Private Dinner with Camunda | NY & NJ

The Governance Gap: A Candid Conversation on Scaling AI in Pharma

Wednesday, September 2nd | 6:00-9:00 PM ET

The barrier to production-grade AI in pharma is rarely the model. It's structural: systems that don't speak to each other, pilots that stall at the regulatory gate, and the manual exceptions — deviations, CAPAs, prior authorization, change control — that quietly consume most of your operational capacity.

The stakes are rising. FDA's updated quality system rules, EMA's Annex 22 on AI in GMP,  and harmonized global expectations are arriving just as patent-cliff pressure forces every technology investment to prove measurable return. The window to build governed AI infrastructure — before regulators ask for it — is closing.

We're hosting a small group of senior IT, AI, and quality leaders from the region's leading pharma companies for a candid, off-the-record dinner at Ninety Acres at Pendry Natirar — a private farm-to-table setting in Somerset County, NJ, chosen deliberately for a conversation that won't happen in a conference room.

No slides. No pitch. An honest conversation about what it actually takes to move AI from experiment to governed, production-grade operation.

What we'll explore over dinner:

• Governance without gridlock, letting agents act inside regulated processes while keeping every decision auditable and stopping one mid-process when you have to.
• The exception problem where manual handoffs (deviations, CAPAs, prior authorization, change control) still eat the most time, and what peers have actually put into production.
• Open standards versus lock-in, modernizing legacy BPM platforms without trading one dependency for another, and what portability actually means when process logic lives in proprietary tooling.
• Investing under scrutiny by choosing which AI bets to scale when every dollar has to show a return against a patent cliff or a budget cycle.

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