Advancing Neurology Clinical Development

Due to the complexity of neurology / CNS clinical trials, successful execution requires careful planning, the right technology, bioinformatics expertise, and a disciplined clinical approach. We support neurology therapeutic development with over 25 years of experience designing and executing neurology and CNS clinical trials, particularly in the orphan disease space.

At Precision, we incorporate advances in neurology biomarkers and biomarker detection technology to build a robust multi-parameter biomarker strategy for therapeutic development.

Advancing Neurology Clinical Development

Due to the complexity of neurology / CNS clinical trials, successful execution requires careful planning, the right technology, bioinformatics expertise, and a disciplined clinical approach. We support neurology therapeutic development with over 25 years of experience designing and executing neurology and CNS clinical trials, particularly in the orphan disease space.

At Precision, we incorporate advances in neurology biomarkers and biomarker detection technology to build a robust multi-parameter biomarker strategy for therapeutic development.

Advanced and novel biomarker detection platforms for neurology / CNS clinical trials

In addition to many standard biomarker detection and analysis platforms (eg, flow cytometry, ELISA), Precision utilizes state-of-the-art and proprietary technology platforms to enable detection of the most relevant and actionable neurology biomarkers.
  •  Quanterix® SIMOA® platform to detect low-level, blood-based, CNS-derived biomarkers to monitor neuronal pathophysiology including proteinopathies.
  •  Epiontis ID™, our proprietary epigenetic qPCR-based technology for fluid-based immune cell monitoring and immunophenotyping. Epiontis ID, which has several advantages over flow cytometry, has been successfully utilized to enable clinical studies in neurology, including in multiple sclerosis.
  •  QuartzBio™, proprietary solutions that enable multi-parameter, multi-omic approaches to biomarker discovery and development. QuartzBio can harmonize and support the analysis of biomarker data from multiple sources and assay types while utilizing computational biology approaches to extract insight and value – including the identification of biomarker patterns correlating with disease subtypes and progression.
  •  Neuron-Derived Exosomes (NDEs), which are isolated from patient blood, provide a non-invasive means to monitor neuronal physiology and pathophysiology. NDEs are amenable to standard downstream biochemical assays to facilitate the identification and validation of novel diagnostic, prognostic, and predictive biomarkers.

Developing a comprehensive biomarker strategy for neurology therapeutic development

Over 25 years of experience designing and executing neurology / CNS clinical trials

Precision delivers end-to-end, biomarker-driven clinical trial execution: Rapid study startup, integrated biomarker strategies, and full-service complex global clinical trials – all to accelerate the path to market for emerging and mid-stage biopharma companies in the United States, European Union, and Asia Pacific. What makes Precision unique are the scientists, clinicians, and operational experts dedicated to biomarker-driven clinical development.

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Expertise in supporting gene therapy-based neurology therapeutics

Successfully bringing a gene therapy to market requires a deep understanding not only of the science, but also of the specific regulatory needs unique to gene therapies. Precision provides end-to-end solutions to support development of gene therapy products.

  • Leadership in regulatory strategy
  • Gene therapy-specific assay design and execution
  • Specialization in immunogenicity studies
  • Excellence in rare and orphan disease trials (awarded Best Orphan Drug CRO for 2 consecutive years)
  • Expertise to effectively coordinate both a therapeutic and companion diagnostic strategy in parallel

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Case Study: Development of a biomarker strategy for ALS

Amyotrophic Lateral Sclerosis (ALS) can be broken down into three major underlying pathology components: neurodegeneration, inflammation, and neuromuscular dysfunction. At Precision, we’ve developed a strategy covering diagnostic/predictive and pharmacodynamic/prognostic biomarkers for each of these three disease components. In the hypothetical case shown here, the therapeutic is a gene therapy and neuron-derived exosomes provide a unique means for assessing target engagement by quantifying the gene product’s neuronal expression level.

Epiontis ID, a Precision-developed technology for immunophenotyping, is also useful for assessing whether a therapeutic modulates the altered immune cell profile associated with ALS.

Discover how our neurology / CNS expertise can advance your clinical development program

Discover how our neurology / CNS clinical trial expertise can advance your clinical development program

Services supporting clinical development of neurology / CNS therapeutics

Clinical Trial Design

Advanced trial-design approaches-including basket, umbrella, and adaptive trials-deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.

Bioanalytical Testing

Bioanalytical analysis of biologics, cell therapies, gene therapies, and companion diagnostics development from the globally-recognized leaders in immunogenicity testing.

Computational Biology

From patient stratification to signature development, predictive modeling of drug response to preclinical modeling, characterizing the MOA to selecting the co-therapeutic target pathway, our scientists accelerate and expand insights.