Metabolomics in Pharmaceutical R&D

Lack of translatability from preclinical to clinical stages, toxicities and non-response remain prevalent in drug development, leading to high attrition rates across indications.
Metabolomics has proven to be a versatile tool across the pharmaceutical R&D cycle, improving the understanding of how new therapeutic agents act, ultimately providing insights for personalized therapies.

Metabolomics in Pharmaceutical R&D

Lack of translatability from preclinical to clinical stages, toxicities and non-response remain prevalent in drug development, leading to high attrition rates across indications.
Metabolomics has proven to be a versatile tool across the pharmaceutical R&D cycle, improving the understanding of how new therapeutic agents act, ultimately providing insights for personalized therapies.

Pharmacometabolomics

Why metabolomics is relevant in Pharma R&D and clinical research

Insufficient knowledge of a compound’s biology contributes to late-stage attrition

Identification of drug actions beyond the immediate target
Improved prioritization of promising compounds

Failure to translate preclinical findings into clinical research

Metabolome: highly conserved through evolution
Molecular profiling for more accurate replication of pathophysiology

Lack of suitable response biomarkers, unknown influencing factors:

Comprehensive patient phenotyping
Integration of hereditary factors, age, lifestyle, etc.

Crossing the translational barrier

A quantitative Mx biomarker strategy increases the success probability of your compound

Only around one in 5,000 compounds that are being tested in the discovery stage eventually are approved for routine use. Even then, a number of issues typically arise in real-world settings:

Non-response is an ubiquitous issue, with typically 1/3 of patients or more not experiencing a clinical benefit
Drugs may become ineffective due to acquired resistance mechanisms and/or progression of disease
There is a lack of actionable biomarkerst hat would aid in the choice of the best course of therapy and supportive therapies

Metabolism is highly conserved over evolution, thus the technology can be used in all areas of pharmaceutical R&D, from MoA and molecular toxicology to predictivebiomarker research.

Besides improving the translatability of finding between the stages of drug development, understanding the relationship between a drug’s molecular on- and off-target effects and the patient’s metabolic phenotype can give hints at which courses of co-medication to avoid and which supportive therapies to pursue, in order to improve outcomes and mitigate risks.

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Why study the metabolome in pharmaceutical R&D?

What is the value in adding metabolomics tot he pharmaceutical R&D toolbox? How can it improve the workflow and make it more effective?

Advancing cancer treatment by targeting dysregulated metabolism – A roadmap

This webinar contribution by Dr. Anna Halama (from Weill Cornell Medicine) gives an overview of the application of metabolomics in the study of cancer.

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Adverse effects in immunotherapy

This article by Stefan Ledinger summarizes different views on the role of metabolism in regulating immune responses and perturbations in immunometabolic pathways that contribute to a large variety of diseases including cancer. There is growing scientific evidence that metabolomics can provide biomarkers indicative of patient outcome in immunotherapy. If we want to understand why a patient responds to immunotherapy favorably, with adverse effects, or not at all, metabolomics could be instrumental in doing so.

Why do we need to understand the role of metabolism in immunotherapy?

Therapy resistance – Could metabolomic biomarkers remove this major roadblock to successful pharmaceutical research and development programs?

Pharmaceutical therapies have contributed to an extended healthy life span for the overall population. But current therapies are not universally effective. This is due to differences among individual patients, which are not fully appreciated in conventional approaches to pharmaceutical biomarker research.

In this article Stefan Ledinger discusses the rationale for metabolomics as a biomarker technology that could improve outcomes by facilitating the development of personalized therapies. He also presents scientific evidence from oncology and other indications to support this.