The new company will focus on proprietary simulation projects for pharma

RESEARCH TRIANGLE PARK, N.C. – DILIsym Services, Inc., (www.dilisymservices.com), is a newly launched services-focused business that aims to use mechanistic modeling to solve liver toxicity problems for the pharmaceutical industry. Day-to-day operations of the company will be led by Dr. Brett Howell as Chief Executive Officer, and Dr. Scott Siler as President.   

DILIsym Services, Inc. evaluates the risk of Drug Induced Liver Injury (DILI) for new drug candidates throughout the clinical development pipeline, and provides clients access to simulation results to better inform internal decision making via its team of experts. To accomplish this, the company utilizes DILIsym^® software, a mechanistic, mathematical model of drug-induced liver injury that has been developed as a part of the DILI-sim Initiative since 2011. Predictions on liver safety are made by entering into the model results of laboratory testing that does not involve animals.  In addition to making predictions of liver toxicity for new drug candidates, DILIsym^® has also been applied to provide an enhanced understanding of traditional and novel blood tests used to evaluate liver safety in clinical trials.  Simulation analyses with DILIsym^® have been included in multiple communications with regulatory agencies. DILIsym^® is a registered trademark licensed to DILIsym Services, Inc. 

The DILIsym^® software was developed under the DILI-sim Initiative, a major public-private partnership including scientists from 13 major pharmaceutical companies and the FDA, which have provided financial and in-kind support. The DILI-sim Initiative, now in its fourth year, is led by Dr. Paul B. Watkins, Director of the University of North Carolina Institute for Drug Safety Sciences, who also will serve as a scientific advisor to DILIsym Services, Inc.  Drs. Brett Howell and Scott Siler have led the development of the DILIsym^® software since its inception, and will continue in their roles as Associate Directors of the DILI-sim Initiative going forward.

QUOTES:

Dr. Paul Watkins, director of the University of North Carolina Institute for Drug Safety Sciences and chair of the board of directors of DILIsym Services, Inc.:

“The DILI-sim Initiative has been a tremendous success as a public-private partnership.   When liver safety concerns surface in a clinical trial, the question is increasingly asked “What does the DILIsym^®modeling show?”  The creation of DILIsym Services, Inc. will provide a means to rapidly answer this question without diluting the continued development of the software through the public-private partnership (the DILI-sim Initiative). DILIsym Services, Inc. will greatly improve the efficiency of drug development while reducing the need for animal testing.”

Dr. Brett Howell, Chief Executive Officer of DILIsym Services, Inc.,:

"DILIsym Services will provide us the opportunity to increasingly apply the DILIsym^® software to liver safety scenarios within drug development to impact decision-making.  I am excited to continue working for Dr. Watkins and alongside Dr. Siler and our development team to support both the development of the software through the DILI-sim Initiative as well as its application through this new venture."

MEDIA CONTENT:

- DILIsym Services, Inc. website
http://www.dilisymservices.com

ABOUT DR. BRETT HOWELL:

Brett Howell, Ph.D., is the Chief Executive Officer of DILIsym Services, Inc. and has served as Associate Director of the DILI-sim Initiative since 2011. In addition to being involved in operations, training oversight, software architecture, personnel management, and budget oversight, Dr. Howell has and continues to contribute technically in the areas of PBPK modeling, immune response, and biomarkers.  Dr. Howell has published numerous scientific papers in the areas of PBPK/PD modeling, in vitro toxicity testing, and novel drug delivery systems.  He holds Bachelors of Science degrees in chemical engineering and textile engineering from North Carolina State University and a Ph.D. in chemical engineering from the University of Florida.

ABOUT DR. SCOTT SILER:

Scott Q Siler, Ph.D. is the President of DILIsym Services, Inc. Dr. Siler graduated with a Ph.D. in Nutrition from the University of California, Berkeley and worked for more than 12 years integrating physiology and mathematics with the company Entelos. While with Entelos, Dr. Siler oversaw the development of the Metabolism PhysioLab model and he led multiple projects evaluating potential treatments for type 2 diabetes. Dr. Siler began working with the Hamner Institutes in 2011 as an associate director of the DILI-sim Initiative.