Biopharma Solutions

Metabolomics Solutions for Clinical Drug Development Workflows

Metabolomics is enabling the next wave of new, innovative therapeutics. By unraveling complex interactions between biological processes and the environment, metabolomics is improving clinical trial design and efficacy to bring more life-saving drugs to market faster.

Failed Clinical Trials Cost You Time and Money

Clinical trials require significant financial investment and time commitment. Although they are necessary for drugs to reach patients, a large proportion of clinical trials fail. These failures raise the overall cost of executing clinical trials and delay the arrival of drugs to the market, which means patients must wait longer for the drugs they need and pay more for them when they are finally able to get them.

Metabolon’s Panels and Single Analyte Assays Deliver the Insights You Need

Better insights mean fewer failures. With Metabolon’s targeted and custom panel development, you’ll gain unprecedented metabolomic insights into the impact and mechanism of action of your drug. Use these insights to develop a clinical trial protocol designed to maximize the chances of success.
Metabolon’s Panels and Assays Deliver the Insights You Need
A Clearer Understanding of your Drug’s Mechanism of Action (MoA)

A Clearer Understanding of your Drug’s Mechanism of Action (MoA)

Metabolomics can help clarify your MoA faster by providing deep and unparalleled insights:

  • Correlate changes in levels of highly annotated biochemicals with all other MoA and mechanistic data from your trial, from mid-translation through NDA submission
  • Reveal pleiotropic effects from a majority of targets, including kinases, receptors, apoptosis factors, and immune modulators
  • Provide a unique and comprehensive view of biochemical pathways to identify alterations that directly influence outcomes

See how Metabolon can advance your path to preclinical and clinical insights

Direct Evidence of Real-time Phenotypic Response

Metabolomics can clarify ambiguities by letting you see the comprehensive effects of your drug in patients:

  • Measure small-molecule biomarkers that are the result of a real-time response to your drug
  • Provide deeper insights into precise biomarkers and MoA for disease instead of broad enzymatic activity that regulates a class of molecules
  • Understand systemic alterations from drug treatment, providing a multi-organ snapshot of the effects of your drug in each patient
Clarify Real-time Phenotypic Response
Reduce Noise with A Chemocentric Approach

Reduce Noise with A Chemocentric Approach

Metabolon Discovery: Global Panel leverages market leading technology and the world’s largest biochemical reference library to quickly deliver quality insights.

Our chemocentric approach rapidly and efficiently removes noise and positively identifies metabolites. Our proprietary technology compares the generated data against our extensive metabolite library to isolate relevant metabolites in a matter of minutes. The result is accurate, reproducible, and actionable data delivering a higher resolution and quality beyond what’s possible with traditional ion-centric approaches.

Consultative Expertise

We are with you every step of the clinical trials process, from protocol development to regulatory submission. Each project begins with a scientist-to-scientist consultation to determine your panel needs, including regulatory requirements and project timeline. We explore how to best meet your needs through existing panels, custom-developed panels, or a combination.
Consultative Expertise
Metabolon Provides Solutions for Every Stage of Drug Development

Metabolon Provides Solutions for Every Stage of Drug Development

Drug development is a lengthy process comprised of multiple steps, each with its own challenges and requirements. Metabolon has a solution for every step along the way.

  • Cast a wide research net with our Global Discovery Panel, which enables the identification of 5400+ metabolites across 70 major biochemical pathways.
  • Once you’ve identified candidate biomarkers, use pre-developed or custom-targeted panels that deliver absolute quantification for research and biomarker applications.

We are ISO 9001, CAP and CLIA certified and can adhere to GCP/GCLP, where needed—so you can advance your biomarkers through clinical trials and commercial diagnostic testing.

Full Adherence to Research and Clinical Regulations

Utilize Metabolon’s suite of tools without worry—we are fully compliant with a range of research and clinical regulations:

  • All services and products adhere to ISO 9001:2015 standards.
  • Targeted panels, including custom targeted panels, can be developed and validated to GCP/GCLP standards for Phase I-III clinical trials.
  • Metabolon’s clinical diagnostics tests, such as the Quantose™ Insulin Resistance test, adhere to CLIA, CAP, and New York State CLEP to support patient testing and clinical diagnostics.

We are ISO 9001, CAP and CLIA certified and can adhere to GCP/GCLP, where needed—so you can advance your biomarkers through clinical trials and commercial diagnostic testing.

Full Adherence to Research and Clinical Regulations
“Metabolomics is clearly linked to genotype and, more interestingly, to phenotype. It allows a unique view of the relationships among genes, gene expression, environments, lifestyles, microbiomes, treatments, and pathologies.”2

WILLETTE ET AL. 2021

How Metabolon Helps Improve Trial Design and Supports Trial Success

Channeling the Power of Metabolomics to Navigate Uncharted Regulatory Pathways for Microbiome Therapeutic Development

When an investigational microbiome therapeutic for preventing C. dificile

recurrence, SER-109, failed Phase II clinical trials, the company had to rethink its clinical trial design.

