COPD Biomarker Qualification Consortium

As a result of the COPD Biomarker Qualification Workshop in 2011, the Biomarkers Consortium was created to help fast track research for better treatment and medicines that’ll help improve the lives of those with COPD. Here’s how.

First, A Biomarker

A biomarker can take many forms depending on what is being studied. The National Institutes of Health defines a biomarker as, “a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.”

In other words, biomarkers can help researchers see if there are any changes in the body due to a new therapy. In COPD research, biomarkers include the results of your six-minute walk test, your score on the St. Georges Respiratory Questionnaire, and levels of certain chemicals in your blood and urine.

How do biomarkers help research?

When pharmaceutical companies work to identify a new and better treatment, they look for changes in certain indicators (biomarkers) to prove their therapies were effective.

According to the Food and Drug Administration (FDA), most of the existing treatments for COPD have historically focused on improving airway obstruction, so the person can exhale easier and with less wheezing.

While this is important, the medical community has identified other significant health impacts of the disease that can shape research moving forward, and find new therapies that will improve the overall health of someone with COPD. These therapies could help stop or slow exacerbation episodes, or they could even try to slow the progression of the disease.

What did the workshop do to help with biomarker research?

At the Biomarkers workshop, and in unprecedented fashion, multiple pharmaceutical companies, academic investigators, and government agencies shared and evaluated existing data from different studies to prove that individual biomarkers can be used effectively in the drug development process. This is going to help stop duplication of efforts.

By combining all of the data these researchers have, they’re working towards a set of biomarkers to submit through the FDA’s review process to qualify them for use in specific contexts of research. Large amounts of data are, however, required to fulfill the requirements of the FDA’s qualification process.

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