The FDA Office of Orphan Products Development seeks to advance the evaluation of drugs and diagnostics to treat rare diseases. A growing toolkit of incentives has helped drive the development of new products for rare diseases, but the need remains great. We spoke to Gayatri Rao, director of the FDA’s Office of Orphan Products Development, about the rare disease landscape, how scientific developments are reshaping clinical trials and the use of biomarkers, and what the agency is doing to better incorporate patients’ perspectives into the drug review process.

Dr. Gayatri Rao will be speaking at the 2015 Patient Advocacy Summit about how patients can craft meetings with the FDA, and when is it appropriate to do so. Learn more about the summit and how you can get involved here.

RARECast is a weekly series by Daniel S. Levine. Levine is an award-winning business journalist who has reported on the life sciences, economic development, and business policy issues throughout his 25-year career. He founded Levine Media Group in 2013, which produces The Bio Report and RARECast podcasts. Read his full bio here.