Amit Somani, Ph.D.

UF Postdoctoral Associate (September 2013 to November 2014)

Currently working as a Clinical Pharmacology Reviewer at FDA.


  • Ph.D. in Pharmaceutical Sciences, 2012; Virginia Commonwealth University, Richmond, VA, USA
  • B.Pharm, 2004; Shri B.M. Shah College of Pharmaceutical Education and Research, Modasa, Gujarat, India

Biographical Sketch:

Dr. Amit Somani joined the Center for Pharmacometrics and Systems Pharmacology in the Department of Pharmaceutics, University of Florida at Lake Nona (Orlando) in September 2013 as a Postdoctoral Research Associate under the mentorship of Dr. Lawrence J. Lesko and Dr. Stephan Schmidt. One of the projects Dr. Somani worked on was “Evaluation of Changes in Oral Drug Absorption in Preterm Neonates”. Dr. Somani won an outstanding research abstract award from the American College of Clinical Pharmacology (ACCP) for this research and was also invited for a podium presentation to discuss the research findings. The poster was showcased on all three days during the 2014 ACCP annual meeting in Atlanta, GA. This project was conducted in collaboration with Bayer Technology Services (BTS). Dr. Somani greatly appreciates the support of Primary Investigator, Dr. Schmidt and BTS throughout this study. Another project that Dr. Somani was involved in was “Value of Information from Pharmacokinetic (PK) Drug-Drug Interaction (DDI) Studies for FDA Approved New Molecular Entities (NMEs) from the Years 2004, 2012 & 2013”. A poster was presented about this research during the American Society of Clinical Pharmacology and Therapeutics (ASCPT) meeting on March, 6th in New Orleans, LA this year. Dr. Somani greatly appreciates the opportunity to work on this project from Dr. Lesko, who was the Primary Investigator on this study.

Close to completion of Dr. Somani’s doctoral program, he worked as an Intern in the Clinical Pharmacology and Translational Medicine Department with Reckitt Benckiser Pharmaceuticals (RBP), now Indivior. While at RBP, Dr. Somani was involved in providing clinical pharmacology input across different stages of the life-cycle of several drug development programs in the area of addiction, schizophrenia and other mental health disorders and contributed to protocol review, PK data interpretation, PK/PD analysis, clinical study report (CSR) preparation and review. He won a “Spot” award for his outstanding contribution in the CSR reviews for the clinical team, which was presented to him by the Global Head, Research and Development team at RBP. While at RBP, he greatly helped enhance the knowledge of the department and the entire scientific team regarding the major challenges in anti-psychotic drug development and contributed in the development of strategies to overcome them. Dr. Somani led the paper and presentation “Challenges in Schizophrenia Clinical Trials and Approaches to overcome them” and the work was presented to the senior leadership and global R & D team. One of the main areas of focus for the paper was development of strategies to minimize the issue of increasing placebo response, which is one of the major challenges affecting drug development in the central nervous disorders such as Schizophrenia, Depression, Alzheimer’s disease and others.

Dr.Somani obtained a Ph.D. in Pharmaceutical Sciences with specialization in pharmacokinetics, clinical research and biopharmaceutics from Virginia Commonwealth University (VCU) and his dissertation advisors were Drs. William H. Barr and William R. Garnett. While at VCU, Dr. Somani worked as a Research Associate at the Center for Drug Studies for over 4 years. This experience provided him the unique opportunity to participate and learn from the various ongoing industry sponsored clinical studies at the center. In addition, prior to joining the graduate program at VCU, Dr. Somani has over a year of experience as a formulation scientist at Claris LifeSciences. Dr. Somani earned a Bachelor’s in Pharmacy degree from Shri B. M. Shah College of Pharmaceutical Education and Research, Modasa, Gujarat, India.


When I look back, it is amazing to think of the impact my experience as a Postdoctoral Research Associate at CPSP has had on my career. Both, faculty and staff are very supportive and always ensure that students and postdoctoral fellows have all the resources and support they need to be extremely productive during their tenure at the center. I am very grateful to have had the opportunity to work with Dr. Lesko. There was not even one interaction with him when I didn’t learn something from him. He never ceased to amaze me with his enthusiasm for science and making a difference in this world with our work. The center is unique in many ways – The outstanding leadership and experience of Dr. Lesko from FDA, industry and academia is reflected upon in the daily activities of the center. Under his leadership, the center really goes over and beyond to ensure that the program is personalized to ensure the overall development of students and fellows, so they can be successful in their choice of future endeavors. The collaborations with industry and FDA on research projects provide a unique set of unmatched real world experience to the fellows during their tenure at the center. I have myself gained a lot from the many talks from the pharmaceutical industry scientists and executives, opportunity for interaction with invited speakers, networking opportunities during the annual leadership council meetings, many interactions with center faculty and staff, journal clubs, working on time-sensitive projects and an emphasis on soft-skills development.

Many thanks for giving me this wonderful opportunity to work as a Post Doctoral Research Associate at the CPSP. I greatly enjoyed working with Dr. Schmidt on the project looking into changes in oral drug absorption in preterm neonates. Winning the ACCP award for this project is one of the highlights of my career thus far, which wouldn’t have been possible without the excellent mentorship from Dr. Schmidt. I will always cherish the same. I would also like to thank Dr. Mirjam Trame for her guidance and support when needed during my tenure at the center. I have greatly enjoyed knowing and working with Ms. Traci Wellington and Ms. Milena Ozimek. Together, the faculty and staff are all a wonderful team and I highly recommend this program for anyone intending to further their training in the field of clinical pharmacology, pharmacometrics and systems pharmacology.