AI Summit Agenda
If you missed the 2023 AI Summit, here’s what we covered:
Breakfast
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesJoin your colleagues from around the globe as we kick off the AI Summit with a complimentary hot breakfast!
Let’s Make a Difference!
Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
The Solutions Exchange
Moderator: Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific;
Cindy Ipach, President & CEO, Compliance Insight
Insight From the FDA Digital Health Center of Excellence
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Break
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesUpdate on Global AI/ML Regulations and Standards
Moderator: Brian Edwards, Fellow, Regulatory Affairs, Digital Health/Cybersecurity, Boston Scientific
Speakers: Pat Baird, Regulatory Head of Global Software Standards, Philips; Brandon O'Shea, Sr. Regulatory Affairs Manager - Digital, GE HealthCare
Cultivating a Community of Practice to Ensure the Safe, Effective, and Equitable Use of AI
Moderator: TBA
Speakers: Mark Sendak, Population Health & Data Science Lead, Duke Institute for Health Innovation
Suresh Balu, Director for DIHI, and Associate Dean, Innovation and Partnership for School of Medicine, Duke Institute for Health Innovation
Lunch
Sit with FDA officials, speakers, industry experts, and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion while sharing a meal together!
Emerging AI Applications and the AI Health Ecosystem
Moderators: Steve Frigon, Data Integration Team Lead, The Christ Hospital Health Network; Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
Speakers: Bakul Patel, Senior Director, Global Digital Health Strategy & Regulatory Google; Gary Turner, Managing Director, Additive Manufacturing North America, Ricoh USA, Inc
Break
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesFireside Chat: AI Regulators & Policy Makers
Moderator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Speakers: Laura Adams, Senior Advisor, National Academy of Medicine (NAM);
Dr. Brian Anderson, Chief Digital Health Physician, Mitre | CO-Founder, Coalition for Health AI (CHAI);
Bakul Patel, Senior Director, Global Digital Health Strategy & Regulatory, Google
Troy Tazbaz, Director of Digital Health, Center for Devices and Radiological Health (CDRH), FDA
Jupyter Intro
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals
Networking Reception
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United States
Breakfast
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesJoin your colleagues from around the globe as we kick off the AI Summit with a complimentary hot breakfast!
Day 2 Open
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
AI in Action
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Cindy Ipach, President & CEO, Compliance Insight
Speakers:
Craig Douglass, Co-founder and CEO of Contact CI
Douglas Fagaly, Co-Founder, Chief Strategy Officer, E Tech Group
Thomas Friedli, Director, Institute of Technology Management, University of St. Gallen
Understanding and Managing Bias in AI: A Risk-Based Approach
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Pat Baird, Regulatory Head of Global Software Standards, Philips
Speaker: Yarmela Pavlovic,, VP Global Regulatory Affairs, Strategy & Policy, Medtronic; Annie Saha, Assistant Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA
Break
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesCybersecurity Session: How to Use AI as a Tool to Detect Cybersecurity Breaches
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Pat Baird, Regulatory Head of Global Software Standards, Philips
Lunch
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesSit with FDA officials, speakers, industry experts, and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion while sharing a meal together!
AI Foundations Workshop: From Planning to Production
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesFacilitators: Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
Toni Manzano, Co-Founder & CSO, Aizon; Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals;
Break
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesAI Working Teams & Experts Network – Report Out
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Team Leaders (Invited)
Speakers: AI Working Team Co-Chairs
Break and travel to breakout rooms
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesAI Working Teams – Deep Dives
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Team Leaders
Breakfast
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesJoin your colleagues from around the globe as we kick off the AI Summit with a complimentary hot breakfast!
Day 3 Open
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Fireside Chat
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesMatt Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA
Suchi Saria, CEO & Founder, Chief Scientific Officer, Bayesian Health
The Journey to Bringing a Diagnostic Screening Algorithm to Market: Validation, Product Design, and Regulatory Considerations
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Speakers: Patrick Pavlick, Senior Digital Diagnostics Director, Sanofi
Break
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesTransparency vs. Explainability: Practicalities, Benefits, and Issues
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United States Moderator: Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals
Speaker: Hussein Ezzeldin, Senior Staff Fellow, Center for Biologics Evaluation and Research (CBER), FDA; Shawn Forrest, Biomedical Engineer, Center for Devices and Radiological Health (CDRH), FDA; Mike Salem, Associate Director of Data Science - Quality Assurance, Gilead Sciences
FDA’s PCCP Draft Guidance Deep Dive
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Speakers: Alex Cadotte, Senior Director, Digital Health and Imaging, MCRA; MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA; Cassie Scherer, Senior Director US Regulatory and Global Digital Health Policy, Medtronic
Lunch
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesSit with FDA officials, speakers, industry experts, and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion while sharing a meal together!
Managing the AI Software Development Life Cycle
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding; Kip Wolf, Head of Technical Operations and Portfolo Management, X-Vax Technology, Inc
Summit Close
The Westin Cincinnati 21 E 5th Street, Cincinnati, OH, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative