Simulations Plus, Inc.  

Lancaster,  CA 
United States
http://www.simulations-plus.com
  • Booth: 952


Simulations Plus invites you to visit us at SOT- booth 952!

Say “I do!” to the QSAR/PBPK marriage with the GastroPlus™ & ADMET Predictor™ software from Simulations Plus. The combination of the industry’s leading PBPK modeling & simulation platform, with the #1-ranked QSAR models, provides an unprecedented ability to screen drugs and chemicals, administered through oral, inhalation, dermal, or IV routes, using virtual animal & human models! Our consulting teams can also assist with the production of high-quality risk assessment reports for submissions.

Visit us anytime at www.simulations-plus.com


 Press Releases

  • LANCASTER, CA, September 17, 2015 – Simulations Plus, Inc. (NASDAQ: SLP), the leading provider of consulting services and software for pharmaceutical discovery and development, today announced that the U.S. Food and Drug Administration’s (FDA) Office of New Drug Products, Division of Biopharmaceutics has placed an order for 50 additional licenses to the Company’s GastroPlusTM software. This brings to 70 the total number of GastroPlus licenses in use at the FDA. The licenses are spread across various divisions, including the Office of Generic Drugs, Center for Veterinary Medicine, Office of Clinical Pharmacology, and the National Center for Toxicological Research.

    John DiBella, vice president of marketing and sales for Simulations Plus, said, “We are very pleased with the expanding use of our software products by regulatory agencies. The FDA Office of Generic Drugs has purchased 10 licenses to GastroPlus for many years. One of the reasons for an order for additional licenses of this magnitude is to meet the needs of other FDA divisions to review an increasing number of regulatory submissions referencing GastroPlus modeling. Scientists at the FDA want to understand how they can encourage more use of the software program to address questions related to complex drug product behaviors.”

    Simulations Plus also recently announced that the company has been awarded a second cooperative agreement from the FDA for $200,000 per year for up to three years. This award is in addition to another project the company was awarded by the FDA last year, and which was recently renewed for the second year. This new project is for “Development of PBPK simulations for long-acting injectable microspheres.”

    Dr. Ted Grasela, president of Simulations Plus and its wholly owned subsidiary, Cognigen, said, “We are pleased to build on our relationships with the FDA and industry-wide recognition of the value of our software products. The FDA continues to explore new ways of utilizing modeling and simulation in all aspects of research and development, and this is reflected in the need for additional licenses.”

    Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

    About Simulations Plus, Inc.

    Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation software, which is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies worldwide. For more information, visit our Web site at www.simulations-plus.com.

    Cognigen Corporation, a wholly owned subsidiary of Simulations Plus, Inc., is a leading provider of population modeling and simulation contract research services for the pharmaceutical and biotechnology industries. For more information, visit Cognigen’s website at www.cognigencorp.com.

    The combined company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. 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.

    Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Our actual future results could differ significantly from those statements.  Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software products and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, and a sustainable market.  Further information on our risk factors is contained in our quarterly and annual reports as filed with the U.S. Securities and Exchange Commission.

     ###

  • LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced it is expanding its offerings of best-in-class software for pharmaceutical research and development with PKPlus™, a new program that provides high-quality, user-friendly analysis and reporting of clinical trial data for use in submissions to regulatory agencies.

    John DiBella, vice president for marketing and sales for Simulations Plus, said: “We believe PKPlus represents a major addition to our product line with the potential to become one of our leading sources of revenues and earnings. Many in the industry have been under the mistaken impression that there is only one software program that meets the requirements of regulatory agencies for analysis and reporting of noncompartmental analysis results for clinical trial data. We intend to correct that misconception. We have taken the core elements of our PKPlus Module, originally introduced as an optional module in our flagship GastroPlus™ software over 15 years ago, and are turning it into a standalone program that will provide:

    • calculation of pharmacokinetic parameters using noncompartmental analysis,
    • calculation of pharmacokinetic parameters using compartmental analysis with 1, 2, or 3 compartments,
    • support for importing and exporting common data file types,
    • data management functions to deal with organizing and examining data,
    • highly flexible selection of records to analyze and compare desired subsets of a total data set,
    • production of high-quality tables, figures, and listings for export to reporting programs,
    • audit trail (saving all software settings) to ensure the ability to duplicate results from submitted analyses in the future.”

    Walt Woltosz, CEO of Simulations Plus and its wholly owned subsidiary, Cognigen Corporation, said, “We are designing PKPlus to be a friendly but powerful program to satisfy pharmaceutical researchers’ needs while providing better value than alternative programs. The development of PKPlus is an excellent illustration of the synergies between Simulations Plus and our Cognigen subsidiary. We expect a beta release of PKPlus in November, with full release expected in January, but we are announcing it now in order to be able to discuss it at our annual Japan User Meeting for this year in Tokyo tomorrow as well as at the 2015 American Association of Pharmaceutical Scientists Annual Meeting in Orlando, Florida, starting on October 25.”

    About Simulations Plus, Inc.

    Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation software, which is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies worldwide. For more information, visit our Web site at www.simulations-plus.com.

    Cognigen Corporation, a wholly owned subsidiary of Simulations Plus, Inc., is a leading provider of population modeling and simulation contract research services for the pharmaceutical and biotechnology industries. For more information, visit Cognigen’s website at www.cognigencorp.com.

    The combined company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. 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.

    Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995 – With the exception of historical information, the matters discussed in this press release are forward-looking statements that involve a number of risks and uncertainties. Words like “believe,” “expect” and “anticipate” mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the U.S. Securities and Exchange Commission.


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