highlights from exl pharma's 12th investigator initiated trials

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Highlights from ExL Pharma’s 12 th Investigator Initiated Trials September 27-28, 2010 Burlingame, CA

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Highlights from ExL Pharmas 12th Investigator Initiated Trials

Highlights from ExL Pharmas 12th Investigator Initiated TrialsSeptember 27-28, 2010Burlingame, CA

A Governance Modelfor Review & Decisions of Investigator- initiated Research

Investigator-initiated StudiesUnsolicitedNon-Clinical and ClinicalInvestigator - DrivenTypically single centerDuration up to two yearsScientifically drivenSupport drug and /or funding

Building a Committee CharterScope and PurposeEstablish strategic review committeeAcquire appropriate membershipDefine roles and responsibilitiesEstablish meeting logisticsEstablish operating principlesAgree to decisions rightsDevelop key metricsMeasure success

Planning: Develop StrategyGlobal Strategy DocumentProvides a disease area with consolidated documentation of scientific areas of focusIncludes key regional considerationsIdentifies areas of research interest for investigator initiated studies to enable: An avenue for investigators worldwide to design and conduct their own research Feasibility of new scientific ideasDiscovery of emerging trends and signalsTransparency and avoid duplication of studies

Planning: BudgetPlanningGenerate budget and average cost per studyTie to areas of research strategyForecastingManagement of budgetPlanning: OperationsIdentify key stakeholdersInternal and external Acquire qualified staff to support programsEstablish standard SOPs / guidelinesInclude timelinesIdentify training needsDevelop standardized tools for investigatorsSubmission /Concept templates

Planning: OperationsTechnology Web portal, IT supportDocument managementEstablish Metrics to measure progressPerformanceComplianceCycle timeFormal MeetingOpen session: Scientific and strategic discussion Ensure appropriate committee membership All members have the role of providing meaningful input based on the area of expertise

Closed session: Voting / decisionMarketing representative is excused from the meeting prior to making decisionsSummarization of discussions and final decisions

Review and Decision ProcessAssessment of research proposal is required to ensure transparency and uniformityReview of research proposalComplete and quality proposalScientific merit (scientific importance, methodological rigor)Alignment with therapeutic area strategyUniqueness (should not compete or conflict with company research programsBudget consistent with Fair Market Value

Review and Decision ProcessInvestigator AssessmentCapability and feasibility of successQualified to conduct research and assume responsibilities as sponsor of the studyExperiencedSufficient resources to conduct the studyPast performance Feasibility of study timelinesAbility to publish

Communication to InvestigatorsDevelop a Communication PlanWhat do you what to communicate?Request for more informationClarify on requestDecisionProvide clarity/rationale if the decision is to decline the proposalWho is communicating ?Who is being notified?When does the communication occur?Establish timelineDocument decisions

Setting ExpectationsWhat you should expect from potential investigatorsA well written proposalAbility to conduct and complete studyAbility to meet study timelinesSubmission of complete and timely quarterly progress updatesTo seek expert statistical help in analyzing the dataAbility to submit well written abstract and manuscriptSetting ExpectationsWhat investigators should expect from youPrompt response to a proposalThorough scientific review of the proposalTimely decision on acceptance or rejection of proposalClear rationale regarding rejectionUpon study completion, timely and discretionary comments ofabstract and manuscript

Elements of SuccessA well structured operating model that focuses on rigorous scientific review of investigator-initiated proposals will ensure:Program IntegrityTransparency of IntentDecisions are based on good science

Elements of SuccessBuild trust and respectCommunication should be clear, complete and timelyEstablish and agree to expectations Effective documentation and tracking will ensure a compliant and efficient program

Bringing MSL Value to Investigator Initiated TrialsRoles and Responsibilities of the MSLStudies Scientific information

Feedback Presentations

18Proactive vs ReactiveCharacteristics of the MSLEducational Preparation

Experience

CompetenciesCore Competencies of the MSLTechnical expertise

Communication

Relationship building

Team work

Medical Science Liaisons Work Across Multiple Functions Medical InformationCommercial PartnersClinical DevelopmentLegalPublicationsMSL21To identify what the ideal roles for an MSL should beI interviewed the groups the MSL would be interfacing with the most

Physician survey 100 oncologists community and academicCS Pam, Bob, Kip, GwenOps Sue Tremlett, Jackie Moore, othersBiometrics didnt talk to Alex but we do interface on ISTsMed Comm- Barry, Christine Gilmore Commercial directors from the brand teams including omnitarg, ATL, MC, Commercial Learning & Dev.Sales directors and RMs

From this arrived at key MSL strategic rolesInvestigator Initiated Trials (IIT)RESOURCING question:

In relation to other trials in the program, how important is the IIT to the development of drugs?

Product Specific Strategy

Extend and Entrench Increase breadth in core business and ongoing indicationsPursue combinations as disease appropriateExtend IP protection on new therapeutic optionsBroad regulatory approval Expansion

ExploreConsolidate & pursue ongoing indicationsManage Follow on CompoundsMedium Term3-5 yearLong Term10 yearMaximize Global ValueShort Term1 yearEstablishCore business Aggressive filing/ launch plans Broadly explore Regulatory approvals in key indicationsIn applying overall strategy to a specific product, the questions addressed by the IIT must fit in the LCM plan.Overall Strategy:Post-Marketing/Medical Affairs Strategic PrioritiesTreatment Optimization

Launch Preparation/Market Entrenchment

Positioning

Explore Patient Eligibility

Signal Seeking

Prioritization of IITs:Trial PriorityHighMediumLowResourcingMSLOperations/ContractsTimelines

Methodology for the IIT Program

Goals/Objectives

IIT Resource Allocation

Team review and prioritization

Evaluation of IIT Proposals Three Criteria for Evaluation

Strategy

Design

Site

Strategic Development

Measuring MSL Value Balanced Score Card

Strategy Map

KPI/KPM Key Performance IndicatorsKey Performance Measures

Total Quality Management

Balanced Score Card

R.Kaplan and D.Norton (1992)Strategy Map

R.Kaplan and D.Norton (1996)

Key Performance Indicators/MeasuresStrategy

ObjectivesSMART format

KPIsA KPI can follow the SMART criteria. This means the measure has a Specific purpose for the business, it is Measurable to really get a value of the KPI, the defined norms have to be Achievable, the KPI has to be Relevant to measure (and thereby to manage) and it must be Time phased, which means the value or outcomes are shown for a predefined and relevant period.KPI/KPMSome examples are:New investigators acquired Analysis of individuals applying to become investigatorsStatus of existing investigators Investigator attrition Project activation, monitoring, and completion

Total Quality Management (TQM)Technology

Organization

PeopleConclusionMSLs are a highly educated group of clinicians/researchers and an important part of the development of new drugs. Evaluation of the value MSLs bring to the IIT program should focus on controllable areas and objectives. Still have any questions? For additional information on ExL Pharmas Investigator Initiated Trials Conferences, please visit www.exlpharma.com