COPD Biomarker Qualification Consortium Collaborating to Bring Innovative Medicines to COPD Patients

May 31, 2012

Washington, D.C.--The COPD Foundation’s COPD Biomarker Qualification Consortium (CBQC) recently submitted an Initial Briefing Package to the Food and Drug Administration (FDA), formally starting the qualification process for Plasma Fibrinogen as a “biomarker” identifying COPD patients at risk for hospitalization and death.

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 which identifies a group representing 25-30% of all COPD patients (a COPD subtype).

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 into groups 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 highlighted 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 evaluating the impact of new therapies on disease activity in early-phase drug trials in COPD,” she said.

The CBQC is a public-private partnership—a collaborative group of academic researchers, pharmaceutical companies and government parties and agencies that are working toward the common goal of finding better and faster ways to develop new treatments for COPD.

“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 won’t need to repeat them,” Debbie Merrill, Senior Director of the CBQC, said. “We’re 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.

“The COPD Foundation is extremely pleased to facilitate this close collaboration between industry, academia and governmental bodies pursuing the same goal: ultimately getting innovative medicines to patients with COPD who need them most,” John Walsh, president and co-founder of the COPD Foundation, said.

About COPD Foundation
The mission of the COPD Foundation is to develop and support programs, which improve the quality of life through research, education, early diagnosis, and enhanced therapy for persons whose lives are impacted by Chronic Obstructive Pulmonary Disease. The C.O.P.D. Information Line, 866-316-COPD (2673), is a toll-free number for information and referrals on COPD, offering callers access to peer-to-peer patients and caregiver associates.  
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