FDA Commissioner’s Fellowship Program - Food and … · FDA Commissioner’s Fellowship Program...
Transcript of FDA Commissioner’s Fellowship Program - Food and … · FDA Commissioner’s Fellowship Program...
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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 Shultz, Kimberly…………………………………… 21
Kannan, Lakshmi …………………………………. 13 Windsor, Amanda………………………………….. 22
Khajanchi, Bijay …………….………………………..
Lee, Stella……………………………………………..
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Yang, Li………………………………………………
Zheng, Yan ………………………………………….
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FDA Commissioner’s Fellowship Program
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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FDA Commissioner’s Fellowship Program
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)
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FDA Commissioner’s Fellowship Program
2015 Preceptors and Fellows by Center
CBER Preceptors Fellows Jane Bai Chia-Wen Hsu Alex Bailey Ryan Ortega Keith Peden Stella Lee Denise Gavin Kimberly Schultz CDER Preceptors Fellows Dionna Green Janelle Baker Michael Pacanowski Adeniyi Oluseyi CDRH Preceptor Fellow Aric Kaiser John Jameson Allison Kumar Lakshmi Kannan CFSAN Preceptors Fellow Jonathan Deeds Amanda Windsor 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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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.
CenterforDrugEvaluationandResearch
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.
Scienti ic&ProfessionalBackground
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
Preceptor:JaneBai,Ph.D.
Scienti ic&ProfessionalBackground
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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Scienti ic&ProfessionalBackground
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)
Scienti ic&ProfessionalBackground
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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Scienti ic&ProfessionalBackground
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.
CenterforBiologicsEvaluationandResearch(CBER)
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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Scienti ic&ProfessionalBackground
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
CenterforBiologicsEvaluationandResearch(CBER)
CenterforDevicesandRadiologicalHealth(CDRH)
Preceptors:AlexBailey(CBER),TinaMorrison
CDRH),BrianPullin(CDRH)
Scienti ic&ProfessionalBackground
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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Scienti ic&ProfessionalBackground
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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Scienti ic&ProfessionalBackground
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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KimberlyShultz,Ph.D.
CenterforBiologicsEvaluationandResearch(CBER)
Preceptor:DeniseGavin,Ph.D.
Scienti ic&ProfessionalBackground
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.
.
Scienti ic&ProfessionalBackground
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.
Scienti ic&ProfessionalBackground
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.
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Background:
Ph.D.Pharmaceutics
MasterdegreeinAppliedmathematics
BS:Pharmacy
FDAemployment:August,2005‐present
ResearchInterests:
1. Constructingtheknowledgeanddatabaseforknownbiologicalandchemicalthreats,
2. Systemspharmacologyapproachestomappingthebiologicalpathways/networksperturbedbybiologicalandchemicalthreats,
JaneBai,Ph.D.
CenterforDrugEvaluationandResearch(CDER)
SilverSpring,MD20993
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AlexM.Bailey,Ph.D.
TeamLead,Pharmacology/ToxicologyBranch(PTB)
DivisionofClinicalEvaluationandPharmacology/Toxicology(DCEPT)
Of iceofCellular,Tissue,andGeneTherapies(OCTGT)
CenterforBiologicsEvaluationandResearch(CBER)
USFDA
10903NewHampshireAvenue
SilverSpring,MD20993
FDA/CBER/OCTGT
Background:
B.S.(MechanicalEngineering),TuftsUniversity
Ph.D.(BiomedicalEngineering),UniversityofVirginia
AttheUSFDAsince2010
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FrederickA.Beland,Ph.D.
DivisionofBiochemicalToxicology
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
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ArefEl‐Demerdash,Ph.D.
KansasCityLaboratory
SouthwestRegion
Of iceofRegulatoryAffairs
U.S.FoodandDrugAdministration
11510W.80thStreet
Lenexa,KS66214and
B
Background:
6yearsofFDAemployment
Ph.D.Environmentaltoxicology
ResearchInterests:
Developingmethods/fastscreeningmethodstodetectAPI’sindietarysupplements;developingmassspectrometrybasedmethodstocharacterizedrugsubstancesordrugproducts.
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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
NationalCenterforToxicologicalResearch
Jefferson,AR72079
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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.
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DeniseGavin,Ph.D.
GenetherapyBranch,DivisionofCellandGeneTherapy
10903NewHampshireAve
WO71‐5328
SilverSpring,MD
Background:
Dr.GavinistheActingGeneTherapyBranchChief.ShehasbeenwiththeFDAfor13years.ShehasbeeninGTBfor13yrs.
ResearchInterests:
Cancerimmunotherapy,cellandgenetherapies,productmanufacturingandtesting
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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
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StephanieL.Healey,M.S.
WinchesterEngineeringandAnalyticalCenter,
ORA
Winchester,MA
Background:
SupervisoryChemist
B.S.GeologicalSciences
M.S.Geochemistry
6yearstotalexperiencewithFDA
5yearsemploymentwithFDA
1yearresearchexperiencewithFDAascontractor
ResearchInterests:MethodDevelopmentinthedetectionofradioactivecontaminationoffoodproductsandpackaging.
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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
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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.
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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
CenterforDrugEvaluationandResearch
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]
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Background:
Ph.D.degree
Twenty‐oneyearsatCBER/FDA
ResearchInterests:
InvestigatingthemechanismofoncogenictransformationbyDNAtumorviruses;establishinginvivoassaystodetectandquantifytheoncogenicactivityofcellularDNA;developinginvitroassaysthatquantifythereductioninthebiologicalactivityofDNA;understandingtherelationshipbetweenthemechanismbywhichacellbecomestumorigenicandthesafetyofbiologicalsmanufacturedintumorigeniccells;determiningtheroleofepigeneticsinestablishingatumorigenicphenotype;developingneutralizationassaysthatcanbeadaptedtohighthroughputandthatmightfacilitatetheintroductionofnewvaccinesbyevaluatingthehostimmuneresponsestothevaccines.
KeithPeden,Ph.D.
Chief,LaboratoryofDNAViruses
DivisionofViralProducts
CenterforBiologicsEvaluationandResearch(CBER)
SilverSpring,MD
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IgorP.Pogribny,M.D.,Ph.D.
DivisionofBiochemicalToxicology
NationalCenterforToxicologicalResearch
Background:
M.D.,Ivano‐FrankivskMedicalUniversity
Ph.D.,KyivNationalMedicalUniversity
FDAExperience,16years
ResearchInterests:
Moleculartoxicology,molecularcarcinogenesis,genetics,andepigenetics.
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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.
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FenhongSong,Ph.D.
ElementBuilding
Of iceofRegulatoryScience
Of iceofRegulatoryAffairs
U.S.FoodandDrugAdministration
12420ParklawnDrive
Rockville,MD20857
Background:
Ph.D.JohnsHopkinsUniversity
6yearsofFDAemployment
ResearchInterests:
Developingmethods/fastscreeningmethodstodetectAPI’sindietarysupplements;developingmassspectrometrybasedmethodstocharacterizedrugsubstancesordrugproducts.