosphate(ATP)bioluminescence,chemi‐ luminescence,andcarbondioxideheadspacemeasurement.Undertheregulationsspon‐sors are allowed to use such alternatemethods for sterility determination, however, theymustdemonstrateequivalencyofthealternatemethodwiththeCFRmethod.Unfortunately,nocompre‐hensivecomparisonoftheserapidmicrobiologicalmethods(RMMs)exists.ThefellowshippositionwillhaveastrongregulatoryfocusandtheFellowwilllearnandperformregulatoryreview.Theprimaryprojectwouldbe tocompileandreviewtheexistingdata for itsadequacy to support equivalence betweenRMMs and the CFRmethod, and identify any criticalgapsinthedata.Sourcesofexistingdataincludethescienti icliteratureanddatasubmittedtoin‐dividualregulatoryapplications.TheFellowmayalsohavetheopportunitytoworkinCBERmi‐crobiologylaboratoriesandinotherareasofCBERrelevanttothegoalsoftheproject.

KimberlyBenton,Ph.D.

Of iceofCellular,Tissue,andGeneTherapiesCenterforBiologicsEvaluationandResearch(CBER)

Rockville,MD

44

BackgroundPharmD,PediatricClinicalPharmacology3yearsatFDAResearchInterestsMyresearchforthepast10yearshasfocusedontheapplicationofpharmacogenomicstoexplainthevariabilityindrugresponse,especiallyinpediatricpatients.Morerecently,Ihaveexploredtheapplicability of pharmacogenomics to drug safetywith immunosuppressive drugs, and have anongoingstudyofwarfarinpharmacogenomicsinpediatricpatientsrecruitedatthreenationalchil‐dren'shospitals.Mycollaborators includeadiversegroupof clinical scientistsatmajormedicalcentersandattheNIH.

GilbertBurckart,PharmD

Of iceofTranslationalSciencesOf iceofClinicalPharmacology

CenterforDrugEvaluationandResearch(CDER)SilverSpring,MD

45

BackgroundD.V.M.—BuenosAires,ArgentinaM.S.—UniversidadAutonomadeBarcelona,SpainPh.D.—UniversidadAutonomadeBarcelona,SpainFDAexperience—10yearsResearchInterestsDevelopmentoftissue luidcorrelationsforantimicrobialagents.

O.AlbertoChiesa,D.V.M.,M.S.,Ph.D.

Of iceofResearchDivisionofAnimalresearch

CenterforVeterinaryMedicine(CVM)Laurel,MD

46

BackgroundEducationPh.D.inBiomedicalEngineering(Dec.2005),FloridaInternationalUniversity(FIU),MSinBiomedicalEngineering(Dec.2000),TexasA&MUniversityProfessionalExperienceStaffFellow,CDRH/OSEL,‐5/2009‐presentResearchAssociate,CardiovascularandEngineeringCenter,FIU,Miami,FL,06/2002–05/2008BiomedicalEngineer,MicroSystemsEngineering,Biotronik,Inc.,Portland,OR08/2000–06/2002ResearchInterests:TheOSEL/DSFMSolidMechanics laboratoryassistsCDRHwithissuesrelatedtotheresponseofmedicaldevicematerialsandstructurestoappliedstressinbothpre‐marketevaluationsandpost‐marketadverseeventreports.Thematerialsofinterestincludetraditionalengineeringmaterialslikemetalsandpolymers,inadditiontomaterialsofbiologicaloriginandthoseusedintissueen‐gineeredmedicalproducts(TEMPs).Commonprinciplesofstressanalysiscanbeappliedtothisbroadspectrumofmaterials.Wehavethecapabilitiestomeasuremechanicalpropertiesrangingfromthe tensile strengthof suturesandmedical glovematerials, to the fatiguestrengthof totaljointprostheses. Besidespurelymechanicalcharacterizations,ourmeasurementcapabilitiesforTEMPsconstructsandscaffolds includequanti icationofphenotypic stability and thehistomor‐phologyofTEMPsrelevantcelltypes.Thecombinedoutputofthiseffortincludesimprovedcriti‐cal review ofmanufacturers' claims and data, testmethod development,material andmethodsstandardsandguidancedocumentdevelopment,andpublicationsrelatedtothepublichealthim‐pactofmedicaldevicematerialsdesign,fabrication,orfailure.Currently,mymainresearchworkfocussesonlea letdynamicswithpercutaneousheartvalvesandperforationpotentialwithpace‐maker/de ibrillatorleads

NandiniDuraiswamy,Ph.D.

