Lisa LaVange, PhD, Appointed to Board of Directors of Simulations Plus
May 01 2019 - 4:15PM
Business Wire
Brings 35+ Years of Industry and Regulatory
Expertise to Board
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
Center.
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 silico modeling as a member
of the Simulations Plus Board of Directors.”
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.”
Shawn O’Connor, 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 services 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
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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