Simulations Plus Hosts the 2022 Model-Informed Drug Development (MIDD+) Scientific Conference

Attendees from 57 Countries Spend Two Days Focused on Advancing Model-Informed Drug Development

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, announced record-setting attendance and virtual content delivery for the 2022 MIDD+ Scientific Conference which was held February 16–17, 2022. The conference was focused on delivering real-world case studies using modeling and simulations. Tracks included dedicated sessions covering all stages of the drug development process, including Discovery, Pre-clinical, Clinical, and Post-Approval/Generics.

Shawn O’Connor, chief executive officer of Simulations Plus, said: “We were pleased with the momentum that carried forward from our inaugural MIDD+ event last year resulting in the record-setting attendance at this year’s MIDD+ Scientific Conference. As a leader in providing software tools and services to support the industry and our clients in their efforts to leverage modeling and simulation for more efficient and timely drug development, we were pleased to provide this virtual forum.”

The conference opened on February 16, with Rajanikanth Madabushi, Ph.D., Associate Director for Guidance and Scientific Policy, Office of Clinical Pharmacology, OTS/CDER at the U.S. Food and Drug Administration (FDA), delivering his keynote talk entitled, “Advancing Model-Informed Drug Development (MIDD): A Holistic and Integrative Approach.” On day two, speakers worldwide, including representatives from the U.S. FDA, the Brazilian regulatory agency ANVISA, Health Canada, and MHRA-UK, provided attendees with case studies and global regulatory perspectives on the development and validation of MIDD.

Other session topics ranged from building and validating machine-learning models and using population PK/PD approaches to support late-phase dose selection. Of note, the Women in Science roundtable, led by Cognigen’s Divisional President, Jill Fiedler-Kelly, highlighted meaningful topics for women within the scientific pharmaceutical industry including the power of mentorship, closing the STEM gap, and bringing your “authentic self” to the workplace. All talks are available for replay in the Simulations Plus Resource Center. Presentations and slide decks may be found on our website and YouTube channel.

Programming and speaker requests for next year’s 2023 MIDD+ Scientific Conference are invited and may be sent to Arlene Padron at arlene.padron@simulations-plus.com.

About Simulations Plus

Serving clients worldwide for 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that 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, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on Twitter | LinkedIn.

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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.bouche@simulations-plus.com

Hayden IR

Mr. Brian Siegel

346-396-8696

brian@haydenir.com

Source: Simulations Plus, Inc.