Alliance Organizational Structure

Trini Ajazi, MMAlliance Chief Administrative Officer

Clinical Research Professional Orientation

May 10, 2017

NCI-NCTN• NationalCancerInstitute(NCI)NationalClinicalTrialsNetwork(NCTN)isaconsolidated,integratednetworkcomprisedoforganizationsthatconductdefinitive,randomizedclinicaltreatmenttrialsacrossabroadrangeofdiseasesanddiversepatientpopulations

• 4AdultNetworkGroups,1Canadianand1PediatricGroupthatsponsorandleadNCTNtrials

NCORP• NCICommunityOncologyResearchProgram(NCORP)– communitybasedprogramdesignedtobringclinicaltrialstoindividualsintheirowncommunitiesandcontributetoimprovedpatientoutcomesandreductionincancerdisparities

• NCORPdesignsandconductscancerprevention,control,screening,postsurveillanceandcancercaredeliveryclinicaltrials

• FacilitatesaccesstotreatmentandimagingtrialsfromNCTN

About the Alliance for Clinical Trials in OncologyNational Clinical Trials Network (NCTN) Group consists of nearly 10,000 cancer specialists at approximately 1000 hospitals, medical centers, and community sites across the United States and Canada.

Vision: to reduce the impact of cancer by uniting a broad community of scientists and clinicians from many disciplines, committed to discovering, validating and disseminating effective strategies for the prevention and treatment of cancer

Alliance MissionAlliance achieves its purpose by

conducting high quality multidisciplinary cancer control, prevention, and treatment trials that engage a

comprehensive research network;

furthering our understanding of the biological basis of the cancer process and its treatment, from discovery, to

validation, to clinical practice;

providing a scientific and operational infrastructure for innovative clinical and translational research in

academic and community settings

AllianceHistoryMergerofthreeGroups11bythemergerofthreecooperativegroups:• AmericanCollegeofSurgeonsOncologyGroup(ACOSOG)• CancerandLeukemiaGroupB(CALGB)• NorthCentralCancerTreatmentGroup(NCCTG)• Merger initiated in 2011 and completed March 2014

with start of new NCTN grant period

• ThemergerofthesecooperativegroupsreflectsthecallinApril2010fromtheInstituteofMedicine(IOM)tostrengthenandstreamlineoperationsamongNCIclinicaltrialscooperativegroupprograms.

AllianceNetworkMembership

• InstitutionsmustmeetAllianceaccrualandperformancerequirementsperAlliancePoliciesandProcedures

• Membersareacademicandcommunitysites,includingNCIgrantfundedLeadAcademicParticipatingSites(LAPS)andNCICommunityOncologyResearchProgram(NCORP)sites

• MoststudiesareavailabletoallNCTNmembersitesviaanopenmenu

Alliance: Overview of Governance and Program Structure

Alliance Board of Directors

Alliance Group Chair

Director, Statistics & Data Management Program

Group Vice Chair

Director, Central Protocol Operations Program

Director, Translational Research Program

Director, Cancer Control Program

Chief Administrative Officer

Director, ACS Clinical Research Program

Chief Financial Officer

Executive CommitteeThe primary governance body of the Alliance is the Board of Directors, which represents the group’s institutional members.

The Alliance is led by the group chair with assistance from the group vice chair. The Alliance is also

supported by five program directors, each responsible for a specific program integrating discipline-related science and operational functions across all disease committees.

The Executive Committee represents the Board of Directors and assists the group chair in planning and coordinating group activities.

Leukemia LymphomaRespiratoryGenito-urinary

Gastro-intestinalBreast MyelomaNeuro-

Oncology

ScientificModality/Disciplines

SurgicalOncology,ResearchProgram,Transplant,RadiationOncology,Pathology,Imaging,OncologyNursing,ClinicalResearchProfessionals,Biostatistics,Bioinformatics,

Pharmacology,Pharmacogenomics,PatientAdvocates,HealthOutcomes,SymptomIntervention,ExperimentalTherapeutics,

CommunityOncology,ResearchEthics,LaboratoryMedicine,CancerPrevention,CancerCareDelivery,YoungInvestigators,Pharmacy

