Shalini Yapa

Shalini joined Certara in August 2022. Prior to joining Certara, she was a Clinical Pharmacology reviewer for 6+ years at the U.S. FDA working on a range of therapeutic areas in the Division of Inflammation and Immune Pharmacology. She has extensive regulatory experience in the U.S. FDA approval process for drugs (505(b)(1)/505(b)(2)), biologics (351(a)), and biosimilar (351(k)) products spanning the range of drug development from FIH to post-marketing studies. Shalini has a degree in Pharmacy and a PhD in Pharmaceutical Sciences from Monash University in Melbourne, Australia. She completed a 2-year clinical PK/PD postdoctoral fellowship at UNC and GSK in North Carolina.