Simulations Plus Convenes Industry and Regulatory Leaders to Define Responsible AI in MIDD

Expert panel at the 2026 ASCPT Annual Meeting brings together leaders with industry and regulatory experience to explore practical, accountable AI implementation

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced a high-impact panel discussion, “From Debate to Deployment: Responsible, Practical AI in MIDD,” to be held during the upcoming American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting on March 5, 2026 at 12:00 PM MST in Denver, CO.

“There is no longer a question of whether artificial intelligence (AI) should be used in drug development, but how to implement it responsibly, defensibly, and with measurable value,” said Dr. Viera Lukacova, Chief Scientific Officer of Simulations Plus and moderator of the panel. “We are excited to bring together leaders who can share perspectives influenced by their industry and regulatory experiences to discuss the cost and impact that should be considered by scientists, stakeholders and leaders involved in AI decision-making and implementation.”

During the session, panelists will discuss how AI is currently being deployed as part of model-informed drug development (MIDD) workflows. The session will focus on:

• Where AI is delivering measurable impact today
• How organizations are navigating strategic decisions around building, buying, or partnering to enable sustainable implementation
• The regulatory principles shaping AI-enabled development strategies

Beyond technology, the session will also address the human dimensions of AI integration, discussing where expert judgment is still central, how scientific roles and workflows are adapting to this technology, and the skills scientists will need to succeed in an increasingly AI-enabled future.

“So much of the conversation around AI revolves around abstract future potential, but we recognize that scientists and stakeholders need practical and operational insights they can put to use now,” said John DiBella, Chief Revenue Officer of Simulations Plus. “Our product strategy is centered on integrating AI directly into our core engines and model-informed workflows where it enhances scientific judgment, improves efficiency, and stands up to regulatory scrutiny. This panel is an extension of that commitment, and we are excited to help the industry move from discussion to disciplined deployment.”

Panelists include:

• Rajanikanth Madabushi, Associate Director for Guidance and Scientific Policy, Office of Clinical Pharmacology, CDER/FDA
• Jeff Barrett, Vice President, Clinical Pharmacology & Quantitative Science, Genmab
• John Mondick, Head of Clinical and Quantitative Pharmacology, Incyte
• Mohamed Shahin, AI Strategy Lead, Pfizer
• Yue Zhao, Director, Pharmacometrics, Bristol Myers Squibb
• Amparo de la Peña, Vice President, Pharmacometric Services, Simulations Plus
• Susie Zhang, Vice President, Regulatory Strategies, Simulations Plus

The panel will be held during the ASCPT Annual Meeting in room Summit 9. Interested attendees are encouraged to arrive early as space is limited.

About Simulations Plus, Inc.

Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.

Forward-Looking Statements

Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will”, “can”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) mean that these are our best estimates as of this writing, but 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. Forward-looking statements include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance, regulatory compliance and commercialization of AI-enabled and could-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, 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, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual, and current reports and filed with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.

Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com