Funded collaboration will leverage current
FDA partnership to include additional LAI technologies
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 that it has been awarded a
newly funded grant from the U.S. Food and Drug Administration (FDA)
to use physiologically based pharmacokinetic (PBPK) approaches in
GastroPlus® to build and validate mechanistic in vitro-in vivo
correlations (IVIVCs) for long-acting injectable (LAI) technologies
through a joint proposal with the University of Connecticut’s
School of Pharmacy, Department of Pharmaceutical Sciences.
This project aims to use the GastroPlus PBPK platform to
investigate the intricate relationship between LAI formulation
critical quality attributes (CQAs) and physiological factors at the
injection site to accurately predict in vivo drug release and
absorption. Dr. Diane Burgess, Board of Trustees Distinguished
Professor of Pharmaceutics and Pfizer Distinguished Endowed Chair
of Pharmaceutical Technology at the University of Connecticut and
her lab will generate in vitro and in vivo data for marketed LAI
suspension products using novel discriminatory systems. The
scientific team at Simulations Plus will use this data, along with
additional inputs from research collaborators, to develop PBPK
models and apply them to validate mechanistic IVIVCs. This effort
is expected to lay the groundwork for a practical alternative to in
vivo studies in establishing bioequivalence (BE) for additional LAI
product technologies.
“LAI formulations are becoming increasingly important in
pharmaceutical pipelines and product portfolios due to their
ability to improve patient compliance and deliver extended drug
release,” said Dr. Daniela Silva Ryan, Scientist II at Simulations
Plus and principal investigator for this grant. “Preclinical and
clinical studies to evaluate new formulation designs are lengthy
and expensive. With this new grant, we expect our work within
GastroPlus to demonstrate how PBPK modeling can reduce development
time and costs, while streamlining regulatory processes for both
innovator and generic formulations.”
FDA scientific and program staff will actively collaborate with
the University of Connecticut, Simulations Plus, and select
industry partners. Dr. Silva Ryan, with assistance from scientists
at Simulations Plus, will coordinate the contract’s modeling and
simulation activities.
“It is a privilege to continue combining our expertise with
Simulations Plus and the FDA to advance the research on LAI
formulation performance even further,” added Dr. Burgess. “The
agency’s trust and confidence in this partnership underscores the
leadership role both organizations have in our respective spaces.
Together, we aim to develop models that bridge the gap between
animal and human data and reveal the intricate relationships
between formulation properties and injection site physiology,
providing insight into virtual BE approaches for this growing drug
delivery technology.”
Funding for this collaboration is made possible by the FDA
through grant award 1U01FD008304-01. 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 organizations imply
endorsement by the United States Government.
About the Burgess laboratory at the University of
Connecticut
The Burgess laboratory in the Department of Pharmaceutical
Sciences at the University of Connecticut’s School of Pharmacy has
a research focus on formulation science, drug delivery and
manufacturing science of complex parenterals. Research efforts
cover the basic science of interfacial chemistry, the application
of this in preformulation and formulation development, the
development of novel drug delivery systems, and the in vitro and in
vivo testing of these drug delivery systems including investigation
of biopharmaceutics and pharmacodynamics. This research is applied
to solving problems with respect to drug and gene delivery and
focuses on microsphere, nanoparticle, liposome, emulsion, hydrogel
and in situ forming delivery systems. Efforts are also focused on
biocompatible coatings to prevent the foreign body reaction that
would otherwise result in loss of functionality of parenteral
implantable devices.
Major contributions include: development of novel microcapsule
dosage forms; development of “real-time” and accelerated
performance tests for complex parenteral dosage forms and
development of IVIVCs for these complex dosage forms; modeling of
the pharmacokinetics of protein therapeutics from microsphere
dosage forms; correlation of interfacial properties with emulsion
and nanoparticle stability; development of a novel composite
coating for implantable devices that has been shown to prevent the
foreign body response in animal models in excess of 6 months;
development of a method that allows long-term intracellular and
intranuclear tracking of gene therapeutics and gene delivery
vectors; design of safe, efficient and stable non-viral gene
delivery systems; application of quality-by-design principles to
nanoparticles and liposomes; and development of novel manufacturing
methods for liposomes and emulsions, including the development of
continuous manufacturing methods with process analytical technology
for complex parenterals such as liposomes, lipid nanoparticles
(LNPs)
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, physiologically based biopharmaceutics,
quantitative systems pharmacology/toxicology, 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.
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: our ability to successfully integrate the Pro-ficiency
business with our own, as well as expenses we may incur in
connection therewith, the efficiency and effectiveness of our
internal business restructuring and leadership changes, 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, 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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version on businesswire.com: https://www.businesswire.com/news/home/20241113179366/en/
Financial Profiles Lisa Fortuna
310-622-8234 slp@finprofiles.com
Simulations Plus Investor Relations
Cristin Ryman 984-444-8358 cristin.ryman@simulations-plus.com
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