If you are affected by COPD you may often find yourself wondering about what is being done by doctors, researchers and organizations (like ours) that will help improve your quality of life. You hear often of millions of dollars spent on research but get frustrated that it still takes so long for any benefit of that research to translate into something that can help you directly. The Foundation's core mission is to improve the quality of life for the millions touched in one way or another by COPD and that is why we are excited to announce that we will be holding the COPD Biomarker Qualification Workshop on January 27th and 28th in Bethesda, MD.
By the time this magazine reaches your hands, the workshop will have given individuals representing academia, industryand government the ability to share ideas inhopes of improving the speed of development of new therapies and increase the number thats available to help manage COPD. For two days, over 100 attendees will have watched presentations and analyzed the data from multiple studies that, together, will prove if a biomarker can be qualified for use in COPD drug development research.
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.
When pharmaceutical companies work to identify a new and better treatment, there are certain indicators (biomarkers) that they need to show have changed in order to prove their therapies were effective. According to the Food and Drug Administration (FDA), most of the existing treatments have historically focused on improving airway obstruction so those with COPD can exhale easier and with less wheezing. While it is still important to develop better treatments for improving indicators (such as FEV1, the measurement of the air you blow out in the first second of your spirometry test), COPD patients and the medical community are becoming increasingly familiar with other significant health impacts of the disease.
Whats the Goal?
The ultimate goal is to find a cure for COPD. But as important research goes forward, there are new therapies that could be developed to improve the overall health of an individual with COPD. These therapies could help stop or slow exacerbation episodes or they could even try to slow the progression of the disease. Many universities and pharmaceutical companies are working to find drugs that help do this, but their collaboration could be the key to fast-tracking potential therapies to the market. In order to prove that a therapy is effective, researchers must prove, among other things, that the biomarkers they measured are relevant in a clinical setting, that they were affected by the proposed therapy, whether its a long term or short term benefit, and whether the results can be duplicated and confirmed.
The Long Road Home
Everyone knows that research is expensive and strong studies can take years to complete. Clinical trials must be designed and reviewed but they can only be successful if enough patients agree to participate. The COPD Foundation sponsors the COPD Research Registry and encourages COPDers to join so that they can be notified when important research opportunities come about. Whether from a regulatory perspective or from a recruitment perspective, there is no doubt that increasing the time it takes to prove a new therapy is effective is a lofty and worthy goal, and one that the Foundation hopes will be advanced through the discussions at the COPD Biomarker Qualification Workshop.
In unprecedented fashion, multiple pharmaceutical companies, academic investigators and government agencies have shared and compiled data from individual studies to try and prove that individual biomarkers can be used effectively in the drug development process. The FDA recently created an official process that will qualify biomarkers for use in specific contexts of research, however large amounts of data are required to fulfill the requirements of the FDAs qualification process.
This is where the workshop becomes important. Rather than waiting for individual companies to compile enough data to support qualification, the community is coming together to collectively evaluate all existing data. This is going to help stop duplication of efforts. The hope is that by combining all of the data these researchers have, and giving them the opportunity to discuss their findings, they will ultimately come to the conclusion that some biomarkers are ready to go through the FDAs review process. The workshop is also likely to reveal gaps that exist in data that supports the qualification of a biomarker, and may even reveal that certain biomarkers can never be qualified.
Making History in Research
Having all the prominent researchers sitting at the same table to collectively share their findings is what makes this workshop the first of its kind. After the workshop, the Foundation will help form a public-private consortium to keep the momentum going and to fill in the missing pieces from the workshop. This spirit and practice of cooperation is what will improve the research process and help get more therapies directly to those who wish that their lives can get just a little bit easier every day.