CDx Commercialization Phasing Partner with Us Planning Pre-Launch Launch Post-Launch Develop plan in collaboration with partner Share market insights and collective knowledge Align Rx / Dx commercial objectives Define commercialization strategy and country- level prioritization/timing Determine activities requiring partner support Identify and nurture key opinion leaders (KOLs) Align CDx development studies with commercialization studies End-user voice of customer to drive product requirements and commercialization considerations Prepare marketing message for PMA submission Establish lab network Create physician awareness Activate KOL network to start commercialization studies Complete HEOR studies, prepare HTAs, request reimbursement coverage Initiate PR and marketing campaigns Expand lab network and physician awareness after reimburement established and guidelines updated Continue to nurture KOLs Monitor and adjust activities to achieve market adoption Transition to maintenance campaigns LabPMM Services Catalog 2019 | 7 Streamlined CDxTM NOVARTIS FLT3 Companion Diagnostic for midostaurin FDA approved in April 2017, Swissmedic approval in May 2017 & European Union approval in Sept. 2017 Breakthrough designation CE-marked Integrated Approach to CDx Development We provide experience efficient handling of all stages of CDx development, from the biomarker discovery proces, through CDx development, and commercialization, including: Supportive collaborative relationship with our pharmaceutical partners Dedicated CDx co-development team with extensive expertise in program management, feasibility studies, product development, quality control, regulatory, and commercialization Sense of urgency and comitment to partner's success Partner with Us Contact us for more information: businessdevelopment@invivoscribe.com Preclinical Phase I Phase II Phase III Reg. Submission Drug Development Process Biomarker ID/ Content IP Assay Design Assay Feasibility Testing & Development CDx Development Prospective testing during phase III Rx Study Reg. Submission CDx Commercialization Biomarker Development Process Companion Diagnostic Product Cycle (CDx) Assay Development Start clinical trial Rx / Dx Co-submission Rx / Dx Co-approval Rx commercialization 6 ASTELLAS FLT3 Companion Diagnostic for gilteritinib fumarate PMDA approved in Japan in Sept. 2018 FDA aproved in Nov. 2018 >140 international collection sites (accelerated SAKIGAKE designation in Japan)