U.S. FDA Renews DILIsym® Software Licenses for 7th Year
04 4월 2024 - 9:30PM
Business Wire
Predicting DILI risk supports informed
decision-making regarding drug evaluations and approvals
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of
modeling and simulation solutions for the pharmaceutical,
biotechnology, chemicals, and consumer goods industries, today
announced that the U.S. FDA has renewed its licenses to the
DILIsym® software platform. DILIsym is the industry gold standard
for quantitative systems toxicology (QST) software designed for the
prediction and investigation of drug-induced liver injury (DILI).
The one-year renewal provides the FDA with continued access to the
DILIsym platform for authorized employees across all FDA
divisions.
DILIsym predicts the potential for DILI risk in new molecules
and provides deeper insight into the mechanisms responsible for
observed DILI responses at various stages of the development
process. This allows pharmaceutical development teams to understand
their compounds and tailor proposed dosing strategies for efficacy
and safety. It also allows the FDA to evaluate the potential DILI
risk across multiple populations, which supports informed
decision-making regarding drug approvals.
Dr. Paul B. Watkins, chair of the Scientific Advisory Board of
the DILI-sim Initiative, said, “It is now known what properties to
avoid to minimize liver toxicity in a new drug candidate -- but
these same properties are often necessary to have therapeutic
efficacy. By predicting safe dosing regimens of such drugs, DILIsym
is now enabling successful development of important therapies that
might otherwise be abandoned.”
“By incorporating disease pathophysiology, clinical
presentation, and clinical outcomes into a unified framework,
quantitative systems pharmacology (QSP) and toxicology (QST) models
are powerful tools for evaluating therapies,” said Dr. Brett A.
Howell, President of Quantitative Systems Pharmacology Solutions at
Simulations Plus. “It’s exciting to see the FDA incorporate these
methodologies and our software platform as part of their review
process for submissions.”
For the last 14 years, Simulations Plus has coordinated the
DILI-sim Initiative, which is a public-private partnership that
guides the development of the DILIsym platform. DILIsym is
available to the pharmaceutical and chemical industries for direct
use to predict and understand liabilities via membership in the
DILI-sim Initiative consortium and/or commercial licenses.
Simulations Plus also routinely uses DILIsym for comprehensive
consulting services on safety-related issues. Companies interested
in a free trial version of the DILIsym software can request it
here.
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 | X | YouTube.
Environmental, Social, and Governance (ESG)
We focus our Environmental, Social, and Governance (ESG) efforts
where we can have the most positive impact. To learn more about our
latest initiatives and priorities, please visit our website to read
our 2023 ESG update.
Forward-Looking Statements
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 U.S. Securities and
Exchange Commission.
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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
Simulations Plus (NASDAQ:SLP)
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