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DISCOVERY METABOLOMICS

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Enabling a deeper understanding of drug mechanisms and supporting the development of new therapeutics.

  • Identify New Biomarkers
  • Discover Novel Drug Targets
  • Improve Drug Efficacy

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Metabolomics Applications Across Drug Development Stages

Metabolomics offers unique insights that enhance your understanding of drug targets, optimize development processes, and increase the likelihood of regulatory approval. Below are examples of how metabolomics benefits each stage of the drug development lifecycle.

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Discover New Biomarkers and Accelerate Drug Development

Metabolomics data can help accelerate drug development pipelines by providing deep insights into disease mechanisms, identifying novel drug targets, and uncovering biomarkers linked to specific conditions. By exploring associated metabolic pathways and metabolites, metabolomics helps you narrow down potential drug targets, prioritizing your time and effort on the most likely effective therapeutics. This approach shortens the timeline from discovery to clinical testing and improves the chances of successful therapeutic outcomes.

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Minimize Clinical Risk 

Untargeted metabolomics has become more accessible and affordable due to advancements in high-throughput technologies like mass spectrometry and chromatography. These innovations have made it easier to analyze complex metabolic profiles. Instrumentation has become more powerful and data analysis tools more efficient, allowing researchers from diverse fields to adopt this approach. This increased accessibility has expanded the use of untargeted metabolomics, enabling more studies to explore the full range of metabolites in biological systems with greater speed and accuracy. This expansion has including using metabolomics in multiomics research as well, complementing other omic technologies such as genomics, transcriptomics, and proteomics. By integrating metabolomics with these approaches, researchers gain a more comprehensive understanding of biological processes and their interactions in health and disease.

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Improve Drug Effectiveness 

Metabolomics enhances efficacy testing by providing insights into a drug’s broader biological effects over time. Through longitudinal studies, metabolomics data can inform optimal dosage levels, treatment regimens, and pharmacodynamic profiling to help determine better candidate selection for therapeutic treatments. Metabolomics enables you to refine drug design, enhance patient outcomes, and ensure your drug works as effectively as possible across different populations and conditions.

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Enhance Regulatory Approval and Market Access

Metabolomics data is pivotal in supporting FDA submissions and other regulatory reviews. By demonstrating a comprehensive understanding of a drug’s impact on biological systems, metabolomics reduces the perceived risks of your drug and strengthens the case for market approval. Routine metabolomics profiling also signals a commitment to quality and patient safety, increasing the likelihood of regulatory success and accelerating your drug’s entry to market.

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Support Across the Pipeline

Metabolomics can be applied throughout the drug development pipeline to uncover biomarkers, monitor drug efficacy and toxicity, gain insights into disease mechanisms, and more.

Discovery and Development

Metabolomics accelerates the discovery process by supporting identifying drug targets, uncovering mechanisms of action, and discovering biomarkers that inform drug candidate selection. Incorporating pathway mapping early in the workflow can reveal critical metabolic associations that inform therapeutic development and de-risk decision-making at an early stage by providing additional pharmacodynamic insights before reaching preclinical testing.

Preclinical Research

During preclinical studies, metabolomics data informs the safety and efficacy of a potential drug through toxicology profiling and ADME (absorption, distribution, metabolism, and excretion) analysis in animal models. These insights provide predictive data, inform effective dosages and risk tolerances, and help ensure that only safe and effective compounds progress to clinical trials.

Clinical Trials

Metabolomics supports clinical trials by enabling patient stratification, evaluating safety and efficacy, and monitoring metabolic changes over time through longitudinal testing. These applications improve trial success rates and provide actionable data for diverse patient populations.

Patient Stratification

Metabolomics enables patient stratification by generating comprehensive metabolic profiles, allowing for more effective grouping of patients for improved trial design. Metabolic markers can also be monitored longitudinally to understand drug response and identify adverse effects, increasing the overall safety of the drug and enhancing trial success rates.

FDA Review

Data generated by Metabolon has been included in regulatory submissions to enhance their quality. Our adherence to ISO 9001:2015 standards and CLIA and CAP certifications ensures the highest data quality and signal clinical and regulatory standards were met during our involvement with the project. We provide detailed, accurate documentation that can be seamlessly integrated into FDA reviews, helping streamline the acceptance process.

Safety Monitoring

Post-approval, metabolomics plays a vital role in monitoring long-term safety through population health studies and drug impact assessments. These longitudinal analyses detect unforeseen metabolic effects, ensuring ongoing efficacy and safety.

Drug Manufacturing

Metabolomics enhances bioprocessing by analyzing growth media and optimizing cell culture conditions, including biosimilar manufacturing. These insights improve upstream and downstream processes, reduce costs, identify contaminants, and shorten yield times. Ultimately, metabolomics ensures consistent therapeutic quality, maximizes yield, and drives efficiency across manufacturing operations.

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“Metabolon has developed a solid, scalable solution to the non-trivial problem of metabolomics biochemical interpretation, specifically tailored to their world-leading data acquisition platform. Leveraging decades of experience in data curation, Metabolon provides intuitive visualization tools for pathway analysis and disease association, adding even more value to an already outstanding product.”

David Broadhurst, PhD
Professor of BioSystems Data Science at Edith Cowan University, Australia.

Featured Resources

Explore how metabolomics can impact drug discovery pipelines in our featured resources below, or click here to view more.

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Drug Target Tools eBook

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Advancing Drug Discovery with Metabolomics Webinar

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Metabolomics for Pharmaceutical Applications Volume 1

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