AdministrativeCommittees:BoardofDirectors,ExecutiveCommittee

ConstitutionandBylaws,Membership,InstitutionalPerformanceEvaluation,ConflictofInterest,Audit,Publications,

DataandSafetyMonitoringBoard

AllianceLeadership• GroupChair:MonicaBertagnolli,MD,Dana-Farber/BrighamWomen’sHospitalCancerCenter

• GroupViceChair:SuzanneGeorge,MD,Dana–FarberCancerInstitute

• GroupStatistician/DirectorSDMP:SumithraMandrekar,PhD,MayoClinic

• Director,CentralProtocolOperationsProgram:GiniFleming,MD,UniversityofChicago

• Director,CancerControlProgram:JanBuckner,MD,MayoClinic• Director,TranslationalResearchProgram,FraserSymmans,MD,MDAndersonCancerCenter

• DirectorAmericanCollegeofSurgeonsClinicalResearchProgram:KellyHunt,MD,MDAndersonCancerCenter

BoardofDirectors

lComprisedof50AlliancePrincipalInvestigatorsorinstitutionalrepresentative

lResponsibleforfinalapprovalofoverallpolicyfortheAlliance,electionofGroupChair,approvalofinstitutionalmembership.

lExecutiveCommitteereportstotheBoardofDirectors

ExecutiveCommitteelLedbyGroupChairandGroupViceChairlMembersincludethe5 programdirectors/co-principalinvestigatorsand4academicBODrepresentativesand4communityBODrepresentatives

lRecommendstotheBoardofDirectorsoverallAlliancepolicy,direction,priorities,andactivities

lApprovescommitteechairandvicechairappointments

OfficeoftheGroupChair

• GroupAdministration• Finance•MembershipServicesandCommunications• RegulatoryComplianceandQuality Assurance

OperationsUnits(locatedatBWHand

UChicago)

• Breast,Gastrointestinal,Genitourinary,Leukemia,Lymphoma,Myeloma,Neuro-oncology,Respiratory,Transplant

• PatientAdvocates,ClinicalResearchProfessionals,ExperimentalTherapeutics,OncologyNursing,RadiationOncology

ScientificCommittees

• Audit,PatientCommunications,ConflictofInterest,Constitution,DSMB,Ethics

• YoungInvestigators,InstitutionalPerformanceEvaluation,Membership,Pharmacy,Publications

AdministrativeCommittees

Group Chair and Principal Investigator: Monica M. Bertagnolli, MD - Dana-Farber/Brigham and Women’s Cancer CenterGroup Vice Chair: Suzanne George- Dana Farber Cancer Institute

StatisticsandDataManagement

••DataManagement••SystemsManagement••InformationSystems••Statistics

••Biostatistics••Bioinformatics

OperationsUnits(locatedatMayoandDuke)

ScientificCommittees

GroupStatisticianandPrincipalInvestigator:Sumithra Mandrekar,PhD- MayoClinicOperationsManager:Cari Cummins– MayoClinic

CentralProtocolOperations

••ProtocolOffice(ProtocolDevelopmentandManagement)••PharmaceuticalAffairs

••StudyConceptReview

OperationsUnits(locatedatUChicago)

ScientificCommittees

PrincipalInvestigatorandDirector:GiniF.Fleming,MD- UniversityofChicagoDirectorofProtocolOperations:MichaelKelly,MA,UniversityofChicago

TranslationalResearchProgram

• IntegratedBiorepositories• TranslationalResearchOperations

OperationsUnits(locatedatMS

Anderson, Uchicago,WashU)

• LeukemiaCorrelativeSciences,SolidTumorCorrelativeScience,Imaging,Pharmacogenomic &PopulationPharmacology,Pathology,Sequencing

ScientificCommittees

• Karotype Review,BiorepositoriesAdministrativeCommittees

PrincipalInvestigatorandDirector:W.FraserSymmans,MD,MDAndersonCancerCenterDirectorBiorespositories:MarkWatson,MD,WashingtonUniversityDirectorTranslationalResearchOperations:Yujia Wen,PhD,UniversityofChicago

