FDA Commissioner’s Fellowship Program · PDF fileFDA Commissioner’s Fellowship Program ... 2001‐2005 Bachelors of Science in Biology ... Development of medical countermeasures

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FDA Commissioner ’s Fellowship Program

Class of 2015

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FDA Commissioner’s Fellowship Program

2015 Fellows

Adeniyi, Oluseyi……………………………………… 7 Lemma Dechassa, Mekonnen ……………………. 16

Baker, Janelle………………………………………… 8 Morales-Garcia, Flavia…………………………….. 17

Dadiboyena, Sureshbabu…………………………… 9 Ortega, Ryan……………………………………..… 18

Hsu, Chia-Wen……………………………………….. 10 Pedersen, Ronnie……………………………......... 19

Hsieh, Ying-Hsin ………………………………...… 11 Rolle, Clarence ..…………………………………… 20

Jameson, John………………………………………. 12 Schultz, Kimberly…………………………………… 21

Kannan, Lakshmi …………………………………. 13 Windsor, Amanda………………………………….. 22

Khajanchi, Bijay …………….………………………..

Lee, Stella……………………………………………..

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Yang, Li………………………………………………

Zheng, Yan ………………………………………….

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2015 Preceptors

Bai, Jane…………...……………………………………….. 26 Hu, Yuan………………………………………… 36

Bailey, Alexander………………………………………..… 27 Hungerford, James…………………………….. 37

Beland, Frederick……..…..………………………………. 28 Kaiser, Aric………..……………………………. 38

Deeds, Jonathan……..…..……………………………….. 29 Kumar, Allison …...…..………………………… 39

El-Demerdash, Aref……………….………………………. 30 Pacanowski, Michael A.……………………….. 40

Foley, Steven………………………………………………. 31 Patri, Anil………………………………………... 41

Garber, Eric A.E.…………………………………………… 32 Peden, Keith……………………………………. 42

Gavin, Denise K. .………………………………………….. 33 Pogribny, Igor….……………………………… 43

Green, Dionna..…………………………………………….

Healey, Stephane………………………………………….

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Sulaiman, Irshad M. ……………………………

Song, Fenhong………………………………….

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2015 Preceptors and Fellows Projects listed by

Regulatory Science Priority Area

Modernize Toxicology to Enhance Product Safety (2) Alex M. Bailey, Tina Morrison, Brian Pullin (Fellow: Ryan Ortega) Frederick A. Beland and Igor P. Pogribny (Fellow: Mekonnen Lemma Dechassa)

Stimulate Innovation in Clinical Trials and Personalized Medicine to Improve Product Develop-ment and Patient Outcomes (2) Dionna J. Green (Fellow: Janelle Baker) Michael A. Pacanowski (Fellow: Oluseyi Adeniyi)

Support New Approaches to Improve Product Manufacturing and Quality (3)

Eric A.E. Garber (Fellow: Ronnie O. Pedersen) Denise Gavin (Fellow: Kimberly Shultz) Anil K. Patri (Fellow: Sureshbabu Dadiboyena)

Ensure FDA Readiness to Evaluate Innovative Emerging Technologies (5)

Jonathan R. Deeds (Fellow: Amanda Windsor) Stephanie L. Healey (Fellow: Clarence Rolle) Yuan Hu (Fellow: Yan Zheng) Aric D. Kaiser (Fellow: John Jameson) Irshad M. Sulaiman (Fellow: Ying-Hsin Hsieh)

Implement a New Prevention-Focused Food Safety System to Protect Public Health (3)

Aref El-Demerdash and Fenhong Song (Fellow: Flavia Morales-Garcia) Steven Foley (Fellow: Bijay Khajanchi) James M. Hungerford (Fellow: Li Yang)

Facilitate Development of Medical Countermeasures to Protect National Health and Security (3)

Jane Bai (Fellow: Chia –Wen (Amy) Hsu) Allison Kumar (Fellow: Lakshmi Kannan) Keith Peden (Fellow : Stella Lee)

http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm268111.htm�

http://wcms.fda.gov/FDAgov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/CommissionersFellowshipProgram/ucm433679.htm�


http://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/ucm342927.htm�
























FDA Commissioner’s Fellowship Program 2015 Preceptors and Fellows by Center

CBER Preceptors Fellows Alex Bailey Ryan Ortega Keith Peden Stella Lee Denise Gavin Kimberly Schultz CDER Preceptors Fellows Dionna Green Janelle Baker Michael Pacanowski Oluseyi Adeniyi Jane Bai Chia-Wen Hsu CDRH Preceptor Fellow Aric Kaiser John Jameson Allison Kumar Lakshmi Kannan CFSAN Preceptors Fellow Jonathan Deeds Amanda Windsor Eric Garber Ronnie Pedersen

NCTR Preceptors Fellows Frederick Beland Mekonnen Lemma Dechassa Steven Foley Bijay Khajanchi Anil Patri Sureshbabu Dadiboyena Igor Pogribny Mekonnen Lemma Dechassa ORA Preceptors Fellows Aref El-Demerdash Flavia Morales-Garcia Stephane Healey Clarence Rolle Yuan Hu Yan Zheng James Hungerford Li Yang Irshad Sulaiman Ying-Hsin Hsieh

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2015 Fellows

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OluseyiAdeniyi,Ph.D.

CenterforDrugEvaluationandResearch

Preceptor:MichaelPacanowski

Scienti ic&ProfessionalBackground

2015 Ph.D.PharmaceuticalSciences,UniversityofMichigan

2009 Pharm.D.UniversityofMichigan

ResearchInterests

PriortojoiningtheFDA,practicedasapharmacistandconductedresearch.Myresearchinterestshavecenteredonimprovingdrugdeliverybycircumventingcellularandsubcellularbarriers.Mainly,Istudiedhowaproteinvaccineadjuvantcanbemanipulatedforcell‐speci ictargetingwhileenhancingimmuneresponsetovaccineantigenandIalsostudiedstrategiestoenhancegenedelivery.MycurrenteffortsattheFDAaredirectedat indingopportunitiesfortargetedtherapiesinclinicaldrugdevelopment,particularlyforcommonchronicdiseases.

CFPProjectSummary

ProjectTitle:IdentifyingopportunitiesforpersonalizationinthedrugdevelopmentpipelineRegulatorySciencePriorityArea:StimulateInnovationinClinicalTrialsandPersonalizedMedicinetoImproveProductDevelopmentandPatientOutcomesThegoaloftheproposedresearchistosystematicallycharacterizeliabilitiesandopportunitiesforbiomarker‐baseddevelopmentinthepharmaceuticalpipeline.Speci ically,foracross‐sectionofdrugsbeingdevelopedforcriticalunmetmedical/publichealthneedsthathaveprogressedthroughPhase1trials,wewillsystematicallyreviewkeyelementsoftheoverallprogramtoidentify(1)thepresenceofpharmacogenomicliabilities(e.g.,racial/ethniceffects,highpharmacokineticvariability/outliers,diseaseordrugtargetgenevariants),and(2)whetherliabilitiesarebeingmanagedthroughprospectivebi‐omarkerassessmentsortargeteddrugdevelopment.Impact:Theproposedresearchwillimpactdrugdevelopmentandregulatoryreviewprocessesby(1)improvingFDAguidancetosponsorswhoaredevelopingdrugsforspeci icdiseasesordrugmechanisms,(2)identifyingbestpracticesfortranslatingexploratorybiomarkerresearchtopersonalizedmedicines,(3)prioritizingallocationoflimitedresourcestoareaswherebiomarkerdevelopmentinvestmentswillbeproductive,and(4)enhancingoperationalaspectsofFDA'sinvestigationaldrugreviewenterprise.

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Scienti icandProfessionalBackground2014‐2015 GeneralPediatrician2011‐2014 PediatricResidency‐StateUniversityofNewYork‐Children’sHospitalofBuffalo2007‐2011 MedicalDoctorate‐RossUniversitySchoolofMedicine2001‐2005 BachelorsofScienceinBiology,UniversityofTexas‐ArlingtonResearchInterestsDr.Baker’sinterestsareinneonatalandpediatricclinicaltrialsanddrugdevelopment.Sheisageneralpediatricianwhohashadmanyyearsofexperienceinclinicalresearch.Herpreviousresearchprojectshaveprimarilyfocusedonclinicaldecision‐makingandjuvenileidiopathicarthritis.CFPProjectSummaryProjectTitle:ClinicalTrialSimulationasaMeanstoImprovePediatricandNeonatalDrugDevelopmentTrialsFDARegulatorySciencePriorityArea:StimulateInnovationinClinicalTrialsandPersonalizedMedicineThepurposeofthisregulatoryresearchprojectistoidentifyfailedpediatricandneonatalclinicaltrials,assessthereasoningfortrialfailure,andconductsimulationexperimentstoexploreadjustmentsintrialmethodologythatcouldhaveenabledtrialsuccess.Clinicaltrialsimulationwillprovideameansfordemonstratingpreviouslyfailedpediatricdevelopmentprogramsthatcouldhavebeensuccessfulwithspeci icadjustmentstotrialmethodology.Bysuccessfullyemployingsimulationtoselecttrials,thisresearchhasthepotentialtopositivelyimpactpublichealthandtheabilitytodesignatrialthathasthegreatestlikelihoodofsuccessforneonatalandpediatricdrugdevelopmentstudies.

