Amit A. Somani, Ph.D Work Address 6550 Sanger Road, Office 473 Cell: 804-‐503-‐1306 Orlando, FL 32827 Email: [email protected] EDUCATION Ph.D in Pharmaceutical Sciences 07/2012 (Pharmacokinetics, Clinical Research and Pharmaceutics) Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University (VCU), Richmond, VA, USA B.Pharm 06/2004 Shri B.M. Shah College of Pharmaceutical Education and Research, Modasa, Gujarat, India PROFESSIONAL & RESEARCH EXPERIENCE School of Pharmacy, University of Florida 09/2013 -‐ Present Center for Pharmacometrics and Systems Pharmacology (CPSP), Post Doctoral Research Associate with Drs. Lawrence J. Lesko and Stephan Schmidt •
Working on PK/PD approaches in the area of pediatric clinical pharmacology •
Data mining from drugs@FDA for NMEs approved in the year 2013, 2012 and 2004 in order to review drug-‐drug interaction studies and find ways to improve the value of information for such studies in future •
Student/Trainee award winner and invited for poster and podium presentation -‐ American College of Clinical Pharmacology (ACCP) 2014 •
Poster presentation -‐ American Society of Clinical Pharmacology and Therapeutics (ASCPT) 2015 •
Mentored a Pharm.D. student during her internship at CPSP over Summer 2014 1
School of Pharmacy, Virginia Commonwealth University 04/2013 – 08/2013 Department of Pharmacotherapy and Outcomes Science, Clinical Pharmacology Post Doctoral Fellow with Dr. William H. Barr Reckitt Benckiser Pharmaceuticals (RBP) 08/2012 – 03/2013 Clinical Pharmacology and Translational Medicine (CPTM) Intern •
PK and PK/PD analysis for ongoing clinical studies in support of NDA submissions •
Study protocol and CSR reviews for over 8 drug development programs from phase I-‐III in teams comprising of the Clinical, Biostatistics and Regulatory affairs (Winner of SPOT award) •
Thorough understanding of anti-‐psychotic drug development and strategy development (including population PK/PD modeling and simulation approaches) to overcome the major issue of placebo response in anti-‐psychotic drug development as RBP moves into phase III trial with their compound •
Review of FDA approved drugs such as Aripiprazole and Iloperidone including thorough understanding of their safety and efficacy studies with regards to how the issue of placebo response was addressed in the clinical studies •
Review of IVIVC development for two clinical programs, leading the discussion and making recommendations for future work •
Presentations to provide clinical pharmacology input to overcome challenges during ongoing drug development programs within the CPTM, clinical and global research and development team at RBP Center for Drug Studies (CDS), School of pharmacy, VCU 01/2006 – 08/2011 Research Associate (RA) reporting to Executive Director, Dr. Barr •
Involved in the development and review of clinical study protocols and statistical analysis plans, performing PK analysis, and writing sections of clinical study reports for Phase I-‐II clinical pharmacology studies 2
•
Gained extensive experience of working in clinical study teams consisting of Primary Investigator, Clinician, Biostatistician, Nurses, CRA and Sponsor •
Have had various roles in clinical studies such as assisting with dose preparation and administration, study site preparation for clinical study initiation and clinical study closure, on-‐site monitoring of clinical study and carrying out PK analyses of the data •
Been involved in meetings that involve discussion on study budget, timelines and allocation of resources •
Performed pharmacokinetic data analysis in absorption studies for drugs administered via parenteral routes (subcutaneous and intramuscular injection), Also conducted simulation of plasma levels and testing of in vitro -‐ in vivo correlations (IVIVC) using the data from clinical studies •
Performed IVIVC’s for orally administered drugs •
Extensive experience in studies performed in accordance with SOP's, center policies and GCP's/ICH guidelines Some of the research activities are listed below: •
