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