Deep Insights to Guide Clinical Drug Development, Trial Design & EvaulationClinical Drug Dev_web_graphic_transparent bkgd.png

Clinical failures continue to plague pharmaceutical and biotechnology companies. Drug development is a risky, complex process; just 12 percent of drugs entering clinical trials ever make it to patients. Thousands never make it past the early discovery and preclinical testing stages. Despite the inherent risks and challenges, biopharmaceutical researchers know that the reward is to discover safer, innovative medicines that improve the lives of patients.

Precision Metabolomics is a valuable health assessment technology for pharmaceutical and biotechnology researchers once drug candidates reach clinical development phase and beyond.

In the clinical stage of the process, having confidence in target engagement, dose and patient population are key elements of success. In many instances, accepted endpoints or biomarkers omit important pieces of information that lead to blind spots in decision-making.

Metabolomics is a powerful -omics science that provides comprehensive characterization of metabolites in any biological system. Unlike genomics, metabolomics measures phenotype, which reflects both the impact of genes and external influences such as the action of a pharmaceutical.

Metabolism is a key component across nearly every indication area including cardiovascular, diabetes, obesity, cancer, autoimmune and inflammatory, aging, neuroscience and the microbiome. Precision Metabolomics evaluates changes across the whole of metabolism with accuracy and precision to advance Phase 1 through 4 clinical drug development and post-approval research and monitoring.

The comprehensive and meaningful assessment of the molecular phenotype supports informed decision-making across the pharmaceutical R&D continuum. Our powerful technology is increasingly used not only in the process of bringing a pharmaceutical successfully to market, but also in precision medicine.

An Asset for Answering Key Clinical Questions

Metabolomics is being applied successfully across clinical drug development, including post-marketing surveillance.

  • Early Clinical Development
    • Assess of target engagement, dose effects & safety
    • Develop more informative biomarkers for PK/PD modeling
  • Later-Stage Clinical Development & Clinical Trials
    • Assess efficacy — individual, subset & group
    • Identify responders and non-responders
    • Delineate baseline characteristics
    • Assess dose, drug concentration, & relationships to response and disease interaction
    • Assess safety
      • Individual patient changes
      • Individual clinically significant abnormalities
    • Study quality
      • Study site issues
      • Individual compliance
      • Metabolic outliers
  • Post-Marketing Surveillance
    • Develop clear differentation

Metabolomics, Lipidomics & Targeted assays

Metabolon offers a range of metabolomics solutions to accelerate clinical drug development:

  • Precision Metabolomics offers a comprehensive, global coverage of metabolism, identifying on the order of 1,000 metabolites in a sample with exquisite precision.
  • If analysis of complex lipids is indicated, we have the capability to quantitatively measure more than 1,100 complex lipids with our Complex Lipid Panel™ and offer related lipid analysis tools.
  • We provide 150 off-the-shelf targeted assays involving over 250 metabolites and the capability to rapidly develop novel, customized, sensitive assays to verify and validate discovery and/or for use in clinical trials. We have particular expertise in the development of metabolite biomarker panels.

Prior to a drug candidate advancing into clinical development, metabolomics can help with preclinical development, too.