Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it is supporting the drug development program for a lifesaving countermeasure to acute radiation syndrome (ARS) in a partnership with a global pharmaceutical company.
DILIsym Services Inc. (DSS), an SLP company, will spearhead development of RADAsym™. The new QSP (Quantitative Systems Pharmacology) platform will allow for prediction of the effects of radiation on mice, non-human primates, and humans, as well as the impact of interventions on radiation syndrome. Several major biological systems will be included, such as bone marrow, the vasculature, the immune system, the liver, the GI tract, and the lung. The platform will be utilized, along with the expertise of the DILIsym Services scientists, to help garner approval for the treatment under the Animal Rule.
Brett Howell, President of DSS, noted, “This is a perfect application of QSP – translation of mechanisms of action from animal to man. Furthermore, we will be able to utilize RADAsym for other radiation scenarios, such as in oncology, as well as other disease areas with overlapping modalities.”
Cognigen, an SLP company, will be supporting the sponsor directly through data curation and exploration as well as pharmacometric modeling activities, and indirectly by partnering with DSS to characterize the pharmacokinetic and pharmacodynamic (PKPD) aspects of this therapy for incorporation in RADAsym.
Jill Fiedler-Kelly, President of Cognigen, added, “The scientific team at Cognigen looks forward to assisting in the development of a comprehensive translational modeling and simulation strategy to support dose selection for this important lifesaving treatment.”
Shawn O’Connor, chief executive officer of Simulations Plus, added: “We are pleased to have been engaged by industry to support this critical development effort. Our expertise across QSP and PKPD techniques and model development positions us uniquely to satisfy the requirements of this endeavor. This engagement also demonstrates our ability to cross-sell the capabilities of our divisions.”