Nikunj Patel is a clinical outcome assessment (COA) reviewer in the Office of New Drugs. Dr. Patel advises OND review divisions on COA-based endpoint development and implementation under the IND/NDA/BLA pathway. Additionally, he reviews qualification submissions under the COA type of DDT Qualification Program. Dr. Patel received his Doctor of Pharmacy degree from the University of Maryland Baltimore and his Bachelor of Science (biochemistry) from the University of Maryland College Park.