How Surrogate Endpoint Biomarkers Can Accelerate Clinical and Business Development in Osteoporosis Treatments—An FNIH Case Study

More than 10 million Americans live with osteoporosis. For decades, proving whether a new osteoporosis drug worked meant running massive clinical trials that followed thousands of people for 10–12 years. The Bone Quality Project brought together the largest dataset ever assembled on osteoporosis drug trials, analyzed bone mineral density (BMD), biochemical markers, and advanced imaging to find indicators (biomarkers) that predict fracture risk. Speakers will discuss these trials, and the lessons learned from the result - an increase in hip bone mineral density (BMD) after treatment strongly predicts a lower risk of fracture, so instead of waiting years to see whether a treatment prevents fractures, researchers can now use BMD changes as a trusted early signal of a drug’s effectiveness. As the first biomarker from the FDA’s Biomarker Qualification Program this approval will spur greater interest in development of treatments for osteoporosis, as well as accelerate interest in how biomarkers can fundamentally improve the efficiency of drug development and investment in biopharmaceutical research. The panel is comprised of expert stakeholders in drug development-academia, biopharmaceutical industry, FDA, and investors.