CancerControlProgram

••NCORPResearchBase

••CancerintheElderly,HealthDisparities,HealthOutcomes,Prevention,SymptomIntervention

••CommunityOncology(Administrative)

OperationsUnits(locatedatMayo)

ScientificCommittees

PrincipalInvestigatorandDirector:JanC.Buckner,MD- MayoClinicProgramManager:JacquelineLafky,MS– MayoClinic

ACoS ClinicalResearchProgram

• CommissiononCancer• NationalCancerDatabase• ProgramManagement

OperationsUnits(locatedatMD

Anderson/ACS Chicago)

• CancerCareStandardsDevelopment• CancerCareDeliveryResearch• Dissemination andImplementation

ScientificCommittees

•EducationAdministrativeCommittees

PrincipalInvestigatorandDirector:KellyHunt,MD,MDAndersonCancerCenterProgramManager:AmandaFrancescatti,MS,AmericanCollegeofSurgeons

Alliance for Clinical Trials in Oncology Foundation

Not-for-Profit Corporation created to enhance and expand the ability of Alliance members* to conduct cancer clinical research

• 501(c)3• Governance and operations structure separate from the Alliance

Alliance Foundation Trials, LLC (AFT)• LLC (sole member = Foundation) created to conduct cancer clinical

research involving partners other than the National Cancer Institute

ALLIANCE NCTN/NCORP

Study Design by Scientific and

Modality Committees

Study Operations

OrgCharts

GroupChairMonicaBertagnolli,MD

ChiefFinancialOfficerDeniseBrennan

GrantsAdministration

Finance

MeetingsManagement

ChiefAdministrativeOfficerTrini Ajazi,MM

AdministrativeSupport/OfficeManagement

MemberServices

IT/IS RegulatoryAffairsandCompliance

ProjectManagement

QualityAssurance/Audit

Program

Communications Training

Reporting

GroupVice-ChairSuzanneGeorge,MD

Office of the Group Chair

PrincipalInvestigator/DirectorGiniFleming,MD

ExecutiveOfficersLindaSluman,MDSelinaChow,MD

PriyaKumthekar,MD

PharmaceuticalAffairsManager

LigiMatthews,PharmD

DirectorTranslationalResearchOperations

YujiaWen,PhD

DirectorProtocolOperations

MichaelKelly,MA

ProtocolInformationSpecialist ClinicalTrialManagers

ProtocolCoordinators SeniorProtocolCoordinators

Central Protocol Operations Program

AdditionalSlides– ProgramStructuresandOrgCharts

TranslationalResearchProgram(TRP)

BiorepositorySystems

SpecimenTracking

TissueCollection

TissueStorage

TissueProcessing

InformationTechnology

TRPAdministrative

Core

MolecularReferenceLaboratories

IHC/FISH/PCR

Microarray

SerumProteomics

Pharmacokinetics

Pharmacogenomics

Sequencing

TRPScientificAdvisoryBoard

TRPExecutiveCommittee

BiorepositoryCommittee

ImagingCommittee

KaryotypeReview

LeukemiaCorrelativeScienceCommittee

PathologyCommittee

PharmacogenomicsandPopulationPharmacology

SequencingCommittee

Alliance/American College of Surgeons

Clinical Research Program

Executive Committee

Scientific Committees

Cancer Care Delivery Research

Dissemination & Implementation

Cancer Care Standards

Development

Administrative Committee

Education

Alliance/American College of Surgeons Clinical Research Program Committee Structure

ProgramDirector,ClinicalResearch

Program

Manager,ClinicalResearchProgram

ProjectManagerDeveloper

Alliance/American College of Surgeons Clinical Research Program Staff Structure

President

ChiefAdministrative

Officer

QualityandCompliance

QASupport

ChiefFinancialOfficer

Accounting

AccountingSupport

Budget&FiscalPlanning

ChiefOperatingOfficer

AdministrativeSupport

HR/OfficeManagement

IT/ISRegulatory&Protocol

Management

ProjectManagement ProjectSupport

Sr.SiteManagement

SiteSupport

Contracts&Agreements

ContractSupport

VicePresidentChiefScientificOfficer

AFT Operations Structure