AI-ENABLED PRODUCTIVITY IN PHARMA

Join ISPE NJC for an in-person AI-focused educational program, followed by dinner and networking. 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!