AI Summit Agenda

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

Moderators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca

Speakers: James Bertram, Director, Office of Combination Products; 
John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA;
Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA;
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA;
Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA
Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA
Stephanie Shapley, Senior Advisor, Office of Combination Products, FDA
Sarah Mollo,Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA