Ashutosh Rao U.S. FDA

Dr. Ashutosh Rao is currently a Supervisor in the Office of Biotechnology Products in the Office of Pharmaceutical Quality, CDER, FDA. Dr. Rao received his Ph.D. at the University of Texas M.D. Anderson Cancer Center in 2003. Prior to joining the FDA, Dr. Rao completed a post-doctoral fellowship at the National Cancer Institute. His extensive work and leadership experience includes the regulation of biotechnology product quality and management of a diverse research portfolio on the structure-activity relationship between large proteins and drug quality, safety or efficacy . He has contributed to multiple FDA guidance documents and policy documents, including for analytical method validation and clinically relevant specifications for impurities. He has authored numerous peer-reviewed research articles, including in high-impact journals such as Cell, Nature Reviews and PNAS. Dr. Rao also serves on the editorial board for scientific journals, ICH Expert Working Group for Q1/Q5C, the Chemical Sciences Roundtable of the National Academy of Sciences, as a government liaison to the USP, and has been recognized by national and international awards.