The next US Food and Drug Administration (US FDA) Grand Rounds will be held on August 9, 2018, 12:00 pm–1:00 pm (EDT). Dr. Tina Morrison, chair of the US FDA agency-wide Modeling and Simulation Working Group and regulatory adviser of computational modeling for US FDA Office of Device Evaluation, will give an overview of those methodologies, highlight success stories with simulation, and discuss the potential for in silico clinical trials for advancing medical products. US FDA advocates for using modeling and simulation as one of many research and product development tools. US FDA routinely advises industry on their use to, e.g., 1) predict clinical outcomes, 2) inform clinical trial designs, 3) support evidence of effectiveness, 4) identify the most relevant patients to study, and 5) predict product safety. In some cases, in silico clinical trials are used to replace human clinical trials, especially those that are intended to evaluate the risk of drug interactions. US FDA is advancing these methodologies and techniques to ensure the benefits of product innovation and more rapidly introduce life-saving technology to our nation’s patients. You can visit the event website for more information and to register for the webcast.