Last Call for HCV Workshop Registration - check out the cutting-edge Modeling & Simulation topics!

Please visit the conference website for more information: http://ubsconnect.com/umctm2012.html Here are the outstanding speakers and their presentation topics for the cutting-edge Modeling & Simulation sessions: Dr. Alan Perelson, Los Alamos National Laboratory: Viral kinetic modeling of HCV infection and treatment has provided insights into the effectiveness and mechanism of action of interferon and ribavirin. I will discuss the kinetics of HCV RNA changes observed during monotherapy with the HCV protease inhibitor telaprevir, the HCV nucleoside polymerase inhibitor mericitabine, and the HCV NS5A inhibitor BMS-790052. Dr. Nicholas Frey, Roche: Danoprevir (DNV) is an inhibitor of the HCV NS3/4A protease that has potent activity against HCV. The effect of DNV on HCV RNA viral load data from phase 1 and 2 clinical studies has been investigated by using a mechanistic viral kinetic (VK) model addressing the host-virus-drug interactions with system and drug effect parameters. The robust mechanistic VK model was further used to support the Phase 3 clinical development of DNV. Dr. Jason Chittenden; Dr. Bill Poland, Pharsight: This session will show how the viral dynamics shown in the simulation session can be estimated in Pharsight Phoenix(tm) and compared to NONMEM estimation. Participants are encouraged to follow along on their laptops. Material will include: - Simultaneous estimation of viral dynamics (reproductive ratio, cell and virus death rates, etc.) and potencies of multiple drugs from multiple studies - Initial condition setup - Inter-individual variability estimation - Different approaches to BLQ and BLD data - Symptoms of over-parameterization - Diagnostics and predictive checks - Comparison of fits across different estimation methods - Tips for faster estimation, including MPI and carefully reducing the dataset Dr. Rajasekhar Thatavarti, GVK Bio: Clinical trial outcomes databases collect summary level safety and efficacy outcome data available in public domain medical literature for the treatments that are approved and in development. These databases support Model Based Meta Analysis, a rationale strategy that uses the available data for better decision making HCV database includes the efficacy and safety information on all long-acting pegylated interferons as well as newer small molecules currently approved or in development from 151 trials, 578 unique arms, and 41 compounds. Dr. Sachin Sanduja, Rudraya: In a large global clinical trial; the process to collect, transform and analyze information is extensive and time consuming process. For rapid strategic and informed decision making project teams need to streamline data management, analysis and reporting. The focus of this presentation will be on utilizing cloud based high performance computing platform with MashFrame technology to streamline and automate modeling & simulation analysis to facilitate early decision making, maximizing efficiency & productivity and reducing overall cost of clinical trial conduct. [cid:[email protected]] Joga Gobburu, PhD, FCP, MBA | Professor | School of Pharmacy | School of Medicine Executive Director |Center for Translational Medicine N407, 20 N Pine, Baltimore, MD-21201 Office: (410) 706-5907 | E-mail: [email protected]<mailto:[email protected]> To receive latest Pharmacometrics news subscribe at http://www.pharmacy.umaryland.edu/ctm/ To unsubscribe, send email to [email protected]<mailto:[email protected]> <<inline: image001.png>>