b"Partner with Us PartnerJoin the 60+ Pharma Companies Worldwide who arewith UsWorking with Invivoscribe on Comprehensive ProjectsCDx Commercialization Phasing CONTACT US FOR MORE INFORMATION: businessdevelopment@invivoscribe.comPlanningPre-Launch Launch Post-LaunchIntegrated Approach to CDx DevelopmentDevelop plan in collaboration Identify and nurture key Establish lab networkExpand lab network and with partner opinion leaders (KOLs) physician awareness after We provide efficient handling of all stages of CDx development, from the biomarker discovery process reimburement establishedto commercialization, including: Share market insights and Align CDx development studies Create physician awarenessand guidelines updatedSupportive, collaborative relationship with our pharmaceutical partners collective knowledge with commercialization studiesContinue to nurture KOLs Dedicated CDx development team with extensive expertise in program management, feasibility studies, productAlign Rx / Dx commercial Voice of customer to drive Activate KOL network to start development, quality control, regulatory, and commercializationobjectives product requirements andcommercialization studies Monitor and adjust activitiesSense of urgency and commitment to partner's successcommercialization to achieve market adoptionDefine commercialization considerations Complete HEOR studies,strategy and country levelprepare HTAs, requestTransition to maintenance prioritization/timing Prepare marketing message reimbursement coverage campaignsfor PMA submissionDetermine activities requiringInitiate PR and marketing partner support campaignsDrug Development ProcessPreclinical Phase I Phase II Phase III Reg. Submission RxCommercializationExamples of FLT3 CDxPartnerships:Assay StartRx / DxRx / Dx Development Clinical Trial Co-submission Co-approval NOVARTIS ASTELLASDAIICHI-SANKYO Biomarker Development ProcessTesting &FLT3 CDx for RYDAPT (midostaurin)FLT3 CDx for XOSPATA (gilteritinib fumarate) FLT3 CDx for VANFLYTA(quizartinibBiomarker ID/ Content IP Assay Design Assay Feasibility hydrochloride)Development Breakthrough designation in the USA 140 international collection sites Bridging study for multiple labs in theFDA, Swissmedic & EU approval in 2017PMDA approval in Japan in 2018 USA, Europe and AsiaPMDA approval in Japan in 2019ARTG-inclusion in AUS Reimbursement approved in Japan Biomarker Development ProcessFDA approval in USA in 2018 Prospective testingCDxCDx Development during phase III Reg. SubmissionRx Study Commercialization EU approval in 2019 8 LabPMM Services Catalog 2021|9"