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Simulations Plus Hosts the Inaugural 2021 MIDD+ Scientific Conference with over 50 Model-Informed Drug Development Sessions

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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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Contacts

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