Sr. Director
Merck & Co., Inc.
Edison, New Jersey, United States
Dr. Lokesh Jain is currently a Senior Director in the Quantitative Pharmacology and Pharmacometrics – Immune Oncology (QP2- IO) group as well as the Clinical Director supporting the NSCLC Product Development Team at Merck. In his role as the QP2-IO Group Lead, he oversees a team that supported planning and execution of Clinical Pharmacology and Pharmacometrics components for all regulatory submissions related to Oncology. His team made substantial contributions to several clinical trials and 25+ global filings of Keytruda (including approval of 400 mg Q6W based on modeling and simulation), Belzutifan, Olaparib, Lenvatinib and Selumetinib.
Before joining Merck, he was a Team Leader in the Office of Clinical Pharmacology (OCP) at the US FDA. There he worked on close to 50 New Drug Applications and 100 Investigational New Drug Applications covering aspects of exposure- and dose-response to aid in important decisions such as dosing recommendation, assessment of evidence of effectiveness and benefit-risk, dose adjustments in specific populations including drug-drug interactions, and labeling issues.
Prior to joining FDA, he worked as a Research Associate in the National Cancer Institute (NCI) at the National Institutes of Health (NIH) working on sorafenib clinical trials in CRC, prostate cancer, ovarian cancer, and Kaposi’s sarcoma, covering a range of topics including Pharmacokinetics, Pharmacodynamics, Pharmacogenomics, Biomarkers, and Modeling & Simulations.
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