San Carlos, California, United States of America (Free-Press-Release.com) May 7, 2013 -- Rosa & Co. LLC today announced that Dr. Michael A. Eldon, Principal Scientific Fellow, VP, Clinical Pharmacology, Nektar Therapeutics, will present a webinar entitled "PK/PD Modeling and Simulation: Applications in Discovery through Development" on Wednesday, May 15, 2013 at 1:00 - 2:00 pm EDT. This webinar is part of Rosa's ongoing monthly public webinar series. The purpose of the series, "Impact of Modeling & Simulation in Drug Development", is to foster the use of Modeling and Simulation (M&S) activities in biotechnology, pharmaceutics, and other life science industries. This series is geared to illustrate current applications and the advantages of using M&S in product discovery, development, and marketing programs.
According to Dr. Eldon, "Technology has provided us with excellent tools to measure drug effect and drug/metabolite concentration vs. time profiles, even during discovery and early development phases. We now have high sensitivity LC/MS-MS assays, biomarkers, and good old-fashioned pharmacologic endpoints, plus software that allows the use of sophisticated PBPK and nonlinear mixed effect PK/PD models on every desktop. It appears that in silico PBPK modeling is superior to in vivo allometric scaling approaches, thus making PK/PD relationships transportable across species. Given this scenario, when is it acceptable to measure only PK or PD? Not very often, if we consider the cost of delaying knowledge of key exposure-response relationships at each step of the discovery and development continuum. The key is maximum utilization of these tools early, which requires strong study designs aimed at explicit questions. Some recent examples from the speaker's work will be used to illustrate these recommendations."
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 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.
