Product Development Process
Historically drug manufacturers have faced the challenge of knowing the need for a Companion Dx but having to mitigate risks by delaying decisions to engage an IVD partner. This approach was predicated on the knowledge that IVD companies did not generally have the skills needed to support the entire continuum of a drug lifecycle from concept to commercialization. As such, misalignment between drug and CDx development timelines often resulted with enrollment of CDx partners only occurring in Phase II/III.
At Asuragen, our partnership model is different as we built capabilities and competencies to support partnering with you from concept to commercialization. This approach enables you to engage an IVD partner early in a stage-gated approach that ensures that when you are ready to accelerate, we as a partner already have the foundation that allows us to execute rapidly on a companion Dx and match the pace of your drug.
Our experience over many successful partnered R&D and product development partnerships has led to the understanding that a clear and flexible Product Development Process (PDP) provides optimized time- and cost-to-market for companion diagnostics.
In order to achieve this, our PDP focuses on four key areas of partnering to maximize success:
- Agile technology selection
- Project management
- Partner process integration
- Commercial alignment
Agile Technology Selection | With a broad portfolio of assay chemistries, bioinformatics and platform access, we help you match the right technology for the right outcome. Our modular product design approach has created ready-to-use, off-the-shelf, pre-validated kit components that can be rapidly adapted to your specific needs.
Project Management | Experience dictates that success is driven through direct ownership and project focus. Your project will be staffed with a dedicated team that will include a proven, IVD-experienced project manager, highly qualified scientists, manufacturing, quality and regulatory personnel to ensure the highest standards are integrated into the planning and delivery of the device, in accordance with guidelines and regulations specific to your product development plan.
Partner Process Integration | We take a consultative approach to product development from concept through commercialization, creating defined but flexible touchpoints to ensure product design requirements, development timelines and analytic performance meet the specific needs of your project. We develop process maps that clearly define specific tasks and owners in order to ensure clarity of accountability at all stages of discovery, development and deployment.
Commercial Alignment | As we partner with your commercial organizations to optimize your product, we also drive a rigorous product launch readiness process that ensures development-thinking also incorporates commercial and market readiness requirements. We focus our readiness preparation on 4 major areas:
- KOL engagement planning
- Reimbursement planning
- Health Economic Outcome Research (HEOR) study development
- Marketing readiness