Next Rosa Impact Webinar Series Presentation

PK/PD Modeling And Simulation: Applications In Discovery Through Development by Dr. Michael A. Eldon Principal Scientific Fellow, VP, Clinical Pharmacology Nektar Therapeutics May 15, 2013 1:00 to 2:00 pm EST >From Dr. Eldon, "Technology has provided us with excellent tools to measure drug effect and drug/metabolite concentration vs. time profiles, even during discovery and early development phases. We now have high sensitivity LC/MS-MS assays, biomarkers, and good old-fashioned pharmacologic endpoints, plus software that allows the use of sophisticated PBPK and nonlinear mixed effect PK/PD models on every desktop. It appears that in silico PBPK modeling is superior to in vivo allometric scaling approaches, thus making PK/PD relationships transportable across species. Given this scenario, when is it acceptable to measure only PK or PD? Not very often, if we consider the cost of delaying knowledge of key exposure-response relationships at each step of the discovery and development continuum. The key is maximum utilization of these tools early, which requires strong study designs aimed at explicit questions. Some recent examples from the speaker's work will be used to illustrate these recommendations." The purpose of the "Impact" series is to foster the use of M&S activities in all phases of drug development by illustrating the advantages and enhancing the applicability of M&S in product discovery, development, and marketing programs. The series is intended for drug development project team members from discovery to phase 4 clinical trials. This includes pharmacologists, ADME scientists, PK/PD modelers, clinical pharmacologists, clinical development team members, regulatory affairs specialists, and other interested professionals. Register for this free webinar at www.rosaandco.com/webinar. After registering you will receive a confirmation email containing information about joining the webinar. More information about the webinar series, an archive of past webinars, and a list of future webinar speakers may be found at www.rosaandco.com/webinar. Please allow 5-10 minutes for a Java applet to be installed on your computer prior to joining our webinar series for the first time. Toufigh Gordi Toufigh Gordi, PhD President, PK/PD and Clinical Pharmacology Services Direct: 408-480-7314 Corp: 408-370-9800 Fax: 408-370-9810 [email protected]

Modeling in Healthcare Economic Evaluations by Dr. Robert Leipold Research Scientist United BioSource Corporation July 18, 2013 1:00 - 2:00 pm EDT This is a reminder that Dr. Leipold's webinar "Modeling in Healthcare Economic http://r20.rs6.net/tn.jsp?e=001YlL0oQL9O_PY3En36RjDDcVPjAzbFU41WcBRSDRnnFqq1H04RVOlMJTr8dHZYACzS7CsaLe2GEcVWjfjGDzpYHtZQG5SImFeVjh5FlszmacVZJ8UoNVjWjmpKBqhQEXpsqIjoDj0oww= will take place on Wednesday, July 18, 2013 at 1:00 pm - 2:00 pm EDT. >From Dr.Leipold, "A new drug, more efficacious and more expensive than the >standard of care, is introduced to the market. How does the higher cost for >the improved health outcomes compare to our willingness to pay? How do we >select the most cost-effective treatment from a number of different treatments >with a wide range of efficacies and costs? How does the addition of a new >treatment to a formulary affect a payer's budget? These are all questions >amenable to economic modeling and analysis. In this presentation, I will >describe a number of different modeling approaches used in health economic >analyses and discuss how the results of those analyses are used to answer >questions such as those posed above." Dr. Leipold's presentation is a part of the monthly world-wide webinar series "Impact of Modeling & Simulation in Drug Development" hosted by Rosa & Co. LLC. The purpose of the "Impact" series is to foster the use of M&S activities in all phases of drug development by illustrating the advantages and enhancing the applicability of M&S in product discovery, development, and marketing programs. The series is intended for drug development project team members from discovery to phase IV clinical trials. This includes pharmacologists, ADME scientists, PK/PD modelers, clinical pharmacologists, clinical development team members, regulatory affairs specialists, and other interested professionals. Register for this free webinar at http://r20.rs6.net/tn.jsp?e=001YlL0oQL9O_PY3En36RjDDcVPjAzbFU41WcBRSDRnnFqq1H04RVOlMJTr8dHZYACzS7CsaLe2GEcVWjfjGDzpYHtZQG5SImFeVjh5FlszmafMQYExZcm7klb9_HctqcJu. After registering you will receive a confirmation email containing information about joining the webinar. More information about the webinar series, an archive of past webinars, and a list of future webinar speakers may be found at http://r20.rs6.net/tn.jsp?e=001YlL0oQL9O_PY3En36RjDDcVPjAzbFU41WcBRSDRnnFqq1H04RVOlMJTr8dHZYACzS7CsaLe2GEcVWjfjGDzpYHtZQG5SImFeVjh5FlszmafMQYExZcm7klb9_HctqcJu. Toufigh Gordi, PhD President of PK/PD and Clinical Pharmacology Services Rosa & Co. LLC [email protected]<mailto:[email protected]> 408-480-7314