Suzanne Caruso | President, Clinical, Regulatory & Intelligence
Norstella

BioTechX USA Day 1 @ 12:45

Same Experts, Smarter Agents: The Next Leap in Clinical Development

AI has already reshaped preclinical development — now it's transforming Phase I-III trials. Study start-up is being compressed through AI-driven protocol design, site selection, and feasibility work. Real-world data is enabling synthetic control arms that can reduce the need to enroll patients into placebo groups, cutting study timelines and costs at a point where every day of a Phase III trial can cost upwards of a million dollars. And patient recruitment itself has flipped from a passive, wait-for-patients-to-come model to a proactive one, with AI matching protocol criteria against real-world data to identify eligible patients and where they're being treated — cutting recruitment workload by roughly 80% The next leap is agentic AI: systems that don't just surface insights but actively execute the work. But speed only matters if you can trust the output. In this session, Suzanne will share what "AI-native" really means in practice — where subject matter experts stay firmly in control of agentic workflows, why sourcing and human oversight are the foundation of trustworthy AI rather than an afterthought, and how real-time monitoring is already compressing feedback cycles from days and weeks down to minutes. Attendees will walk away with:

• Where AI is already delivering measurable time and cost savings versus where it's still maturing
• A practical framework for what "AI-native" means for a clinical organization, and how to keep subject matter experts in control as agents take on more of the operational workload
• Questions to ask any AI vendor or internal team about sourcing, hallucination risk, and oversight before trusting agentic output in a regulated trial environment
• A candid perspective on why "trust takes time" with AI — and concrete first steps for piloting agentic tools now rather than waiting for perfect reliability

Suzanne Caruso, President, Clinical, Regulatory & Intelligence, Norstella

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Suzanne Caruso / Same Experts, Smarter Agents: The Next Leap in Clinical Development

Suzanne Caruso, President, Clinical, Regulatory & Intelligence,
Norstella

Suzanne Caruso is a senior business executive and clinical trial study start-up expert with over 15 years of experience in the pharmaceutical industry. As President, Strategic Intelligence and Clinical & Regulatory at Norstella, Suzanne leverages her expertise in data analytics and innovative...

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