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

For emerging biotech companies leveraging AI, early operational decisions can define long-term scalability and compliance. This session provides a practical roadmap for creating durable procedures that foster innovation while supporting sustainable growth.

Key Themes:

• What “good” procedures look like in an AI-enabled biotech environment

• Building SOPs that balance flexibility with regulatory readiness

• Embedding quality and reproducibility into workflows from day one

• Common pitfalls in early-stage biotech operations—and how to avoid them

• Aligning data governance, documentation, and decision-making with future scale

• Real-world examples of frameworks that supported successful growth and partnerships

Join industry leaders for a discussion on how flexible leadership can accelerate AI-driven transformation in clinical trials.

• Examine how to move beyond rigid guidelines and instead use them as guardrails to support innovation

• Explore decision-making frameworks for when to build, buy, or bring in external consultants for AI infrastructure

• Discuss the role of transparency and clearly defining end goals before launching transformation initiatives

• Hear lessons learned from early AI and transformation pilots, including what worked, what didn’t, and how teams adapted

• Identify practical strategies to maintain flexibility while still ensuring compliance, quality, and stakeholder trust

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.

Using AI in clinical research is no longer optional—but adoption still isn’t equal. This session explores how organizations move from early experimentation to enterprise-scale maturity, and what it takes to stay ahead of the curve as innovation accelerates.

Key Themes:

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

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

• How top-performing teams sustain momentum while others stall

• The “next leap” in clinical AI: anticipating disruption before it happens

When global scale meets start-up speed—everyone wins. This interactive discussion bridges perspectives from large and emerging organizations to uncover where collaboration creates true value.

Key Themes:

• Comparing AI adoption journeys across organization sizes

• Lessons from both sides: enterprise structure vs. start-up agility

• Identifying partnership models that accelerate innovation and reduce redundancy

• Open exchange on shared roadblocks, wins, and future opportunities

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