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We Love Biomarkers: Our Top 3 Reasons

It’s no secret we’re big fans of biomarkers! We’ve got a whole team of talented and knowledgeable scientists dedicated to supporting clinical research by providing a broad range of bioanalyses. When we asked Kevin Gorman, Avomeen’s Manager of Bioanalytics, what he loved most about biomarkers, he shared his top 3 reasons with us.

3) Enabling Novel Therapies to Reach the Market and Make an Impact

Biomarkers have the potential to impact the entire drug development and approval process, making each stage of the process more efficient. In addition to having the potential to reduce the overall costs of drug discovery by supporting the selection of favorable drug candidates, they can also help to mitigate the risk of failure in later drug development stages. Biomarkers also play a crucial role in clinical trial patient selection, helping researchers better understand the mechanism of action of a drug, reducing the number of patients needed to show clinical benefits in clinical trials.

In short, biomarkers can improve the safety and quality of drugs, reduce drug development costs, and accelerate regulatory approvals. Most importantly, biomarkers can help researchers better understand that the disease they are looking to treat during target discovery.

2) Making Personalized Medicine a Reality

Biomarkers have been used for centuries as not only an indicator of health, but also to diagnose disease, and are used to support preclinical and clinical research of new drugs and therapies. Biomarker based tests enable precision medicine (also known as personalized medicine), enabling clinicians and care teams to determine the best treatment for individual patients based on specific biomarkers (e.g. HER-2 in breast cancer). When disease-specific biomarkers are identified in an individual or subgroup of patients, treatment can be adjusted, improving the health of the patient(s), reducing overall healthcare costs, and saving precious time by identifying the proper treatment rapidly. The role of biomarkers becomes even more critical as the discovery and development of personalized medicines quickly evolves.

Predictive and prognostic biomarkers are especially important for personalized medicine. Although these two types of biomarkers are often confused, they serve very different purposes. Information about how likely (or unlikely) a patient will be to benefit from a specific treatment can be gathered from predictive biomarkers. On the other hand, prognostic biomarkers provide valuable information about long-term outcomes of patients who either receive standard treatment, or who continue to be untreated. The graphic below further compares and contrasts these two types of biomarkers.

Figure 1. The differences between prognostic and predictive biomarkers

1) Early Detection of Disease, which can Enable Early Intervention

While biomarkers have enabled proper diagnosis and personalized treatment of disease, some biomarkers are only prevalent after disease onset. For some diseases, however, early-detection biomarkers that can identify changes prior to symptom onset have been discovered. Perhaps the most well-known example would be glycated hemoglobin (A1C), which is a biomarker for pre-diabetes. By monitoring A1C levels in at-risk patients clinicians can monitor for pre-diabetes, a reversible condition that can be treated prior to development of Type II diabetes, which is irreversible. In this way, early-detection biomarkers can help monitor at-risk patients and enable early intervention to prevent the development of disease.

Harness the Power of Biomarkers

Biomarkers play an invaluable role throughout drug discovery and development, and they are also critical tools that can be used by clinicians and care teams to tailor treatment to an individual patient’s specific needs. Biomarkers are not without their challenges – it is critical to employ a team of scientists with in-depth knowledge and understanding of biomarkers and how to leverage biomarkers for your specific end-use. Avomeen’s team of consultative scientists have an unparalleled depth and breadth of expertise studying biomarkers. Let’s start the conversation about how Avomeen can support your biomarker testing needs today.

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Additional Resources

Learn more about biomarkers and FDA’s BEST resource

Explore how biomarkers are used in drug development

Biomarkers are a critical tool for therapeutic drug monitoring (TDM) – know more

 

Our featured expert is Kevin Gorman, Ph.D., Avomeen’s Manager of Bioanalytics. Kevin’s extensive knowledge of protein biochemistry and molecular biology enables him to provide clients with expert strategic and tactical guidance to help them reach their goals. Kevin has experience in analytical method development, validation, and optimization of test methods in cGMP settings per ICH guidelines. In addition, Kevin has experience developing in-vitro diagnostics, including a serology assay for COVID-19. He is listed as a co-inventor on three patents, and is highly skilled in several research techniques including LC-MS, HPLC, ddPCR, and ELISA.