.jpg "Vikram Sinha, PhD photo")
Vice President, Global Head Quantitative Clinical Pharmacology
Takeda
Vikram Sinha, PhD FCP, is currently Vice President and Head of Quantitative Clinical Pharmacology at Takeda Development Americas.
Prior to his current role, Vikram was at Merck& Co where he served as Associate Vice President and Head of Quantitative Pharmacology and Pharmacometrics. In this role he oversaw clinical pharmacology and pharmacometric activities from late discovery to post-marketing development across a range of therapeutic areas. He focused particularly on establishing translational biomarker-based strategies in neurodegenerative diseases, global regulatory clinical pharmacology strategies (including Keytruda) and strategies to implement pediatric extrapolation.
Prior to Merck, Vikram was Division Director for Pharmacometrics in the Office of Clinical Pharmacology/Translational Sciences, CDER, FDA (2013–2016); the division covered 16 therapeutic areas, including rare diseases and pediatric indications. In this role, he advanced the application of model-based drug development in multiple areas (systems pharmacology models, physiological-based pharmacokinetic models, exposure-response modelling, dose-response assessments, population pharmacokinetics, disease progression modelling) including authorship of three draft guidance documents and impact on regulatory decision-making. He played a principal role in developing and drafting the current PDUFAVI elements for clinical pharmacology.
His early career was spent at Lilly Research Laboratories, Eli Lilly & Co, in Global Pharmacokinetics, Pharmacodynamics and Pharmacometrics. Vikram earned his PhD from University of Arizona and his Bachelor of Pharmacy from KM College of Pharmacy from the University of Bombay (Mumbai). He completed his post-doctoral training under Dr. Tom Ludden at the University of Nebraska Medical Center.
Vikram has had a broad impact on the drug development ecosystem being a co-author of several ICH guidance documents, a leader in the IQ Consortium, associate editor (PSP) and peer reviewer for several notable journals (JPP, AAPS, CPT). He was made a Fellow of the American College of Clinical Pharmacology in 2017. He is passionate about developing new medicines and building great teams.
Disclosure information not submitted.
Friday, March 18, 2022
12:00 PM – 12:15 PM ET
Monday, April 25, 2022
8:00 AM – 1:30 PM ET
.png)