Simulations Plus Announces New Research Project with the International Collaboration on Cosmetics Safety
11 July 2024 - 10:30PM
Business Wire
Objective to define best practices for the
use of novel PBK modeling strategies to support animal-free safety
assessment of new chemicals
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”), a
leading provider of biosimulation, simulation-enabled performance
and intelligence solutions, and medical communications to the
biopharma industry, today announced a newly funded research project
with the International Collaboration on Cosmetics Safety (ICCS) to
evaluate the use of physiologically-based kinetic (PBK) modeling
approaches to advance animal-free science for cosmetics and other
non-pharmaceutical ingredients.
In a competitive bidding process, Simulations Plus was selected
for its proposal to establish workflows for probabilistic PBK
modeling of new chemicals based on pharmacokinetic (PK) analogs.
Simulations Plus will review ICCS-provided data, select
target-source pairs based on similarity criteria, build PBK models
for source chemicals, and apply these in virtual populations to
predict exposure for target chemicals. The results and best
practices will be published.
“We are excited to partner with ICCS and its membership, which
includes major cosmetics and consumer product companies, ingredient
suppliers, trade and research organizations, and animal welfare
NGOs. Our mutual goal is to expand the use of PBK models for the
safety assessment of new chemicals developed in an animal-free
paradigm,” said Dr. Priyata Kalra, Senior Scientist at Simulations
Plus and principal investigator for this collaboration. “Using data
from ICCS, we will collaboratively develop a PBK-based read-across
concept for various chemicals and exposure routes (intravenous,
oral, dermal) across virtual populations of different species
(humans and rodents). This partnership is expected to result in
general workflows and guidance for implementing this approach in
animal-free safety assessments.”
“We have pioneered the integration of machine learning with PBK
models, coupled with limited in vitro data, to accurately predict
safety exposure levels in animals and humans,” added Dr. Maxime Le
Merdy, Director of PBPK Research & Collaborations at
Simulations Plus. “We believe our expertise in this space, combined
with ICCS’s commitment to advancing animal-free research and
development, will help drive innovation in the non-pharmaceutical
markets we serve. As a recognized global leader in modeling and
simulation, we look forward to collaborating on this important
research project that will help establish best practices and a
comprehensive framework as valuable guidance tools for companies
and regulatory agencies.”
About Simulations Plus, Inc.
With more than 25 years of experience serving clients globally,
Simulations Plus stands as a premier provider in the biopharma
sector, offering advanced software and consulting services that
enhance drug discovery, development, research, clinical trial
operations, regulatory submissions, and commercialization. Our
comprehensive biosimulation solutions integrate artificial
intelligence/machine learning (AI/ML), physiologically based
pharmacokinetics (PBPK), quantitative systems
pharmacology/toxicology (QSP/QST), and population PK/PD modeling
approaches. We also deliver simulation-enabled performance and
intelligence solutions alongside medical communications support for
clinical and commercial drug development. Our cutting-edge
technology is licensed and utilized by leading pharmaceutical,
biotechnology, and regulatory agencies worldwide. For more
information, visit our website at www.simulations-plus.com. Follow
us on LinkedIn | X | YouTube.
About the International Collaboration on Cosmetics
Safety
The International Collaboration on Cosmetics Safety (ICCS) is a
global initiative, headquartered in New York, focused on advancing
the adoption of animal-free assessments of cosmetics, and their
ingredients, for human health and environmental safety. ICCS brings
together scientists and experts from cosmetics manufacturers and
suppliers, industry and research associations, and animal
protection organizations to drive greater global awareness and
confidence in animal-free science through research, education, and
regulatory engagement. Building on nearly four decades of progress
in the development, evaluation, and use of animal-free approaches,
we aim to accelerate the transition to animal-free safety science
through widespread adoption and use. For more information, visit
our website at www.iccs-cosmetics.org/.
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
Except for historical information, the matters discussed in this
press release are forward-looking statements that involve risks and
uncertainties. Words like “believe,” “expect,” and “anticipate”
mean that these are our best estimates as of this writing, but
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: changes to our relationship with ICCS, the parameters
and process used to develop the PBK models in collaboration with
ICCS, market and regulatory acceptance of such models, the accuracy
of predictions developed using such models, our ability to maintain
our competitive advantages, acceptance of new software and improved
versions of our existing software, the general economics of the
pharmaceutical industry, market conditions, macroeconomic factors,
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
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