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.

Projects in This Space

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

Case Studies

CDx Go-to-Market Strategy & Implementation Plan+

Leading pharma wanted to develop their drug-CDx go-to-market strategy to ensure high testing rates at launch.

Bionest validated the testing journey and lab dynamics, and aligned the company behind strategic pillars for a successful CDx launch.

Company rolled out the archetype model & CDx launch implementation plan globally.

Reimbursement & Access Strategy for a Novel NGS Biomarker+

A top-5 pharma preparing to launch a therapy with a NGS-based biomarker wished to evaluate the reimbursement and access potential across 17 markets.

Bionest evaluated the landscape in detail, identified funding mechanisms, and developed country-specific recommendations to maximize access.

Company deployed the global strategy with each country / regional teams.

Prioritization of Biomarker and Diagnostic Technologies in Immuno-Oncology+

A leading biopharma company was looking to strengthen its understanding of the current and future Biomarker, Diagnostic and Technology landscape within Immuno-Oncology to determine “where to play” in the longer term and inform their Precision Medicine strategy.

The Bionest team developed a comprehensive and detailed understanding of the future IO Diagnostics landscape, looking at the most disruptive and emerging biomarkers and technologies.

The Bionest team further performed a strategic evaluation of the fit between our client’s current strategy in Immuno-Oncology and the identified biomarker and Dx technology opportunities.

Strategic Evaluation of an Oncology IO Dx Start-Up+

A pharma company was considering partnering with a start-up Diagnostic company developing, in oncology, an artificial intelligence-based Diagnostic platform. Our client was looking for a strategic evaluation of the company, its product, and its go-to-market strategy (incl. business plan & business model).

The Bionest team evaluated the product positioning in the Diagnostic market in Immuno-Oncology, assessed the revenue opportunity for the AI-based IO Dx platform, challenged the go-to-market strategy (timeline and costs), and shared strategic recommendations.