Partnership will produce an enhanced,
validated dermal PBBM/PBPK model to inform product development and
bioequivalence decisions
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, through a joint proposal with the University of
Bath’s Department of Life Sciences and other university partners,
it has been awarded a new funded grant from the U.S. Food and Drug
Administration (FDA). The grant will be used to expand and validate
a multi-functional, multi-purpose physiologically based
biopharmaceutics/pharmacokinetics (PBBM/PBPK) modeling solution for
topical products within the GastroPlus® platform that can inform
regulatory decisions for both innovator and generic products.
For this award, the Skin Biosciences group at the University of
Bath led by M. Begoña Delgado-Charro, Professor in
Biopharmaceutics, and Professor Richard Guy, and partners at the
Colorado School of Mines (Professor Annette Bunge) and the
University of Reading (Professor Adrian Williams) will generate in
vitro data from a series of studies to capture the processes that
occur when patients use topical formulations which transform when
applied and rubbed into the skin. The scientific team at
Simulations Plus will utilize these novel data sets, along with
additional pathophysiology information for skin disease
populations, to enhance and validate the Transdermal Compartmental
Absorption and Transit (TCAT™) model within GastroPlus and
determine the impact of changes to relevant quality attributes
which impact the predictions of dermal absorption. The resulting
outcome will provide the foundation of a viable alternative to in
vivo studies for the establishment of bioequivalence (BE) for
topical products.
“Collaborating with the University of Bath and other partners on
this groundbreaking FDA grant is a remarkable opportunity. Our
joint efforts are set to deliver an advanced, rigorously validated,
and mechanistic dermal PBBM/PBPK model that leverages novel in
vitro experimental designs,” said Dr. Maxime Le Merdy, Associate
Director, Research & Collaborations of PBPK Solutions, and lead
investigator for this grant for Simulations Plus. “This innovation
promises to revolutionize the prediction accuracy of topical drug
product performance. By doing so, we aim to significantly expedite
the regulatory decision-making process, ultimately benefiting
patients and the pharmaceutical industry.”
FDA scientific and program staff will actively collaborate with
the University of Bath, Colorado School of Mines, University of
Reading, and Simulations Plus. Dr. Le Merdy, with assistance from
Dr. Jessica Spires and Dr. Jasmina Novakovic at Simulations Plus,
will coordinate modeling and simulation activities of the
contract.
“By combining our expertise with Simulations Plus’ cutting-edge
research, we are charting a course towards more efficient drug
development and safer healthcare solutions. The project will be a
great way for both industry and academia to make that leap from
research into real life applications, with potential benefits of
tangible patient outcomes,” added Dr. Delgado-Charro. “Our primary
objective is to enable the creation of innovative models that
bridge the divide between in vitro and in vivo data. The
comprehensive framework and best practices established through this
contract will hold significant value for both the FDA and the
companies involved in developing topical formulations.”
Funding for this collaboration is made possible by the Food and
Drug Administration through grant award 1U01FD007957-01. 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 the Delgado-Charro laboratory in the Department of Life
Sciences at the University of Bath
Professor Delgado-Charro’s laboratory focuses on transdermal and
topical drug delivery, development of optimized methods to treat
nail diseases such as onychomycosis and psoriasis, non-invasive
sampling for drug monitoring and pharmacokinetics, and mathematical
modeling to predict the accumulation and absorption of chemicals in
and across the skin. Her research has been funded by esteemed
organizations including the Leo Foundation, the UK Engineering and
Physics Research Council, EPSRC, Parkinson’s Disease Society UK,
the UK Medical Research Council, the Swiss National Foundation, the
NHS-NIC, the U.S. FDA and several pharmaceutical companies.
Professor Delgado-Charro has published 123 peer-reviewed articles
in highly respected journals in the pharmaceutics and chemicals
fields as well as 11 book chapters.
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 Statement
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
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