Biomarker Strategy and Identification

We combine scientific consultancy, laboratory capabilities, clinical research expertise and statistical analysis to support biomarker programmes from identification and selection all the way through to laboratory analysis and clinical application. 

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From Biomarker Complexity to Decision-Ready Evidence

Biomarkers can provide critical insight into disease biology, treatment response and pharmacodynamic effects, but their value ultimately depends on selecting the right biomarkers, measuring them effectively and understanding how the results fit within the wider development programme.

We combine scientific consultancy, laboratory capabilities, clinical research expertise and statistical analysis to support biomarker programmes from identification and selection all the way through to laboratory analysis and clinical application. 

Whether you are starting with a biological question, assessing potential candidate biomarkers, developing an assay or integrating biomarker assessments into an existing clinical study, we bring all the relevant expertise together within a single organisation. 

Turn biomarker complexity into clear evidence that supports better-informed decisions.

Talk to our Biomarker Team Today

A Biomarker Strategy Built Around Development Questions

A strong biomarker strategy begins with the development question and the evidence needed to answer it.

Biomarker analysis can help test and validate whether a drug's recognised mechanism of action is supported by direct or indirect biomarker evidence, while also providing useful insight into treatment response, efficacy, safety, and patient stratification.

Depending on the programme, biomarker analysis can provide evidence around:

Target Engagement

Assess whether an intervention is interacting with its intended biological target.

Mechanism of Action

Use biomarker evidence to test and support the proposed biological mechanism through which a treatment is expected to act. 

Pharmacodynamic Response

Measure biological changes following treatment and assess their relationship to exposure or intervention.  

Patient Stratification

Help identify or characterise patient or participant populations based on relevant biological characteristics.

Treatment Response

Investigate biological responses associated with treatment and variation between individuals or groups. 

Disease Biology

Characterise biological or immune responses associated with disease or therapeutic intervention. 

From Biomarker Strategy to Clinical Evidence

We support multiple stages of the biomarker journey, bringing together strategy, laboratory analysis, clinical study integration and data interpretation.

From the initial biological question to the right biomarkers

We can support:

  • Scientific and literature review
  • Identification of candidate biomarkers
  • Biomarker selection and prioritisation
  • Assessment of biological rationale and relevance
  • Consideration of intended use
  • Selection of appropriate samples and analytical approaches
  • Development of a programme-specific biomarker strategy

If you already have a biomarker strategy, we can also support you further along the pathway, including assay development, testing, or clinical implementation.

Turning biomarker strategies into measurable data

Depending on the biomarker and project requirements, we can support:

  • Assay selection
  • Assay development and optimisation
  • Technology or assay transfer
  • Biomarker sample analysis
  • Fit-for-purpose analytical validation using a phase-specific approach aligned to the intended context of use

Potential analytical approaches include ELISA, multiplex cytokine analysis, ELISpot and FluoroSpot, cellular and functional assays and PCR/qPCR. Where specialist analysis is not available in-house, we can coordinate and oversee external biomarker testing.

Planning biomarker assessments alongside the wider study

Biomarker assessments must work within the practical and scientific requirements of the clinical study, rather than being seen solely as separate laboratory measures.

We can assess:

  • Patient or volunteer populations
  • Clinical endpoints
  • Sample type and volume
  • Sampling time points
  • Sample collection and handling
  • Study design
  • Pharmacodynamic assessments
  • The relationship between biomarker changes and clinical outcomes

Considering these factors early helps ensure biomarker sampling is practical, relevant and aligned to the wider study.

Putting biomarker data into the context of the study

Depending on the programme, we can support:

  • Statistical analysis
  • Correlation and association analysis
  • Longitudinal biomarker analysis
  • Comparison of biomarker responses between groups
  • Analysis against clinical endpoints
  • Integration with clinical trial data
  • Biological and clinical interpretation

This connects biomarker measurements with clinical outcomes, pharmacodynamic responses and wider development questions.

Designing Biomarkers into the Study

Ultimately, a biomarker strategy is only as useful as the data it produces.

