Partnership aims to integrate experimental
data and PBPK modeling to identify key formulation factors to
accelerate modified-release product development
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 Northeastern
University and The TIM Company, it has been awarded a new funded
grant from the U.S. Food and Drug Administration (FDA). The project
will aid in the understanding of oral modified-release (MR)
formulations and advance the development and approval of generic
oral MR drug products through the combination of novel in vitro
testing and mechanistic modeling and simulation.
For this award, Dr. Jie Shen, Associate Professor of
Pharmaceutical Sciences, and her lab at Northeastern University,
along with partners at The TIM Company, will generate in vitro data
characterizing the critical quality attributes (CQAs) and
dissolution of multiple strengths of MR formulations. The newly
generated data will be used to parameterize physiologically based
pharmacokinetic/physiologically based biopharmaceutic (PBPK/PBBM)
models predicting clinical pharmacokinetics of those MR
formulations following their oral administration. The combination
of in vitro and in silico studies will support the identification
of the appropriate factors to scale the MR formulation for
additional strengths, and to identify the CQAs and formulation
design spaces for oral MR tablets.
“This collaboration is an exciting step forward, as we combine
our PBPK/PBBM modeling and simulation expertise with Northeastern
University's research excellence and The TIM Company's
groundbreaking tiny-TIMsg model,” said Dr. Xavier Pepin, Associate
Vice President, Regulatory Strategies and lead investigator for
this grant for Simulations Plus. “Together, we are charting a
course towards more efficient drug development and safer healthcare
solutions. We believe the comprehensive framework established
through this collaboration will have value for both the FDA and the
companies involved in developing oral MR formulations.”
“The research efforts of our team and Dr. Shen have the
potential to accelerate the availability of critical treatments to
patients across the world, with minimized need for clinical
trials,” said Susann Bellmann, Chief Technology Officer at The TIM
Company. “We are proud to support those efforts and this
collaboration through the use of our dynamic in vitro
gastrointestinal model, tiny-TIMsg.”
FDA scientific and program staff will actively collaborate with
Northeastern University, The TIM Company, and Simulations Plus. Dr.
Pepin, with assistance from Dr. Maxime Le Merdy at Simulations
Plus, will oversee the modeling and simulation activities of the
contract.
Funding for this collaboration is made possible by the Food and
Drug Administration through grant award 1U01FD007959-01. 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 Professor Jie Shen’s Laboratory at Northeastern
University
Professor Jie Shen’s laboratory at Northeastern University is
dedicated to innovative and collaborative interdisciplinary
pharmaceutical and biomedical research to enhance public access to
high quality and cost-effective medications to ultimately improve
public health. Professor Shen’s laboratory is specialized in the
formulation development and characterization, bioequivalence
assessment strategies, and IVIVC (in vitro-in vivo correlation) of
complex drug products (such as long-acting or locally-acting dosage
forms, nanomedicines, modified release formulations). For more
information, visit our website or follow us on LinkedIn. Founded in
1898, Northeastern is a global research university and the
recognized leader in experience-driven lifelong learning. Our
world-renowned experiential approach empowers our students,
faculty, alumni, and partners to create impact far beyond the
confines of discipline, degree, and campus.
About The TIM Company
The TIM Company expands its legacy of expertise within in vitro
gastrointestinal models, combining over 35 years of experience.
Headquartered in Delft, The Netherlands, The TIM Company is driven
by the goal of developing alternative technologies to dissolution
methods and animal research. Through its highly predictive
technologies, it strongly contributes to the successful evaluation
of oral formulation behavior and formulation performance prior to
entering clinical trials. Data from TIM have guided clients
worldwide with decision-making in different stages of oral drug
development, i.e., led to the decrease in formulation reiterations,
effectively de-risked clinical trials, and shortened
time-to-market. For more information, visit our website at
www.theTIMcompany.com or follow us on LinkedIn.
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.
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 2022 ESG update.
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 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 Tamara Gonzalez
310-622-8234 slp@finprofiles.com
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