Speakers from Academia, Large Pharma
Collaborations and Regulatory Agencies shared their real-world
impact using modeling & simulation technology
Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of
modeling and simulation software and services for pharmaceutical
safety and efficacy, announced the successful launch of its 2021
MIDD+ Scientific Conference, a two-day event focused on delivering
customized modeling and simulation content specifically for
pharmaceutical scientists and their organizations. Tracks included
dedicated sessions covering all stages of the drug development
process including Discovery, Pre-clinical, First in Human
(FIH)/Phase I through Post-Approval and Generics.
Shawn O’Connor, chief executive officer of Simulations Plus,
said: “The evolution of modeling and simulation in Pharma drug
development has matured tremendously. From its beginnings more than
20 years ago when its earliest advocates were searching for
applications and proof points, modeling and simulation has today
become an integral part of the drug development process, providing
significant improvements in the timely and cost-efficient delivery
of new drug candidates to regulatory approval. As a leading
provider of the software tools and services that facilitate this
achievement, we were pleased to provide this virtual venue for
industry, regulatory bodies, and academia to meet and share the
means by which modeling and simulation supports, and will in the
future more fully support, model-based drug development.”
Over two days, March 3 and 4, speakers worldwide, including
representatives from the U.S. FDA Offices of Clinical Pharmacology,
New Drug Products, Research and Standards, Translational Sciences,
the Center for Drug Evaluation and Research, and the National
Center for Toxicological Research, as well as ANVISA and Health
Canada, provided over 1,000 registered attendees with case studies,
software demonstrations, and engaging Q&A sessions. Topics
ranged from building and validating machine-learning models, to
using population PK/PD approaches to support later phase dose
selection, to regulatory perspectives for reliable model-informed
drug development.
The event featured a panel discussion on the ascent of
model-informed drug development and the increasing importance of
developing next generation technology. Participants included a
Chief Scientific Officer, Vice Presidents of Simulation Sciences,
Regulatory Affairs, and Pharmacometric Services, and a Chief
Operating Officer with, collectively, almost 100 years of modeling
experience. A wide range of questions were fielded from a diverse
audience that represented commercial and academic markets as well
as global regulators. Ideas shared during the discussion included
the importance of relevant data and improving the modeler's
communication skills, especially to non-modelers. All panelists
expressed a commitment to advocating for the continued education of
the next generation of modeling and simulation scientists.
The Women in Science roundtable led by divisional president Jill
Fiedler-Kelly highlighted the gender gap in career, salary,
scientific publications, and departure from the workforce due to
COVID-19. The panel, including ten female scientists representing
each division of Simulations Plus, also discussed the importance of
mentorship, mental health, a solid support system for working
mothers, and the Family and Medical Leave Act. It was a morning of
emotion, inspiration, humor, and passion, with one speaker
emphatically stating, “I am a mother, but I am ALSO A
SCIENTIST.”
The conference included a live presentation of three Simulation
Plus awards: the 2021 Outstanding Woman in Science winner
Julie Stone, Distinguished Scientist, Quantitative Pharmacology and
Pharmacometrics, Merck; the Award for Excellence in
Academia winner Stephan Schmidt, Director, Center for
Pharmacometrics and Systems Pharmacology at University of Florida;
and the STEM Forward Award winner Aruna Dontabhaktuni,
Founder & CEO, PharmaPro Consulting and Project
Dontabhaktuni.
Award descriptions, speaker profiles, and video presentations
may be found on our website; programming and speaker requests for
the 2022 MIDD+ Scientific Conference should be forwarded to
arlene@simulations-plus.com.
About Simulations Plus, Inc. Simulations Plus, Inc. is a
leading provider of modeling and simulation software and consulting
services supporting drug discovery, development research, and
regulatory submissions. With our subsidiaries, Cognigen, DILIsym
Services, and Lixoft, we offer solutions which bridge 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, chemical, consumer goods 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 Relations
Ms. Renee Bouche 661-723-7723 renee@simulations-plus.com
Hayden IR Mr. Cameron Donahue
651-653-1854 slp@haydenir.com
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