Krithika Shetty, PhD臨床薬理学担当シニア・ディレクター, サターラ オーストラリア
Krithika is a Director of Clinical Pharmacology at Certara. Prior to joining Certara in 2021, she was a clinical pharmacology reviewer at the Division of Cancer Pharmacology I at the US FDA for 3 years. While at the FDA she contributed to scientific review of numerous regulatory submissions across all phases from INDs to BLA/NDA submissions. Prior to that, Krithika was at Novartis for 3.5 years where she focused on the DMPK and early clinical development of biologics. Krithika has a degree in Pharmacy from the Birla Institute of Technology and Science (BITS) in Pilani India, and a PhD in Pharmaceutical Sciences from the State University of New York in Buffalo, US.
Since joining Certara Krithika has focused on providing strategic regulatory clinical pharmacology support to client programs including navigating the requirements of Project Optimus, development program risk evaluation, due diligence subject matter expertise, health authority meeting strategy and support, pharmacometrics strategy, clinical hold responses, NDA/BLA module strategy and support as well as review-cycle support.