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]>
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