JanelleBaker,M.D.


Of iceofClinicalPharmacology

Preceptor:DionnaGreen,M.D.





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SureshbabuDadiboyena,Ph.D.Na onal Center for Toxicological Research

Division of Nanotechnology (NCTR‐ORA)

Preceptor: Anil K. Patri, Ph.D.


2012‐2015 HenryM.JacksonFellow,NationalInstitutesofHealth(NIMH),Bethesda,MD2010‐2012 Post‐doctoralAssociate,TorreyPinesInstitute,PortSt.Lucie,FL2008‐2009 Post‐doctoralFellow,RevivaPharmaceuticals,SanJose,CA2010‐2014 DiplomainIntellectualProperty,WIPO‐UNISA,Geneva2003‐2008 PhD,SyntheticOrganicChemistry,JacksonStateUniversity,Jackson,MSResearchInterests:Suresh’spreviousresearchwasintheareasof:(a)TotalSynthesisandMethodologyofNaturalProducts,BioactiveHeterocyclesandPeptides, (b)DevelopmentofNovelPETradioligands for Imaging tau‐proteinaggregates,and(c)CNSDrug‐Discoverytherapeutics,andcombinatorialchemistry.CFPProjectSummaryProjectTitle:Synthesis,Surfacefunctionalization,Quanti icationofcoatingsandtheirin luenceonBiologicalpropertiesofNanomaterialsFDARegulatorySciencePriorityArea:SupportNewApproachestoImproveProductManufacturingandQualityNanoparticle‐based therapeutic agents contain passivating surface coatings tominimize immune systemrecognition thereby prolonging their blood half‐life and enhanced accumulation in tumor tissue byenhancedpermeationandretention(EPR)effect.Itisknownthatlackofthispassivatingcoatingwillleadtoimmediateopsonization,macrophageuptakeandliverandspleendistribution,minimizingthetherapeu‐tic ef icacy of nanomedicines. Themolecularweight, density, stability, hydrophobicity and uniformity ofcoatings dictate the product safety, biodistribution and ef icacy. These critical attributes should bemonitored for product quality and consistency to assure reproducible and predictable safety,bio‐distribution, and ef icacy in clinical trials and beyond. The scienti ic rationale of this project is tocontributetoFDA’sscienti icunderstanding of thenanoparticlesby:(a)Synthesizingnanoparticleswithvariabledegreeofsurfacecoatingssimilartothoseused innanomedicines incurrentproducts inclinicaltrials, (b) Quantitative assessment of the stability of coatings through HPLC, TGA, Quartz‐crystalmicrobalance(QCM),andseparationthroughFieldFlowFractionationtechniques,(c)conductinvitrobio‐compatibility and in vivo pharmacokinetic studies of nanoparticles with variable degree of coatings torelatehowcoatingsmighteffectsafetyandeffectiveness.Theregulatoryobjectiveofthisresearchprojectistodevelopstandardsforthesetestmethodstoassistinregulatoryreviewofemergingtechnologies.

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Chia‐Wen(Amy)Hsu,Ph.D.

CenterforDrugEvaluationandResearch(CDER)

Of iceofClinicalPharmacology(OCP)

DivisionofAppliedRegulatorySciences(DARS)

Preceptor:JaneBai,Ph.D.


2012‐2015PostdoctoralResearchFellow,NationalCenterforAdvancingTranslational

Sciences(NCATS),NationalInstitutesofHealth(NIH)

2012Ph.D.,PharmaceuticalSciences

UniversityofNorthCarolinaatChapelHill

2006B.S.,Chemistry

NationalTaiwanUniversity

ResearchInterests

Amy is interested in drug repurposing and safety assessment using her systems pharmacology andsystems toxicology expertise. As a postdoctoral fellow at the NIH/NCATS, Amy worked with the U.S.Toxicology in the 21st Century (Tox21) program,where she utilized in vitro assays, quantitative high‐throughput screening (qHTS), and informatics approaches to rapidly and ef iciently test ~10Kenvironmentalchemicalsanddrugs for theirability tocausepotentialadverseeffectsonhumansorbeused for oncologydrugdevelopment and for the compounds’mechanismof action (MOA). In graduateschool, Amydeveloped novel technologies such as live cell biosensors and optogenetic tools to enablequantitativeimagingandanalysisofsignalingnetworksinlivingcells.

CFPProjectSummary

ProjectTitle:DevelopmentofmedicalcountermeasuresfortreatingEbolavirusdisease

FDARegulatorySciencePriorityArea:FacilitateDevelopmentofMedicalCountermeasurestoProtectNationalHealthandSecurity

Ebolavirusdisease(EVD)causednearly28,000deathsmainlyinWestAfricawithsomesporadiccasesintheU.S.andEuropeintherecentoutbreak.EVDremainstobeasigni icantthreattoglobalpublichealthduetolackofapprovedanti‐Ebolamedicalcountermeasures(MCMs).Todateover100approveddrugs,includingFDA‐regulatedproductswithestablishedsafetyandpharmacokineticpro ilesandcommercialavailability, have been shown to suppress Ebola infectivity in vitro and/in vitro. However,most drugsmightnotbeeffectiveagainstEVDattheiralreadyapproveddosesandtheiranti‐EVDmechanismsofac‐tion(MOAs)remainunclear.Therefore,theobjectiveoftheproposedprojectistoidentifyef icaciousandsafe anti‐Ebola MCMs based on potent drug pairs with complementary MOAs and optimalpharmacokineticandsafetypro iles.Theanti‐EbolaMCMsandresultsobtainedfromthisstudywillhelptheFDApreventandcontrolfutureEVDepidemic.

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2000B.S.NutritionScience,TaipeiMedicalUniversity

2002M.S.MolecularandCellularBiology,TaipeiMedicalUniversity

2007M.S.MolecularGeneticsandBiochemistry,GeorgiaStateUniversity

2011Ph.D.Microbiology,GeorgiaStateUniversity

2012‐2015ResearchScientist,GeorgiaStateUniversity

ResearchInterests

Dr.Hsieh’sgeneral research interest ison thebiologyofbacterialpathogensandhowtheyrelate to thehuman diseases. Although most bacterial infections can be reduced by either vaccination or antibiotictreatment,therearestillsomenewidenti iedbacterialpathogensandsomeoldbacteriumwithnewformsof virulence due to resistance of antibiotics without the cure. Thus, to establish rapid and accuratediagnostic methods and to develop the potential therapies would be the key for the public healthsurveillance.

CFPProjectSummary

ProjectTitle:RapidDiagnosticMethodDevelopmentfortheDetectionandDifferentiationofCampylobacter

FDARegulatorySciencePriorityArea:EnsureFDAReadinesstoEvaluateInnovativeEmerging

Technologies

Description: Campylobacter is a Gram‐negative bacterium and is themain cause of diarrhea in US andworldwide due to the consumption of uncooked food. This type of bacteria is highly contagious andharmfultochildren,elders,andimmunocompromisedpeoplewhohaveaweakenedimmunesystem.Thedamagecanberangedfrommildtoseveredependingonthestrains.SeveralspeciesincludingC.jejuniandC.colihavebeenidenti iedforcausinghumanpathogenicdiseases.Thus,isolation,identi ication,andtheclassi ication of Campylobacter from food, outbreak or other sources would be a key for the infectionsurveillance. In addition, using multi‐locus sequence typing (MLST) and the whole genome sequencingapproachwouldfurtherprovidepreciseevaluationonthestrainsandthedetailsofstrainscharacteristics.These toolsare thekey forconductingsurveillancestudiesand for the treatmentdevelopmentofpublichealthimportance.

Ying‐HsinHsieh,Ph.D.MicrobiologicalSciencesBranch

SoutheastRegionalLaboratory

Of iceofRegulatoryAffairs

Preceptor:IrshadM.Sulaiman,MSc,MPhil,Ph.D.

