rwe: can it be used in the real world? · real-world data. as internationally recognized expert in...
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RWE: Can it be used in the Real World?
• SeminarGroundRules― Practicegoodhygiene― Studentattendance― Askquestions― Network
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• Abbreviatedagenda-Sat― 1:00Speakers― 2:45Break― 3:00Speakers― 4:30Break― 4:45Speakers― 6:00Groupcasestudyprep― 7:00Dinner
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RWE: Can it be used in the Real World?
• SeminarGroundRules― Practicegoodhygiene― Studentattendance― Askquestions― Network
2
• Abbreviatedagenda-Sun― 7:00Breakfast― 8:00Speakers― 9:30Break― 9:45Speakers― 12:00Lunch― 1:00Casestudypresentations― 2:00Dismiss
![Page 3: RWE: Can it be used in the Real World? · real-world data. As internationally recognized expert in drug safety, she has chaired the Food and Drug Administration’s Drug Safety and](https://reader034.vdocuments.us/reader034/viewer/2022050602/5faa0aa118932701dd7ee21b/html5/thumbnails/3.jpg)
LCDR Kenneth Quinto M.D., M.P.H. Senior Medical Advisor, Real World Evidence Analytics Staff, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, U.S. Department of Health and Human Services
LCDRQuintoservesasaseniormedicaladvisorintheRealWorldEvidenceAnalyticsStaffintheOfficeofMedicalPolicy(OMP)atFDA’sCenterforDrugEvaluationandResearch(CDER).Heoverseesdemonstrationprojectsintendedtosupporttheagency’sevaluationofrealworldevidence,evaluatesrealworldevidenceusecases,andcontributestomedicalpolicydevelopmentmandatedbythe21stCenturyCuresAct.KeyfocusareasincludeFDA-CatalystandPCORIpragmatictrialsaswellasreplicationofclinicaltrialresultswithnon-interventionalstudydesigns.
Prior,LCDRQuintowasthemedicalofficeratFDA’sOfficeofPediatricTherapeuticsreviewingpost-marketsafetyandadverseeventreportingofdrugs,biologics,vaccines,andmedicaldevicesusedinchildren.HehasheldvariouspositionsatdifferentU.S.DepartmentofHealthandHumanServices’agenciesincludingasanEpidemicIntelligenceServiceOfficerattheCentersforDiseaseControlandPrevention’sNationalCenterforHealthStatisticsandasamedicalofficerattheCentersforMedicareandMedicaidServicesprovidingmedicalexpertiseinepidemiology,pediatrics,allergyandimmunology,andanalyticalsupportinperforminghisjobduties.
In2012,LCDRQuintowascommissionedintheU.S.PublicHealthServiceandholdstherankoflieutenantcommander.HecompletedhisallergyandimmunologyfellowshipandpediatricresidencyattheUniversityofCalifornia,SanDiego,earnedhisM.D.fromtheUniversityofCalifornia,SanFrancisco,hisM.P.HfromUniversityofCalifornia,BerkeleyandhisB.S.fromtheUniversityofCalifornia,LosAngeles.
3POP Seminar Faculty Bios 2020
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David Van Brunt, PhD Head, Evidence and Analytics, HEOR, Abbvie Adjunct faculty, University of Tennessee Health Science Center, College of Medicine, Department of Preventive Medicine
Dr.VanBrunthasauniqueconfluenceofskillsthatallowhimtoleadteamstoexcellence.Specifically,hebrings:• Morethan20yearsofleadershipandpost-doctorateexpertiseacrossmanyenvironments,demonstratingconsistent,high-impactperformance
• Technicalcredibilitythatstemsfromasolidbaseofbothacademicteachingandresearchaswellasappliedindustryresearchandstrategydevelopmentthatspansthedevelopmentpipeline
• Organizationalsavvyderivedfromhistraininginpsychologythathehasappliedtoinspireloyalty,optimizeproductivity,andmaintainthestabilityofhisteams
Hehasledteamsofmorethan30highcaliberscientistsinsupportofbothmarketedproductsandpipelineprogramsinimmunology,oncology,andneuroscience.Hehasbuiltahealtheconomicsandoutcomesresearch(HEOR)forearlydevelopment,movingHEORtoearlierinthepipelinethanhadbeendonebefore.Histeamsprepareinformationtosupportvalueandaccessfromcandidateselectionpastlaunch.Hehascollaboratedeffectivelyinmatrixenvironmentswithcolleaguesinepidemiology,marketing,medicine,payerengagement,pricing,andbiostatisticstocultivateabig-pictureviewofhowtobringvaluetothebusinesswhileretainingadeepappreciationforthedetailsofconductingsolidscience.
