Ashutosh Rao


Dr. Ashutosh Rao is currently the Chief of the Laboratory of Applied Biochemistry and Product Quality Team Leader in the Office of Biotechnology Products, Office of Pharmaceutical Sciences at CDER/FDA. Dr. Rao received his Ph.D. in molecular pharmacology at the University of Texas M.D. Anderson Cancer Center. Prior to joining the FDA, Dr. Rao completed post-doctoral fellowships in biochemistry and in molecular pharmacology at the NCI in Bethesda, MD. As a researcher-reviewer, Dr. Rao is responsible for the regulation of therapeutic proteins such as monoclonal antibodies, enzymes, and cytokines, and serves as an expert reviewer for biomarkers. He serves on FDA working groups to develop regulatory policy on the development and validation of analytical methods, excipients, reference standards, and on surrogate markers for accelerated approval. He also serves as the FDA liaison to a USP joint subcommittee on polysorbates. Additionally, Dr. Rao directs a laboratory research program that investigates the structure-activity relationship between protein oxidation and drug quality, safety or efficacy. He has authored several peer-reviewed research articles, book chapters, and FDA regulatory guidances. Dr. Rao serves on the editorial board for Cancer Research and as a member of the Chemical Sciences Roundtable of the National Academy of Sciences. Dr. Rao has been recognized by awards from the FDA, American Association for Cancer Research, and the NIH.