# Validated AI Conference — Cambridge, MA Join us for a free half-day conference focused on validating AI in regulated environments. Request an invite to attend in person in Cambridge or join virtually from anywhere. You'll learn how leading teams are integrating AI into products and development processes without sacrificing compliance or speed through expert-led sessions and candid peer discussions. Hear from experts, connect with peers, and be part of a community working to bring safe, effective AI to patients faster. ## Industry Leaders Attending ## What's in Store? Insights and strategies to accelerate AI adoption in regulated industries - ### Compliance Frameworks for AI Systems Discover validation frameworks for AI systems in regulated environments. Learn how to implement FDA guidance on AI/ML validation, create audit-ready documentation for AI, and maintain end-to-end traceability. - ### Pilot to Production: Real AI Validation Journeys Hear real-world case studies of how companies validated AI in production under IEC 62304 and ISO 14971. Learn documentation strategies that passed audits, governance frameworks that worked, and honest lessons learned from pilot to production. - ### Validating AI Workflows in Practice Learn practical frameworks for validating AI in regulated workflows—from automated testing to change impact analysis. Explore how to implement human-in-the-loop controls, build audit trails that satisfy FDA requirements, and incorporate AI in regulated environments. ## Venue The Engine is a venture firm built by MIT that invests in founders solving the world's toughest problems through breakthrough science and engineering. The Engine by MIT · 750 Main St, Cambridge, MA 02139 ## Agenda An afternoon of expert insights, hands-on learning, and meaningful connections. 01. 12:00 – 12:45 PM ### Registration & Networking Check in and connect with fellow attendees. 02. 12:45 – 1:05 PM ### Building Safety-Critical AI Doctors are diagnosing with AI, autonomous vehicles are navigating city streets, and labs are compressing months of experiments into days. This session explains what validated AI is making possible, and how to take a risk-based approach to building safety-critical AI systems. Erez Kaminski 03. 1:05 – 2:00 PM ### AI Adoption in Life Sciences: What's Working The question is no longer whether to adopt AI. It's how companies are putting it to work in practice. This session explores how life sciences organizations are deploying AI across imaging, patient monitoring, clinical development, and commercial functions, what's driving adoption, and what it takes to operationalize these initiatives at scale. Scott Rosen Mike Monovoukas Erez Kaminski 04. 2:10 – 2:45 PM ### Accelerating AI-Native Product Development AI coding tools like Claude Code and Cursor are already in your engineers' hands. This session covers what changes when AI is writing production code and hardware in a regulated environment: how code review practices need to evolve, where CI/CD needs guardrails, and how quality teams need to operate when the way software gets built has fundamentally changed. Gabriel Pascualy Don O'Neill Prachee Chaturvedi 05. 2:45 – 3:20 PM ### AI Maturity Across the SDLC: From Design to Deployment AI is now a standard part of how software is built, but in regulated environments, every change still needs to be understood, validated, and tied to intended use. This session explores how teams progress along an AI maturity curve, from deterministic processes to AI-assisted development, and how they accelerate from a mature foundation without losing control. You'll hear how leading teams connect risk, requirements, and validation as change becomes continuous, so they can move faster while staying audit-ready. Jenn Dixon Joy Foster 06. 3:20 – 3:45 PM ### Networking Break Recharge and connect with fellow attendees. 07. 3:45 – 4:20 PM ### Making AI Work in Life Science AI is managing batch records, flagging deviations, and monitoring processes in real time. This session explains what AI actually looks like inside GxP operations right now, what it takes to get there, and what the industry can learn from organizations that have already made the leap from concept to compliant deployment. Michelle Vuolo Behnam Partopour Tim Brodeur 08. 4:20 – 5:00 PM ### Getting AI Past the Pilot Whether it's compliant handling, change impact assessment, or regulatory document generation, the gap between proof of concept and production is familiar to anyone trying to accelerate AI adoption in their organization. This session offers advice to close that gap, showing what it takes to build coalitions, make the case, and create the conditions where AI becomes how work gets done. Norm Lord Rajesh Misra Varun Ramdevan Mary Brook Delano 09. 5:00 – 5:15 PM ### Closing Remarks Erez Kaminski 10. 5:15 – 6:15 PM ### Cocktail Hour & Networking Wind down with drinks, bites, and meaningful conversations. ## Speakers Insights from leaders accelerating innovation at high growth companies and Fortune 50 enterprises - ### Erez Kaminski Former Head of AI Amgen Now Founder & CEO, Ketryx - ### Michael Monovoukas Co-Founder & CEO AcuityMD - ### Michelle Vuolo Head of Quality Tulip - ### Rajesh Misra Principal Life Sciences Quality and Regulatory KPMG - ### Jenn Dixon Former Director of QA/RA Omniscient Neurotechnology Now Director of AI Quality & Regulatory Strategy, Ketryx - ### Don O'Neill Vice President of Engineering Sequel Med Tech - ### Mary Brook Delano Former Senior VP Life Sciences Definitive Healthcare Now Chief Business Officer, Ketryx - ### Varun Ramdevan External Innovation and Partnerships, Enterprise Technology Johnson & Johnson - ### Scott Rosen Partner Transformation Capital - ### Norm Lord Vice President, Digital Products Revvity - ### Prachee Chaturvedi Director, Digital & AI Product R&D Sanofi - ### Behnam Partopour Principal Scientist Sartorius - ### Joy Foster Head of the Lab and Clinical Engineering Platform GeneDx - ### Gabriel Pascualy Former Principal Investigator MITRE Now Head of Product, Ketryx - ### Tim Brodeur Former VP of Customer Success Causaly Now VP Success & Delivery, Ketryx ## Meet Your Moderator Join us for an evening with Erez Kaminski, who advises three of the top five medical device companies and brings deep expertise in regulated AI development and a passion for improving patient outcomes. ### Erez Kaminski CEO & Founder • Ketryx Former Head of AI, Amgen ## Save the Date The next Validated AI conference is **Thursday, October 1, 2026**. Sign up to be the first to know when registration opens. ## Presented by Ketryx transforms the product lifecycle of life science teams to deliver safer products, faster. Trusted by four of the world's top five medical device manufacturers, its AI-powered compliance platform overlays existing tools to automate documentation, create traceability, and accelerate release cycles—without disrupting existing workflows. Ketryx AI Agents cut manual work by 90 percent and close compliance gaps, elevating speed and quality across the entire product lifecycle.