Of iceofScience&EngineeringLaboratoriesDivisionofSolid&FluidMechanics

CenterforDevicesandRadiologicalHealth(CDRH)

47

BackgroundB.A.,WakeForestUniversity,Winston‐Salem,NC,ChemistryPh.D.,DukeUniversity,Durham,NC.,MicrobiologyandImmunologySeniorinvestigator/regulatoryreviewer,CBER,1993‐presentResearchInterestsTheresearchinterestsintheElkinslaboratoryconcernmechanismsofprotectiveimmunitytoin‐tracellularpathogens,includingpotentialbioterrorismagents.Correspondingly,INDandBLAre‐viewwork involvesvaccineproducts indicated forpreventionofdiseasecausedby intracellularpathogens, includingtuberculosis, tularemia,malaria,Leishmania,andQ fever(Coxiellaburnetti).Usingmousemodelsofinfectioninvivo,ourresearchfocusesonroleofTandBlymphocytes,mac‐rophages,dendriticcells,NKcells,neutrophils,andtheirproducts(e.g.,antibodies,cytokines,andchemokines), inprotective immunity toFrancisellatularensisandMycobacteriumtuberculosis.Weareparticularly interested inunderstanding thenatureof invivoTcelleffectormechanismsthatcontrolintramacrophagebacterialgrowth.Thegoalofthesestudiesisthederivationofpracticalcorrelates that will predict vaccine‐induced protection against intracellular bacteria (includingfunctionalcorrelatesandbiomarkers).

KarenL.Elkins,Ph.D.

LaboratoryofMycobacterialDiseasesandCellularImmunologyDivisionofBacterial,Parasitic,andAllergenicProducts

Of iceofVaccinesResearchandReview,CenterforBiologicalEvaluationandResearch(CBER)

NIHBuildingBethesda,MD

48

BackgroundPh.D.–1987MiamiUniversity(Zoology/Toxicology)FDAExperience–1Year

ResearchInterestsThedevelopmentanduseofphysiologicallybasedpharmacokinetic(PBPK)modelsandbiological‐lybaseddoseresponse(BBDR)modelsforhumanhealthriskassessment.

JeffreyFisher,Ph.D.

DivisionofBiochemicalToxicologyNationalCenterforToxicologicalResearch(NCTR)

Jefferson,AR

49

BackgroundBSBiologyIowaStateUniversityMACellandMolecularBiology,SanFranciscoStateUniversityFDAExperience‐23yearsResearchInterests:Detectionandidenti icationofentericvirusesandbacteriainfoodmatrices.

GaryHartman,MA

SanFranciscoDistrictLaboratoryOf iceofRegulatoryAffairs(ORA)

Alameda,CA

50

BackgroundPh.D.inComparativePathology,UniversityofCaliforniaatDavis.MasterofPreventiveVeterinaryMedicine,UniversityofCaliforniaatDavis.DoctorofVeterinaryMedicine,ChulalongkornUniversity,Thailand.GovernmentWorkExperiences2yearswithFDA7yearswithCaliforniaDepartmentofPublicHealthResearchInterests Rapidmolecularmethodsfordetectionandidenti icationoffoodbornepathogens. Moleculartypingmethodsformicrobialsourcetracking.

SuneeHimathongkham,D.V.M.,M.P.V.M.,Ph.D.

Of iceofRegulatoryAffairsSanFranciscoDistrictLaboratory

Alameda,CA

51

BackgroundPh.D.–UniversityofNorthCarolina,ChapelHillSchoolofPublicHealthB.S.–Biochemistry,UniversityoftheSciencesinPhiladelphiaFDAExperience–2yearsResearchInterestsResearchactivitieshavetoucheduponenvironmentalmicrobiology(e.g.transmissionofinfectiousagentsintheenvironment),themicrobiocidalef icacyofchemicaldisinfectants,andoftencom‐binedepidemiology‐based ieldworkwithmicrobiologicallaboratoryresearch.Interestsfocuseduponbacteriaandvirusesspreadzoonotically(e.g.shigatoxigenicE.coli,Brucellaspp.,HepatitisEvirus)andpotentiallythroughparticularfoodcommodities.

