COPD Biomarkers Qualification Consortium launched

The COPD Foundation announces the launch of an unprecedented collaborative effort to pool information on Chronic Obstructive Pulmonary Disease (COPD): the COPD Biomarkers Qualification Consortium (CBQC). The CBQC brings together government agencies, academic institutions and pharmaceutical companies that will share research data on COPD biomarkers—indicators of disease progression/severity. The goal is to assemble data under the auspices of the Consortium that will permit official recognition of biomarkers that can improve disease monitoring and expedite new therapies for the world's fourth leading cause of death.

“On behalf of the academic and pharmaceutical company members of the CBQC, we are committed to data sharing and collaboration to develop new biomarkers that will ultimately improve patient care. This collaboration should expedite the process of development and approval of new treatments for COPD.”

"The establishment of this collaboration is a milestone that demonstrates a commitment by the researchers, government agencies, industry and the community to accelerate the development of new therapies for the treatment of COPD," says John W. Walsh, president and co-founder of the COPD Foundation.

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." Biomarkers are measures that can help researchers determine if a treatment has promise as a new therapy.

Walsh explains that biomarkers help researchers keep track of any effects a new drug may have on a patient. In COPD research, some biomarkers include exercise tests, breathing tests, CT scans, quality-of-life questionnaires and lab test results.

"The progression of COPD can move at very slow speeds," says Walsh. "Therapies aimed at altering the course of the disease and improving overall wellbeing of the individual may require years to demonstrate their beneficial impact. Biomarkers allow researchers and drug companies to more rapidly observe and measure these beneficial effects."

He points out that the ultimate goal is to find a cure for COPD, but as research goes forward, new therapies could be developed to improve the overall health of an individual with COPD.

"New therapies could help stop or slow exacerbation episodes or they could even try to slow the progression of the disease," says Walsh. "Many universities and pharmaceutical companies are working to find new drugs that can help the estimated 12 million individuals currently identified to be living with COPD. In order to prove that a new therapy is effective, researchers must demonstrate that the biomarkers they measured are relevant in a clinical setting, that they were affected by the proposed therapy—whether it's a long- or short-term benefit—and whether the results can be duplicated and confirmed."

The COPD Biomarkers Qualification Consortium grew out of the COPD Biomarker Qualification Workshop conducted earlier this year, which focused on collectively evaluating existing COPD data. The Workshop allowed researchers to conclude that some biomarkers are ready for the Food and Drug Administration's (FDA) biomarker qualification process, whereby agency reviewers rigorously determine if the biomarker effectively measures an important aspect of COPD and that it can be used as part of the drug development process. The collaborative spirit of cooperation between governmental agencies, academia, and industry allows these next steps to progress.

The Consortium will take that next step by assembling a data package for submission to the FDA for review.

Professor Stephen Rennard from the University of Nebraska Medical Center, and Dr. Ruth Tal-Singer of GlaxoSmithKline, Academic and Industry Co-Chairs of the CBQC, express their commitment to the consortium: "On behalf of the academic and pharmaceutical company members of the CBQC, we are committed to data sharing and collaboration to develop new biomarkers that will ultimately improve patient care. This collaboration should expedite the process of development and approval of new treatments for COPD."