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JohnJameson,Ph.D.

Multi‐CenterFellowshipinRegenerativeMedicine

CenterforDevicesandRadiologicalHealth(CDRH)

CenterforBiologicsEvaluationandResearch(CBER)

PrimaryPreceptor:AricKaiser,M.S.(CDRH)


2014‐2015 ResearchFellow,MayoClinic,Rochester,MN

2014 Ph.D.BiomedicalEngineering,MarquetteUniversity,Milwaukee,WI

2012‐2014 AdvancedLightSource(ALS)DoctoralFellowinResidence,LawrenceBerkeleyNational

Laboratory,Berkeley,CA

2007 B.S.BiomedicalEngineering,UniversityofVirginia,Charlottesville,VA

ResearchInterests

John’sresearchinterestsareincharacterizationandmechanicaltestingofbiomaterialsandhumantissues.Hisgraduateresearchfocusedonexaminingrelationshipsbetweenthemineralization,porosity,andmechanicalpropertiesofhealthyanddiseasedhumanbone.Aspartofthiswork,heservedasaninvestigatorontheX‐raytomography,X‐rayscattering,andinfraredendstationsattheALSparticleacceleratorinBerkeley,CA.Duringhispost‐doctoraltrainingattheMayoClinic,hedevelopedcomputationalmodelingtechniquestosimulateX‐rayphasecontrastimagingofsofttissuesforcardiovascularapplications.

CFPProjectSummary

ProjectTitle:EnsuringFDAreadinesstoregulatemodernbonevoid illerdevices:aninvestigationofregenerativetermsusedinpremarketnoti icationsandscienti icliteratureFDAScienti icPriorityArea:EnsureFDAReadinesstoEvaluateInnovateEmergingTechnologiesThegoalofregenerativemedicineproductsistorestorebodilyfunctionthroughreplacementorregenerationofhumancells,tissues,ororgans.Recentadvancesinbiomaterialsprocessingtechniqueshaveenabledmodi icationstothephysicalpropertiesoftheseproducts,whichhavesubsequentlybeentiedtoenhancedregenerativecapabilitiesafterimplantation.Inorthopaedics,thesepracticesarebecomingincreasinglyapparentinregulatorysubmissionsinvolvingbonevoid illerdevices,whichareintendedto illskeletalvoidsintheextremities,spine,andpelvis.Thepurposeofthisprojectisto:1.)provideabetterunderstandingofregenerativetermsusedinbonevoid illerdevicesubmissionsandinthescienti icliterature,and2.)developpracticaltoolsthatfacilitatetransparencyandcontributetoamoreef icientreviewprocessforfuturebonevoid illerdevices.


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Scienti ic&ProfessionalBackground:Education:2009:PhD,Cell&MolecularBiology,UniversityofArkansas2004:M.S.,Biotechnology,UniversityofMadras2002:B.S.,Chemistry,UniversityofMadrasExperience:2014‐15:InstructorinMedicine,HarvardMedicalSchool/BIDMC2009‐14:PostdoctoralResearchFellow,HarvardMedicalSchool/BIDMC2005‐09:SeniorGraduateResearchAssistant,UniversityofArkansasResearchInterests:Dr.LakshmiKannan’scurrentresearchanddevelopmentinterestsspanacrossAcuteTraumaandCriticalCare,TraumaticBrainInjury,Ischemia,BiomarkersandPhysiologicalMonitoring,andRegulatoryStrategy.AsaninstructoratHarvardMedicalSchoolandduringherpostdoctoralresearchwork,Dr.Kannanextensivelystudiedtraumaandtissueinjurytoidentifynovelbiomarkersforthediagnosisofdiseasesandtherapeuticagents,withspecialfocusonischemia/reperfusioninjury.CFPProjectSummary:ProjectTitle:AdvancingthedevelopmentofendpointsinTBI:Scienti ic,Clinical,PatientandRegulatoryConsiderationsFDARegulatorySciencePriorityArea:FacilitateDevelopmentofMedicalCountermeasurestoProtectNationalHealthandSecurityProjectDescription:TraumaticBrainInjury(TBI)isamajormedicalproblem.EachyearintheUnitedStates,about2millionpeoplesufferTBI;itisacontributingfactorinathirdofallinjury‐relatedUSdeaths.Inthemilitary,TBIisoneofthemostcommoncausesofinjuryanddisabilityinactivedutyser‐vicemembers.ResearchershavebeenactivelyworkingonbetterwaystodiagnoseandtreatTBI,butatpresent,wehaveno"cures"forTBI,orevenverygoodwaystodiagnoseifithashappened,oritsseverity.Assuch,FDAhasnotapprovedanytherapeuticdrug,medicaldeviceordiagnostictoolforpatientssufferingfrommildandmoderateTBIs.MyFDACommissioner'sFellowresearchprojectfocusesonthedevelopmentofacross‐Centerandcross‐Agencyteamofsubjectmatterexpertsthatwouldhelpfacilitateanapproachforadoptionofbraindisease‐speci icopendatastandardsinordertoimprovethequality,ef iciencyandcost‐effectivenessofTBIclinicaltrials.AligningwiththeTED(TraumaticBrainInjuryEndpointsDevelopment)initiative,whichisfundedthroughCongressionallyDirectedMedicalResearchProgram,Iamworkingtowardsdevelopingscienti icandconsensus‐drivenendpointsthatcanbeusedintheclinicaltrialsneededtosupportapprovalofproductsinTBIdiagnosisandtreatment.

LakshmiKannan,Ph.D.

EmergencyPreparedness/OperationsandMedicalCountermeas‐uresProgram(EMCM)

Of iceofCenterDirector,CenterforDevicesandRadiologicalHealth(CDRH)

Preceptor:AllisonKumar,Ph.D.

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Scienti ic&ProfessionalBackground:

Institution Degree Year Field

UniversityofDhaka,Bangladesh B.Sc. 2000 Microbiology

UniversityofDhaka,Bangladesh M.Sc. 2002 Microbiology

UniversityofTexasatGalveston Ph.D. 2011 Microbiology&Immunology

UniversityofTexasatHouston Postdoc 2011‐2015 MolecularBiology

ResearchInterests:

Myresearch interest is to investigate theroleofdifferentsignalingsystems inregulatinggeneexpressionand virulencemechanisms of Gram‐negative bacteria particular interest in to the food‐ borne pathogensusing cutting‐edgemolecular techniques. I amspeci ically interested tounderstand thedetail underliningmechanisms as to how plasmid encoded virulence determinants and antibiotic resistance factors spreadamongbacterialpathogensisolatedfromfoodsources,animalsandhumans.Inthelongterm,Iwouldliketodiscovernewmoleculartoolstorapidlyandef icientlyidentifyemergingfoodbornepathogensaswellasIaminterestedtodevelopnovelstrategiestocontrolspreadoftheplasmidencodedvirulenceandantibioticresistant factors that allow bacterial pathogens to increase their ability to causes severe public healthproblem.

CFPProjectSummary:ProjectTitle:EvaluationofincompatibilitygroupIncFIBplasmid‐mediatedvirulenceinSalmonellaenterica

FDARegulatory SciencePriorityArea:Priority area6: Advancing Regulatory Science at FDA strategicplan,to“ImplementaNewPrevention‐FocusedFoodSafetySystemtoProtectPublicHealth”

Salmonellosis,thesecondleadingcauseofbacterialfoodborneillnessintheUnitedStates,ismainlyassociatedwiththeconsumptionoffoodscontaminatedwithSalmonella.IntheUS,Salmonellainfectionsleadto~20,000hospitalizationand~400deathsannually.Incurrentstudy,IaminvestigatingtheroleincompatibilitygroupIncFIBplasmid‐encodedfactors,suchasironacquisitioncomponent(s)inregulatingvirulenceofSalmonellaenterica.Thelongtermgoalofthisstudyistounderstandhowplasmidencodedfactorsin luencevirulenceandhorizontalgenetransmissionamongSalmonellaandrelatedspecies,whichmaybebene icialtodevelopnovelstrategiestocontrolthespreadofvirulenceandantimicrobialplasmidsamongfoodbornepathogens.TheoutcomesofthisresearchmayaidFDAscientistsbyinformingregulatorydecisionsassociatedwiththeuseofantimicrobialagentsinfoodanimalproductionandimprovehumanfoodsafetyguidelines.

BijayKhajanchi,Ph.D.

DivisionofMicrobiologyNationalCenterforToxicologicalResearch(NCTR)

Jefferson,AR72079

Preceptor:StevenFoley,Ph.D.