Sample type, collection timing, processing requirements, sample volume and assay methodology can all influence the quality and interpretability of biomarker data. These factors should therefore be incorporated into the study design from the outset.

Our clinical and laboratory expertise can help align these factors below. This integrated approach reduces avoidable complexity, improves overall study feasibility, and generates biomarker data more closely aligned with the decisions the programme needs to make.

01

Biomarker Identification

02

Clinical Study Design

03

Assay Development and Validation

04

Integrated Sampling

05

Processing and Analysis

06

Endpoint

07

Statistical Analysis and Reporting

Biomarker Capabilities

We support biomarker programmes across areas including:

Immunological biomarkers

Immune responses and changes associated with disease or therapeutic intervention.

Inflammatory biomarkers

Inflammatory pathways and biological responses relevant to disease and treatment.

Cytokines and chemokines

Soluble mediators involved in immune and inflammatory responses.

Infectious disease biomarkers

Biomarkers associated with infection, disease biology, and response to intervention.

Biomarkers Across the Development Programme

Biomarker needs can change as a therapeutic programme progresses. Early research may focus on disease biology and on identifying potential biomarkers, while clinical development may require appropriate biomarker selection, assay implementation, sampling strategies, and an assessment of biomarker responses alongside clinical outcomes. 

Our integrated model considers biomarker activities across all phases of drug development, helping maintain continuity between scientific rationale, laboratory measurement, and clinical application. 

Why Choose hVIVO for Biomarker Strategy & Identification?

Samples need to reach the relevant processing laboratory within the required timeframe. hVIVO works with sponsors to develop sample collection and transport workflows tailored to study requirements rather than relying on a fixed geographic radius.

  • Integrated expertise: Consultancy, laboratory, clinical and statistical expertise are brought together within a single organisation.
  • Translational perspective: We consider biomarkers not just as laboratory measurements, but in the context of the clinical development programme they support.
  • Clinical integration: We look at the biomarker strategy alongside the overall study design, sampling, endpoints and other clinical assessments.
  • Flexible approach: We tailor our approach to the sponsor’s therapeutic programme, scientific questions, existing biomarker strategy and development objectives.
  • Fewer hand-offs: We coordinate strategy, laboratory analysis, clinical implementation and data interpretation through an integrated delivery model.
  • Decision-focused: We generate biomarker evidence that’s designed to help you understand biological responses and make more informed development decisions.
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FAQ

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A biomarker is a measurable characteristic that provides information about a biological process, disease state or response to intervention. 

Biomarkers can provide useful insight into disease biology, mechanism of action, pharmacodynamic response and treatment effects, helping inform drug development decisions. 

A biomarker strategy defines how biomarkers will be identified, selected, measured and interpreted to answer specific scientific and clinical questions within a development programme. 

A preclinical biomarker may be used to investigate disease biology, target engagement or treatment response before clinical development. A clinical biomarker is evaluated in human studies and may support pharmacodynamic assessment, patient selection, treatment response, or other clinical development objectives.

Yes, hVIVO can support biomarker identification and selection, depending on the programme and scope of engagement. 

hVIVO can support assay selection, development, optimisation, transfer and analytical validation, depending on the biomarker and project requirements.

Potential sample types include whole blood, plasma, serum, PBMCs, as well as other specialist sample types depending on the specific biomarker and analytical method used. 

Yes. Biomarker sampling can be considered alongside study design, sample collection, sampling timepoints, clinical endpoints and other study requirements. 

Depending on the project, hVIVO can support statistical analysis and assess the relationships between biomarker data and clinical study information. 

Yes! hVIVO can support programmes where biomarkers have already been selected, and the sponsor requires assay development, laboratory analysis, clinical implementation or other support.

Planning a Biomarker Strategy?

Whether you’re identifying candidate biomarkers, developing an assay or planning how biomarkers should be incorporated into a clinical study, hVIVO can help connect the scientific, laboratory and clinical considerations.

Talk to our Biomarker Team Today

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