Simulations Plus Convening Panel to Define AI's Practical Regulatory Path in Drug Development
Event summary
- Simulations Plus is hosting a panel discussion, 'From Debate to Deployment: Responsible, Practical AI in MIDD,' at the ASCPT Annual Meeting on March 5, 2026.
- The panel will focus on the practical implementation of AI in model-informed drug development (MIDD) workflows.
- Key panelists include representatives from the FDA, Genmab, Incyte, Pfizer, Bristol Myers Squibb, and Simulations Plus.
- The discussion aims to move beyond theoretical AI potential and address operational insights for scientists and stakeholders.
The big picture
The press release highlights a pivotal shift in the biopharmaceutical industry, moving beyond the hype surrounding AI to focus on practical, regulated implementation. Simulations Plus's initiative underscores the growing recognition that AI's value lies in its ability to augment, not replace, human expertise within complex drug development processes. This effort positions Simulations Plus to benefit from the increasing demand for validated AI solutions within a sector facing mounting pressure to accelerate timelines and reduce costs.
What we're watching
- Regulatory Scrutiny
- The FDA’s involvement signals increasing regulatory focus on AI in drug development, potentially leading to stricter guidelines and validation requirements for AI-driven processes.
- Workflow Integration
- The success of Simulations Plus’s strategy hinges on the ability of MIDD workflows to genuinely integrate AI, rather than simply layering it on existing processes, which will impact adoption rates.
- Talent Shift
- The panel’s discussion of evolving scientific roles suggests a need for upskilling and reskilling within biopharma, which could create a bottleneck if not addressed proactively.
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