JulieKase,Ph.D.

Of iceoftheCenterDirectorCenterforFoodSafetyandAppliedNutrition(CFSAN)

CollegePark,MD

52

BackgroundPh.D.–BiologyB.A.–MolecularandCellBiologyFDAExperience–7yearsResearchInterests non‐O157ShigatoxinproducingE.coli DetectionofHepatitisAvirus Highthroughput96wellformatanalysis

AndrewP.Lin,Ph.D.

SanFransiscoLabBranchSanFranciscoDistrictLaboratoryOf iceofRegulatoryAffairs(ORA)

Alameda,CA

53

BackgroundPh.D.–AnalyticalChemistry,UniversityofArkansasB.S.–Chemistry,HendersonStateUniversityFDAExperience–2YearsResearchInterestsMycurrentresearchinterestsinclude:1. DevelopmentofScreeningMethodologiesfortheDetectionofNanoscaleSilverUsingInduc‐tivelyCoupledPlasmaMassSpectrometry(ICP‐MS).2. EvaluationofX‐rayFluorescence(XRF)SpectroscopyasaScreeningToolforNanoscaleSilverinFDARegulatedFoodProducts.3. NanosilverMigrationfromFoodContactMaterials.AnalysisofAntibioticsandExcipientsonEnvironmentalSwabMaterialsUsingHighResolutionMassSpectrometry.

SeanW.Linder,Ph.D.

GeneralChemistryBranchArkansasRegionalLaboratory(ARL)

Of iceofRegulatoryAffairs(ORA)Jefferson,AR

54

BackgroundM.D.andPh.D.(Pharmacology),JohnsHopkinsUniversitySchoolofMedicineBoard‐Certi ied–DermatologyPriorworkasAttendingPhysician,BethesdaNationalNavalMedicalCenterFDAExperience–13years

ResearchInterestsTheOf iceofDeviceEvaluation (ODE), Center forDevices andRadiologicalHealth (CDRH) con‐ductspremarketreviewofcuttingedgetherapeuticanddiagnosticdevicetechnologies.Thiscom‐ponentoftheFDAevaluatesthesafetyandeffectivenessofnewmedicaldevicespriortotheirin‐troductionintothemarketplace.Dr.Lukehasresearch interests inclinicalstudydesign,clinicalendpointsassessment,andscaledevelopment(includingpatient‐reportedoutcomes)forbothef icacyandsafetydeterminationofmedicalproducts.Speci icattributesofmedicaldevicesandtheirimpactonblindingandvariabil‐itywhenusedinthehandsofcliniciansandimpactonclinicaltrialvalidityandoutcomearecur‐rentlybeingassessed.Dr.Lukehasover11yearsofregulatoryexperienceinclinicalevaluationofdevice,drug,andbiologicalproductsattheFoodandDrugAdministration.

MarkhamC.Luke,M.D.,Ph.D.

Of iceofDeviceEvaluation(ODE)CenterforDevicesandRadiologicalHealth(CDRH)

SilverSpring,MD

55

BackgroundCellandMolecularBiology‐Ph.D.FDAExperience‐22yearsResearchInterests PharmacogenomicsandPersonalizedMedicine SexDifferencesinDrugToxicityandAdverseDrugReactions EpigeneticandGeneticRegulationofDrugTransporters MechanismsInvolvedinLupusEtiology MechanisticActionofDietaryAgentsandCancerDrugsinPancreaticandBreastCancer (nutrigenomics)

BeverlyLyn‐Cook,Ph.D.

Coordinator,NCTRWomen’sHealthResearchProgram,Of iceoftheAssociateDirectorofRegulatoryActivities

