Abstract

Identification of biomarker and validation of biomarker-based tests is an urgent task and an essential prerequisite for the development of disease modifying therapies. Robust and reliable biomarkers, even panel of multimodal biomarkers, are needed to support decision making at various stages from drug discovery up to different phases of drug development including clinical trials:
- Pharmacodynamic, efficacy and target engagement biomarkers
- Stratification biomarkers to support the identification of a target patient population
- Alternate tissue or pathway read-outs (surrogate biomarkers)
- Safety biomarkers to monitor toxicity
Evotec has a longstanding experience in applying various techniques and technologies to support biomarker studies in any type of cell, tissue or animal model to confirm that drugs achieve the right exposure, hit the desired target and generate a pharmacological response.
We have established a wide portfolio of robust and reliable immunoassays and imaging tools to investigate changes in neurodegenerative biomarker levels such as Huntington protein. We have applied such assays to monitor disease progression in pre-clinical and clinical samples, including assessment in biofluids such as CSF. These assays are valuable tools to support current therapeutic approaches targeting lowering of misfolded and aggregated proteins.