Please join us at the Charles River Biotech Symposium September 8-10th, at Cape Rey Hilton Resort & Spa, Carlsbad, CA.  The Charles River Biotech Symposium unites drug development professionals in an interactive setting to discuss the nonclinical development of biotherapeutics, including regulatory issues and innovative approaches to problem solving. The collegial spirit of this meeting creates exceptional opportunities for information sharing and networking. Please join us in beautiful Southern California for another unique and exciting educational opportunity.

Can’t Miss Presentation

Application of Quantitative Systems Toxicology Modeling to Evaluate Safety Risk for Small Molecules and Biologics
Presenter: Scott Q. Siler, Chief Science Officer, Simulations Plus
Date/Time: Monday, September 8th | 4:00-4:35 PM PT

Two trends in particular have emerged over the last two decades across the pharma industry—a reduction in resources applied to safety evaluations of compounds in development and increasing utilization of biologics-based treatments. Developing and deploying novel approaches to evaluate safety for these biologics (including monoclonal antibodies and antisense oligonucleotides) is becoming increasingly necessary. One such new approach method (NAM) is mechanistic, mathematical modeling, or quantitate systems toxicology (QST). QST modeling has been used for more than a dozen years to evaluate the drug-induced liver injury (DILI) risk of small molecules with DILIsym. A recent, parallel QST model has established proof of concept in evaluating DILI risk for biologics as well—BIOLOGXsym. These two QST models will be described, including the types of data that are used to characterize the compounds being modeled. Moreover, some examples of past use and some plans for future expansion will be described.