推动精准医药开发——医疗大数据和通用数据模型应用案例.pptx

Unlock the potential of precision medicine – Role of real world data and common data model 推动精准医疗开发 - 医疗大数据和通用数据模型应用案例 The continuous increase of costs with declining productivity means an overhaul of the RD model more important than ever $2.6 Billion ~5.5% â 30% AverageꢀRDꢀcostꢀperꢀ approvedꢀNMEꢀversusꢀ justꢀ$1Bꢀtenꢀyearsꢀago ROIꢀofꢀRDꢀspendꢀinꢀ 2014,ꢀdecliningꢀfromꢀ 10%ꢀinꢀ2010 Declineꢀinꢀtheꢀtotalꢀlifetimeꢀ revenuesꢀofꢀpharmaꢀassets (2ꢀofꢀ10ꢀdrugꢀrevenuesꢀꢀRDꢀcost) Patient enrollmentis a leading cause of delays Challenging Patient Enrollment Protocols today have twice as many end points, eligibility criteria,and investigative sites as used in the past Increased Complexity 37% sites under-enroll patients 11% sites fail to enroll a single patient Half the total cost of bringing a drug to market is attributable to opportunity costs associated with a lengthy drug 80% of clinical trials fail to meet milestones due to operational delays while conducting the trial High Opportunity Costs Increased Cycle Times developmentperiod ($403 million) 2 Data-driven decision-making has proven to support the common drivers of accelerated RD, from strategy and design to trial execution Asset Program Trial Design Trial Planning Trial Execution Strategy Target product profile Country site selection End-point design Trial marketing Patient enrollment retention Portfolio fit assessment Inclusion/ Exclusion criteria CRO contracting Competitive assessment Protocol optimization Regulatory approval Data management review Trial planning and sequencing Enrichment strategy Study report submission Site initiation 3 Collaborating with clients, we have supported programs to leverage RWD and clinical patient-level data to support the full lifecycle of drug development Pre-clinical PhaseꢀI PhaseꢀII/PhaseꢀIII PostꢀMarketing Portfolio evaluation prioritization Target ProductProfile (TPP) Development Patient profiling cohort construction Inclusion/Exclusion Criteria Optimization Outcomes for sta