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2015‐2015 PostdoctoralFellow,DepartmentofMolecularBiologyandGenetics,JohnsHopkinsUniversitySchoolofMedicine,Baltimore,MD

2009‐2015 Ph.D.HumanGeneticsandMolecularBiology,JohnsHopkinsUniversitySchoolofMedicine,Baltimore,MD

2006‐2009 M.S.CarverCollegeofMedicine,UniversityofIowa,IowaCity,IA

2002‐2006 B.S.EwhaWomansUniversity,Seoul,SouthKorea

ResearchInterestsStellahasbeeninterestedinsolvingfundamentalscienti icquestionsthathavesigni icantclinicalrelevance.Previously,shepioneeredaprojecttounderstandtheregulationoftelomerelength.Dysregulatedtelomerelengthaffectsmanycancerandage‐relateddisorders;thus,understandingthemechanismoftelomerelengthregulationiscritical.Shedevelopedanewmammalianassaythatallowsvisualizationoftelomereelongationatasingletelomereinjustonecellcycle.Usingthisassay,shediscoverednovelregulatorsoftelomereelongation.

CFPProjectSummary

Projecttitle:Developmentofacommonplatformtoassessneutralizingantibodiesforpathogenichumanviruses

FDARegulatorySciencePriorityArea:FacilitateDevelopmentofMedicalCountermeasurestoProtectNationalHealthandSecurity

Determinationofvaccineeffectivenessisfrequentlydonebymeasuringthepresenceofneutralizingantibodies.Amajorproblemwithmeasuringneutralizingantibodiesagainsthighlypathogenicviruses,e.g.,Ebolavirus,isthatsuchstudiesneedtobecarriedoutinhigh‐containmentlevellaboratories,whichareverylimitedinavailabilityandexpensivetooperate.Theoverallgoalofthisprojectistodevelopahigh‐throughputplatformtechnologytoassessneutralizingantibodiesforvariouspathogenicvirusesthatcanbeperformedunderstandardlaboratoryconditions.Thisplatformwillacceleratetheevaluationofvaccinecandidatesandaidinnewvaccinedevelopment,contributingtothepublic‐healthresponsetoemerginglethalpathogenicviruses.

StellaLee,Ph.D.


Preceptor:KeithPeden,Ph.D.(CBER)

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MekonnenLemmaDechassa,D.V.M.,Ph.D.

NationalCenterforToxicologicalResearch(NCTR)

DivisionofBiochemicalToxicology

Preceptors:Dr.IgorPogribnyand

Dr.FredrickBeland

Education

1990‐1996 D.V.M.,AddisAbabaUniversity,Ethiopia

1999‐2001 M.Sc.inMolecularBiology,KatholiekeUniversitetLeuven,Belgium

2003‐2008 Ph.D.,MolecularBiology,MicrobiologyandBiochemistry,SouthernIllinoisUniversityCarbondale

ProfessionalExperience

1996‐1999 LectureratAddisAbabaUniversity,Ethiopia

2009‐2010 PostdoctoralFellowatColoradoStateUniversity

2010‐2012 AmericanHeartAssociationPostdoctoralFellow,Grant10POST4190042,ColoradoStateUniversity

2012‐2015 HHMIPostdoctoralFellow,ColoradoStateUniversity

Researchinterest:

The focus of my graduate and postdoctoral research experience includes biochemical and biophysicalcharacterization of proteins, protein‐protein/protein‐DNA interactions, mechanism of ATP‐dependentchromatin remodeling and chromatin structural analysis. Currently, I am interested to understand howchromatinstructureandepigeneticmarksarerelatedtodiseasedevelopment.Iaminterestedtoinvestigatehowvarioussignalsinducechangesinchromatinaccessibilityandaltergeneexpressionthatleadtodiseaseinitiationandprogression,andusesuchinformationinidentifyingnewdrugtargetsandbiomarkersforearlydiseasedetectionaswellasforassessingdrugsafety.

CFPProjectSummary:

ProjectTitle:ChromatinstructuralstatedynamicsduringNAFLDassociatedlivercarcinogenesis

FDARegulatorySciencePriorityArea:ModernizeToxicologytoEnhanceProductSafety

Nonalcoholic fatty liver disease (NAFLD) is one of the risk factors for hepatocellular carcinoma (HCC). Themolecular mechanisms of NAFLD‐associated HCC are not well known and, early detection and treatmentoptionsare limited.Thisproject involves theanalysisofchromatinstructure,histoneepigeneticmarks,andgeneexpressionpro ilesatdifferentstagesoftheNAFLD‐HCCusingarelevantmousemodel.Thedifferentialchromatin structural states associatedwith the disease development andprogressionwill be analyzed andcorrelatedwithepigeneticmarksandgeneexpressionpatternstoidentifyregulatoryDNAelementsthatareassociatedwithdifferentiallyexpressedgenes inNAFLD‐HCC.The indings fromtheproposedstudywillbepartofanefforttowardunderstandingthemolecularmechanismofNAFLD‐HCCdevelopment,whichiscriticalinidentifyingnewtargetsforthediagnosisandtreatmentofthedisease.

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2015PostdoctoralResearchAssociate,UniversityofPuertoRico

2014‐2015AssistantProfessor,UniversityofPuertoRicoinHumacao

2014Ph.D.,AnalyticalChemistry,UniversityofPuertoRico

1999B.S.,Chemistry,UniversityofPuertoRico,Rı́oPiedrasCampus

ResearchInterestsDr. Morales‐Garcia’s research background lies in developing methods for quantifying atmosphericaerosolsintheCaribbeanbasin.Hergraduateresearchfocusedonthephysicochemicalcharacterizationandsize‐resolvedanalysisofatmosphericparticles.Shealsohasthreeyearsofexperienceinaregulatedpharmaceuticalindustry,executingtheanalyticalmethodtransferof inalproducts,aswellasperforminganalytical testing of inished products as part of validation and stability studies. Her current researchinterest is indevelopingmassspectrometry‐basedmethodstodetectactivepharmaceutical ingredientsindietarysupplementsandtocharacterizedrugsubstances.

CFPProjectSummary

ProjectTitle:Methoddevelopmentforthescreeningandquanti icationofundeclareddrugsindietarysupplementsusingultra‐highperformanceliquidchromatography‐quadrupole‐orbitrapmassspectrometry

FDARegulatorySciencePriorityArea:ImplementaNewPrevention‐FocusedFoodSafetySystemtoProtectPublicHealth

Thescienti iccommunityhasreportedthatanalarmingnumberofdietarysupplementsareadulteratedwith active pharmaceutical ingredients (APIs), such as steroids, statins, growth hormones, and painkillers;medicationsforerectiledysfunction,weightloss,andhairloss;andotherregulateddrugs.Theseadulterated supplementsare illegalandrepresenta serioushealth risk formembersof thepublicwhoconsume the dietary supplements without knowing about the presence of the adulterating drugs. Toaddress this problem, this project aims to use state‐of‐the‐art high resolution mass spectrometrytechniquestodeterminethepresenceandquantityofAPIsindietarysupplementsandthusadvancetheFDAmissionofprotectingthepublichealth.

FlaviaMorales‐García,Ph.D.Of iceofRegulatoryAffairs(ORA)

Preceptors:FenhongSong,Ph.D.andArefEl‐Demerdash,Ph.D.

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RyanOrtega,Ph.D.Multi‐centerFellowshipinRegenerativeMedicine


CenterforDevicesandRadiologicalHealth(CDRH)

Preceptors:AlexBailey(CBER),TinaMorrison

CDRH),BrianPullin(CDRH)


2014–PhDinBiomedicalEngineering,VanderbiltUniversity

2012–TeachingAf iliate,VanderbiltCenterforTeaching

2010–M.S.inBiomedicalEngineering,VanderbiltUniversity

2008‐2014–ProvostFellow,VanderbiltUniversity

2008–B.E.inBiomedicalEngineering,VanderbiltUniversity

ResearchInterests

My current research interests include computational and mathematical modeling for regenerativemedicine,andregulatoryissuessurroundingthisarea.Previousresearchprojectsincludeddevelopinga novel mathematical model of the magnetic properties of iron oxide nanoparticles as well asdiscovery phase research with a macrophage targeting, siRNA delivering nanoparticle forimmunologicalengineering.

