Press release

Lisa LaVange, PhD, Appointed to Board of Directors of Simulations Plus

Sponsored by Businesswire

Simulations Plus, Inc. (Nasdaq:SLP), the premier provider of simulation
and modeling software and consulting services for all stages of
pharmaceutical discovery and development, today announced the
appointment of Dr. Lisa LaVange to the Company’s Board of Directors.
With a distinguished career spanning more than 35 years, Dr. LaVange
brings expertise in biostatistics and experience with academia,
commercial organizations, including Quintiles, the largest
pharmaceutical outsourcing services company in the U.S., and government
regulators, including a senior position at the U.S. Food and Drug
Administration (FDA).

Dr. LaVange currently serves as Professor and Associate Chair of the
Department of Biostatistics in the Gillings School of Global Public
Health at the University of North Carolina at Chapel Hill. At UNC, she
directs the establishment of a new Master’s in Public Health (MPH)
program with a concentration in data science, and is planning a
regulatory science curriculum focused on statistical methodologies in
two areas: precision medicine and real-world evidence. In addition, she
is currently Principal Investigator (PI) of the coordinating centers for
two large and complex trial networks: the NICHD-sponsored Adolescent
Medicine Trials in HIV/AIDS Interventions Network (ATN) and the
NHLBI-sponsored Precision Medicine in Severe and Exacerbation-Prone
Asthma Network (PreciSE).

From 2011 to 2017, Dr. LaVange served as Director of the Office of
Biostatistics in the Center for Drug Evaluation and Research (CDER) at
the U.S. Food and Drug Administration (FDA). In this role, she directed
215 statistical reviewers, analysts, and support staff involved in the
development and application of statistical methodology for drug
regulation. She was responsible for statistical review of all
investigational drugs, therapeutic biologics, biosimilar products, and
generic drugs. She also chaired the Statistical Policy Council and was a
member of CDER’s Medical Policy Council, setting statistical policy and
overseeing statistical guidance development and publication for the

Previously, she worked for six years at Quintiles, Inc. (now IQVIA),
serving as Vice President of Biostatistics for her last three years.
Quintiles is the largest pharmaceutical outsourcing services company in
the U.S. In this role, she directed over 200 statisticians and
programmers located in five offices across North America, supporting
clinical trial operations, regulatory submissions, and post-marketing
evaluations for a variety of large and small pharmaceutical and
biotechnology companies. Dr. LaVange also served as Vice President,
Biostatistics and Data Management, for Inspire Pharmaceuticals, Inc. Dr.
LaVange is an elected fellow of the American Statistical Association
(ASA) and was the 2018 ASA President. She is also former president of
the Eastern North American Region of the International Biometric Society
(ENAR-IBS) and former IBS Board member.

“For more than 35 years, I have worked with commercial organizations,
academic researchers, and government regulators in areas of statistical
research and methodologies, with a particular focus on biotechnology,”
commented Dr. LaVange. “Throughout most of that time, Simulations Plus
has been a leader in the advancement of sophisticated modeling and
simulation technology in this sector. I am honored and excited to join
the Board of Directors, and I look forward to helping Simulations Plus
continue its growth. Technology continues to play an increasingly vital
role in drug development, and I hope to accelerate adoption of in
modeling as a member of the Simulations Plus Board of

Walt Woltosz, Founder and Chairman of the Board, added: “Dr. LaVange was
selected after the most exhaustive search for a new independent director
in our company’s history, and we could not be more thrilled to add a
leader with her broad and noteworthy expertise to our board. Her tenures
at Quintiles and Inspire provide highly relevant experience to our
board, enabling her to easily put herself in the position of our
customers. In addition, the Board and management will benefit from her
experience with the FDA, as well as her deep academic background.
Concurrently, Dr. Ted Grasela has resigned from the Board. He remains
Cognigen President and will continue to focus on the growth of our
consulting practice and his work with key clients and the FDA. We thank
Ted for his outstanding service to the Board of Directors.”

, Chief Executive Officer of Simulations Plus, added: “Dr.
LaVange adds highly relevant experience across all facets of our
industry to an already strong Board of Directors. Our entire management
team looks forward to benefiting from her experience and expertise.”

Dr. LaVange will serve as an independent director, with a term through
the 2020 annual shareholder meeting. It is anticipated that Dr. LaVange
will serve as the Chairman of the Compensation Committee and also will
be a member of the nominating and audit committees.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and
development software as well as a leading provider of both preclinical
and clinical pharmacometric consulting
for regulatory submissions and quantitative
systems pharmacology models
for drug-induced
liver injury
, drug-induced
kidney injury
, and nonalcoholic
fatty liver disease
. The company is a global leader focused on
improving the ways scientists use knowledge and data to predict the
properties and outcomes of pharmaceutical, biotechnology, and chemical
agents. Our software is licensed to and used in the conduct of drug
research by major pharmaceutical, biotechnology, chemical, and consumer
goods companies and regulatory agencies worldwide. Our innovations in
integrating new and existing science in medicinal chemistry,
computational chemistry, pharmaceutical science, biology, and physiology
into our software have made us the leading software provider for physiologically
based pharmacokinetic modeling and simulation
. For more information,
visit our website at

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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