Second Workshop on Pharmacometrics

Dear Colleagues, Registration is open for the second http://pharmacometrica.webs.com Workshop on Pharmacometrics as a tool for optimizing drug development, Château de Longcol, La Fouillade (France), May 14-16, 2013, http://www.pharmacometrica.webs.com The Pharmaceutical industry is undergoing major structural changes to fundamentally re-engineer the current R&D process in order to reduce the time, cost, and risk of innovation, and to enhance capacity for developing high quality, truly innovative products that address unmet medical needs. One dimension of this change is the shift from empiric drug development to model-based drug development as suggested by the FDA ‘critical path’ initiative. To address this need the ‘pharmacometrics’ approach has been proposed. Pharmacometrics is the science of interpreting and describing pharmacology, physiology, disease, and patients’ characteristics in a quantitative fashion by integrating and applying mathematical, statistical and genetic 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 (including the number of patients enrolled), 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 The workshop is intended for scientists in the pharmaceutical industry, regulatory agencies, contract research firms, and universities who are expected to deploy innovative pharmacometrics concepts and strategies to better support and increase the efficiency of drug development. For more information about the course, including the daily schedule, please visit the workshop website: http://www.pharmacometrica.webs.com. Workshop venue: Château de Longcol (France): http://www.chateaudelongcol.com www.chateaudelongcol.com 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

Dear Colleagues, Registration is open for the second Workshop on Pharmacometrics as a tool for optimizing drug development, Château de Longcol, La Fouillade (France), May 14-16, 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 universities who are expected to deploy innovative pharmacometrics concepts and strategies to better support and increase the efficiency of drug development. For more information about the course, including the daily schedule, please visit the workshop website: http://www.pharmacometrica.webs.com. Workshop venue: Château de Longcol (France): http://www.chateaudelongcol.com www.chateaudelongcol.com Roberto Gomeni, PhD HDR PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: [email protected] Mobile: +33(0) 760 45 1976 Fax: +33 (0) 983 23 3188 www.pharmacometrica.com

Dear Colleagues, Registration is open for the second Workshop on Pharmacometrics as a tool for optimizing drug development, Château de Longcol, La Fouillade (France), May 13-16, 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 universities who are expected to deploy innovative pharmacometrics concepts and strategies to better support and increase the efficiency of drug development. For more information about the course, including the daily schedule, please visit the workshop website: http://www.pharmacometrica.webs.com. Workshop venue: Château de Longcol (France): http://www.chateaudelongcol.com www.chateaudelongcol.com Roberto Gomeni, PhD HDR PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: [email protected] Mobile: +33(0) 760 45 1976 Fax: +33 (0) 983 23 3188 www.pharmacometrica.com

Dear Colleagues, Registration is open for the second Workshop on Pharmacometrics as a tool for optimizing drug development, Château de Longcol, La Fouillade (France), May 13-16, 2013: 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://www.pharmacometrica.webs.com. Workshop venue: Château de Longcol (France): www.chateaudelongcol.com Roberto Gomeni, PhD, HDR PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: [email protected] http://www.pharmacometrica.com www.pharmacometrica.com www.pharmacometrica.webs.com

Final call: Second Workshop on Pharmacometrics, a tool for optimizing drug development, Château de Longcol, La Fouillade (France), May 13-16, 2013: 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://www.pharmacometrica.webs.com Workshop venue: Château de Longcol (France): www.chateaudelongcol.com Roberto Gomeni, PhD HDR PharmacoMetrica Longcol, 12270 La Fouillade (France) E-mail: [email protected] Mobile: +33(0) 760 45 1976 Fax: +33 (0) 983 23 3188 www.pharmacometrica.com