Biomarker and CDx Strategy
Biomarker testing has become increasingly complex over the past 5 years.
Biomarker testing has become increasingly complex over the past 5 years: not just single biomarkers, but signatures / panels; not just genomics, but proteomics, and metabolomics; not just once during the patient journey, but several times throughout it.
Today, biomarker testing not only requires a strong molecular biology and pathology skill-set, but also access to sophisticated bioinformatics systems.
Oncology has paved the way, cementing biomarker testing into standard of care and pushing science and analytical / technical capabilities forward. However, other therapeutic areas such as CNS, auto-immune and infectious diseases are poised to follow the same precision medicine track.
Numerous challenges remain for the realization of diagnostics-enabled precision medicine across therapeutic areas: how can we ensure complex biomarkers can be routinely assessed in practice across markets, despite heterogeneous testing practices and dynamics? How will payer systems adapt to cover increasingly high testing costs, far beyond the “$50 per test per patient” concept of the past?
Pharma and Dx companies must address these complex questions to truly deliver on the promises of Precision Medicine, and our belief is, that they will need to reevaluate how they partner together to be successful.
01. Biomarker / Dx Market Understanding
- Testing & technology landscape assessment
- Assessment of novel technologies (e.g., AI-based)
- Tissue & testing journey
02. Dx Partnership Strategy
- Guidance to select and partner with Dx companies
- Operating model design to maximize success
03. Regulatory Strategy
- Country-specific regulations & requirements
- Regulatory and HTA readiness
- Impact of IVDR on EMA label
04. Access and Reimbursement
- Assessment of funding / reimbursement mechanisms
- Gap analysis on evidence requirements
- Driving access to complex, high-priced tests
- Guidance for Payer engagement
05. CDx/Dx Go-to-Market Strategy
- Lab/test model per market
- Driving testing on a market-by-market level
- Stakeholder engagement and education