NONMEM/TMDD Workshops in Maryland, week of April 8, 2014

Dear NMusers: ICON Development Solutions is presenting a 4-day workshop which will be hosted in Howard County, Maryland, April 8-11. First two days are beginner/intermediate NONMEM / PDxPoP workshop The third day is for Monte Carlo Expectation/Maximization and full Bayesian analyses. In addition, example problems that use new features of NONMEM 7.3 will be demonstrated, such as using new abbreviated code features for easier modeling of inter-occasion variability, modeling additional mixed effects levels for grouping individuals, such as inter-clinical site variability, and using the new DO loop feature in abbreviated code, useful for handling multiple bolus doses in models that use the analytical absorption function for multiple transit compartments. Day 4 will be a workshop on Modeling Biologics with Target-Mediated Disposition (TMDD) presented by Leonid and Ekaterina Gibiansky of QuantPharm LLC (see below). http://www.iconplc.com/news-events/events/workshops/ Title: A 1-day workshop on Modeling Biologics with Target-Mediated Disposition The workshop is intended for PK scientists with or without prior population PK modeling experience. It provides an overview of the PK of biologics, introduces target-mediated drug disposition (TMDD) modeling concepts, and discusses some applications of TMDD modeling to drug development of biologics. NONMEM codes, inputs and outputs for TMDD modeling are provided to the participants. Workshop summary: The 1-day workshop is intended for PK scientists with or without prior experience in population PK modeling of therapeutic proteins. It will provide an overview of the PK of biologics, introduce target-mediated drug disposition (TMDD) modeling concepts, and discuss some applications of TMDD modeling to drug development of biologics. We will start with the detailed introduction of the TMDD system. Equations that describe the TMDD process will be introduced and implicit and explicit assumptions of these equations will be reviewed. Characteristic features of the TMDD system will be demonstrated on the simulated examples. Data that are typically available for the analysis and assay properties will be reviewed. It will be demonstrated why TMDD models are often overparameterized and poorly identifiable. The hierarchy of TMDD approximations (rapid binding, quasi-steady-state, irreversible binding, and Michaelis-Menten) will be derived and discussed. Extensions of the TMDD equations to more general systems, including antibody-drug conjugates will be demonstrated. Experience-based recommendations for modeling of TMDD systems will be discussed and demonstrated on case studies. Nonmem control streams that implement TMDD equations and its approximations will be provided. Biological considerations for choice of TMDD approximations will be introduced. We will review allometric scaling for FIH exposure predictions, covariates that may influence PK properties of biologics, and possible drug-drug interactions. Methods for detection, evaluation and modeling of immunogenicity will be discussed. Use of different Nonmem estimation methods and parallelization for TMDD models will be reviewed. You may register for the Beginners course (days 1 & 2), the Advanced course (day 3) or all three. The TMDD workshop can also be registered for in conjunction with the NONMEM/PDXPOP courses or separately. Cost: Industry - $800 USD/day Academia - $600 USD/day Lisa R. Wilhelm Customer Service Representative ICON Development Solutions Internal Tel: 7210 3060 External Tel: (410) 696-3060 Fax: (215) 789-9549 Email: [email protected]<mailto:[email protected]> Web: http://www.iconplc.com/ [Description: cid:[email protected]]