CFPProjectSummary

ProjectTitle:EnhancingRegulatoryReviewofComputationalandMathematicalModelingforRegenerativeMedicineProducts

FDARegulatorySciencePriorityArea:ModernizeToxicologytoEnhanceProductSafety

Due to the innovativenatureandcomplexityof regenerativemedicine (RM)products, theabilityoftraditionalpharmacology/toxicology(P/T)testingstrategiesandavailableanimalmodelstoidentifyand characterize safety and bioactivity pro iles is often limited. Computational and mathematicalmodeling and simulation (CMMS) are being used to support development of RM products at thediscoveryphase,andareincreasinglymoreimportantforlaterphaseproductdevelopment.TheuseofCMMStechniquestosupporttheuseofRMproductshasthepotentialtocomplementand/orreplacecertainanimal testingstrategiesand invitro tests throughtherapidandcost‐effectiveevaluationofmultipleparametersand/orexperimentalsystems.WhilesomeproductareashavearobusthistoryofutilizingCMMS in regulatory submissions, theuseofCMMS in the translationaldevelopmentofRMproductshasbeenlimitedto‐date.Therefore,inordertoinformP/TreviewersinCBER/OCTGTaboutthe possible applications of CMMS that exist and to provide themwith tools to facilitate review ofsubmissionsthatcontainsomeCMMScomponent,IwillsurveythemodelingexpertisethatcurrentlyexistswithinCBERandotherFDACentersthentranslateandorganizethatexpertiseintoasetofbestpractices and considerations (e.g., job‐aid or Standard Operating Procedure [SOP]) for reviewingCMMSspeci icallyforregenerativemedicine.

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2014–2015 Chemist,AnalyticalSupport,NovoNordisk,Denmark

2009–2014 PhD,Chemistry,DukeUniversity,USA

2008–2009 MSc,Nanoscience,AarhusUniversity,Denmark

ResearchInterests

ApplyingLEANthinkingtoanalyticalmethoddevelopmentwithinscienti icandregulatorycontext.ThisfollowsfrommyworkasagraduatestudentwhereIresearchedself‐assembledDNAnanostructures.Theprojectincludeddevelopmentofananoscalescaffoldingplatformforcellreceptorstimulation,whichhaspotentialapplicationsintissueengineeringandwoundhealing.Developingthisrequiredtheuseandoptimizationofawiderangeofanalyticalmethodssuchasbioassays,ELISA,PAGEandmicroscopy.AtNovoNordisk,Ifurtherpursuedthisinterest,workingprimarilywithELISAandFTIRwithinbothGLPandcGMPLEANenvironments.

CFPProjectSummary

ProjectTitle:PerformanceEvaluationofaMultiallergenImmunoAssayinBotanicalDietarySupplementsandSpices

FDARegulatorySciencePriorityArea:SupportNewApproachestoImproveProductManufacturingandQuality

Theaimofmyresearchprojectistoevaluateandoptimizetheperformanceofanewlydevelopedmultipleximmunoassaywithbotanicaldietarysupplementsandspices.FDAenforcementoftheFoodAllergenLabelingandConsumerProtectionActof2004(FALCPA)reliesoncon irmationbetweentwosingle‐analyteELISAs.Suchassaysrequiretwodaystocompleteforasingleallergenatacostexceeding$1,200.Asaresult,enforcementofFALCPAusingcurrentmethodsisexceedinglyexpensive.Thenewlydevelopedmultiallergenimmunoassaysimultaneouslydetectsglutenand14differentfoodallergensusingmultipleantibodies,cuttingthetimeandcostofanalysisbymorethananorderofmagnitude.MyprojectispartoftheextensiveevaluationandvalidationneededfortheFDAtoformallyadoptthisassay.

RonnieO.Pedersen,Ph.D.CenterforFoodSafetyandAppliedNutrition

DivisionofBioanalyticalChemistry

Preceptor:EricA.E.Garber,Ph.D.

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2012‐2015 PostdoctoralFellow,JohnsHopkinsUniversity,Baltimore,MD

2011 Ph.D.inChemistry,GeorgiaInstituteofTechnology,Atlanta,GA

2005 B.S.inChemistry,HobartandWilliamSmithColleges,Geneva,NY

ResearchInterests

Dr. Rolle is an inorganic chemist with extensive research experience in the synthesis andcharacterization of small molecules. In his work, he has investigated the development ofenvironmentallybenigntransitionmetalcatalysts,assolutionstooutstandingproblemsinbench‐toporganicsynthesis, commoditychemicalproductionandenergystorage.Currently,he is interested inreducing the impact that anthropogenic sources of chemicals have on human health and theenvironment.

CFPProjectSummary

ProjectTitle:Methoddevelopmentinthedetectionofradioactivecontaminationoffoodproducts

FDARegulatorySciencePriorityArea:EnsureFDAReadinesstoEvaluateInnovativeEmergingTechnologies

Commissioner’sFellowshipProjectOverview

TheFDAfacesincreasingchallengesinensuringthesafetyofthenation’sfoodsupplyfromradioactivecontamination.Itisimperativethattheagencyiscapableofrapidlydetectinggamma‐radiationinfoods,duetothepossibilityofcontaminationfromeithernuclearaccidentsorterrorism.Gamma‐rayspectroscopyisapowerfulandinformativetoolusedtoidentifyradioactivematerialandhaspreviouslybeensuccessfullyimplementedatWEACtodetectcontaminationinfoods.However,currentmethodsarelimitedbecausecalibrationsmustbemadebeforesamplescanbemeasured.Thesecalibrationsaretimeconsuming,requiringcerti iedgammaradiationsourcesthatmatchthegeometryandmatrixofthefoodsampleinquestion.Toovercometheseissues,anumberofsoftwareandmodelingtechniques,whicharecapableofsimulatingavarietyofsamplegeometriesandcompositions,willbeexaminedasalternativemethodforcalibration.Implementingthistechnologywouldimprovethelaboratory’scapabilitiestoquicklydetectcontaminationandprotectthepublic.

ClarenceJ.Rolle,Ph.D.

Of iceofRegulatoryAffairs(ORA)

Preceptor:StephanieHealey:

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KimberlySchultz,Ph.D.


Preceptor:DeniseGavin,Ph.D.


2008‐2015 PostdoctoralFellow,DepartmentofMolecularMicrobiologyandImmunology,JohnsHopkinsBloombergSchoolofPublicHealth

2002‐2008 Ph.D.CellularandMolecularBiology,UniversityofWisconsin–Madison

1998‐2002 B.S.Biology,SUNYGeneseo

ResearchInterests(checkpasttense)

Kim’sresearchhasfocusedonvirus‐hostinteractions.Hergraduatestudiesidenti iedvirus‐activatedcellularsignalingpathwaysandintegrationpointsthatdeterminecellularfate.HerpostdoctoralstudiesinvestigatedcontroloftheimmuneresponseduringviralinfectionoftheCentralNervousSystem(CNS).Shedeterminedthattranscriptionfactorexpressionwasassociatedwithdevelopmental‐determinantsofinfectioninculturedneurons.Additionally,shedemonstratedthatthesetranscriptionfactorsworkedindependentlyofoneanothertoregulatetheinnateandadaptiveimmuneresponsesandviralRNAclearance.Shealsousedhigh‐throughputanalysistoidentifyuniqueantibody‐mediatedsignalingpathwaysthatmaylimitintracellularvirusreplication.

CFPProjectSummary

ProjectTitle:Establishmentofadatabaseandmeta‐analysisofChimericAntigenReceptorT‐cellstargetingCD19(CART19):Analysisofproductcharacteristicsandcriticalproductattributestoguidechemistry,manufacturing,andcontrol(CMC).

FDARegulatorySciencePriorityArea:SupportNewApproachestoImproveProductManufacturingandQuality

Immunotherapiesaugmentormodulatethepatient’sownimmunesystemtotreattheirdisease.T‐cells,acomponentofourimmunesystem,canbegeneticallyengineeredtotargetcellsresponsiblefordisease.ChimericAntigenReceptorT‐cell(CART)immunotherapyusesexvivogeneticallyreprogramedT‐cellstospeci icallytargettumorcellsfordestructionfollowinginfusion.Thistherapy,whichhaspotentialasatreatmentforcancerswithuniquecellularmarkers,hasbeenmostthoroughlyinvestigatedforcancersofwhitebloodcellsthatexpressthecellularmarkerCD19,suchasleukemia.CART19therapyhasledtocompleteremissioninsomepatientsforwhomallothertherapieshavefailed,butforothers,ithasledtolife‐threateningsideeffects.Thistherapycombinesgenetherapywithindividualizedmedicine,creatingapatient‐speci icproductthroughamulti‐stepmanufacturingprocedurethatraisesscienti icandtechnicalissuesthatmayimpactproductsafety.Theoverarchinggoalofthisprojectistodevelopanalyticsthatwillsupportriskpredictiontominimizesevereadverseevents.Uponanalysis,theFDAwillprovideindustrywithrecommendationsdescribinghowcriticalproductattributesandprocessparametersarerelatedtosafeandeffectiveCART19therapies.

