Tuesday, April 23rd, 2026: Day TwoThursday, 23 April 2026 - US/Eastern

As submission timelines tighten and trial complexity grows, biometrics and statistical programming teams are exploring how Agentic AI can transform SDTM and ADaM generation. In this session, Benzi Mathew will present alongside a pharma partner to share practical perspectives on applying Agentic AI to accelerate submission readiness while increasing productivity.

Key themes include:
• Real-world implementation of Agentic AI in SDTM and ADaM workflows
• Productivity gains within statistical programming and biometrics teams
• Ensuring regulatory compliance, traceability, and audit readiness

AI is no longer just drafting documents. It is transforming how clinical and scientific information is structured, queried, and operationalized across healthcare and biotech. This session explores how LLMs are being applied to turn unstructured clinical data into decision ready intelligence, supporting patient engagement, research workflows, and precision medicine without replacing expert judgment.

Key Themes:

• Using LLMs to structure and operationalize complex clinical and research data
• Applying AI to Genomic Tumor Board workflows and precision oncology decision support
• Designing physician curated and source grounded AI systems for patient facing use cases
• Balancing automation with clinical oversight, trust, and accountability
• Moving from static documentation to living knowledge systems

Digital innovation in healthcare is a marathon, not a sprint. This session will explore Roche’s multiyear journey toward becoming a digital Regulatory organization and outline its future investment plan. From strategy to execution, attendees will gain insights into how Roche leverages data, technology, and AI to create scalable solutions that deliver real-world impact.

Moving to enterprise scale demands cultural alignment and cross functional fluency. This executive roundtable brings together leaders driving AI transformation to explore how organizations accelerate adoption, overcome workforce barriers, and build AI fluent clinical teams that sustain innovation.

Key Themes:

• Mapping where your organization falls on the AI maturity curve from pilot to portfolio

• Overcoming adoption barriers: talent, culture, compliance, and trust

• Designing training frameworks that translate AI capability into clinical and regulatory practice

• Building collaboration across clinical, biometrics, regulatory, and data teams

• Sustaining momentum by embedding AI fluency into organizational culture

• Preparing teams for the next wave of acceleration in clinical AI

Automation meets accuracy. This session explores how AI-powered documentation is transforming regulatory writing, CSR generation, and submission prep—without compromising scientific integrity.

Key Themes:

• Automating repetitive writing tasks while maintaining precision and tone

• Using NLP and generative AI to draft CSRs, protocols, and IB updates

• Establishing validation and review workflows that satisfy regulators

• How human-AI collaboration accelerates timelines yet preserves credibility

A collaborative exercise to turn inspiration into execution. Participants synthesize insights from both days and map out actionable priorities for the year ahead.

Key Themes:

• Rapid recap of key trends and takeaways

• Building a 12-month AI roadmap tailored to your organization

• Peer-to-peer exchange: what’s working, what’s next

• Committing to measurable outcomes before reconvening in 2026

As AI becomes increasingly embedded in clinical trial design and decision-making, maintaining quality, ethics, and human oversight is critical. This closing panel brings together clinical, quality, and technology leaders to explore how organizations can responsibly scale automation without compromising scientific rigor, patient safety, or trust.

Key Themes:

• Defining human-in-the-loop models that ensure accountability and data integrity

• The evolving role of quality leadership in AI-enabled clinical operations

• Embedding ethics, transparency, and auditability into automated systems

• Preserving patient-centricity and clinical judgment in increasingly digital trials