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Nitin Mehrotra, PhD

Senior Director & Head of Pharmacometrics
AInylam Pharmaceuticals Inc

Nitin Mehrotra is a Senior Director and Head of Pharmacometrics at Alnylam Pharmaceuticals overseing the portfolio from modeling and simulation standpoint to influence decisions such as dose selection, trial design, GNG decisons etc. Prior to joining Alnylam, Nitin was at Merck leading the Neuroscience TA within the quantitative pharmacology and pharmacometrics group. He also supported the vaccines portfolio and utilization of model based decision in vaccines drug development. He was the QT-IRT lead and Pharmacometrics team leader at OCP, FDA and provided scientific, technical and operational oversight of NDA, BLA and IND reviews while actively engaged in regulatory research and guidance modernaization initiaves. Nitin has presented externally and chaired symposiium at multiple conferences. He has widely published especially on the role of MIDD in drug development and regulatory decisions. Nitin has demonstrated leadership in utilizing innovative quantitative approaches and effective communication to impact drug development, approval and labeling decisions. His goal is to utilize strategic leadership experience and regulatory knowledge to promote cutting-edge drug development, regulatory and therapeutic science to influence patients’ health.

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