An open-‐label, double conversion study to characterize the pharmacokinetics of anti-‐
epileptic drug (Lamotrigine) when switching patients with epilepsy on Immediate-‐
release (IR) to Extended-‐release (ER) formulation and vice-‐versa •
Simulation of a Cough suppressant formulation Ø Characterization of in vitro release Ø Estimation of IR profile Ø Calculation of plasma concentrations of ER dosage form assuming in vitro release rates parallels in vivo absorption •
Evaluation of the gastrointestinal absorption following separate administrations of drug X and drug Y by nasocolonic intubation and oral administration in healthy subjects •
Preparation of report on Curcumin (Turmeric) that has been tested extensively for various therapeutic conditions (Cancer, Alzheimer’s disease and many others) •
Evaluation of the effect of ammonia on nicotine pharmacokinetics using rapid arterial sampling 3
•
Preparation of research protocol and research subject information and consent form -‐ Correlation of in vitro dissolution profile of naltrexone implants with in vivo profile observed in patients •
In vitro -‐ in vivo correlation for different formulations (Extended release/Immediate release) of an analgesic drug •
Provided clinical pharmacology input to determine analgesic effects of different salt forms of Ibuprofen •
Review of literature relevant to the TIM gastrointestinal models and participation in discussion regarding the possibility of conducting studies at the Center for Drug Studies, VCU Ph.D. Dissertation Project In Vitro – In Vivo Methods and Pharmacokinetic Models for Subcutaneously Administered Peptide Drug Products Advisors: Drs. William H. Barr, Pharm.D., Ph.D and William R. Garnett, Pharm.D In vivo component •
Bioequivalence testing of drug products manufactured at two different sites •
Pharmacokinetic analysis on clinical data from subcutaneously administered Iplex® (IGF-‐I, Insulin like growth factor -‐ I bound to IGFBP-‐3, Insulin like growth factor binding protein -‐ 3) and Increlex® (unbound IGF-‐1) •
Characterizing drug absorption of Increlex® and Iplex® from subcutaneous tissue In vitro component •
Molecular modeling work to estimate size of the IGF-‐I (Insulin like growth factor -‐ I), IGFBP-‐3 (Insulin like growth factor binding protein -‐ 3) and ALS (Acid labile subunit), in order to understand and characterize the permeability characteristics of these peptides through blood capillary pores or lymphatic capillary pores •
Development of Modified Hanson Microette® device for in vitro testing of Iplex® and Increlex® 4
•
In vitro permeation/release studies with the proposed biorelevant method for peptide based drug products and analysis of the in vitro samples using validated RP-‐HPLC method •
Membrane characterization using Scanning Electron Microscope Reviewer, Journal of Clinical Pharmacology 07/2010 -‐ Present Co-‐reviewer with Dr. Stephan Schmidt, Clinical Therapeutics 03/2014 -‐ Present Co-‐reviewer with Dr. Catherine Sherwin, 12/2014 onwards Also, invited to write a review article -‐ Expert Review of Clinical Pharmacology Invited to write a contribute a Research Article, 11/2014 Review Article or a Short Commentary -‐ Journal of Bioequivalence and Bioavailability Department of Pharmacotherapy and Outcomes Sciences, VCU Graduate Teaching Assistant for Pharm D. students 08/2005 – 08/2009 Claris LifeSciences Ltd., India Research and Development Officer, R&D Department 11/2004 -‐ 06/2005 Cadila Pharmaceuticals Ltd Pharmacology Department, Bioequivalence study intern 06/2003 -‐ 07/2003 TRAINING Software -‐ Working knowledge of WinNonlin, WinNonlin Phoenix, Pirana, NONMEM, R, Scientist, JMP statistical software, SYBYL 7.3, HEX, HINT, GOLD and familiar with MATLAB, Monolix, SimBiology, Simcyp, PK-‐Sim and GastroPlus Workshop -‐ Advanced PK/PD modeling workshop at VCU, Dr. Jürgen Venitz, 2006 and 2007 -‐
