Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that its DILIsym Services (DSS) division has formed a Scientific Advisory Board (SAB) to provide guidance and direction for development of its RENAsym quantitative systems toxicology (QST) kidney injury software platform.
The SAB has been formed within the RENAsym Consortium, and consists of the following experts:
- Dr. Lauren Aleksunes, Professor of Pharmacology and Toxicology at the Rutgers University Ernest Mario School of Pharmacy;
- Dr. Zheng Dong, Regents’ Professor and Leon H. Charbonnier Endowed Chair at the Medical College of Georgia of Augusta University and the Director of Research & Development at the Charlie Norwood VA Medical Center;
- Dr. K. Melissa Hallow, Associate Professor at the University of Georgia School of Chemical, Materials, and Biomedical Engineering;
- Dr. Ravindra Mehta, Professor at the University of California at San Diego School of Medicine;
- Dr. Frank D. Sistare, Former Scientific Associate Vice President at Merck Research Laboratories and Captain in the U.S. Public Health Service at the Food and Drug Administration’s Center for Drug Evaluation and Research;
- Dr. Paul B. Watkins, RENAsym and DILI-sim SAB Chair, Howard Q. Ferguson Distinguished Professor and Director of the Institute for Drug Safety Sciences at the University of North Carolina.
For the past 10 years, DSS has coordinated the DILI-sim Initiative, which is a public-private partnership that has guided development of the DILIsym® software package. The RENAsym Consortium was recently launched in a similar fashion for the development of the RENAsym® software program, which uses properties of drugs to predict their risk of causing kidney injury in patients. RENAsym version 1A will be released in the latter half of 2021 for drug developers to use in-house or engage via consulting. The combined liver and kidney safety capabilities of DILIsym and RENAsym will allow DSS to address a larger portion of the safety issues facing drug developers.
Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the RENAsym Consortium, remarked: “Given the tremendous success of the DILIsym® software in predicting liver injury due to drugs, many stakeholders urged the team to take on kidney toxicity and we are delighted to see this happening. The members of the Scientific Advisory Board are internationally recognized scientists with expertise spanning basic kidney biology, novel new tests to detect kidney injury, and the various ways drugs can harm kidneys in patients. I am very excited to be working with this team.”
Newly appointed SAB member, Dr. Frank Sistare, commented: “I am honored to be part of this effort. Drug safety toolboxes are expanding in areas of region-specific translational kidney safety biomarkers, advanced in vitro kidney models, and mechanistic molecular tissue biomarkers. It makes perfect sense to work collaboratively to expand mathematical modeling capabilities that can pull these data streams together to provide more accurate perspectives on kidney effects at target clinical exposures and improve drug development decision making.”
Dr. Brett A. Howell, president of DILIsym Services, added, “All of our new RENAsym SAB members are extremely knowledgeable and distinguished scientific leaders. Our establishment of this new SAB under the RENAsym Consortium umbrella is just another example of our commitment to top level science within our products and services.”