A biomarker is a tool that can be used for early detection of a disease, selection of subjects for clinical trials or as an endpoint (outcome) for clinical trials.
Fibrinogen, a protein that can be measured in the blood, is a promising biomarker.
There is strong evidence of an association of fibrinogen with COPD, the presence and frequency of exacerbations, and with death. It is likely to be a useful biomarker to categorize individuals with COPD who might have more chance of a poor health and also determine which patients have a better chance of responding to specific treatments.
Ruth Tal-Singer, the Industry chair of CBQC highlights the significance of this first submission to the Pharmaceutical Industry.
Like many other chronic diseases, COPD is a disease involving many pathways which are difficult to distinguish. This may have led to failure of promising drug candidates in the past. There is an urgent need for simple tools, such as plasma fibrinogen, for selecting COPD patients for clinical trials of pathway specific treatments and for evaluating the impact of new therapies on disease activity in early-phase drug trials in COPD, she says.
The CBQC is a public-private partnershipa collaborative group of academic researchers, pharmaceutical companies, and government parties and agencies working toward the common goal of finding improved ways to develop new treatments for COPD.
Dr. Stephen Rennard, Academic Co-Chair of CBQC, says this is the first time a group has come together like this to work toward this goal.
This has never been done before, and this is the first step toward developing fibrinogen as a qualified tool to be used in the development of new drugs. Qualified means that companies can be assured that the FDA accepts it for the qualified context of use, Dr. Rennard says. ?is is an important step giving companies tools to develop novel therapies. The end result for COPD patients is that this will facilitate the development of new treatments.
The introduction of new biomarkers is beneficial to the COPD community because it may lead to pharmaceutical companies being able to develop treatments more quickly. The CBQC work will provide appropriate tests that all companies can use, so each company wont need to repeat them, Debbie Merrill, Senior Director of the CBQC, says. Were coming together as one large group, trying to benefit COPD patients.
One of the most important aspects of the CBQC is collaboration among groups that normally would be competing.
COPD patients will ultimately benefit from this close collaboration between industry, academia and governmental bodies pursuing the same goal: getting innovative medicines to the patients who need them most, John Walsh, president and co-founder of the COPD Foundation, says.