NONMEM workshop by FDA Pharmacometrics group, Drs. Joga Gobburu, Christoffer, Tornoe, Pravin Jadhav and Yaning Wang at VCU, 2008 -‐
Evaluation of drug product performance at VCU, Dr. Leon Shargel, 2009 5
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Hands-‐on SAS workshop at VCU, 2011 -‐
Hands-‐on Simcyp workshop at VCU, Dr. Joe Grillo, 2013 -‐ Medical Science Liasion conference, Philadelphia, Pennsylvania, 2013 -‐
Hands-‐on MATLAB and SimBiology workshop for pharmacokinetic and mechanistic modeling by MathWorks, 2014 -‐
Scientific symposium, Metabolic Origins of Disease, 2014 -‐
Lake Nona Leadership Council Meeting and Scientific Symposium (Model Qualification and Trends in Systems Pharmacology), 2014 -‐
Time to event analysis workshop, Dr. Ben Weber, 2014 -‐
Introductory/Intermediate and Advanced NONMEM and PDx-‐Pop workshop, Drs. Robert Bauer and Brian Sadler, 2014 -‐
PK-‐Sim workshop at CPSP, Bayer Technology Services, 2014 -‐
Simcyp workshop at CPSP, Simcyp, 2014 -‐
GastroPlus workshop at CPSP, Simulations Plus, 2014 -‐
Monolix workshop at CPSP, CPSP faculty, 2014 LEADERSHIP Pharmacy Graduate Student Association – President 2008 – 2009 Reaching Out Dil Se – Co-‐Founder 2010 AWARDS And SCHOLARSHIPS •
Student/Trainee award winner -‐ American College of Clinical Pharmacology 2014 •
Invited Podium presentation -‐ American College of Clinical Pharmacology 2014 •
Student Highlight Interview -‐ American College of Clinical Pharmacology 2014 •
Winner of “Spot” award at Reckitt Benckiser Pharmaceuticals 2012 •
Recipient of Thesis/Dissertation Assistantship Award 2010 – 2011 •
Graduate Teaching Assistantship Award 08/2005 – 08/2009 •
Graduate Research Assistantship Award 01/2006 – 08/2011 •
PACME Award 2009 -‐2010 6
(Presidential Award for Community Multicultural Enrichment) – Nomination •
Phi Kappa Phi (honor society for academic excellence) Membership Award 2007 •
Award from Sahu Jain Trust 2005 RECENT POSTER PRESENTATIONS University of Florida, Postdoc Research Symposium Poster presentation PAGE 2014 Poster presentation ACCP 2014 Poster presented in all 3 poster sessions and invited to give a podium presentation University of Florida -‐ Translational Research Institute Research Day Poster presentation ASCPT 2015 Poster presentation PUBLICATIONS Somani A, Lagishetty C, Bartolome L, Lesko L, “Value of Information from Pharmacokinetic (PK) Drug-‐Drug Interaction (DDI) Studies for FDA Approved New Molecular Entities (NMEs) from the Years 2004, 2012 & 2013”, Manuscript under preparation Somani A, Thelen K, Zheng S, Trame M, Coboeken K, Meyer M, Schnizler K, Ince I, Willmann S, Schmidt, “Evaluation of changes in oral drug absorption in preterm neonates”, Manuscript under preparation Somani A, Zheng B, Nasser A, “Challenges in schizophrenia clinical trials and 7
Approaches to overcome it”, Internal white paper published on the same and is on Reckitt Benckiser Pharmaceutical’s hard drive Diana M, Maria G, Bruce D, Viswanathan R, Kelly F, Hans C, Karnes H, Garnett W, Iyer S, Somani A, Kobal G, Barr W. "Evaluation of the Effect of Ammonia on Nicotine Pharmacokinetics Using Rapid Arterial Sampling", Nicotine and Tobacco Research (2012) 14 (5): 586-‐595 PROFESSIONAL AFFILIATIONS American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2014 -‐ Present International Society of Pharmacometrics (ISoP) 2014 -‐ Present American College of Clinical Pharmacology (ACCP) 2012 -‐ Present American Association of Pharmaceutical Scientists (AAPS) 2006 -‐ Present American Association for the Advancement of Science (AAAS) 2011 -‐ Present OTHER ACTIVITIES Founder of non-‐profit organization (Reaching Out -‐ Dil Se) to help provide for educational needs of underprivileged children and give back to the community in the Greater Richmond, Virginia through partnerships with various non-‐profit organizations in the area Actively participated and led the group of students in India during NSS (National Service Scheme) camps that were held in rural parts of India 8