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!
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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
Breakfast
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesNotified Body Opinion Workshop – Experiences and Lessons for Combination Products in EU
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesLeading Facilitators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, Abbvie
Facilitators: Arabe Ahmed, Bsi Group; Timothy Chesworth, Senior Director Regulatory Affairs - Devices & Digital Therapeutic, AstraZeneca; Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie; Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer
Workshop
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesFDA Office Hours
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesFacilitators: James Bertram, Director, Office of Combination Products (OCP), FDA; John “Barr” Weiner, Associate Director for Policy, Office of Combination Products (OCP), FDA
Break
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesCombination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesLeading Facilitators: Tine Albeck, Senior Quality Assurance Professional, ALK A/S
Facilitators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Rick Wedge, Compliance Lead / Associate Research Fellow, Pfizer; Milind Ganjawala, Division Director of Drug Quality II, Center for Drug Evaluation and Research (CDER), FDA
Lunch
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesBreak
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesRisk management application in post-market safety & other PMSR Hot topics
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesLeading Facilitators: Khaudeja Bano, Vice President, Combination Product Quality, Amgen; Rich Wolf, Head of Pv Operations at CSL Behring
Facilitators: John "Barr" Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA; Fubin Wu, Co-founder, GessNet Safety Engineering; Kate Gillespie, Sr. Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson
Q&A Session
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United States
Breakfast
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesJoin your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!
Let’s Make a Difference!
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
The Solutions Exchange
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators:Fran DeGrazio, Executive Advisor, Kymanox
Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC;
From the Desk of the Office of Combination Products: Strategic Priorities & Action
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Speakers: James Bertram, Director of the Office of Combination Products (OCP), FDA; John "Barr" Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA
Break
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesGlobal Harmonization Opportunities in Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Khaudeja Bano, VP Combination Product Quality, Amgen
Speakers: Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Academy(EMA); Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI; Joo Hee Kim Professor, Regulatory Strategy center for Combination Products (RSCP), Ajou University; Mike Wallenstein, Global Head Regulatory Medical Devices, Combination Products & Precision Medicine, Novartis; John "Barr" Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA
Platform Drug-Delivery Devices: Regulatory and Technical Considerations
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Chin-Wei Soo, Global Regulatory Head - CMC/Devices and Combination Products, Genentech
Speakers: Jiaying Shen, Distinguished Scientist, Merck; Kent Abrahamson, Director, Combination Product and Device Development, Abbvie; James Bertram, Director of the Office of Combination Products (OCP), FDA; Patricia Love, Deputy Director, FDA’s Office of Combination Products (OCP), FDA (Invited)
Lunch
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, 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!
Evolution of Essential Performance Requirements
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Rumi Young, Director, Regulatory Policy, BD
Speakers: Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals; Subhi Saadeh, Sr. Manager - Combination Products QA, Gilead Sciences; Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA; Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA; Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC
Devices, AbbVie
Use of Non-integral Medical Devices in Medicinal Product Clinical Studies
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Jason Lipman, Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi
Speakers Jonathan Amaya-Hodges, Director, Technical Services, Sutton Creek; Suzette Roan, Associate VP, Head of GRA Devices, Sanofi
Break
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesUse of Emerging Digital Health Technologies for Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers: Katie Chowdhury,Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie; MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA; Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA; Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA
Next-Generation Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Sandy Boyd, Independent Consultant
Speakers: Dan Groszmann, Director of Engineering, Amgen; Geoff Hamilton , Chief Executive Officer, Stemson Therapeutics; Steven Oh, Deputy Office Director, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research (CBER), FDA; James Wabby, Global Head, Regulatory Affairs (CoE) - Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow - Regulatory Science, Abbvie;
Networking Reception
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United States
Breakfast
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesJoin your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!