June 13, 2012
-- Rosa & Co. LLC today announced that Dr. Scott Siler, DILI-sim Consultant, will present a webinar “The DILIsym model and its application to hepatotoxicity testing in drug development”
on Tuesday, June 19, 2012 at 1:00 - 2:00 pm EDT as 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 the advantages and applicability of M&S in product discovery, development, and marketing programs.
According to Dr. Siler, “Drug induced liver injury (DILI) presents a substantial challenge to drug development, with DILI being responsible for multiple drugs being withdrawn from the market or receiving black box warnings at great cost. A mechanistic, multi-scale, mathematical model, DILIsym™, is being developed to assist in the safety characterization of compounds in in vitro to in vivo preclinical to first in human clinical development. Simulated humans, dogs, rats, and mice are included, with differences in biochemical variability amongst populations captured in SimPops™. The effects of reactive metabolites to elicit hepatotoxicity are included in v1A of the DILIsym™ model, with multiple drugs (e.g., acetaminophen)
serving as exemplars for validation. Additional potential hepatotoxic participants, such as bile acids and mitochondria, are currently under development, broadening the range of compound types that can be evaluated with the model. Examples of how the DILIsym™ model can be used to support drug development safety assessment, experimental design, and increase understanding of DILI will be presented.”
Register for this free webinar at http://www.rosaandco.com/webinar
. After registering, a confirmation email will be sent with directions for 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 http://www.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/
More information can be found online at http://www.rosaandco.com
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