NationalCenterforToxicologicalResearch

56

BackgroundB.Sc.Hons.–UniversityofWarwick,UKPh.D.–UniversityofWarwick,UKFDAExperience–10yearsResearchInterestsHepatitisCvirus(HCV) isaseriouspublichealthconcern, there isnovaccineand85percentofpeoplethatbecomeinfectedwiththevirusdeveloppersistentinfectionsthatcan,inlaterlife,leadtosevere liverproblemssuchascirrhosisorhepatocellularcarcinoma(HCC).HCC isoneof thefewcancersincreasinginfrequencyandmortalityintheU.S.,studiesshowthat~50%ofHCCcas‐esoccurasaresultofchronicHCVinfection.ThisresearchprogramfocusesonunderstandingtheimmunobiologyandpathogenesisofHCVthroughstudiesinthefollowingareas:The identi ication of immunological correlates of protection. Thiswork involves the analysis ofTcell and antibody responses.Weare analyzing the speci icity andphenotypes of antibody andTcells induced following vaccination and comparing thesewith the types of responses inducedduringnaturalHCVinfections.Thesestudieswillprovideimportantbiomarkerstobeusedinpre‐dictingtheeffectivenessofvaccine‐inducedimmuneresponses.DevelopmentofneutralizationtestsforHCVandef icientinductionofcross‐neutralizingantibod‐ies.Animportantgoalofanyantibodybasedvaccineistheinductionofpotentandeffectiveanti‐bodiesthatcanneutralizeallvariantsofthevirus.Crossneutralizingantibodieshavebeenisolat‐edfrominfectedpatientsbutthechallengeremainsofhowtoinducetheseantibodieswithare‐combinantvaccine.WearefocusingonsystemsthatcaninducepotentneutralizingantibodiesinvivoandtestsinvitrotoanalyzetheabilityofantibodiestoneutralizeallgenotypesofHCV.There‐by identifying themost cross reactive immune responses thatwill protect against the greatestnumberofHCVisolates.

MarianE.Major,Ph.D.

Of iceofVaccineResearchandReview(OVRR)CenterforBiologicsResearchandEvaluation(CBER)

NIHCampus,Bethesda,MD

57

ResearchInterestsSince the implementationof theMedicalDeviceAmendments (MDA)of1976FDAhasgenerallyexercisedenforcementdiscretionandnotenforcedapplicableregulationswithrespecttoLabora‐toryDevelopedTests(LDTs),aclassofinvitrodiagnosticsthataremanufactured,includingbeingdevelopedandvalidated,andoffered,withinasinglelaboratory.Since1976,thenatureoflabora‐torydevelopedtestinghaschangeddramatically.Today,manyLDTsarebecomingmorecomplex,anddiagnostictestsareplayinganincreasinglyimportantroleinclinicaldecisionmakinganddis‐easemanagement,particularlyinthecontextofpersonalizedmedicine.However,LDTsthathavenotbeenproperlyvalidatedfortheirintendeduseputpatientsatrisk.Risksincludemisseddiag‐nosis,wrongdiagnosis,andfailuretoreceiveappropriatetreatment.Inresponsetothesepublichealthconcerns, theAgency is in theprocessof reconsidering itspolicyofblanketenforcementdiscretionovermostLDTs.Atthistime,FDAbelievesthatarisk‐basedapplicationofoversighttoLDTs is the appropriate approach to achieve thedesiredpublic healthgoals, and to assure thattestsusedintheprovisionofhealthcare,whetherdevelopedbyalaboratoryorothermanufactur‐er,aresafeandeffective.

ElizabethMans ield,Ph.D.

Of iceofInVitroDiagnosticDeviceEvaluationandSafety(OIVD)CenterforDevicesandRadiologicalHealth(CDRH)

SilverSpring,MD

BackgroundPh.D.–JohnsHopkinsUniversity

KatherineSerrano,B.S.

Of iceofInVitroDiagnosticDeviceEvaluationandSafety(OIVD)CenterforDevicesandRadiologicalHealth(CDRH)

SilverSpring,MD

BackgroundB.S.–UniversityofMinnesota,TwinCities

58

BackgroundPh.D.–MaterialScienceEngineering,CornellUniversityFDAExperience–18yearsResearchInterestsDr.McNamee’sprimarytraininghasbeenintheareaofmaterialscienceengineering,whichseekstounderstandtherelationshipsbetweenthestructureofmaterialsandtheirproperties. Hehasalsobeenworking intheareaof transmissiblespongiformencephalopathy(TSE)as itrelatestomedicaldevicesthatutilizeanimaltissues(primarilybovine)andtheriskstothepublicfromhu‐man TSEs such as Creutzfeld‐Jacob Disease. His currentwork for the Of ice of Compliance in‐cludesunderstandingtherisksandbene itsofnanotechnologyinthemanufactureofmedicalde‐vices,keepingabreastof theadvances inregenerativemedicine(alsoknownastissueengineer‐ing),andbeingpartofthereviewofmedicaldevicefailuresresultinginrecalls.Failureanalysis,orrootcauseanalysis,iscriticallyimportanttotheCenter’sworkinCompliance,andtherolethatclimatechangeandnaturaldisastersmayhaveinsuchfailureswillbeonefocusofthisproposedproject.

