To create value for our customers by accelerating and reducing the costs of R&D through innovative science-based software and consulting solutions that optimize treatment options and improve patient lives.
A brief history in time…
Simulations Plus, Inc. (Nasdaq: SLP) is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge machine learning, physiologically based biopharmaceutics/pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies, and regulatory agencies worldwide.
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A not-so-brief history…
In 1981, Words+, Inc. was founded by Walter and Virginia Woltosz in Sunnyvale, CA, in response to an urgent personal need: Virginia’s mother was suffering from ALS (amyotrophic lateral sclerosis). From that first home computer, repurposed by Walt to meet his mother-in-law’s needs, emerged Words+, Inc., which, for 30 years, designed, manufactured, and sold computer-based communication systems for people experiencing a variety of disabilities. Walt was the first person to create an integrated communication system based on a personal computer, and his work in this area radically transformed the way that people with disabilities could communicate. Words+ communication systems have been used by people with disabilities throughout the world, including Cambridge University’s Professor Sir Stephen Hawking.
On July 11, 1996, Simulations Plus was incorporated, at which time Words+ became a wholly owned subsidiary until it was sold on November 30, 2011. The Company was located in several offices in Lancaster and Palmdale, California until February 4, 2006, when it moved to its present location at 42505 10th Street West in Lancaster.
The Company’s award-winning educational software product, FutureLab™, simulated Physical Science and Chemistry laboratory science experiments for high school and college-level science and engineering classes. The Company released its first FutureLab titles in May of 1997. FutureLab development was discontinued in 1998, however, to focus on simulation and modeling software for pharmaceutical research.
Simulations Plus released its first such pharmaceutical software product, GastroPlus®, in August 1998. GastroPlus is a mechanistically based simulation program that simulates intravenous, oral, oral cavity, ocular, intranasal, and pulmonary absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals. Since its release, GastroPlus has become the most commonly used software of its kind and has been licensed by most top 25 pharmaceutical companies in the U.S. and Europe, along with international companies in Japan and across Asia. In addition, GastroPlus has been the focus of several recent publications and workshops from the FDA.
In April of 1999, Simulations Plus released its second core pharmaceutical software product, QMPRPlus™ (Quantitative Molecular Permeability Relationships), which, at that time, provided estimates of four important ADME (Absorption, Distribution, Metabolism, and Elimination) characteristics of new molecules in the earliest phases of new drug research. In January of 2005, QMPRPlus was renamed ADMET Predictor® to better communicate its purpose to customers and investors and, among many program enhancements, toxicity models were added to the new release. ADMET Predictor’s advanced predictive models have consistently been ranked as the most accurate by third-party comparisons.
In February of 2005, Simulations Plus released DDDPlus™ (Dose Disintegration and Dissolution Plus), an advanced technology computer program that models and simulates the in vitro dissolution of active pharmaceutical ingredients (API) and formulation excipients dosed as powders, tablets, capsules, and swellable or non-swellable polymer matrices under various experimental conditions.
Also in 2005, Simulations Plus acquired all the assets of two Santa Fe, New Mexico companies, Sage Informatics and Bioreason, including Sage Informatics’ ChemTK and Bioreason’s ClassPharmer software programs. These two programs were merged and retooled into the current MedChem Studio™, an intuitive medicinal chemistry platform for computational and medicinal chemists supporting lead identification and optimization, in silico ligand-based design, and the clustering/classifying of compound libraries.
In February of 2011, Simulations Plus launched MedChem Designer™ to work seamlessly with ADMET Predictor and MedChem Studio – collectively known as our ADMET Design Suite™. MedChem Designer is a free-to-download software tool that combines innovative molecule-drawing features with a few ADMET property predictions from ADMET Predictor.
The pharmaceutical industry employs a limited variety of laboratory experiments using cell cultures and artificial membranes to determine how well new molecules will be absorbed into cells in the gastrointestinal tracts of animals and humans, but the results of these experiments can vary widely across different laboratories. With MembranePlus™, released in October 2014, we provide a cellular simulation model to account for how measured permeabilities are affected by a variety of factors under experimental conditions and how to interpret the results of experiments from different laboratories.
In September of 2014, Simulations Plus acquired Cognigen Corporation of Buffalo, NY, as a wholly-owned subsidiary. Cognigen is a leading provider of population modeling and simulation contract research services for the pharmaceutical and biotechnology industries. In 2013, Cognigen created KIWI™, a cloud-based, validated platform designed to efficiently and consistently organize, process, and communicate pharmacometric results and the story in front of pharmacometric analyses. Managing output from modeling projects and sharing results with colleagues around the globe can be a challenge, which is what makes KIWI such an important innovation. The acquisition of Cognigen more than doubled our staff from 30 to 65, and we can now serve clients from our Lancaster or Buffalo offices, with the added ability to offer top-quality modeling and simulation expertise that utilize clinical trial data.
In September of 2016, we released the next-generation, standalone PKPlus™ tool for preclinical and clinical trial PK data analysis, following from the PKPlus™ module, which has been in our GastroPlus software since 2000. Every lead compound that enters preclinical testing warrants some form of non-validated, non-compartmental analysis (NCA), with promising candidates moved into clinical trials requiring validated NCA as part of the new drug applications submitted to regulatory agencies. Compartmental PK analysis (CA) is also often used to support submissions as well as to understand how various factors affect the absorption, distribution, and elimination of drugs from the body.
In June of 2017, DILIsym became a wholly-owned subsidiary of Simulations Plus and will continue to operate under the DILIsym name. The leading provider of drug-induced liver injury simulation software and related consulting services to the pharmaceutical industry DILIsym Services Inc., offers software products MITOsym® for simulating in vitro mitochondrial function and a newer product called NAFLDsym™ for the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options. With the acquisition of DILIsym Services, Inc. the total number of Simulations Plus employees has increased from 70 to 81.
In June of 2018, Simulations Plus, Inc., appointed Shawn O’Connor as the next CEO of the company. Co-founder, Walt Woltosz, will continue to be Chairman of the Board.
In April of 2020, Lixoft became a wholly-owned subsidiary of Simulations Plus and will continue to operate under the Lixoft name. Lixoft was founded in 2011 by Jérôme Kalifa and Marc Lavielle to design software solutions based on scientific breakthroughs to reduce the cost and increase the success rate of new drug development. The highly regarded Monolix Suite™ is a leading platform for population PKPD modeling functionality.
The combined company now known as Simulations Plus is a global leader focused on improving the ways scientists utilize knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents.