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If disease-modifying therapies for conditions such as Huntington’s disease are to become reality, clinicians and researchers need validated biomarkers. Different biomarkers will be required to monitor disease development (or regression) in the clinic, and to support decision-making in the drug development process. For example, biomarkers can identify:
- Pharmacodynamic, efficacy and target engagement
- Stratification within a target patient population
- Alternative tissue or pathway read-outs (surrogate biomarkers)
- Toxicity events
Evotec has a wide portfolio of robust and reliable immunoassays to investigate changes in neurodegenerative biomarker levels, including the Huntingtin protein (HTT). Evotec’s assay detects mutant HTT proteins in the cerebrospinal fluid of patients with Huntington’s disease, and is sensitive enough to detect decreases in mutant HTT after the administration of an HTT-lowering agent in phase II trials.
This webcast will focus on the establishment of this high-sensitivity immunoassay to detect mutant HTT. The speakers will discuss its performance across several assay platforms, and how to validate it using Good Laboratory Practice. This HTT immunoassay is part of Evotec’s longstanding practice of supporting biomarker assessment in cells, tissues or animal models, in order to confirm that drugs achieve the right exposure, bind the desired target and generate a pharmacological response.
· What critical steps are needed to establish robust biomarker assays?
· What are the challenges of moving biomarker assays from a research grade non-GLP laboratory to a clinical-grade GLP laboratory?
· What are the best ways to plan validation assessments and set related acceptance criteria, following regulatory guidelines, in order to analyse a pivotal clinical-efficacy biomarker?
Evotec SE, Germany
Aptuit Srl, an Evotec Company, Italy