Simulating Viral Dynamics in the New Trial Simulator

On-Demand Webinar

Certara’s Trial Simulator software provides a powerful approach to computer-assisted trial design, balancing ease of use with robust tools for defining design attributes, conducting statistical and sensitivity analysis, and creating graphical summaries to plan effective trials for every phase of clinical drug testing. While it provides an intuitive user interface to help new users learn trial simulation, Trial Simulator also has the versatility to handle complex trial situations, and it now connects directly with R and ggplot for custom plotting.

In this webinar, Dr. Bill Poland will illustrate how Trial Simulator can perform integrated adherence-PK/PD-outcome modeling incorporating basic HIV and HCV viral dynamics under combination treatments. Adherence modeling explores the risk of patients developing drug-resistant viral strains, especially with regimens using longer dose intervals. He will also show how to capture parameter estimate uncertainty to provide confidence bands around short-term and long-term dose-response curves.

Join this webinar to learn how to use simulation to anticipate risks and preview the range of possible trial results before millions of R&D dollars are spent exposing subjects to experimental therapies.

About Our Speaker

Bill PolandDr. Poland has provided pharmaceutical companies guidance in drug development decisions through scientific and decision-analytic modeling and simulation since he joined Certara in 1998. In over 40 projects for top pharmaceutical companies, he has advised on trial and program design for HCV, HIV, and other therapeutic areas, using integrated treatment adherence, pharmacokinetic, pharmacodynamic, and trial models. Recommendations included go/no go, doses and regimens, arm sizes, and target populations. In central nervous system diseases, he has used simulations to develop flexible strategies for optimal Phase 2-3 development of multiple drugs with overlapping indications, incorporating market models to value outcomes. In oncology, he has performed and reported population exposure-efficacy and exposure-tolerability analyses for regulatory submissions.

Poland’s research interests include practical viral dynamics modeling, portfolio optimization, and Bayesian adaptive program design trading off efficacy and side effects, for which he is co-author of a patent submission. Before joining Certara, he performed decision analyses for pharmaceutical and other industries at Strategic Decisions Group. He received his PhD in Engineering-Economic Systems from Stanford University in 1994. He has an MS from the same department, an MS in Operations Research from the University of California at Berkeley, and a BS in Engineering and Applied Sciences from Harvard University.

Certara’s Trial Simulator software provides a powerful approach to computer-assisted trial design, balancing ease of use with robust tools for defining design attributes, conducting statistical and sensitivity analysis, and creating graphical summaries to plan effective trials for every phase of clinical drug testing. While it provides an intuitive user interface to help new users learn trial simulation, Trial Simulator also has the versatility to handle complex trial situations, and it now connects directly with R and ggplot for custom plotting.

In this webinar, Dr. Bill Poland illustrated how Trial Simulator can perform integrated adherence-PK/PD-outcome modeling incorporating basic HIV and HCV viral dynamics under combination treatments. Adherence modeling explores the risk of patients developing drug-resistant viral strains, especially with regimens using longer dose intervals. He also showed how to capture parameter estimate uncertainty to provide confidence bands around short-term and long-term dose-response curves.