Simulations Plus Releases GastroPlus® Version 9.9
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Insights
The release of GastroPlus® 9.9 by Simulations Plus represents a significant advancement in the field of physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM) modeling. This software is critical for pharmaceutical companies as it aids in predicting how drugs behave in the human body, which is pivotal for drug development and regulatory approval. The enhancements in non-oral delivery route models, such as ocular, oral cavity and dermal, are particularly noteworthy as they address a growing segment of the drug delivery market that seeks to bypass the gastrointestinal tract and improve patient compliance.
From an investment standpoint, the fact that this update includes feedback from over 100 companies and incorporates scientific research from peer-reviewed papers indicates a robust customer-centric approach and strong scientific foundation, which could translate into sustained demand and customer loyalty. Moreover, the collaboration with the FDA and the update being partially funded by FDA grants may enhance the credibility and acceptance of the software, potentially leading to increased adoption rates and market penetration.
The enhancements made to the Biologics Module in GastroPlus 9.9 could have a substantial impact on the development of biologic drugs, which are typically more complex than small-molecule drugs. By improving study design mimicking and dose optimization simulations, the software aids in refining clinical trial protocols, which can lead to more efficient trials and potentially reduce the time and cost to bring new biologics to market. This is crucial as biologics continue to gain market share in the treatment of chronic diseases, including cancer and autoimmune disorders.
Investors should note that the success of clinical trials has a direct correlation with a pharmaceutical company's pipeline value and stock performance. Therefore, tools that can enhance clinical trial design and execution are essential for reducing the risk of trial failures and improving the likelihood of regulatory approval and commercial success.
The financial implications of the GastroPlus 9.9 release could be multifaceted. On one hand, the investment in research and development, as well as the collaborations with the FDA, signify a proactive approach to maintaining a competitive edge in the market, which is likely to be well-received by investors. On the other hand, the costs associated with these enhancements must be weighed against the potential for increased sales and licensing revenue.
It's important to consider the scalability of the software and the recurring revenue model that licensing such software typically entails. As Simulations Plus expands its software capabilities, it can potentially command higher licensing fees and attract a broader customer base. This could result in a positive impact on the company's long-term revenue growth and profitability, which are key factors in the assessment of the company's stock valuation.
New version delivers on FDA collaborations and user feedback for expansion of non-oral delivery route models
Key enhancements include:
- Expanded the ocular (OCAT™), oral cavity (OCCAT™), and dermal (TCAT™) models by adding new formulation and PK/PD mechanisms to better capture local and systemic exposure levels in animals and humans
- Extended the ACAT™ model to enhance the evaluation of formulation approaches for local gastrointestinal (GI) disease states
- Improved Biologics Module features to mimic study designs and refine dose optimization simulations for clinical trial success
- Upgraded with ADMET Predictor® version 11 models, enhancing our First in Human Simulator
“Our software updates reflect the needs our customers communicate to us, and GastroPlus 9.9 is no exception,” said Neil Miller, Vice President of Simulation Sciences at Simulations Plus. “We incorporated feedback from more than 100 companies into these latest enhancements, ensuring they truly provide the improved functionality our customers require. And as we do with every software release, we also updated our models with the latest scientific research, leveraging more than 30 peer-reviewed papers to improve the predictive capabilities of our software platform.”
“For many years, we have worked on collaborative projects with the FDA and other regulatory agencies to improve the technology available to the pharmaceutical industry and increase the safety of animal and human trials,” said Dr. Haiying Zhou, Sr. Director of Simulation Technologies at Simulations Plus. “This is one reason our clients know they can rely on data generated with GastroPlus to inform their program design and support regulatory submissions. In GastroPlus 9.9 specifically, our updates to the Additional Dosage Routes (ADR) Module were built with FDA involvement and funding from three separate FDA grants, and these enhancements are now available for the global GastroPlus user community to apply to their research programs to accelerate the development of new therapies to help patients worldwide.”
GastroPlus 9.9 is available now for licensing and download.
About Simulations Plus, Inc.
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | Twitter | YouTube.
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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 and filed with the
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Simulations Plus Investor Relations
Renee Bouche
661-723-7723
renee.bouche@simulations-plus.com
Financial Profiles
Lisa Fortuna
310-622-8251
slp@finprofiles.com
Source: Simulations Plus, Inc.
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