AI-ENABLED PRODUCTIVITY IN PHARMA

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!