Rosa Announces Publication of its PhysioPD(TM) Model Qualification Method and Series of Educational Events
Series of Seminars and Workshops to be held in 2012 across the US and in Europe
- (1888PressRelease) February 29, 2012 - Rosa & Co. LLC, a drug development advisory firm with expertise in drug-disease modeling and simulation, today announced the publication of its Model Qualification Method ("MQM") in the White Paper, "Facilitating Drug Discovery and Development with Mechanistic Physiological Models that are 'Fit for Purpose.'" Rosa created the MQM to enable the broader adoption and use of mechanistic, physiologic models in pharmaceutical research and development. The paper is available for download immediately at www.rosaandco.com/mqmWhitePaperForm.html.
Mechanistic physiological modeling such as Rosa's PhysioPD 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.
"A quality standard such as the MQM is necessary to enable the broad-scale adoption and impact of mechanistic physiological modeling. A standard for judging 'fitness for purpose' is long overdue, and we are proud to build on our decades of experience in PhysioPD modeling, and to lead the promulgation of the MQM. Our clients are already enjoying the benefits of this standard methodology and adopting it systematically. We look forward to sharing our ideas with a broader audience in these public events." said Dr. Ron Beaver, Rosa's Founder and CEO.
Rosa is also broadening its MQM educational activities in 2012 with a series of seminars, workshops, and presentations in the EU and US. The seminar will introduce the MQM's basic principles, and the workshops will take participants step-by-step through the process of planning, building, and qualifying mechanistic physiological models for use in pharmaceutical research and development. Participants will thus be equipped to take first steps toward building or appraising such models, and empowered to ask the right questions to ensure that any models built for are "fit for purpose."
The first event, on Friday, March 2, 2012, will be a seminar titled "Building Focused Models that Support Drug Development Decisions: A Model Qualification Method" sponsored by Bay Area PK/PD, an industry group in the San Francisco Bay Area (www.bapkpd.org).
Subsequently, workshops will take place at the 3rd Annual World PK/PD Summit held from March 27 - 29, 2012 in Boston (http://pkpd-summit.com/) and the 5th Annual EFMC Short Course on Medicinal Chemistry held from April 1 - 4, 2012 in Leiden, The Netherlands (www.ldorganisation.com).
Rosa's education events follow three highly successful events in 2011, at ACoP in San Diego, CA, ICBS in Heidelberg, Germany and the "Impact of Modeling & Simulation in Drug Development" Webinar (www.rosaandco.com/webinarArchive.html). Thomas Klabunde, Head of Computational Biology & Bioinformatics at Sanofi-Aventis and a workshop participant from ICSB 2011, replied "Take it! It will ensure that you'll ask the right questions when taking on a modeling project, and that you focus on the right aspects throughout." Agustin Rodriguez, Senior Scientist in the Division of Systems Biology of Signal Transduction at the German Cancer Research Center and a workshop participant from ICSB 2011, noted "Workshop was even better than expected. The discussions about the criteria and the MQM were great."
To get more information about the MQM, additional events or to arrange for a private workshop, please contact Rosa & Co.
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 unparalleled professional experience in using drug-disease modeling and simulation (M&S) to accelerate drug development and have completed hundreds of engagements with dozens of clients in multiple therapeutic areas. 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.
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