September 26, 2011

FDA Workshop to Qualify Lupus Biomarkers

Today, representatives from the Lupus Foundation of America national office and the LFA Medical-Scientific Advisory Council (MSAC) are participating in a workshop hosted by the U.S. Food and Drug Administration (FDA) to discuss potential biomarkers for lupus. This meeting will bring together representatives of the federal government, the biotech and pharmaceutical industry, key scientific opinion leaders, as well as all lupus advocacy organizations, including the LFA.

Several LFA research grantees and a member of the LFA MSAC will be making presentations, including Dr. Ken Kalunian of the University of California, San Diego, who will present results of LFA Collective Data Analysis Initiative (CDAI), which examines data from past clinical trials of potential lupus drugs. The CDAI is a project of the LFA National Research Program, which seeks to examine the impact of background therapies on trials of potential treatments for lupus. It is unique and the first in its kind in lupus.

Biomarkers are important to lupus drug development, regulatory review and clinical practice. A biomarker is a substance, molecule, gene or characteristic that is used as an indicator of a biological state. It is often used to determine the effect of a particular therapy on a patient with lupus. Validated lupus biomarkers will have a positive impact on accelerating the drug-review process by the FDA of potential new treatments for lupus.

Biomarkers have been an important focus for the LFA's National Research Program: Bringing Down the Barriers. The LFA commissioned a study by the nationally recognized health policy research organization, The Lewin Group, to address barriers to lupus drug development. Their report, entitled "Overcoming Barriers to Drug Development in Lupus," both outlines obstacles to lupus drug development and provides recommendations for overcoming them. One recommendation from the Lewin Report was to "establish and fund a consortium to expedite the identification and validation of biomarkers for lupus", which begins with this workshop. The LFA has provided considerable funding to support the work of the Lupus Biomarkers Working Group which was studying lupus biomarkers. This FDA workshop continues that process.

The two-day meeting is a continuation of a process that began as a series of conference calls hosted by the FDA last summer with members of the lupus medical community. The calls were held to discuss the potential to identify lupus biomarkers that would qualify for the FDA's "Qualification Process." The process starts with a scientific meeting to showcase the scientific state of the art in lupus biomarkers research, review the process for biomarkers qualification at the FDA, and obtain consensus on which biomarkers to pursue for the qualification process.

With more safe treatments, people with lupus can look forward to an improved quality of life. However, biomarkers will need to be well defined and the qualification protocol developed before we can move forward.

Attending the meeting will be LFA President and CEO Sandra C. Raymond and LFA Vice President for Education and Research Leslie Miller Hanrahan. They will be providing updates during the meeting. Keep an eye out on our Twitter feed for tweets from the LFA throughout the day.

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