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AmandaM.Windsor,Ph.D.

CenterforFoodSafetyandAppliedNutritionDivisionofAnalyticalChemistry

Preceptor:JonathanR.Deeds,Ph.D.

.


2013‐2015MolecularSupportScientist,NationalMuseumofNaturalHistory

2012‐2013EndeavourAwardsPostdoctoralFellow,AustralianMuseum

2011‐2012MarineInvertebrateBarcodeTechnician,NationalMuseumofNaturalHistory

2004‐2011PhD.,EnvironmentalandEvolutionaryBiology,UniversityofLouisianaatLafayette

1999‐2003B.S.,MarineScienceandBiology,CoastalCarolinaUniversity

ResearchInterests

AmandaisaCrustaceanBiologistwithafocusontaxonomyandbiodiversity.Herprimaryinterestsinvolveutilizingacombinationofmolecularphylogeneticsandtraditionalmorphologicaldescriptionstoresolvelong‐standingtaxonomicissuesinbrachyurancrabs.ThisapproachhasledAmandaandhercolleaguestodescribe2newspecies,3genera,andreviseafamilyofAmericandecoratorcrabs.AsaCommissioner’sFellow,Amandawillapplyhertrainingtoresolvepressingtaxonomicissueswithincommerciallyimportantcrustaceans.

CFPProjectSummary

ProjectTitle:ResolvingPriorityTaxonomicIssuesinCommercialSwimmingCrabsthatImpactSeafoodLabelingintheUnitedStatesFDARegulatorySciencePriorityArea:EnsureFDAReadinesstoEvaluateInnovativeEmergingTechnologies

ThisprojectaimstoaddressseveralkeyprioritytaxonomicissuesthatarecurrentlyaffectingtheproperregulationandlabelingofcrabmeatinsupportoftheFDA’sroleinregulatingseafoodlabelingstandards.Speci ically,theprojectwilladdresscurrentlyunresolvedtaxonomicissueswithintwoofthemostwidelytradedcrabspecies,Callinectessapidus(bluecrab)and“Portunushaanii”(redswimmingcrab)whichwillrequireacombinationofmorphologicalandmolecularanalysesofspecimenscollectedfromthroughouttheirrespectivegeographicranges.Theprimaryobjectivesareto1)determinewhetherthesouthernsubspeciesofbluecrab,C.sapidusacutidens,ismorphologicallyandgeneticallydistinctenoughtowarrantrecognitionasadistinctspecies;2)determineexactlywhichspeciesofcrabiscurrentlybeingharvestedandsoldasPortunushaaniitoallowproperlabelingoftheseproductsandmanagementofthis ishery;3)generatesequencesfromvoucherspecimensobtainedfrom ishmarketsandresearchcollaboratorsfromaroundtheworldtocontinueexpansionoftheFDAReferenceStandardSequenceLibraryforseafood.

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Scienti ic&ProfessionalBackgroundDr.LiYangcompletedherPhDtrainingwithmajoroftoxicologyfromUniversityofNebraskaMedicalCenterin2010.DuringherPhDtraining,shehasconductedbreastcancercase‐controlandcross‐sectionalstudies,and prostate cancer case‐control studywith the goal of detecting early biomarkers of these diseases. Byusing ultra‐performance liquid chromatography (UPLC) coupled with tandem triple quadrupole massspectrometer (MS/MS), Dr. Yang found that there is signi icantly higher level of estrogen DNA adducts,whicharebiomarkersofDNAdamage,intheblood/urinesamplesincancercasescomparingwithhealthycontrols.Aftercompletingtheseprojects,Dr.Yang joinedUniversityofPittsburghSchoolofMedicineasafellow in 2010. From 2011 to 2014, Dr. Yang was awarded for a Department of Defense Breast cancerresearch program Postdoc fellowship. Dr. Yang has conducted cell study and animal model to test thehypothesis that sulforaphane, bioactive component extracted from broccoli, canmodulate estrogen DNAoxidation pathway by up‐regulating Nrf2‐Keap1 pathway. Dr. Yang found that sulforaphane can be anantioxidanttopreventestrogenDNAdamage,which indicates itspotentialasachemopreventionagent intheclinicalsettings.Insummary,Dr.Yanghasaccumulatedexperienceinepidemiology,biostatistics,massspectrometry,cellstudy,animalmodel,andcancerpreventionstrategiesbyusingfoodbasedantioxidant.ResearchInterests:Developing fast screening methods to detect toxins in food and dietary supplements; developing massspectrometrybasedmethodstocharacterizethesetoxinsortheirmetabolites;regulatoryscience.CFPProjectSummaryProjectTitle:Developmentofscreeningmethodsfordiarrheticshell ishtoxinsandazaspiracidshell ishtoxinsusingsurfaceplasmonresonanceandcon irmationbyLC‐MS/MSforregulatoryapplicationinseafoodFDARegulatorySciencePriorityArea:Field‐usabledetectorsformicroorganisms,chemicalhazards,andeconomicadulterantsMarinebiotoxins,producedbymicroalgae,aresmallmoleculesaccumulatedin ilter‐feeding ishorshell ish.Afterconsumingseafoodcontaminatedwithmarinebiotoxins,humansdevelopsymptomssuchasdiarrhea,vomiting, paralysis and even death. These biotoxins are a public health concern and so monitoring iswarranted.Thegoalofthestudyistodeveloprapid ielddetectionmethodstoquicklytestdiarrheicshell‐ishtoxins(DSTs),azaspiracidshell ishtoxins(AZTs)anddomoicacid(DA)inshell ish.Liquidchromatog‐raphycoupledwithmassspectrometry(LC‐MS/MS)methodswillbedevelopedasregulatorycon irmatoryapproaches.AThermotriplequadrupoleandaQexactivemassspectrometerwillbeused.Byconductingproposedstudy,foodsafetywillbeprotectedandpublichealthwillbepromoted.

LiYang,Ph.D.,DABT,

AppliedTechnologyCenter,PRL‐NW,ORA

Preceptor:JamesHungerford,PhD

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YanZheng,Ph.D.

Of iceofRegulatoryAffairs,NortheastRegion

Preceptor:YuanHu,M.D.


2015(May‐Oct)Intern/TempProjectAssociateII,RegeneronPharmaceuticals,Inc.

2014PostdoctoralFellow,DepartmentofPathology,NYULangoneMedicalCenter

2013Ph.D.Virology&CellBiology,AlbertEinsteinCollegeofMedicine

2007B.S.BiologicalSciences,PekingUniversity,China

ResearchInterests

Yanisinterestedinthe ieldofinfectiousdiseases.Hergraduateresearchanalyzedthecellularentryandreleasemechanismofalphaviruses,whichcauseencephalitisorarthritis,forantiviralstrategy.Herpostdoctoralresearchisolatedandanalyzedpatients’neutralizingantibodiesforbetterHIVvaccinedevelopment.

CFPProjectSummary

ProjectTitle:Developmentoffoodbornevirusconcentrationmethodanditsapplicationinviralpathogende‐tectionfromfoodmatrix

FDARegulatorySciencePriorityArea:EnsureFDAReadinesstoEvaluateInnovativeEmergingTechnologies

HepatitisAvirus(HAV)ranksfourthamongidenti iedcausesoffoodbornediseases.ThepresenceofHAVisrarelycon irmedthroughdirectisolationfromcontaminatedfoodsamples,suggestingtheneedforamoreef icientvirusdetectionmethod.CurrentHAVdetectionprocedureincludessamplepreparationsuchasvirusconcentrationandRNA‐extraction,aswellasfollow‐upmolecularampli icationandanalysis.Atalowviralconcentration,whichistypicalforfoodmatrix,highersamplepreparationef iciencyleadsanimprovedsensitivityofvirusdetection.Myfellowshipprojectwillfocusonoptimizingthesamplepreparationmethod.Speci ically,Iwilloptimizecurrentlabinternalpolystyrenecarboxylatebead‐basedapproach,andcompareitin‐parallelwithotherpublishedorin‐housemethodstoidentifythemostrapid,ef icient,andconsistentprocedureforfoodbornevirusisolationanddetection.

25


2015 Preceptors

26

Background:

Ph.D.Pharmaceutics

MasterdegreeinAppliedmathematics

BS:Pharmacy

FDAemployment:August,2005‐present

ResearchInterests:

1. Constructingtheknowledgeanddatabaseforknownbiologicalandchemicalthreats,

2. Systemspharmacologyapproachestomappingthebiologicalpathways/networksperturbedbybiologicalandchemicalthreats,

JaneBai,Ph.D.