ScottMcNamee,Ph.D.

Of iceofCompliance(OC)CenterforDevicesandRadiologicalHealth(CDRH)

SilverSpring,MD

59

BackgroundPh.D.–PharmaceuticalSciencesFDAExperience–1yearResearchInterestsMycurrentinterestistodevelopinvitromodelsbyidentifyingproperdissolutionequipmentandmediaandthenusetheinvitrodatatopredicttheinvivopharmacokineticpro ileofadrug.Modelcompoundsrangingfrombiologicalsafetycabinets(BSCII)(lowsolubilityandhighpermeability)toextended releasedosage formswillbeutilized.Thisworkwill enableus todevelopbetter invitromodelssothatFDAcangrantfasterpostapprovalchangesandmandatefewerclinicalstud‐ies.

TahseenMirza,Ph.D.

Of iceofPharmaceuticalScience(OPS)CenterforDrugEvaluationandResearch(CDER)

SilverSpring,MD

60

AsAssociateDirector forTechnologyandInnovation(Acting),MegandirectstheCenter’sEntre‐preneurs inResidenceprogram,aWhiteHouse sponsoredprogramthatbrings thought leadersintoagenciestosolvechallengingproblems. TargetingtheInnovationPathway,theEIRteamofmedicaldevice innovators,businessprocess innovators,andvisionaries launched theEndStageRenalDisease InnovationChallenge in January, 2012, to spurmedical device innovation forpa‐tientswithESRD.TheteamlaunchedInnovationPathway2.0onApril9,2012,astreamlinedreg‐ulatorypathwayforpioneeringmedicaldevicesthatwasbuiltusingleanstart‐uptechniques.In2010,Megan led theCDRHExternalDe ibrillator Improvement Initiative, aneffort touseFDA’sregulatoryoversightandpublichealthin luencetoimprovetheperformanceofexternalde ibrilla‐tors.MeganbringsinsightintotheuniquecultureandworkingsofFDA’sCenterforDevicesandRadiologicalHealth,havingover16yearsexperienceatFDAincludingsixyearsasthebranchchiefforthepremarketbranchresponsiblefornewpacemakersandde ibrillators.Hersuccessfulcross‐functionalworkinggroupbecamethemodelforaCenter‐widereorganizationin2008.In2009,shewasthechiefarchitectfortheCenter’sSignalEscalationprogram,aCenter‐widebusinesspro‐cess focusedonproduct safety thatwascultivatedasan in‐house“start‐up”. Meganhasbeenamemberof theOf iceof theCenterDirector since2008. Herbackground is inbiomedical engi‐neeringwithemphasisonelectricalengineeringandcontrolsystems.Hercurrentareasoffocusontheinnovationteamincludewirelesstelemetry,continuousphysiologicalmonitoring,biosen‐sors,androbotics.

MeganMoynahan,M.S.

Of iceoftheCenterDirector(OCD)CenterforDevicesandRadiologicalHealth(CDRH)

SilverSpring,MD

61

BackgroundM.D.FDAExperience–10yearsResearchInterestsTodevelopandimproveregulatoryscience fortherapies intendedforthetreatmentofraredis‐eases fromearlyphasedrugdevelopment throughmarketingapproval.This researchwould in‐cludeadetailedanalysisofthelevelofevidenceusedtosupportpriordrugapprovalsforOrphandrugs,identi icationoffactorsthatimpedethedevelopmentofproductsintendedtotreatraredis‐eases,andinvestigationandinnovationintohowtofurtherdrugdevelopmentforrarediseases.

AnnePariser,M.D.

