Rosa Diabetes PhysioPD(TM) Collaboration with Pfizer to be Presented at World PK/PD Summit

Top Quote Diabetes PhysioPD model used to predict long-term clinical outcomes and select doses using only summary pharmacokinetic data from a competitor's short-term Phase I clinical trial. End Quote
  • San Francisco, CA (1888PressRelease) April 19, 2011 - Rosa & Co. LLC, a drug development advisory firm with expertise in drug-disease modeling and simulation, today announced that results from its Diabetes PhysioPD™ collaboration with Pfizer will be presented at the Biorbis World PK/PD Summit in Cambridge, MA April 26-29, 2011. David A. Tess, Principal Scientist, of Pfizer Inc. will be presenting a 30-minutescientific presentation entitled "Creating and Using a Physiological Model to Support Development of a GPR119 Agonist Diabetes Therapy". The presentation will describe the development, testing, and use of a custom-designed Diabetes PhysioPD model, including use of the model to clarify mechanisms of action, support compound selection, select First-In-Human doses, and predict longer-term (HbA1c lowering) clinical outcomes. The model was built using literature data and only limited summary pharmacokinetic data from a competitor's short-duration phase I trial. The presentation will also highlight the extensive testing regime to which the PhysioPD model was subjected.

    "We are pleased to present results from our collaboration with Pfizer. They are leaders in the adoption of systems pharmacology modeling, and this work represents some of our early successes in this process," said Dr. Ron Beaver, Rosa's Founder and CEO.

    About Rosa
    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.

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