Services.
Business development, contract negotiation & financial review -
based on partnering experience
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Companion diagnostics (CDx) partnering requires the early identification of the best biomarker and assay technology and the selection of the future CDx partner. Good decision-making ensures efficient Rx/CDx co-development.
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We support all phases of the CDx/Rx co-development process by providing advice on the optimal diagnostic, regulatory, and CDx partnering strategy.
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CDx development is expensive and can add additional risk to the Rx program if not executed properly. Development costs alone can range from $8 - $14 million. Naturally, a potential partner's initial proposal will be on the high-end. We provide a critical review during agreement negotiation and help you with the implementation based on experience and technical and regulatory expertise.
Planning & operational alignment of Rx/CDx
co-development
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Operational planning requires clinical trial assay (CTA) development, its analytical validation (AV), and the potential filing of the IDE (Investigational Device Exemption). The integrated process can take 6-9 months and includes the execution of a Rx/CDx collaboration agreement with an external CDx partner.
Regulatory strategy
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Prospective patient selection may require filing an IDE (in the US) before the clinical trial can start. Often, time for First Patient First Visit (FPFV) is limited. We are here to provide input and a critical review of your CDx plan based on CDx development, regulatory and overall strategic experience in planning Rx/CDx co-development projects.
Specialized
advisory
services
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Assay configurations available during early clinical Rx stages are often not aligned with the global development needs and future commercialization requirements (post-approval). Paying early attention to the integrated CDx/Rx strategy needs will streamline Rx/CDx co-development and render the Rx/CDx co-development process more efficient.