Lupus Experts Gather at the FDA to Explore Potential for Biomarkers to Accelerate Clinical Trials
Two Investigators Present Discoveries Funded by Lupus Research Institute
WASHINGTON, DC – September 27, 2011 – Biomarkers, potential indicators to monitor disease progress and treatment success, are among the most challenging and critical areas of lupus research according representatives of industry, academia, government and advocacy attending a U.S. Food and Drug Administration workshop this week. The meeting was convened to focus on the development of biomarkers to predict acute worsening of disease, called a flare, and their potential for accelerating lupus clinical trials and new drug approvals.
Scientists from academia and the pharmaceutical industry shared new data from clinical trials and studies looking at the effectiveness of biomarkers in predicting and monitoring the course of the disease. Biomarker is typically defined as a measurable substance that increases or decreases according to the degree of disease, taking much of the guesswork out of determining treatment and patient responses to treatment.