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RWE: Can it be used in the Real World?

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• Abbreviatedagenda-Sat―  1:00Speakers―  2:45Break―  3:00Speakers―  4:30Break―  4:45Speakers―  6:00Groupcasestudyprep―  7:00Dinner

RWE: Can it be used in the Real World?

•  SeminarGroundRules―  Practicegoodhygiene―  Studentattendance―  Askquestions―  Network

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• Abbreviatedagenda-Sun―  7:00Breakfast―  8:00Speakers―  9:30Break―  9:45Speakers―  12:00Lunch―  1:00Casestudypresentations―  2:00Dismiss

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

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

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

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

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

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

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

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