U.S. FDA Renews DILIsym Software Licenses
May 16 2019 - 8:30AM
Business Wire
U.S. FDA Remains Committed to Streamline
& Accelerate Drug Development using Model-Informed Drug
Development (MIDD) technology
DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP)
and a leading provider of simulation and modeling software for
pharmaceutical safety and efficacy, today announced that the U.S.
Food and Drug Administration has renewed its multi-seat license for
the company’s flagship quantitative systems toxicology (QST)
modeling software, DILIsym®. The renewal provides DILIsym access to
FDA employees across all FDA divisions.
DILIsym prospectively supports key management decisions by
providing information about potential drug-induced liver injury
(DILI) risk in upcoming experimental or clinical study designs, as
well as mechanistic rationale for the underlying biochemical events
that could cause liver toxicity. The information from such studies
serves to guide go/no-go decisions on major projects, potentially
avoiding the disastrous financial effects of failed clinical
trials, or better, providing assurances that drug-induced liver
injury will not be an insurmountable obstacle to establishing the
safety of a new compound or dose. DILIsym is the product of an
ongoing public-private partnership (the DILI-sim Initiative) that
involves scientists from the pharmaceutical industry and
academia.
Dr. Paul Watkins, chair of the DILI-sim Scientific Advisory
Board, said: “DILI remains a major problem for drug developers and
regulators. DILIsym modeling software is helping to address this
challenge. We’re excited to see the DILI-sim Initiative QST
platform continue to be available to the FDA, especially as sponsor
submissions with DILIsym results are ever increasing.”
Dr. Brett Howell, president of DILIsym Services, added: “The
cost of developing new drugs continues to rise, and liver safety is
an important component of this cost. If not adequately addressed
during the drug development process, this issue can either force
companies to run unrealistically large clinical trials to support
safety or to abandon their molecule after expensive large trials
and even drug approval in some cases. DILIsym is now helping
companies address these concerns through the use of QST, and we are
delighted to see that the FDA remains engaged in this process
through the renewal of its license package for DILIsym.”
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 DILIsym Service, Inc.
DILIsym Services, Inc. was founded in 2015 in Research Triangle
Park, North Carolina, and has developed DILIsym and NAFLDsym® QSP
software, and is developing IPFsym™ and RENAsym™ QSP software, to
provide the pharmaceutical industry with the tools and resources to
efficiently develop safe and effective drug therapies. DILIsym and
RENAsym are designed to address drug-induced liver injury (DILI)
and drug-induced acute kidney injury, respectively. NAFLDsym and
IPFsym are designed for target or compound evaluation of
therapeutic efficacy in nonalcoholic fatty liver disease (NAFLD or
NASH) and idiopathic pulmonary fibrosis (IPF), respectively. Thus,
DILIsym and RENAsym may be applied to address drug safety across
therapeutic areas, while NAFLDsym and IPFsym may be applied to
support the development of efficacious drugs in these therapeutic
areas. DILIsym Services makes these tools available to small,
mid-size and large pharmaceutical organizations and regulatory
agencies through its licensing programs. In addition to performing
consulting services using the modeling software, the expert
scientific team engages clients from initial program design through
data input and “results” interpretation. The company’s mission is
to apply its modeling and simulation expertise to support the
development of safe and efficacious drug therapies. More
information is available on the company’s web page at
www.dilisymservices.com.
About Simulations Plus, Inc.
Simulations Plus, Inc. is the premier developer of modeling and
simulation software and consulting services supporting drug
discovery, development research, and regulatory submissions. With
our subsidiaries, Cognigen Corporation and DILIsym Services, we
offer #1-ranked, easy-to-use software to bridge data mining and
compound library screening with QSAR models, PBPK/TK modeling and
simulation in animals and humans following administration around
the body, and quantitative systems pharmacology approaches. Our
technology is now licensed and used by major pharmaceutical and
biotechnology companies and regulatory agencies worldwide. For more
information, visit our website at www.simulations-plus.com.
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
RelationsMs. Renee
Bouche661-723-7723renee@simulations-plus.com
Hayden IRMr. Cameron
Donahue651-653-1854cameron@haydenir.com
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