About this Event
ISPE NJ | AI-Enabled Productivity in Pharma
From regulation and governance to engineering, construction, automation, and quality, this program brings together multiple perspectives on how AI is moving from experimentation to practical implementation across the life sciences industry.
Thursday, November 5, 2026 | 2:00–8:00 PM
2 Tower Center, East Brunswick, NJ 08816
In-person educational program followed by dinner and networking
PROGRAM SCHEDULE
2:00–2:30 PM | Registration & Opening Remarks
2:30–3:00 PM | KEYNOTE
Ben Stevens | Alnylam Pharmaceuticals
Senior Director, Regulatory Affairs CMC Policy & Advocacy
Regulatory Considerations for Artificial Intelligence in Pharmaceutical Manufacturing
Explore the evolving regulatory landscape for AI and machine learning in pharmaceutical manufacturing, including emerging legislation, GMP expectations, the draft FDA AI guideline, and Annex 22. The session will highlight the guardrails taking shape around responsible AI use and practical considerations as deployment accelerates.
3:00–3:30 PM | GOVERNANCE & ALIGNMENT
Bill Reid | Google Cloud
Healthcare & Life Sciences Leader, Office of the CISO
Title: Getting Alignment: Governance of AI in Life Sciences
This discussion explores AI governance through the lenses of model alignment, agentic control, cybersecurity, and operational resiliency, while considering how the life sciences industry's existing disciplines can support the responsible and productive adoption of AI.
3:30–4:00 PM | ENGINEERING & FEASIBILITY
James Sessions | Century 3
Senior Vice President
Title: From Field Productivity to AI-Assisted Feasibility
See how AI-enabled tools are being applied from field productivity through feasibility development. The session focuses on accelerating feasibility studies while maintaining visible assumptions, sources, calculations, review decisions, data quality, human approvals, and engineering judgment.
4:00–4:20 PM | Networking Break
4:20–4:50 PM | AUTOMATION DESIGN
Guru Thakkar | InflexionPoint
Director of Engineering
Title: Engineering Life Sciences with AI: Precision, Flexibility, and Responsible Governance from Concept to Validation
Explore how AI is being incorporated across automation and digital-system delivery, from scoping and requirements through design, implementation, testing, commissioning, and validation. Practical use cases demonstrate opportunities to improve engineering productivity, identify gaps earlier, and support flexible facility designs while preserving governance, traceability, technical rigor, and human accountability.
4:50–5:20 PM | PROJECT DELIVERY & CONSTRUCTION TECHNOLOGY
Lisa Dunmeyer & Michael "MC" Contreras | STO Building Group
TECH Ops
Title: Leveraging AI Tools for Project Delivery
Explore how AI and digital tools can improve efficiency and quality throughout the project lifecycle. The session will address technology strategy, identifying design ambiguities and risk earlier, and using digital twins, automation, and schedule information to strengthen project communication and collaboration.
5:20–5:50 PM | DRAWING INTELLIGENCE & AI LIMITATIONS
John Altieri, P.E. | Trunk Tools
Construction PM
Title: Why Off-the-Shelf AI Fails on Construction Drawings
Construction drawings are interconnected visual systems of symbols, details, revisions, relationships, and design intent, creating challenges for general-purpose AI. This session examines how construction-specific AI combines visual understanding, document relationships, and project context to identify changes, compare revisions, and translate complex drawing information into actionable project insights.
5:50–6:20 PM | QUALITY & DATA LAYER
Zephaniah Odidika | KeyPedia
Co-Founder & COO
Title: Your Quality Team Is Already Using AI. Feed It Better Data
Learn why the quality of the data behind AI matters as much as the AI itself. The session explores connecting FDA and global enforcement information with AI applications to help quality organizations create more structured approaches to regulatory information, risk identification, and AI-supported decision-making.
6:30–8:00 PM | Dinner & Networking
Join Us
A full afternoon of insight, practical application, and cross-industry collaboration—followed by dinner and networking with leaders shaping the future of AI in life sciences.
Registration & Sponsorship
ISPE Member $120
Non-Member $150
Event Sponsor (4 available) $500
Food & Beverage Sponsor (4 available) $250
REGISTER TODAY TO SAVE YOUR SPOT!
Agenda
🕑: 02:00 PM - 02:30 PM
Registration & Networking
🕑: 02:30 PM - 04:00 PM
Sessions 1-3
🕑: 04:00 PM - 04:20 PM
Break
🕑: 04:20 PM - 06:20 PM
Sessions 4-7
🕑: 06:30 PM - 08:00 PM
Dinner & Networking
Event venue & nearby stays
2 Tower Center Blvd, 2 Tower Center Boulevard, East Brunswick, United States