Rosa Announces Publication of its PhysioPD Model Qualification Method and Series of Educational Events

SAN CARLOS, CA, February 29, 2012 (Press-News.org) 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 facilitate the broader adoption and use of mechanistic, physiologic models in pharmaceutical research and development. The white paper is available for free download at http://www.rosaandco.com/mqmWhitePaperForm.html.

Mechanistic physiological modeling, like the PhysioPD approach offered by Rosa, is employed by pharmaceutical companies to support decisions at every step of the drug development pipeline. However, a method for qualifying the model is needed in order to meet future regulatory and internal scientific demands. Drawing on decades of experience, Rosa has developed a rigorous and systematic method, known as the MQM, which can fully address questions of model relevance, scope, uncertainty, variability, use of data, and consistency with both qualitative and quantitative data, so that model-based research can proceed with confidence.

"A quality standard, such as the MQM, is necessary to facilitate broad-scale adoption and to strengthen the impact of mechanistic physiological modeling. A standard for judging 'fitness for purpose' is long overdue, and we are proud that our decades of experience in PhysioPD modeling have enabled us to lead the way with our 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 public events like the Modeling Workshop series." said Dr. Ron Beaver, Rosa's Founder and CEO.

Rosa is offering MQM-focused educational activities in 2012 with a series of seminars, workshops, and presentations in the EU and US. The seminars 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 steps toward building and/or appraising such models. This process will empower participants to ask the right questions to ensure that their models are "fit for purpose."

The first event, on Friday, March 2, 2012, will be a seminar entitled "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).

Subsequent workshops will be offered at the 3rd Annual World PK/PD Summit, March 27 - 29, 2012 in Boston (pkpd-summit.com) and at the 5th Annual EFMC Short Course on Medicinal Chemistry, April 1 - 4, 2012 in Leiden, The Netherlands. A third workshop is under development for the West Coast later in 2012 (www.ldorganisation.com).

Rosa's educational events were planned in response to three highly successful events in 2011: the ACoP in San Diego, CA, the ICBS in Heidelberg, Germany, and Rosa's "Impact of Modeling & Simulation in Drug Development" Webinar series (www.rosaandco.com/webinarArchive.html). Thomas Klabunde, Head of Computational Biology & Bioinformatics at Sanofi-Aventis and a workshop participant at ICSB 2011, remarked "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."

For more information about the MQM, additional events, or to arrange for a private workshop, please contact Rosa & Co at spagano@rosaandco.com.

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 http://www.rosaandco.com.
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