COPD Foundation Makes Progress on Biomarker Qualification to Speed New Drug Development
September 13, 2011 |
The COPD Foundation recently met with Dr. Janet Woodcock, Director of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), as well as other FDA staff members. The meeting focused on the need to move forward with qualification of biomarkers that could be used to speed development of new therapies for COPD. The COPD Foundation, through its COPD Biomarkers Qualification Consortium (CBQC), has brought together pharmaceutical companies, academic researchers and representatives of NHLBI willing to share pre-competitive data with the intent of developing new tools to benefit all COPD drug development. The meeting allowed the Foundation to clarify a number of issues that have previously hindered progress.
“The CBQC is seeking FDA acceptance of new tools (biomarkers) for use in clinical trials of new drugs. This is an innovative approach that should speed the drug development to treat individuals struggling with COPD,” says John W. Walsh, President of the COPD Foundation.
“It was a very positive meeting and now we have a clear path forward for progressing in the three biomarker qualification efforts the CBQC team has chosen to pursue,” says Debbie Merrill, Senior Director of the COPD Foundation CBQC.
(Pictured: Dr. Janet Woodcock and John W. Walsh)