Using the Metabolon Discovery: Global Panel, the company was able to develop a more efficacious dosing strategy and redesign their clinical trial strategy. The troubleshooting worked—the Phase III clinical trial for SER-109 was a success. The company used Metabolon’s Good Clinical Practice (GCP)-validated targeted metabolomics panels to demonstrate mode of action and dose response of SER-109 during the trial.

Read the case study

Differentiating Drug Responders and Non-Responders to Develop Precision Medicine Approaches for Treating Pulmonary Arterial Hypertension (PAH)

A pharmaceutical company has been working on therapeutic approaches to treat pulmonary arterial hypertension (PAH), a multifactorial disease affecting numerous metabolic pathways. Precision medicine approaches to treat this disease are attractive but challenging.

The company used Metabolon to uncover unique serum metabolomic profiles between drug responders, drug non-responders, and placebo responders. The company used this responder metabolic fingerprint to bolster their recruitment process, reduce phase III trial dropout rates, and get one step closer to precision medicine treatment for PAH.

Read the case study

Interested in Further Studies?

Why Metabolon?

Once you see the full value of metabolomics, the only remaining question is who does it best? While many laboratories have metabolite profiling or analytical chemistry capabilities, comprehensive metabolomics technologies are extremely rare. Accurate, unbiased metabolite identification across the entire metabolome introduces signal-to-noise challenges that very few labs are equipped to handle. Also, translating massive quantities of data into actionable information is slow, if not impossible, for most because proper interpretation takes two things that are in short supply: experience and a comprehensive database.

Only Metabolon has all four core metabolomics capabilities

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Coverage

Ability to interrogate thousands of metabolites across diverse biochemical space, revealing new insights and opportunities

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Comparability

Ability to integrate the data from different studies into the same dataset, in different geographies, among different patients over time
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Competency

Ability to inform on proper study design, generate high‐quality data, derive biological insights, and make actionable recommendations
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Capacity

Ability to process hundreds of thousands of samples quickly and cost‐efficiently to service rapidly growing demand

Partner with Metabolon to access:

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A library of 5400+ known metabolites, 2000 in human plasma, all referenced in the context of biochemical pathways

  • That’s 5x the metabolites of the closest competitor
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Unparalleled depth and breadth of experience analyzing and interpreting metabolomic data to find meaningful results

  • 10,000+ projects with hundreds of clients
  • 2,000+ publications covering 500 diseases, including numerous peer-reviewed journals such as Cell, Nature and Science
  • Nearly 40 PhDs in data science, molecular biology, and biochemistry

Using our robust platform and visualization tools, our experts are uniquely able to tell you more about your molecule and develop assay panels to help you zero in on the results you need.

Contact Us

Talk with an expert

Request a quote for our services or more information on sample types and handling procedures, need a letter of support, or simply have questions about how metabolomics can advance your research.

Corporate Headquarters

617 Davis Drive, Suite 100
Morrisville, NC 27560

Mailing Address:
P.O. Box 110407
Research Triangle Park, NC 27709

+1 (919) 572-1711

+1 (919) 572-1721

International Headquarters

Metabolon GmbH

Zeppelinstraße 3
85399 Hallbergmoos
Germany

+49 89 99017752

References

1. Malinowska JM, Viant MR. Confidence in metabolite identification dictates the applicability of metabolomics to regulatory toxicology. Current Opinion in Toxicology. 2019/08/01/ 2019;16:32-38. doi:10.1016/j.cotox.2019.03.006

2. Frédérich M, Pirotte B, Fillet M, de Tullio P. Metabolomics as a Challenging Approach for Medicinal Chemistry and Personalized Medicine. Journal of medicinal chemistry. 2016;59 19:8649-8666.

3. Zgoda-Pols JR, Chowdhury S, Wirth M, Milburn MV, Alexander DC, Alton KB. Metabolomics analysis reveals elevation of 3-indoxyl sulfate in plasma and brain during chemically-induced acute kidney injury in mice: investigation of nicotinic acid receptor agonists. Toxicol Appl Pharmacol. Aug 15 2011;255(1):48-56. doi:10.1016/j.taap.2011.05.015

4. Wang G, Korfmacher WA. Development of a biomarker assay for 3-indoxyl sulfate in mouse plasma and brain by liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. Jul 2009;23(13):2061-9. doi:10.1002/rcm.4111

5. Loomba R, Kayali Z, Noureddin M, et al. GS-0976 Reduces Hepatic Steatosis and Fibrosis Markers in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. Nov 2018;155(5):1463-1473.e6. doi:10.1053/j.gastro.2018.07.027