Cognigen Corporation, a Simulations Plus company (NASDAQ: SLP) and a leading provider of population pharmacokinetic and pharmacodynamic modeling and simulation services, today announced that it has released Version 2 of its KIWI™ Pharmacometric Communication and Collaboration Platform.

Drug development programs rely increasingly on modeling and simulation analyses to support decision making and submissions to regulatory agencies. To ensure high-quality analyses, organizations must not only apply high-quality science, they must be able to support the science by validating the results. KIWI is a cloud-based web application that was developed to efficiently organize, process, maintain, and communicate the volume of data and results generated by pharmacologists and scientists over the duration of a drug development program. The validated workflow and tools within KIWI promote traceability and reproducibility of results.

Dr. Ted Grasela, president of Cognigen, said: “This latest version of KIWI introduces a repository within the KIWI Cloud service to facilitate the management and organization of data and documents produced and used to support the modeling and simulation analyses which, in part, are used to submit new drug applications. The user interface provides a predefined directory structure that can be customized, allows file version control, and provides a comprehensive roles and permissions structure to enhance collaboration amongst a local and/or global community of users. As part of this initiative, an enhanced authentication framework foundation was included to provide clients with the ability to customize authentication rules according to their internal regulatory policies and procedures. In addition, since it can take hundreds of models to create one final model, an automated diagnostics dashboard has been added that visually displays the results of over 10 diagnostics that are used by modelers to decide what direction to take their modeling, with the potential of significantly reducing the time required to arrive at a final model. We are continuing to enhance KIWI as part of our five-year, almost-$5 million contract with a leading global research foundation.”

About Cognigen Corporation

Cognigen Corporation was founded in 1993 in Buffalo, New York and has grown to become one of the leading providers of population pharmacokinetic and pharmacodynamic modeling and simulation services. The services of the company are well-recognized as providing insightful analysis and reports that guide regulatory decision making, which minimizes follow-up questions from regulators, saving sponsors considerable time and money in getting new pharmaceutical products to market. Cognigen Corporation deployed KIWI in 2011 to provide pharmacometricians and clinical team leads access to a dynamic modeling and simulation platform for population analyses. Cognigen Corporation joined the Simulations Plus family of companies on September 2, 2014. More information is available on the company’s website at www.cognigencorp.com.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injury and nonalcoholic fatty liver disease. As a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical, biotechnology, and chemical agents, our software is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and consumer goods companies and regulatory agencies worldwide. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation. For more information, visit our website at www.simulations-plus.com.

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