Head of the US FDA Division of Pharmacometrics to Kick-off Rosa’s World-Wide Webinar Series, “Impact of Modeling & Simulation in Drug Development”
|Pressemitteilung von: Rosa and Co|
(openPR) - Rosa & Co. LLC today announced that Dr. Jogarao V. Gobburu, Head of the US FDA Division of Pharmacometrics, will present the inaugural webinar in Rosa’s monthly public webinar series “Impact of Modeling & Simulation in Drug Development” ” on April 18, 2011 at 1:00 pm EDT (GMT -5:00). The purpose of the “Impact” series is to foster the use of Modeling and Simulation (M&S) activities in biotechnology, pharmaceutics, and other life science industries. This series will illustrate the advantages and enhancing the applicability of M&S in product discovery, development, and marketing programs. Dr. Gobburu’s talk, The “Learn & Apply” Paradigm in Drug Development, will summarize the state of the art in applying drug-disease-trial models to decision-making processes in drug development.|
“PK/PD and physiologic M&S techniques have been established commercial disciplines for more than a decade,” said Dr. Ron Beaver, Rosa’s Founder and CEO. “However, the ultimate potential for these techniques to speed development, improve efficacy, and reduce costs is far from being realized. Our webinar series is designed to extend the ability of both providers and consumers of drug-disease M&S to recognize when and how these techniques can be harnessed in real-world applications throughout a product’s lifecycle.”
This webinar series will primarily focus on M&S of drug action, disease progression, and trial populations and outcomes. From time to time, special webinars will focus on related M&S topics of interest in product development; for example, scientifically-rigorous market modeling. The series is intended for project team members and executives from research through Phase IV clinical trials. This includes ADME scientists, PK/PD modelers, clinical pharmacologists, clinical development team members, regulatory affairs specialists, Chief Medical Officers or Scientists, and other interested professionals.
“Dr. Gobburu’s talk will provide valuable insights into the latest achievements of M&S in bringing much needed medicines to patients faster. As the head of the Division of Pharmacometrics at FDA, he is well placed to have a broad view of M&S activities in pharmaceutical companies and regulatory decision-making processes.” said Dr. Toufigh Gordi, the Coordinator of the “Impact” series and President of Rosa’s PK/PD and Clinical Pharmacology Services.
Register for this free webinar at www.rosaandco.com/webinar. After registering you will receive a confirmation email containing information about joining the webinar. More information about the webinar series, an archive of past webinars, and a list of future webinar speakers may be found at www.rosaandco.com/webinar.
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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