Profile: Simulations Plus Inc (SLP.OQ)
24 May 2019
Simulations Plus, Inc., incorporated on July 17, 1996, is a provider of simulation and modeling software for pharmaceutical discovery and development. The Company offers its products and services through two business units, including Simulations Plus, Inc. and Cognigen Corporation. The Company also provides consulting services ranging from early drug discovery through preclinical and clinical trial data analysis and reporting to regulatory agencies. The Company offers over seven software products for pharmaceutical research and development, including three simulation programs that provide time-dependent results-based on solving various sets of differential equations: GastroPlus, DDDPlus and MembranePlus; three programs that are based on predicting and analyzing static properties of chemicals: ADMET Predictor, MedChem Designer and MedChem Studio, which is a combination of ADMET Predictor, MedChem Designer and MedChem Studio is called its ADMET Design Suite, and a program that supports data analysis and reporting through its secure cloud called KIWI. The Company's PKPlus software product is used for non-compartmental pharmacokinetic analysis and reporting. The Company distributes its products and offers its services in North America, South America, Europe, Japan, Australia, New Zealand, India, Singapore and the People's Republic of China.
The Company's GastroPlus product simulates the absorption, pharmacokinetics and pharmacodynamics of drugs administered to humans and animals. The Company offers a Version 9.0 of GastroPlus.
The Company's DDDPlus software simulates in vitro laboratory experiments used to measure the rate of dissolution of the drug and sometimes the additives (excipients) contained in tablets and capsules under a range of experimental conditions. This software program is used by formulation scientists in industry and the United States Food and Drug Administration (FDA) to understand the physical mechanisms affecting the dissolution rate for various formulations; to reduce the number of cut-and-try attempts to design drug formulations, and to design in vitro dissolution experiments to mimic in vivo conditions.
The Company's MembranePlus software is similar to DDDPlus. Its MembranePlus laboratory experiments are for measuring permeability of drug-like molecules through various membranes, including various cell cultures, as well as artificially formulated membranes.
The Company's PKPlus software product provides fitting of compartmental and non-compartmental analysis (NCA) pharmacokinetic models for oral and intravenous doses. The Company's PKPlus program provides the level of functionality needed by pharmaceutical industry scientists to generate the analyses and the outputs needed to satisfy regulatory agency requirements for both NCA and compartmental pharmacokinetics.
The Company's ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) Predictor is a chemistry-based computer program that takes molecular structures as inputs and predicts approximately 150 different properties for them at an average rate of over 100,000 compounds per hour on a modern laptop computer. This capability allows chemists to generate estimates for a number of molecular properties without the need to synthesize and test the molecules, or to generate estimates of unknown properties for molecules that have been synthesized. The Company's ADMET Predictor version 7.2 contains updated cytochrome P450 enzyme kinetics models that are integrated into the GastroPlus Version 9.0, for the synergy between predicted properties and physiologically based pharmacokinetics (PBPK) simulations. The Company is focusing on ADMET Predictor 8.0, which features a redesigned interface. The ADMET Modeler subprogram that is integrated into ADMET Predictor enables scientists to use their experimental data to create predictive models.
The Company provides MedChem Designer for free to its customers. The free version includes a set of ADMET Predictor property predictions allowing the chemist to modify molecular structures. With a paid ADMET Predictor license, the chemist can see the entire approximately 150 predictions that are available. When coupled with a license for ADMET Predictor, MedChem Designer becomes a de novo molecule design tool for medicinal chemists. With it the scientists can draw molecular structures and have approximately 150 properties for each structure calculated in seconds. The Company's MedChem Designer version 3.0, adds the ability to capture the image of a molecular structure from a range of publication files with a snapshot tool, and then the program automatically converts the graphic image into various computer-based chemical structure files.
The Company's MedChem Studio is a tool that is used both for data mining and for de novo design of molecules. In its data-mining role, MedChem Studio facilitates searching of large chemical libraries to find molecules that contain identified substructures, and it enables generation of clusters (classes) of molecules that share common substructures from high-throughput screening (HTS) data. MedChem Studio can be used to create and screen (with ADMET Predictor) various number of molecules down to a few lead candidates. When MedChem Studio is used with ADMET Predictor and MedChem Designer, the programs provide an unmatched capability for chemists to search through large libraries of compounds that have undergone high-throughput screening experiments to find the classes (groups of molecules with a large common part of their structures) and molecules that are active against a particular target. In addition, MedChem Studio can take an interesting (but not acceptable) molecule and, using a range of design algorithms, generate many thousands to millions of analogs (similar new molecules). These molecules can then be screened using ADMET Predictor to find molecules that are both active against the target, as well as acceptable in a range of ADMET properties.
The Company's New Chemical Entity (NCE) design project is used to design molecules and have them synthesized and tested. The Company has conducted over two NCE design projects, the Company has designed molecules to test against the malaria parasite and in the other it has designed molecules to test against the cyclo-oxygenase-2 (COX-2) enzyme that is the target for Celebrex.
The Company's KIWI is a cloud-based Web application that organizes, processes, maintains and communicates the volume of data and results generated by pharmacologists and scientists over the duration of a drug development program. KIWI Version 1.3 provides its user community with access to features that accelerate completion of modeling projects by decreasing run times, and facilitating the comparison and exporting of results across models. These features include comparisons of model parameter estimates and diagnostic plots, export of model run records for regulatory submissions and accelerated infrastructure with the upgrade to the versions of NONMEM and Perl-speaks-NONMEM running in a 64-bit Linux environment.
Simulations Plus Inc
42505 10th St W
LANCASTER CA 93534-7059