PAT THOUGHT LEADERSHIP CONCLAVE

PAT THOUGHT LEADERSHIP CONCLAVE

Manufacturing is moving toward autonomy faster than most organizations are ready for, AI is rewriting how process decisions get made, and modality after modality is forcing Process Analytical Technology (PAT) teams to rethink established approaches for monoclonal antibodies. Building on the momentum from our previous PAT Thought Leaders Workshop, with leaders from Merck, Lilly, Pfizer, Sanofi, AstraZeneca, and BMS, Waters is convening a small, closed working session to push further into next generation of PAT capabilities and anticipate challenges ahead.

What You'll Gain

• A direct read on how peers in other organizations are approaching the future state of PAT and roadblocks to implementation.
• A direct line into what Waters builds next on autonomous manufacturing, AI-driven process control, and PAT for new modalities.
• Working-level access to Waters senior leadership, including Rob Carpio (SVP), Dave Leitham (VP Informatics), and David Curtin (VP Biologics).

The Issues That Will Drive the Discussion

• Lights-Out Manufacturing and Labs: what it takes to reduce human intervention, and where today's technology still falls short.
• Data, Digital and AI Integration: separating real AI/ML impact on process control from the hype.
• PAT for New Modalities: practical approaches for peptides, ADCs, liposomes, and viral vectors.
• PAT for Synthetic Biology: where cell therapy and synthetic biology are pushing PAT into new territory.

Agenda

08:00: Registration & Coffee
Anastasia Dawson, Waters Corporation

08:30: Welcome & framing "We heard you and made progress"
Ranjeet Patil, Waters Corporation

08:45: Opening remarks
Rob Carpio (SVP), Waters Corporation

09:00: Theme 1: Lights-Out Manufacturing & Labs
Ranjeet Patil, Waters Corporation

10:15: Break

10:30: Theme 2: Data, Digital & AI Integration
Dave Leitham (VP Informatics), Waters Corporation

11:45: Lunch

12:30: Theme 3: PAT for New Modalities (peptides, ADCs, AOCs, liposomes)
Jen Halsey, Waters Corporation

1:45: Break

2:00: Theme 4: PAT for Synthetic Biology & New Modalities
TBC

3:15: Break

3:30: Closing synthesis session — themes & commitments
Ranjeet Patil, Waters Corporation / Jen Halsey, Waters Corporation

4:15: Closing remarks
David Curtin (VP Biologics), Waters Corporation

4:30: Informal networking / wrap-up
All

When?

Where?

For more information, please contact:
Jen Halsey Jennifer_halsey@waters.com or Ranjeet Patil ranjeet_patil@waters.com