Of iceofNewDrugs(OND)CenterforDrugEvaluationandResearch(CDER)

SilverSpring,MD

62

BackgroundB.A.–UniversityofPennsylvaniaV.M.D.–UniversityofPennsylvaniaCollegeofVeterinaryMedicinePh.D.–UniversityofMarylandFDAExperience–12YearsResearchInterestsDr.Reimschuesselstartedveterinarypracticein1981,specializinginexoticanimalmedicine. In1989sheobtainedaPh.D. inpathology,withafocusonaquaticanimalresponsestotoxicantin‐duced injury. Shedirected theAquaticPathobiologyCenteratUniversityofMarylandSchoolofMedicineuntil1999whenshejoinedFDAtoheadupCVM’sAquacultureResearchProgram.Herresearchinterestsinclude: TherapeutantDevelopmentforAquaculture; PharmacokineticsandSpeciesGroupingforDrugApprovals,Antimicrobialsusceptibilitytest‐

ing; Melamine related renal injury andFeedContamination/Adulteration –Recently shehasbe‐

come the Program Director for CVM’s Veterinary Laboratory Response Network (VEtlRN)whichwillworkwithveterinarydiagnosticlaboratoriestoinvestigatepotentialfeedcontami‐nation/adulterationevents.

RenateReimschuessel,V.M.D.,Ph.D.

Of iceofResearchCenterforVeterinaryMedicine(CVM)

Laurel,MD

63

BackgroundB.S.–MedicalTechnologyM.A.S.–BusinessAdministrationFDAExperience–20years

AnitaRichardson,M.A.S.

Of iceofComplianceandBiologicsQuality(OCBQ)CenterforBiologicsEvaluationandResearch(CBER)

Rockville,MD

64

BackgroundPh.D.–AnalyticalChemistryFDAExperience–7YearsResearchInterestsMetabolomics,biomarkersoftoxicityanddisease,nuclearmagneticresonance(NMR)spectrosco‐py,liquidchromatography(LC),solidphaseextraction(SPE),magicanglespinning(MAS)NMR

LauraK.Schnackenberg,Ph.D.

DivisionofSystemsBiology(DSB)NationalCenterforToxicologicalResearch(NCTR)

Jefferson,AR

65

BackgroundPh.D.inImmunology–UniversityofPennsylvania,SchoolofMedicine,Philadelphia,PAB.S.inBiochemistry–UniversityoftheSciences,Philadelphia,PAFDAExperience–1yearResearchInterestsVickiSeyfert‐Margolis,Ph.D.,servesastheSeniorScienceAdvisortotheFDA’sChiefScientist inthemissionofupgradingscience,withafocusonbioinformaticsandadvancingregulatoryscience.She hasmost recently been Chief Scienti ic Of icer at Immune Tolerance Network, a non‐pro itconsortiumofresearchersseekingnewtreatmentsfordiseasesoftheimmunesystem;andanAd‐junct Associate Professorwith the Department ofMedicine at the University of California‐ SanFrancisco.Priortothat,Seyfert‐Margoliswasaprogramdirectorininnovativescienti icresearchattheNationalInstituteofAllergyandInfectiousDiseases,NationalInstitutesofHealth.Dr.Sey‐fert‐Margolis research interests are: Immunology, biomarkerdevelopment, advancing scienti iccomputingenvironment/highdensitydata,health information technology, validationandstand‐ardsdevelopment.

VickiSeyfert‐Margolis,Ph.D.

Of iceoftheChiefScientist(OCS)Of iceofRegulationScienceandCriticalPath(ORSCP)

Of iceoftheCommissioner(OC)SilverSpring,MD

66

BackgroundM.S.–FoodMicrobiology,UniversityofGeorgiaPh.D.–FoodMicrobiology,CornellUniversityResearchFaculty–UniversityofNorthCarolina,ChapelHill;andTulaneUniversitySchoolofMedicineFDAExperience‐14yearsResearchInterestsVirussurvival in foodsduringstorageandprocessingconditions,noroviruscross‐contamination/transfer rates, virus diversity in naturally contaminated foods, and virusreplicationinmammaliancells

Y.CarolShieh,Ph.D.

