Next Rosa Impact Webinar: Integration of in vitro data into a viral kinetics model to investigate rapid development of Hepatitis C resistance to therapy

Integration of in vitro data into a viral kinetics model to investigate rapid development of Hepatitis C resistance to therapy By Arthur Lo, PhD Senior Scientist at Theravance November 14, 2012 1:00 to 2:00 pm EST Viral kinetics is a classic example of mathematical biology where insights derived from the modeling have had significant impact on the understanding and treatment of viral diseases causing chronic infection. The fundamental structure of the viral kinetics model for HIV has been adapted to other diseases such as Hepatitis B (HBV) and Hepatitis C (HCV), resulting in a broader understanding of chronic viral infection. The current search for approvable, interferon-free combination therapies for HCV has led to significant investment in this area of research, with many pharmaceutical companies developing therapies that target the virus with different mechanisms of action. The combination of available clinical data for these new therapies, preclinical and clinical pharmacokinetic (PK) data and internal in vitro data for comparable compounds has led to an opportunity where the models can be refined to provide additional information that can be used to optimize compound selection and predicted efficacy in comparison to the expected standard of care. I will describe the application of one approach to viral kinetics modeling where preclinical and clinical data from competitor compounds has been incorporated into a model that includes the dynamics of mutant strains of virus. In addition, I will discuss how insights derived from the modeling work have helped shape our understanding of internal candidate compounds and helped to differentiate between competing compounds based on the predicted ability to reduce the viral load in response to therapy in patients. The purpose of the "Impact" series is to foster the use of M&S activities in all phases of drug development by illustrating the advantages and enhancing the applicability of M&S in product discovery, development, and marketing programs. The series is intended for drug development project team members from discovery to phase 4 clinical trials. This includes pharmacologists, ADME scientists, PK/PD modelers, clinical pharmacologists, clinical development team members, regulatory affairs specialists, and other interested professionals. Register for this free webinar at www.rosaandco.com/webinar. After registering you will receive a confirmation email containing information about joining the webinar. More information about the webinar series, an archive of past webinars, and a list of future webinar speakers may be found at www.rosaandco.com/webinar. Please allow 5-10 minutes for a Java applet to be installed on your computer prior to joining our webinar series for the first time. Toufigh Gordi Toufigh Gordi, PhD President, PK/PD and Clinical Pharmacology Services Direct: 408-480-7314 Corp: 408-370-9800 Fax: 408-370-9810 [email protected]