4POP Seminar Faculty Bios 2020
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Prabashni Reddy, PharmD, RPh Director, Center for Drug Policy, Partners Healthcare
PrabashniReddyestablishedtheCenterforDrugPolicyatPartnersHealthcarewheresheoverseesateamofpharmacistsandanalyststhatapplyclinical,operational,andanalyticskillstoguideandmanagesystem-leveldrugpolicywork.TheCenter’sscopeextendstothesystem’shospitalandambulatorysettingsofcareaswellastothepayergroups;theyrunthePharmacy&TherapeuticsCommittee,EmployeeHealthsubcommittee,ChiefPharmacyOfficersCouncil,andSubstanceUseSteeringCommittee.
Dr.ReddyearnedherBS(Pharmacy)andMasterofMedicalScience(Pharmacology)inSouthAfrica.SheholdsaPharmDdegreefromtheAlbanyCollegeofPharmacyandcompletedafellowshipinPharmacoeconomicsandOutcomesResearch,ajointprogramfromHartfordHospitalandtheUniversityofConnecticut.Dr.Reddyhasworkedasastaffpharmacistinhospitalsettings,anAssistantProfessorintheDepartmentofPharmacyPracticeattheUniversityofConnecticut,andasDirectorofClinicalOutcomesResearchatAbtAssociates,aconsultingcompany.
ShehasservedontheCenterforMedicareandMedicaidService’sMedicareEvidenceDevelopment&CoverageAdvisoryCommittee,chairedtheEducationCommitteeoftheInternationalSocietyofPharmacoeconomicsandOutcomesResearch,andiscurrentlyontheEditorialAdvisoryBoardoftheJournalofManagedCarePharmacy.
5POP Seminar Faculty Bios 2020
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Sengwee Darren Toh, ScD Associate Professor, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Chief Scientist, Sentinel System
DarrenToh,ScDisanAssociateProfessorintheDepartmentofPopulationMedicineatHarvardMedicalSchoolandHarvardPilgrimHealthCareInstitute.Heisapharmacoepidemiologistwithaninterestinthecomparativesafetyandeffectivenessresearchofmedicalproducts.Hisresearchfocuseson1)assessingtherisksandbenefitsofmedicalproductsusingelectronicdatacollectedaspartofroutinehealthcaredelivery,and2)developingandapplyingprivacy-protectinganalyticmethodstoconductmulti-centerstudiesindistributeddatanetworks.
DarrenisChiefScientistattheOperationsCenteroftheFDA-fundedSentinelSystem,acongressionallymandatednationalmedicalproductsafetysurveillancesystem.HeisPrincipalInvestigatorofprojectsfundedbytheNationalInstitutesofHealth(U01EB023683),theAgencyforHealthcareResearchandQuality(R01HS026214),thePatient-CenteredOutcomesResearchInstitute(ME-1403-11305),andtheFoodandDrugAdministration.DarrenreceivedhisdoctoraldegreeinEpidemiologyfromtheHarvardSchoolofPublicHealth.
6POP Seminar Faculty Bios 2020
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Jennifer Graff, PharmD Vice President, Comparative Effectiveness Research, National Pharmaceutical Council
JenniferGraff,PharmD,istheNationalPharmaceuticalCouncil's(NPC)vicepresidentofcomparativeeffectivenessresearch.Inthisrole,sheleadsresearchandpolicyinitiativestoadvancetheuseofevidencetoinformhealthcaredecision-making.Herareasoffocusincluderesearchandeducationtosupportincreasedaccesstoanduseofhigh-qualitydata,developmentandadoptionofgoodresearchmethods,andpoliciestoenabletheexchangeoftruthfulandnon-misleadinginformationtosupportstakeholderdecision-making.
PriortojoiningNPCin2009,Dr.GraffledstrategichealtheconomicandoutcomesresearchactivitiesatMedImmuneandPfizerPharmaceuticals.Shehasauthoredover20peer-reviewedarticlesandpresentsfrequentlyonpolicyissuesaffectingthebiopharmaceuticalindustry.ShecurrentlyservesasanassociateeditoroftheAcademyHealthjournaleGEMSandasamemberoftheAcademyofManagedCarePharmacyFormatExecutiveCommittee.
Dr.GraffholdsaDoctorateofPharmacyfromtheUniversityofNebraskaMedicalCenter,andcompletedaHealthOutcomesandPharmacoeconomicsfellowshipattheUniversityofMichigan.