DivisionofFoodProcessingScienceandTechnology(DFPST)CenterforFoodSafety&AppliedNutrition(CFSAN)

Summit‐Argo,IL

67

BackgroundB.E.(ElectronicsandCommunicationEngineering),MaduraiKamarajUniversity,IndiaM.S.(SystemsandInformation),BirlaInstituteofTechnologyandScience,IndiaPh.D.–AppliedScience/AppliedComputing,UniversityofArkansasatLittleRock,USAResearchandDevelopmentExperience–20+yearsFDA–since2008ResearchInterestsTheDivisionofElectricalandSoftwareEngineering(DESE)undertheOf iceofScienceandEngi‐neeringLaboratories,conductsresearch,participatesindevicereviewactivities,developsconsen‐susstandardsbothdomesticand international,developsregulatoryguidance, tests forensicandregulatorysamples,andprovideseducationalprogramsintheareaofelectricalengineeringandsoftware.Speci ically, thesemanticminingresearchatDESE isgeared touncoverhiddensafetysignals inreal‐timebyanalyzingunstructurednaturallanguagetextinlargeregulatorydocumentreposito‐ries.Thesedocumentrepositoriescontinuetogrow.Weaimforveryhighrecallandprecision.Weuse InformationRetrieval,Machine Learning, TopicModeling, aswell asNatural LanguagePro‐cessing techniques in our research.Dictionaries, ontologies, standards andguidancedocumentsare some of the reference sources.Wework in close collaborationwith the High PerformanceComputingCenter.

SithuD.Sudarsan,Ph.D.

Of iceofScienceandEngineeringLaboratories(OSEL)CenterforDevicesandRadiologicalHealth(CDRH)

SilverSpring,MD

68

BackgroundPh.D.–PharmacologyandToxicology,VirginiaCommonwealthUniversityM.S.–EnvironmentalMicrobiologyandToxicology,UniversityofFloridaExperiencewithpatentapplicationreviewofdrugsanddevicesattheU.S.Patent&TrademarkOf iceandriskassessmentconsultingFDAExperience–1yearResearchInterestsTheOf iceofSciencesupportstheCenterforTobaccoProductsbyprovidingsoundscienti icevi‐denceforimplementationoftheFamilySmokingPreventionandTobaccoControlAct.TheOf iceofSciencereviewsapplicationsforsubstantialequivalenttobaccoproducts,newtobaccoproducts,andmodi iedrisktobaccoproducts.Evaluationofmodi iedriskproductsrequirestheconsidera‐tionoftherisksoftobaccoproductstopublichealthbothattheindividualandpopulationlevel.Intheframeworkofquantitativeriskassessmentresearch,concernsinclude: Methodsofreportingandanalyzingconstituentconcentrationsintobaccoproducts; Analysisofexposureparametersindiversetobacco‐usingpopulations; Toxicologicalbasisofdose‐responserelationshipsbetweenconstituentsandtobacco‐related disease; Assessingtherisksoftobaccoproductstousersandnon‐users.

RaymondPhilipYeager,Ph.D.

Of iceofScience(OS)CenterforTobaccoProducts(CTP)

Rockville,MD

69

BackgroundPh.D.–BiomedicalEngineering,TheJohnsHopkinsUniversitySchoolofMedicineB.S.–BiomedicalEngineering,TheJohnsHopkinsUniversitySchoolofEngineeringResearchandRegulatoryInterestsDr.DangjoinedtheFDAasascienti icreviewerin2007shortlyaftercompletingherPh.D.thesisinthe ieldoftissueengineeringandregenerativemedicine.Inadditiontopremarketproductre‐view,sheisinvolvedinstandardsreviewandpost‐marketissuemanagementteams.Shepartici‐pates in various CDRH‐CBER inter‐Center activities related to regenerativemedicine, includingconsultative review of cell‐scaffold products, organization of workshops/seminars, and journalclubs. Dr. Dang has review expertise in surgicalmesh devices and other polymer/biomaterialsbasedproductsintendedfortissuereconstructionorrepair.

JiyoungM.Dang,Ph.D.

DivisionofSurgical,Restorative,andOrthopedicDevices(DSROD)Of iceofDeviceEvaluation(ODE)

