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

Keywords: ai, AI Predictions, AI-accelerated drug development, AI-assisted drug discovery and design, biopharma, MIDD

 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.