7POP Seminar Faculty Bios 2020
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Lucinda S. Orsini, DPM, MPH Associate Chief Science Officer, International Society of Pharmacoeconomics and Outcomes Research
LucindaOrsiniiscurrentlyAssociateChiefScienceOfficeratISPOR,theleadingsocietyforhealtheconomicsandoutcomeresearch.ThescienceofficeatISPORdevelops,leads,andsupportsstrategicinitiativesrelatedtoresearch,scientific,andcontentpriorities.WhileLucindaholdsaprofessionalmedicaldegree,shehasspentmostofher~20-yearcareerinhealtheconomicsandoutcomesresearch.StartingatTheMedstatGroup(TruvenHealthAnalytics)Lucindamanagedprojectsusinghealthcareclaimsdataforexternalclients.ShehasworkedinthepharmaceuticalindustryatBristol-MyersSquibbandsubsidiariesinGlobalHEORfocusedononcologyandimmunotherapyleadingandpublishingonpatientreportedoutcomes,healtheconomicmodelingandreal-worldevidencestudies–bothprospectiveandretrospectiveinmanydifferenttumortypes.LucindahasrecentlyledHEOReffortsatPAREXELafull-servicecontractresearchgrouppriortocomingtoISPOR.
8POP Seminar Faculty Bios 2020
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Shirley V Wang PhD, ScM Assistant Professor Division of Pharmacoepidemiology, Department of Medicine Brigham and Women’s Hospital and Harvard Medical School
Dr.WanghasaPhDinepidemiologyandScMinbiostatisticsfromBrownUniversity.Herresearchisfocusedon1)developinginnovative,non-traditionalanalyticmethodstounderstandthesafetyandeffectivenessofmedicationuseinroutineclinicalcareaswellas2)facilitatingappropriateuseofcomplexmethodsforanalyzinglargeobservationalhealthcaredata.ShehasreceivedawardsforhermethodsworkfromtheSocietyforEpidemiologicResearchandtheInternationalSocietyofPharmacoepidemiology.
Dr.WanghasbeenaninvestigatorwiththeFoodandDrugAdministration’sSentinelProgramsince2011.Sherecentlyco-ledajointtaskforcefortheInternationalSocietyofPharmacoepidemiology(ISPE)andtheInternationalSocietyforPharmacoeconomicsandOutcomesResearch(ISPOR)focusedreal-worldevidenceforhealthcaredecision-making.SheiscurrentlyontheSteeringCommitteeforaTransparencyInitiativeledbyISPORinpartnershipwithISPE,DukeMargolis,andtheNationalPharmaceuticalCouncil.In2017,shelaunchedtheREPEATInitiative,anon-profitprogramwithprojectsaimedatimprovingtransparency,reproducibilityandrobustnessofevidencefromhealthcaredatabases.
9POP Seminar Faculty Bios 2020
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Almut Winterstein, R.Ph., Ph.D., FISPE Professor And Chair In Medication Safety, Department of Pharmaceutical Outcomes & Policy, College of Pharmacy, University of Florida
AlmutWintersteinreceivedherpharmacydegreefromFriedrichWilhelmUniversityinBonn,GermanyandherPhDinPharmacoepidemiologyfromtheCharitéHumboldtUniversityinBerlin,Germany.SheholdsthepositionofProfessorandChairintheDepartmentofPharmaceuticalOutcomesandPolicyattheCollegeofPharmacy,andanaffiliateappointmentintheDepartmentofEpidemiologyattheCollegesofMedicineandPublicHealthandHealthProfessions,bothattheUniversityofFlorida.In2017,shewasnamedtheDr.RobertandBarbaraCrisafiChairinrecognitionofherresearchonevaluatingdrugsafetyandeffectivenessinreal-worldpopulationsandondevisingwaystoimprovemedicationuse.
SincejoiningtheUFCollegeofPharmacyin2000,Wintersteinhasservedasprincipalinvestigatoronmorethan25extramurallyfundedgrantsandcontractsandpublishedmorethan300manuscriptsandconferenceabstracts.Herresearchinterestshavecenteredonthepost-marketingevaluationofdrugsinpediatricsandperinatalcare,infectiousdiseaseandpsychiatryandtheevaluationandimprovementofqualitysurroundingmedicationuseusingreal-worlddata.Asinternationallyrecognizedexpertindrugsafety,shehaschairedtheFoodandDrugAdministration’sDrugSafetyandRiskManagementAdvisoryCommitteefrom2012-2018.Recognizinghercontributionsinpharmacoepidemiology,Dr.WintersteinwasinductedasafellowoftheInternationalSocietyofPharmacoepidemiologyin2013andstartedhertermaspresident-electofthesocietyin2018.Beforeshebecamedepartmentchairin2016,Dr.Wintersteinservedasgraduateprogramdirectorinherdepartment,whichincludedresponsibilityforaMSprogramfortheFDA.Shehaschairedatotalof21PhDcommitteesandhasservedasmemberonseveralothersinherdepartment,andtheDepartmentsofEpidemiology,BiostatisticsandStatistics.
10POP Seminar Faculty Bios 2020