b"Partner with Us Partner with UsContact us for more information: businessdevelopment@invivoscribe.comStreamlined CDxCDx Commercialization PhasingNOVARTIS ASTELLASDAIICHI-SANKYOFLT3 CDx for XOSPATA (gilteritinib)FLT3 CDx for VANFLYTA(quizartinib PlanningPre-Launch Launch Post-Launch FLT3 CDx for RYDAPT(midostaurin)hydrochloride)Breakthrough designation in the USA 140 international collection sites Bridging study for multiple labs in theFDA, Swissmedic & EU approval in 2017 PMDA approval in Japan in 2018 USA, Europe and AsiaDevelop plan in collaboration Identify and nurture key Establish lab network Expand lab network andPMDA approval in Japan in 2019 with partner opinion leaders (KOLs) physician awareness afterReimbursement approved in Japanreimburement establishedShare market insights and Align CDx development studies Create physician awareness and guidelines updatedFDA approval in the USA in 2018collective knowledge with commercialization studies EU approval in 2019 Continue to nurture KOLs Align Rx / Dx commercial Voice of customer to drive productActivate KOL network to start Integrated Approach to CDx Developmentobjectives requirements and commercializationcommercialization studies Monitor and adjust activitiesconsiderations to achieve market adoptionWe provide efficient handling of all stages of CDx development, from the biomarker discovery process Define commercialization Complete HEOR studies,and commercialization, including: strategy and country levelPrepare marketing message prepare HTAs, requestTransition to maintenance Supportive, collaborative relationship with our pharmaceutical partners prioritization/timing for PMA submission reimbursement coverage campaignsDedicated CDx development team with extensive expertise in program management, feasibility studies, productDetermine activities requiringInitiate PR and marketing development, quality control, regulatory, and commercializationpartner support campaignsSense of urgency and commitment to partner's success Preclinical Phase I Phase II Phase III Reg. Submission Rx commercializationDrug DevelopmentProcessAssay Start Rx / Dx Rx / DxDevelopment clinical trial Co-submission Co-approvalBiomarker ID/Assay Design Assay Feasibility Testing & DevelopmentContent IPBiomarker DevelopmentProcessProspective testing CDx Development during phase III Reg. Submission CDx CommercializationRx StudyCompanion DiagnosticProduct Cycle (CDx)8 LabPMM Services Catalog 2020|9"