What separates translational biomarkers that reach the clinic from those that fail? Strategic alignment of discovery, clinical development, and regulatory requirements. Evotec's platform provides end-to-end support across therapeutic areas through collaboration with 80+ experts.
Download our factsheet to learn how we design IND-ready approaches that de-risk development.
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Why Translational Biomarkers Matter in Clinical Development
Biomarkers, measurable biological parameters, such as protein expression, genetic mutations, or metabolic markers, reveal how the body responds to diseases and treatments.
In clinical settings, translational biomarkers:
- Support disease diagnosis
- Help customize treatment, i.e., precision medicine
- De-risk therapeutic drug development by providing proof of mechanism and target engagement
- Guide safe and effective drug dosing and use through pharmacodynamic monitoring
- Stratify patient populations to identify patients likely to respond well to a therapeutic
Therefore, translational biomarkers provide better precision treatments and objective decision-making, increasing the overall value to the health care system. An end-to-end clinical biomarker strategy defines regulatory requirements to move novel biomarkers from discovery to medical practice.
Build Your Translational Biomarkers Strategy with Evotec
Evotec’s Translational Biomarker Strategy Platform empowers clinical and regulatory success by designing and implementing tailored, clinically meaningful biomarker solutions.
Through scientifically robust and indication-relevant methods, the platform ensures that biomarkers effectively support decision-making across the entire development continuum (Figure 1).
Figure 1. Evotec’s Translational Biomarker Strategy
Evotec’s Translational Biomarkers Strategy Platform provides comprehensive, end‑to‑end support for the design, selection, and implementation of biomarkers from early research through clinical validation. The approach ensures that biomarker selection remains tightly aligned with therapeutic intent, clinical strategy, and regulatory expectations.
Evotec’s biomarker strategy encompasses the following capabilities:
- Unified framework
- Connects discovery research, assay development, and clinical deployment to guarantee that biomarker strategies remain coherent across all development phases and directly support program decision‑making
- Leverages both targeted and untargeted methodologies
- Uncovers and validates biomarkers across multiple categories, including drug‑related markers, pharmacodynamic readouts, and patient stratification or enrichment biomarkers
- These capabilities enable the identification of biologically meaningful markers that support mechanism elucidation, optimize dose selection, and refine patient stratification
- Integrated biological and clinical data
- The platform provides evidence‑based recommendations to define optimal therapeutic indications, identify relevant patient segments, and propose appropriate clinical positioning
- Connects teams with a network of specialists
- Scientists, clinicians, and histopathologists ensure that biomarker strategies remain clinically relevant, operationally feasible, and aligned with real‑world translational needs
Execute Your Translational Biomarker Plan With Evotec: Our Biomarker Capabilities
Evotec’s Translational Biomarker team partners with you from early biomarker discovery through clinical validation to ensure your program is positioned for translational success. Our fully integrated approach brings together biomarker experts, clinicians, and pathologists who provide scientific continuity across all stages of development.
Thanks to strategic collaborations with clinical centers for prospective sampling of human samples, Evotec provides access to diverse, clinically relevant human samples to deliver biomarker validation in physiologically relevant contexts.
Figure 2. Evotec’s Translational Biomarker Capabilities
Evotec delivers high-sensitivity translational biomarkers that power your program from early discovery through clinical application, enabled by our cutting-edge operational platforms, including, among others:
- Molecular Biology
- Proteomics & metabolomics
- High-sensitivity immunoassays
- Flow cytometry
- Histology
- Biomarker testing in clinical samples (in GCP and/or non-GCP environment)
Case Study: Integrated Translational Biomarker Strategy From Discovery to First-In-Human
Evotec guided a comprehensive biomarker strategy to identify, develop, validate, and translate innovative biomarkers from early discovery to Phase 1 clinical trials (Figure 3).
Evotec provided an end-to-end continuum of biomarker support to:
- Define a robust strategy to assess target engagement and confirm the mechanism of action (MOA) through translational biomarker assays
- Propose a stratification biomarker to support patient characterization
- Validate and translate selected biomarkers in tumor and blood samples from cancer patients to ensure readiness for Phase 1 clinical evaluation
Figure 3. Biomarker identification, target engagement, and patient stratification
Why Partner with Evotec for Translational Biomarkers
Evotec scientists work alongside your team as strategic partners on stand-alone projects, integrated discovery programs, and clinical biomarker development. We bring proven translational strategies developed over 10+ years, combining deep expertise with honest scientific guidance. We also provide access to expert consultancy supported by our global network of clinical Key Opinion Leaders (KOLs).
Our collaborative approach aligns discovery, clinical development, and regulatory requirements to create tailored biomarker packages, indication selection support, and IND-ready assay plans across therapeutic areas and modalities.
Our Scale and Expertise:
- 80+ experts dedicated to translational biomarkers
- 20+ translational biomarker strategy requests annually across therapeutic areas
- 15+ biomarker plans under evaluation each year from discovery through clinical validation
- 40+ validated methods supporting Phase I clinical trials
In one place, we provide:
- Strategy, sample access & advanced platforms in one place
- Global regulatory submissions to ensure full traceability and compliance
- Clinical development support spanning clinical study design, regulatory strategy, and clinical trials
To learn more about how we design IND-ready approaches that de-risk development, you may download our factsheet.
Ready to advance your biomarker strategy?
Contact our translational biomarkers team to discuss how Evotec can support your projects in Precision Medicine.