CenterforDrugEvaluationandResearch(CDER)

SilverSpring,MD20993

27

AlexM.Bailey,Ph.D.

TeamLead,Pharmacology/ToxicologyBranch(PTB)

DivisionofClinicalEvaluationandPharmacology/Toxicology(DCEPT)

Of iceofCellular,Tissue,andGeneTherapies(OCTGT)


USFDA

10903NewHampshireAvenue

SilverSpring,MD20993

FDA/CBER/OCTGT

Background:

B.S.(MechanicalEngineering),TuftsUniversity

Ph.D.(BiomedicalEngineering),UniversityofVirginia

AttheUSFDAsince2010

28

FrederickA.Beland,Ph.D.


NationalCenterforToxicologicalResearch

Jefferson,AR72079

Background:

B.A.,ColoradoCollege

M.S.,MontanaStateUniversity

Ph.D.,MontanaStateUniversity

FDAExperience‐37years

ResearchInterests:

Moleculartoxicology,molecularcarcinogenesis,genetics,andepigenetics.

29

Background

Ph.D.Marine,Estuarine,andEnvironmentalScience,UniversityofMaryland,2003

M.Sc.EnvironmentalToxicology,UniversityofLouisianaatLafayette,1997

B.S.Biology,UniversityofDayton,1995

ResearchInterests:

Seafood is a highly valued, globally traded commodity. Seafood is unique among the animal productsregulated by the FDA in that several thousand species are harvested and distributed globally, with eachspecieshavingdistinctqualities,availabilities,and,insomecases,associatedhazards.Thesequalities,values,andhazardscansometimesdifferforthesamespeciesbasedonfactorssuchaswhereitwasharvestedandwhether it iswild caught or farmed. Proper labeling of seafood is critical to FDA’s regulatorymission intermsofprotectingU.S. consumers fromseafoodassociatedhazardsand fromprotecting consumers fromeconomicallymotivated fraud. Reliableanalyticalmethods for species identi icationareessential toFDA’sresponsibility toenforce theaccurate labelingof seafood. In theearly1990’s, inresponse tonumerous in‐quiriesregardinglabelingandsubstitutionissues,theAgencystartedaformalprograminseafoodproductidenti ication.Forproductsthatcouldnotbeidenti iedvisually,theanalyticalmethodusedatthattimewasbasedonisoelectricfocusingofproteinsor“IEF.”Around2005,FDA irstbegantoexploretheuseofDNAtoidentifyseafoodproductsasareplacementforthenowoutdatedIEFmethodwhichislessspeci icandmoresubject tochangesdue toprocessingandcooking.By theendof2011,FDAhadvalidatedandpublishedaDNAbasedmethodforidenti icationofseafoodandby2012nineFDAregional ieldlaboratorieshadbeenequipped, trained, andpro iciency tested forDNA testingof seafood,beginning its routineuseat FDA. Inaddition,interagencyagreementsandcontractswereestablishedwithseafoodtaxonomiststobuildaFederalDNA Reference Standard Seafood Library containing standard DNA sequences that link to referencespecimenshousedpermanentlyinmuseumcollectionssuchastheSmithsonianNationalMuseumofNaturalHistoryinWashington,D.C.

JonathanR.Deeds,Ph.D.,M.Sc.

MethodDevelopmentBranch

DivisionofAnalyticalChemistry

Of iceofRegulatoryScience

FDACenterforFoodSafetyandAppliedNutrition

CollegePark,MD

30

ArefEl‐Demerdash,Ph.D.

KansasCityLaboratory

SouthwestRegion


U.S.FoodandDrugAdministration

11510W.80thStreet

Lenexa,KS66214and

B

Background:

6yearsofFDAemployment

Ph.D.Environmentaltoxicology

ResearchInterests:

Developingmethods/fastscreeningmethodstodetectAPI’sindietarysupplements;developingmassspectrometrybasedmethodstocharacterizedrugsubstancesordrugproducts.

31

Background:

B.S.inZoology,NorthDakotaStateUniversity,Fargo,ND

Ph.D.inCellularandMolecularBiology/InfectiousDiseases,NorthDakotaStateUniversity,Fargo,ND

FDAExperience:12years

ResearchInterests:

Myresearchinterestsarelargelyinthe ieldsofbacterialpathogenesis,zoonoses,foodsafety,andmolecularmethodsforpathogencharacterization.Speci icareasofinterestincludeunderstandingthedistributionofentericpathogens,andtheirvirulenceandantimicrobialresistancefactorsinfoodproductionenvironments.Byunderstandingthedistributionmechanismsofpathogens,wemaybeabletodevelopinterventionstoreducethespreadofpathogenicmicroorganismsfromfoodsourcestohumans.Iamalsointerestedinthedevelopmentofmethodstobetterunderstandthecontributionofplasmidencodedgenestoenhancedbacterialfunction.Plasmidsarecapableofhorizontalgenetransfer,whichcouldfacilitatethespreadofantimicrobialresistanceandincreasedvirulenceamongbacterialeadingtomoredif iculttotreatinfections.Thusamorecomprehensiveunderstandingofplasmidgeneticsandassociatedphysiologyshouldultimatelyleadtoimprovedpublichealth.

StevenFoley,PhD

DivisionofMicrobiology


Jefferson,AR72079

32

EricA.E.Garber,Ph.D.

DivisionofBioanalyticalChemistry,Of iceofRegulatoryScience,CenterforFoodSafetyandAppliedNutrition(CFSAN).

LabAddress:CFSAN,HFS‐716,

5100PaintBranchPkwy.,

CollegePark,MD20740

Background:

Ph.D.Biochemistry,BrandeisUniv.1983

B.S.Biochemistry,CCNY1978

Employment

2002–present,FDA

ResearchInterests:

Applicationofproteinspeci icdiagnosticstothedetectionandcharacterizationoffoodasitrelatestosafeguardingconsumers.

33

DeniseGavin,Ph.D.

GenetherapyBranch,DivisionofCellandGeneTherapy

10903NewHampshireAve

WO71‐5328

SilverSpring,MD

Background:

Dr.GavinistheActingGeneTherapyBranchChief.ShehasbeenwiththeFDAfor13years.ShehasbeeninGTBfor13yrs.

ResearchInterests:

Cancerimmunotherapy,cellandgenetherapies,productmanufacturingandtesting

34

Background:

B.S.inBiology,2001;M.D.,2005

PediatricResidency,2008

ClinicalPharmacologyFellowship,2009

FDACommissioner’sFellowshipProgram,2009‐2011

BiohazardousThreatAgentsandEmergingInfectiousDiseases2‐YrCerti icateProgram,2011‐2013

TotalyearsofFDAemployment,6years

ResearchInterests:

Neonatalandpediatricdrugdevelopment,trialmethodology,pharmacogenomics,medicalcountermeasuredevelopment.

DionnaJ.Green,M.D.

MedicalOf icer

PediatricClinicalPharmacologyStaff

Of iceofClinicalPharmacology

Of iceofTranslationalSciences

CDER

35

StephanieL.Healey,M.S.

WinchesterEngineeringandAnalyticalCenter,

ORA

Winchester,MA

Background:

SupervisoryChemist

B.S.GeologicalSciences

M.S.Geochemistry

6yearstotalexperiencewithFDA

5yearsemploymentwithFDA

1yearresearchexperiencewithFDAascontractor

ResearchInterests:MethodDevelopmentinthedetectionofradioactivecontaminationoffoodproductsandpackaging.

36

Background:

1983M.D.GuangzhouMedicalUniversity

1990M.S.St.John’sUniversity

1991‐1999ResearchScientist,AlbertEinstein

MedicalCollege,BronxLebanonHospitalCenter

1999‐PresentFDA,ResearchMicrobiologist(Virologist)

NewYorkStatelicensedclinicallaboratorydirector

ResearchInterests:

1. Isolationandextractionoffoodbornevirusesfromfoodsamples

2. Nestedreal‐timePCRforthedetectionoffoodborneviruses

3. WholeGenomesequencinganalysisoffoodborneviruses

4. Discoveryofunrecognizedanduncharacterizedviralagents

5. HepatitisCvirusspontaneousmutationsincontinuouscelllines

YuanHu,M.D.

NortheastRegionalLaboratory/ORA/FDA

158‐15LibertyAve.

