Krithika Shetty, PhD
临床药理学总监Krithika 是 Certara 临床药理学总监。在 2021 年加入 Certara 之前，她曾在美国 FDA 癌症药理学一部担任临床药理学评审员 3 年。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 拥有印度皮拉尼比尔拉科技学院 (BITS) 的药学学位，以及美国布法罗纽约州立大学的药学博士学位。
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.