CenterforDevicesandRadiologicalHealth(CDRH)SilverSpring,MD

70

BackgroundPostdoctoralFellowshipMatrix/IntegrinBiology–InstituteofMedicine&Engineering/SchoolofMedicine(PENN)Ph.D.Bioengineering–UniversityofPennsylvaniaM.S.PolymerScience–UniversityofConnecticutPolymerProgramB.S.E.Bioengineering–UniversityofPennsylvaniaResearchandRegulatoryInterestsDr.LeejoinedtheFDAin2008afterover10yearsofactiveinterdisciplinaryresearchinthe ieldsofbiomaterialsandtissueengineering/regenerativemedicine(TE/RM).Inadditiontohisroleasprimaryreviewerforbiologics,devicesandcombinationproductssubmissionsasapartoftheOf‐iceofCellular,TissueandGeneTherapies(OCTGT),CenterforBiologicsEvaluationandResearch(CBER),Dr.LeehasspenttimeattheCenterforDevicesandRadiologicalHealth(CDRH)asavisit‐ingreviewscientistin2010.HeactivelyparticipatesinandleadsmanyCross‐CentereffortssuchastheTissueEngineering&RegenerativeMedicineSteeringCommitteeandtheAnnualFDAFo‐rumonDevicesandBiologicsUsedinRegenerativeMedicinewhichheco‐chairs.Dr.Lee’sregula‐toryinterestsincludetheharmonizationofreviewpracticesandpoliciesforbiologics,medicalde‐vicesandcombinationproductsusedasregenerativetherapies.HeregularlyengagesinoutreacheffortsandhasdeliverednumerouspresentationsandpublicationsregardingFDA’sregulationofRegenerativeMedicineproducts.

MarkH.Lee,Ph.D.

DivisionofCellularandGeneTherapies(DCGT)Of iceofCellular,Tissue,andGeneTherapies(OCTGT)CenterforBiologicEvaluationandResearch(CBER)

Rockville,MD

71

BackgroundB.S.–ElectricalEngineering,UniversityofMarylandatCollegeParkFDAExperience–18yearsRegulatoryInterestsOverhiscareeratCDRH,Mr.Mallishasservedinavarietyofregulatoryroles.Asaseniorscien‐ti icreviewer,Mr.Mallisregulatedproductsinthe ieldsofgastroenterology,hemodialysis,extra‐corporeal therapeutics, obstetrics/gynecology, and combinationproductswith a focuson tissueengineering. Insubsequent leadershiproles,Mr.Mallisoversawtheregulatoryreviewscienti icevaluationofcardiovascularmedicaldevices,includingcombinationdevice‐biologicproducts.Inhiscurrentrole,Mr.Mallisleadsanorganizationwhosemissionistoprovideregulatoryeducationtoavastrangeofexternalstakeholdersofmedicaldeviceandradiologicalhealthissues.

EliasMallis,B.S.

DivisionofSmallManufacturers,International,andConsumerAssistance(DSMICA)

Of iceofCommunication,Education,andRadiationPrograms(OCER)

CenterforDevicesandRadiologicalHealth(CDRH)SilverSpring,MD

72

BackgroundPh.D.–UniversityofMichiganPostdoctoralFellowship–JohnsHopkinsUniversitySchoolofMedicineandMassachusettsInstituteofTechnologyFaculty–TuftsUniversitySchoolofMedicineFDAExperience–3yearsRegulatoryInterestsDr. Oh’s regulatory interests include device‐biologic combination products, tissue engineeredproducts,anddeviceswithregenerativeortherapeuticindications.Heactivelyparticipatesinsci‐enti icreviewsofsubmissions,policydevelopment,andstafftrainingintheseproductareasintheOf ice of Cellular, Tissue and Gene Therapies (OCTGT), Center for Biologics Evaluation and Re‐search(CBER).Dr.OhalsospenttimeinCenterforDevicesandRadiologicalHealth(CDRH)serv‐ingasavisitingreviewscientist fromCBER.ThisuniqueexperiencehasbeencrucialtoDr.Oh’sunderstandingandappreciationofbalancedapproachestobiologicanddevicereviewsandpolicydevelopment.UponreturningtoCBERfromCDRH,Dr.Ohhas foundedDeviceBiologicsInterestGroup(DBIG) in2008providinga forumtoregulatorystaff inCBERandCDRHto learnandex‐changeideasaboutregulations,standards,technologies,reviewpractices,andpoliciesapplicabletodevicesanddevice‐biologiccombinationproducts.Hecontinuesintheefforttoharmonizere‐viewpracticesforcombinationproductsanddevicesregulatedbyCBERandCDRH.

StevenS.Oh,Ph.D.

DivisionofCellularandGeneTherapies(DCGT)Of iceofCellular,Tissue,andGeneTherapies(OCTGT)CenterforBiologicEvaluationandResearch(CBER)

Rockville,MD