Upcoming Local (NJ) ASoP event - Feb. 2, in Bridgewater, NJ

All nmusers who are interested are encouraged to attend: The Use of Physiological, Mechanistic Models in Drug Development: Introduction, Case Studies, Impact, and Ideas for Applications Jeff Barrett, PhD, FCP, Research Professor, Lab. for Applied PK/PD, Children's Hospital of Philadelphia Dean Bottino, PhD, Head, Modeling and Simulation - Oncology, Roche Melissa Hallow, PhD, Senior Modeler, Novartis Mike Reed, PhD, Vice President, Rosa & Co. LLC Jim Bosley, PhD, Moderator Physiological, mechanistic models are different than PopPK models that many AsoP members are expert in. What are they? How can they help your company's research programs? Four experts will discuss specific cases in which physiological models were used, emphasizing the positive program impact and insight delivered. A roundtable, to address your questions, follows. Abstract Pharma/Biotech must deliver higher R&D yield (more and better candidates that will show efficacy and safety in human trials) with lower costs (failing flawed drugs early in trials) if research-based drug development is to survive, flourish, and continue to provide new therapies to patients in dire need. Clinical pharmacology has made great advances in improving the decisions we make using human data. Gaps still exist, though, in support for earlier decisions. For example, we must decide which compounds to promote to human trials before human data are available, and animal models aren't always predictive. Another gap exists in our ability to understand the huge and growing mountain of data available, especially when we are facing complex diseases such as diabetes, cancer, and cardiovascular derangements. Human variability and differences between individuals, population groups, the sexes, and adults and children make the gap seem even wider. To face this gap in a rational, scientific way, many companies are now using physiologically-based, mechanistic models to integrate and understand data, and to better predict human outcomes sooner. These models allow more data to be used in a quantitative manner and generate hypotheses that are testable. The models and underlying assumptions that go into them can be documented. Such models account for the complexity of disease, and the variability and uncertainty surrounding subjects and data. In this session, four experts will summarize challenges, describe approaches used, and report outcomes for a specific challenge faced. Ideas for future application of these models will be shared. Event Details Date: Thursday, February 2, 2012 Location: Bridgewater Manor, 1251 Route 202/206, Bridgewater, NJ 08807 - Reception (with cash bar) 5:30-6:45 pm - Presentation 6:45-8:00 pm - Dinner 8:00-9:00 pm Costs: ASoP members receive a discount! Not yet a member? Become an ASoP member at http://www.go-asop.org/events http://www.go-asop.org/events before you sign up for this event. - Event only: $30 ($25 for ASoP members) - Event and dinner: $55 ($45 for ASoP members) Notes about the price: * As we must give final numbers to the hotel on Monday, Jan 30, please sign up before this date. A $10 late fee will be added on to any registration after this date! * If you sign up, please show up! If you can't, please cancel your registration by clicking on the link in your confirmation email - there will be a $2 processing fee for cancellations. * There will be no refunds starting 24 hours before the event as we will have already paid the venue. Thanks for your understanding. Submitted to NMUSER list on behalf of the ASOP Steering Committee, by James R. Bosley, Jr. PhD, PE [email protected] | Direct: +1.610.347.0149 (Philadelphia) | Mobile: +1.610.299.4981 | Fax: +1.610.347.0142 ___________________________________________________________________________ Privileged/Confidential Information may be contained in this message. If you are not the addressee indicated in this message (or responsible for delivery of the message to such person), you may not copy or send this message to anyone. In such case, you should destroy this message and kindly notify the sender by reply e-mail.