Rosa's Christina Friedrich to Lead Model Qualification Workshop at ICSB 2011
The Model Qualification Method is a rigorous, systematic analysis of model relevance, uncertainty, variability, and consistency with data to ensure drug discovery/development models are "fit for purpose".
- (1888PressRelease) July 28, 2011 - Rosa & Co. LLC, a drug development advisory firm with expertise in drug-disease modeling and simulation, today announced that it will be leading a workshop on its Model Qualification Method (MQM) at the 12th International Conference on Systems Biology (ICSB), the major event for the world-wide systems biology community, in Heidelberg/Mannheim, Germany on August 28, 2011.
Mechanistic physiological modeling such as Rosa's PhysioPD™-style approach is employed by pharmaceutical companies to support decisions at every step of the drug development pipeline. In order to meet future regulatory and internal scientific demands, a method is needed to qualify the models. Drawing on decades of experience, Rosa has developed the MQM to ensure that questions of model relevance and scope, uncertainty and variability, and use of and consistency with both qualitative and quantitative data are addressed in a rigorous and systematic fashion, so that model-based research can proceed with confidence.
In a well-planned and executed modeling project, model qualification cannot be left as an exercise at the end of the project; rather, the entire project should be set up with the MQM in mind. The workshop will take participants step-by-step through the process of planning, building and qualifying mechanistic physiological models for use in drug discovery and development. Participants will thus be equipped to take first steps toward building such models, and empowered to ask the right questions to ensure that any models built for drug discovery and development are "fit for purpose."
"A quality standard such as the MQM is necessary to support the broad-scale adoption and impact of mechanistic physiological PhysioPD-style modeling. A standard for judging "fitness for purpose" is long overdue, and we are proud to build on our decades of experience in this type of modeling, and to lead the promulgation of the MQM. We look forward to sharing our ideas with the workshop participants." said Dr. Ron Beaver, Rosa's Founder and CEO.
Rosa informs our customer's most critical decisions - from preclinical through clinical development - with the creation and use of mathematical models that simulate disease physiology, drug action, patient variability, and trial outcomes. To address the full spectrum of related issues, Rosa offers two customized approaches: classic pharmacokinetic/ pharmacodynamic (PK/PD) models and Rosa's innovative PhysioPD™ models. With these approaches, Rosa's clients collaborate in model creation and testing, retain the final model, and acquire the ability to use it and understand its implications for their drug development programs. Rosa's staff have close to two decades of unparalleled professional experience in using drug-disease modeling and simulation (M&S) to accelerate drug development; they have covered hundreds of applications with dozens of clients. The Rosa team is unique in their breadth and depth of disease area experience, which includes metabolic and cardiovascular diseases, oncology, gastro-intestinal disease, inflammatory diseases, immune dysfunction (including rheumatoid arthritis), pain, skin conditions, respiratory disorders, and antibacterials/antivirals. For more information, visit www.rosaandco.com.