That reality is at the heart of the 2026 ISPE AI in Life Sciences Summit, the first-ever ISPE conference dedicated exclusively to AI, taking place 22–23 June 2026 in Boston, Massachusetts. Among its most compelling program elements is the Workforce Preparedness and Organizational Readiness track, designed to equip life sciences organizations with the strategies, frameworks, and real-world lessons needed to successfully adopt and scale AI in regulated environments.
Building AI-Ready Organizations in Regulated Industries
The Workforce Preparedness and Organizational Readiness track focuses on aligning people, processes, and technology to enable responsible AI adoption across the life sciences value chain. Through practical case studies and implementation-focused sessions, speakers share how organizations are:
- Creating AI-ready cultures grounded in trust, transparency, and compliance
- Developing multi-year AI and digital capability roadmaps
- Redefining workforce roles and incentives for an automated future
- Establishing governance models that balance innovation with quality and GxP expectations
A consistent theme across the track is action. These are not theoretical discussions about possibility—they are stories from organizations already navigating AI transformation at scale.
Unifying People, Process, and Technology: Pfizer’s AI Journey
The track opens with a compelling example of enterprise-scale adoption in “GRS: People, Process and Tech Unified for AI Excellence.” Garrett Goodwin and Janine Clulow of Pfizer’s Global Regulatory Strategy (GRS) share how their organization has emerged as a leader in AI adoption—both within Pfizer and across the industry.
Their approach begins with a clear governance framework and a people-first vision focused on recognition, relevance, and relief from low-value work. By embedding AI into performance goals, offering bi-weekly AI office hours, and encouraging colleagues to dedicate 5 percent of their time to experimentation, GRS has normalized AI as part of everyday work. With over 800 colleagues engaged in a thriving AI Community of Practice and more than 60 percent of Copilot users using AI daily, Pfizer demonstrates what’s possible when workforce strategy, incentives, and technology move in sync.
A Five-Year Roadmap for Scaling GenAI in Global Operations
In “Scaling GenAI: A 5-Year Roadmap for Global Biologics,” Jesse Summers, Director of Strategy and PMO for Global Biologics Operations at AstraZeneca, provides a pragmatic blueprint for long-term AI enablement.
The session walks attendees through a capability ladder—from secure, validated GenAI chatbots to enterprise-wide copilots and agent-builder platforms—tied directly to real operational use cases such as tech transfer acceleration, predictive maintenance, and yield optimization. Crucially, Summers outlines a governance funnel that supports citizen developers while ensuring alignment with GxP requirements. The result is a repeatable methodology that turns ideas into prioritized, value-driven solutions with measurable outcomes.
Establishing Guardrails for Pharma-Trusted AI
Trust is a recurring concern when AI systems are applied to manufacturing and quality-critical activities. In “Guardrails for Building Pharma-Trusted AI in Manufacturing,” Rick Johnston, PhD, of Applied Materials reframes the conversation—not around avoiding risk, but around responsibly unlocking AI’s full potential.
Johnston introduces the concept of Pharma-Trusted AI, emphasizing explainability, validation frameworks, and human-in-the-loop oversight. Drawing on examples from process development and manufacturing operations, the session shows how AI can move beyond traditional automation and analytics to become a trusted partner—while maintaining the precision, quality, and safety the industry demands.
From Digital Tools to Submission-Ready Governance
AI adoption in Regulatory Affairs and CMC is maturing rapidly, and with that maturity comes heightened regulatory scrutiny. “AI in Regulatory Affairs and CMC: From Digital Tools to Submission-Ready Governance,” presented by Kelsey Hoontis, of Boston Biodevelopment, addresses this shift head-on.
The session provides a regulatory-focused roadmap for transitioning from fragmented AI tools to structured, inspection-ready governance models aligned with US Food and Drug Administration, European Medicines Agency, and emerging global expectations. Attendees gain practical strategies for preserving data integrity, traceability, and confidence in submission quality—while still realizing the efficiency gains AI enables.
Real Results from Human–AI Collaboration in Quality
Later in the afternoon, Eric Rehberg of Black Mesa Technology shares a powerful case study in “The Human-AI Partnership in Quality Assurance: Real Results.” The session explores how a biomanufacturing facility augmented its QA team with AI-driven error detection—without disrupting existing workflows.
By allowing machines to manage exhaustive pattern detection and humans to focus on judgment and context, the organization achieved faster batch reviews, improved error detection, and more meaningful work for quality professionals. It’s a compelling example of workforce augmentation done right.
Sparking Transformation Through Cross-Functional Collaboration
Closing the track, Michael Grischeau and Paula Gamboa of AbbVie present “How Cross-Functional Collaboration Ignites Transformation.” Their Operations Quality Assurance Innovation Accelerator demonstrates how tiered governance, leadership empowerment, and responsible experimentation can drive scalable, compliant innovation.
By breaking down silos and aligning stakeholders across quality, regulatory, and operations, AbbVie’s model delivers measurable value—time savings, cost avoidance, and increased throughput—while laying a foundation for long-term adaptability.
Be Part of the Summit That Puts People First
The Workforce Preparedness and Organizational Readiness track underscores a defining message of the 2026 ISPE AI in Life Sciences Summit – Powered by GAMP®: AI success in life sciences starts with people.
For leaders, practitioners, and change agents navigating AI adoption in regulated environments, this summit offers unprecedented access to real-world experience, proven frameworks, and a global peer community. Join ISPE in Boston on 22–23 June—and help shape an AI-enabled future that is innovative, compliant, and human-centered.
Learn more and register today.
