Third Workshop on Pharmacometrics & Advanced Workshop on Placebo Response

Dear Colleagues, Registration is open for the third http://pharmacometrica.webs.com Workshop on Pharmacometrics as a tool for optimizing drug development, Château de Longcol, La Fouillade (France), October 28-31, 2013, http://www.pharmacometrica.webs.com http://www.pharmacometrica.webs.com The workshop is intended for scientists in the pharmaceutical industry, regulatory agencies, contract research organizations, and academia who are expected to implement and apply model-based approach and to deploy innovative pharmacometrics concepts and strategies for better supporting and increasing the efficiency of drug development. A Clinical Trial Simulator developed in R will be used to illustrate the use of R in pharmacometrics, the population PK and PK/PD concepts, the relevance of the 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 simulated virtual data will then be used in a population analysis in NONMEM. The R scripts (including the trial simulator) and the NONMEM control streams used will be distributed to the participants. For more information about the course, including the daily schedule, please visit the workshop website: http://pharmacometrica.webs.com http://pharmacometrica.webs.com. Workshop venue: Château de Longcol (France): http://www.chateaudelongcol.com www.chateaudelongcol.com Upcoming Event - Mark Your Calendars !!! Quantitative Methods in Clinical Development: Modeling and Managing Placebo response. Advanced Workshop on Pharmacometrics – February 2014 – Château de Longcol (France) Placebo response appears to play a major role in determining the failure of clinical trials conducted to evaluate the therapeutic properties of novel medications in many different therapeutic areas. The objective of this Advanced Workshop is to present how a model-based approach can be used to characterize the placebo response, estimate the treatment effect retrospectively re-assess the outcome of a clinical trial and prospectively design more informative clinical trials in presence of placebo response. The number of participants is limited; pre-registration is opened now. Roberto Gomeni, PhD HDR 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 http://www.pharmacometrica.com/ www.pharmacometrica.com