Advanced and Basic Workshops on Pharmacometrics

Registration is open to the next workshops on Pharmacometrics -.-.-.-.-.- Pharmacometrics is the science of interpreting and describing pharmacology, physiology, disease, and patients’ characteristics in a quantitative fashion by integrating and applying mathematical and statistical models to characterize, understand, gain insights into the determinants of efficacy and safety outcomes, predict a drug’s and biomarker-outcome, optimize drug development plans and enable critical decision making. The gain in efficiency (cost to decision) associated with the implementation of a pharmacometrics strategy is measured by the saving in time necessary to conduct a study, by the ratio between information gathered and the cost of the trial, by the early detection of signal of efficacy or lack of efficacy triggering the decision to terminate the product development and to redirect resources more productively, and finally by the overall time requested for filing new drug applications. http://www.pharmacometricaworkshop.webs.com www.pharmacometricaworkshop.webs.com -.-.-.-.-.- Program for 2014 Workshop on Quantitative Methods in Pharmacology: Introduction to Pharmacometrics USA: March 24-26, 2014: The Carolina Inn on the Campus of the University of North Carolina at Chapel Hill, NC Europe: November 10-12, 2014: Château de Longcol, La Fouillade (France) This is a 3-day course designed to help scientists to understand and use fundamental pharmacometrics concepts for increasing efficiency in drug discovery and development. The workshop includes lectures and hands-on training on concepts, applications, and software tools for pharmacometrics. A Clinical Trial Simulator developed in R will be used to illustrate the use of R in a pharmacometrics framework including the population PK and PK/PD concepts, inter and intra subject variability and the impact of covariates on the clinical trial outcomes. As a working example, the simulator will be used to generate data of a virtual clinical trial in non-small cell lung cancer. The model will include a semi-mechanistic PK/PD tumor growth component, the link between PK and adverse events and the link between tumor growth and survival. The virtual data will then be used to illustrate the population analysis in NONMEM. The R scripts (including the trial simulator) and the NONMEM control streams used will be distributed to the participants. Special Course on Predictive Models and Enrichment Study Design Strategies Europe: April 21-23, 2014: Château de Longcol, La Fouillade (France) USA: October 20-22, 2014: The Carolina Inn on the Campus of the University of North Carolina at Chapel Hill, NC This is a 3-day advanced course designed to help scientists to develop and use predictive models for implementing enrichment study design with particular emphasis in CNS diseases. The workshop includes lectures and hands-on training on concepts, applications, and software tools. Examples will be presented and discussed for: Decreasing heterogeneity in the response – excluding patients with improvement in clinical scores for reasons other than a response to the test treatment (spontaneous improvement, or placebo response). A case-study in Major Depressive Disorders (MDD) where a model of placebo response will be used for implementing a placebo-lead in enrichment design and an adaptive enrichment approach. Prognostic enrichment strategies − choosing patients with a greater likelihood of having a substantial worsening in condition. Two-case-study in Alzheimer’s disease and in a Rare Diseases (Amyotrophic Lateral Sclerosis) will be used to implement study design where patients with more rapid progression are selected based on a disease-progression model. A Clinical Trial Simulator developed in R will be used to simulate clinical trials and to evaluate the benefit of implementing enrichment strategies. The R scripts for the trial simulator will be distributed to the participants. Additional details are available at: http://www.pharmacometricaworkshop.webs.com www.pharmacometricaworkshop.webs.com Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: <mailto:[email protected]> [email protected] Mobile: +33(0) 760 45 1976 Fax: +33 (0) 983 23 3188 www.pharmacometrica.com http://www.pharmacometrica.com/ Next workshop on pharmacometrics: http://pharmacometricaworkshop.webs.com