Jamaica,NY11433

37

Background:

Ph.D.,UniversityofWashington,Seattle,WA(AnalyticalChemistry)

BS,MS,WesternWashingtonUniversity,Bellingham,WA(Organic)

Mystudiesingraduateschoolandpost‐docdealtwithrapidtestsandautomatedanalyticalchemistry(micro luidicsandFIAworkforPh.D.)andinmyMSworkIwasstudyingorganicandorganometallicsynthesis.IhaveworkedforFDAsince1987asaresearchchemist

ResearchInterests:

Rapidtestsforonsitetestingofseafoods,cytotoxicityassaysforciguatoxinsin ish,detectionofhistamineinish,algalshell ishtoxinsbyHPLCandcellassay,automationofchemicalmethods(FIA)

JamesM.Hungerford,Ph.D.

AppliedTechnologyCenter,PRL‐NW,ORA

2220123rdDrSE,Bothell,WA

38

AricD.Kaiser,M.S.

ExpertBiomedicalEngineer

USFoodandDrugAdministration

CenterforDevicesandRadiologicalHealth

Of iceofDeviceEvaluation

DivisionofOrthopaedicDevices

Background:

B.S.,BiomedicalEngineering,CaseWesternReserveUniversity,1985

M.S.,MechanicalEngineering,UniversityofCincinnati,1987

FDAexperience–since1994

ResearchInterests:

AricKaiser,anexpertbiomedicalengineerwithexperienceintissuemechanicsandmechanicaltesting,hasregulatoryandscienti icinterestsinthedesignandevaluationofproductsintendedtotreatorthopedicdisorders.Ofparticularinterestaretissue‐engineeredmedicalproducts(combinationproducts)anddevicesintendedtoserveasfunctionalreplacementsforthediseasedordamagedtissue,e.g.,productsintendedtorepair/regrowdamagedcartilagewithfunctionaltissueratherthanimplantationofsyntheticmaterialsasintotaljointreplacements.Recentworkhasfocusedonbonevoid illerscontainingcalciumsalts,collagenand/orrecombinanthumanproteinsorsyntheticpeptides.

39

AllisonKumar,Ph.D.

CenterforDevicesandRadiologicalHealth

SilverSpring,MD

Background:

Harvard University - National Preparedness Leadership Institute

Georgetown University – Graduate Certificate, Biohazardous Threat Agents and Emerging Infectious Diseases

Virginia Tech – B.S. Engineering Science & Mechanics

Over 8 years at FDA

Research Interests:

Acute Trauma and Critical Care, Traumatic Brain Injury, Sepsis, Physiological Monitoring, Regulatory Strategy

40

MichaelA.Pacanowski,M.P.H,Pharm.D.

AssociateDirectorforGenomicsandTargetedTherapy


Of iceofTranslationalSciences|Of iceofClinicalPharmacology

10903NewHampshireAvenue,WhiteOakBuilding51,Room2132,HFD870

SilverSpring,MD20993‐0002Of ice(301)796‐3919,Mobile(301)529‐4537

Background:

Pharm.D.,PhiladelphiaCollegeofPharmacy,2004

M.P.H.(Epidemiology),UniversityofFlorida,2008

ClinicalPharmacologyResidency,BassettHealthcare,2004‐05

PharmacogenomicsFellowship,UniversityofFlorida,2005‐08

JoinedtheFDAin2008(6years)

ResearchInterests:

Pharmacogenomics,personalizedmedicine,clinicalpharmacology,rarediseases

41

Background:

Ph.D.

5monthsatFDA(August2014‐present)

Over20yearsexperienceinNanotechnologywith10yearsattheFrederickNationalLaboratoryforCancer

Researchonpreclinicalassessmentofnanomedicines.

ResearchInterests:

Allaspectsofnanotechnologyregulatoryresearchinmedicalproductsfromsynthesisofnanomaterialbaseddrugs,imagingagentsanddevices,materialcharacterization,invitrobiocompatibilityandinvivosafetyandef icacyassessment.

AnilK.Patri,Ph.D.

NCTR‐ORANanotechnologyCoreFacility

Of iceofScienti icCoordination

NationalCenterforToxicologicalResearch(NCTR)

FDAJeffersonLaboratoriesCampus

Jefferson,Arkansas72079

870‐543‐7580;[email protected]

42

Background:

Ph.D.degree

Twenty‐oneyearsatCBER/FDA

ResearchInterests:

InvestigatingthemechanismofoncogenictransformationbyDNAtumorviruses;establishinginvivoassaystodetectandquantifytheoncogenicactivityofcellularDNA;developinginvitroassaysthatquantifythereductioninthebiologicalactivityofDNA;understandingtherelationshipbetweenthemechanismbywhichacellbecomestumorigenicandthesafetyofbiologicalsmanufacturedintumorigeniccells;determiningtheroleofepigeneticsinestablishingatumorigenicphenotype;developingneutralizationassaysthatcanbeadaptedtohighthroughputandthatmightfacilitatetheintroductionofnewvaccinesbyevaluatingthehostimmuneresponsestothevaccines.

KeithPeden,Ph.D.

Chief,LaboratoryofDNAViruses

DivisionofViralProducts


SilverSpring,MD

43

IgorP.Pogribny,M.D.,Ph.D.



Background:

M.D.,Ivano‐FrankivskMedicalUniversity

Ph.D.,KyivNationalMedicalUniversity

FDAExperience,16years

ResearchInterests:

Moleculartoxicology,molecularcarcinogenesis,genetics,andepigenetics.

44

IrshadSulaiman,M.Sc.,M.Phil,Ph.D.

MicrobiologicalSciencesBranchSoutheastRegionalLaboratory(SRL)

Of iceofregulatoryAffairs(ORA)

Background:

Ph.D.–UniversityofDelhi,IndiaM.Phil.–A.M.University,IndiaM.Sc.–A.M.University,India

FDAExperience–4andhalfyears(2008‐Present

ProfessionalExperience:

2011‐Present:AdjunctProfessor,DepartmentofBiology,GeorgiaStateUniversity,Atlanta,Georgia2008‐Present:ResearchMicrobiologist,SoutheastRegionalLaboratory,FDA,Atlanta,Georgia2003‐2008:ResearchScientist,DivisionofScienti icResources,CDC,Atlanta,Georgia1997‐2003:VisitingScientist,DivisionofParasiticDiseases,CDC,Atlanta,Georgia1996‐1997:ResearchFellow,MedicalCollegeofGeorgia,Augusta,Georgia1993‐1996:YoungScientist,NationalInstituteofImmunology,NewDelhi

ResearchInterests:

Dr.SulaimanjoinedtheMicrobiologicalSciencesBranch,SoutheastRegionalLaboratory,U.S.FoodandDrugAdministration,Atlanta,GeorgiaasaResearchMicrobiologistonOctober12thof2008,withover16yearsofresearch experience and expertise in the ield of molecular genetics and its application in methoddevelopmenttodetectanddifferentiatevarioushuman‐pathogenicemerginginfectiousagents.BeforecomingtoFDA,Dr.SulaimanworkedattheCentersforDiseaseControl(CDC)forelevenandhalfyearsfrom1997to2008.Dr.SulaimanobtainedhisPhDdegreein1992tostudyConservationBiology,PopulationGeneticsandEcologyofEndangeredSpeciesfromUniversityofDelhi.

Dr. Sulaiman’s research forover20yearshas focusedon themolecular genetic characterizationand rapiddetection methods for human‐pathogenic parasites (Cyclospora, Cryptosporidium, Giardia), bacteria(Cronobacter, Bacillus, Salmonella), viruses (orthopox, SARS, Hepatitis A), fungi (Microsporidia, Indicatorfungalspeciesfromenvironmentalswabs),andsomepestspecies(theFDA“Dirty22”species)responsibleforthe spreading of foodbornepathogens, fromoutbreak settings, routine surveillance and sporadic cases fortheirDetection,Prevalence,Epidemiology,TransmissionDynamics,Taxonomy,PhylogenyandEvolutionaryRelationshipsofpublichealthimportance.

Dr. Sulaiman has published over 70manuscripts in peer‐reviewed journals with high impact factors, andwritten4bookchaptersinhisareaofexpertise.

45

FenhongSong,Ph.D.

ElementBuilding

Of iceofRegulatoryScience


U.S.FoodandDrugAdministration

12420ParklawnDrive

Rockville,MD20857

Background:

Ph.D.JohnsHopkinsUniversity

6yearsofFDAemployment

ResearchInterests:

Developingmethods/fastscreeningmethodstodetectAPI’sindietarysupplements;developingmassspectrometrybasedmethodstocharacterizedrugsubstancesordrugproducts.

Documents

FDA Commissioner’s Fellowship Program · PDF fileFDA Commissioner’s Fellowship Program ... 2001‐2005 Bachelors of Science in Biology ... Development of medical countermeasures