AI Summit 2023 Presentations
Tue. November 14th 2023
8:15 am – 8:45 am
Let’s Make A Difference!
Moderator:
- Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:45 am – 9:30 am
The Solutions Exchange
Moderators:
- Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
- Cindy Ipach, President & CEO, Compliance Insight
9:30 am – 10:00 am
Insight From The FDA Digital Health Center Of Excellence
Moderator:
- Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Speaker:
- Matt Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA
10:00 am – 10:20 am
BREAK
10:20 am – 11:20 am
Update On Global AI/ML Regulations And Standards
Moderator:
- Brian Edwards, Fellow, Regulatory Affairs, Digital Health/Cybersecurity, Boston Scientific
Speaker:
- Pat Baird, Regulatory Head of Global Software Standards, Philips – No slides used in this discussion
- View PDF Presentation – by Brandon O’Shea, Sr. Regulatory Affairs Manager – Digital, GE HealthCare
11:20 am – 12:30 pm
Cultivating A Community Of Practice To Ensure The Safe, Effective, And Equitable Use Of AI
Speaker:
- View PDF Presentation – Mark Sendak, Population Health & Data Science Lead, Duke Institute for Health Innovation
12:30 pm – 1:30 pm
LUNCH
1:30 pm – 2:30 pm
Emerging AI Applications And The AI Health Ecosystem – View PDF Presentation
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
2:30 pm – 2:45 pm
BREAK
2:45 pm – 4:00 pm
Fireside Chat: AI Regulators & Policy Makers – No slides used in this discussion
Moderators:
- 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
4:00 pm – 4:30 pm
Jupyter Intro
Facilitator:
- Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals
Wed. November 15th 2023
8:00 am – 8:10 am
Day 2 Open
Moderator:
- Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:10 am – 9:10 am
AI In Action
Moderator:
- Cindy Ipach, President & CEO, Compliance Insight
Speakers:
- View PDF Presentation – by Craig Douglass, Co-founder and CEO of Contact CI and Douglas Fagaly, Co-Founder, Chief Strategy Officer, E Tech Group
- View PDF Presentation – by Thomas Friedli, Director, Institute of Technology Management, University of St. Gallen
9:10 am – 10:10am
Understanding And Managing Bias In AI: A Risk-Based Approach – No slides used in this discussion
Moderator:
- Pat Baird, Regulatory Head of Global Software Standards, Philips
Speakers:
- 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
10:10 am – 10:30 am
BREAK
10:30 am – 11:15 am
Cybersecurity Session: How To Use AI As A Tool To Detect Cybersecurity Breaches
- View PDF Presentation – by Pat Baird, Regulatory Head of Global Software Standards, Philips
- View PDF Presentation – by Seth Carmody, VP Regulatory Strategy, MedCrypt
11:15 am – 12:15 pm
LUNCH
12:15 pm – 3:15 pm
AI Foundations Workshop: From Planning To Production – View PDF Presentation
Facilitators:
- Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
- Toni Manzano, Co-Founder & CSO, Aizon
- Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals
3:15 pm – 4:00 pm
AI Working Teams & Experts Network – Report Out
4:00 pm – 5:00 pm
AI Working Teams – Deep Dives
Thu. November 16th 2023
8:00 am – 8:10 am
Day 3 Open
Moderator:
- Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:30 am – 9:10 am
Fireside Chat – No slides used in this discussion
Speakers:
- Matt Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA
- Suchi Saria, CEO & Founder, Chief Scientific Officer, Bayesian Health; John C. Malone Endowed Chair/Founding Director, Malone Center for Engineering in Healthcare; Director of Machine Learning/AI & Healthcare Lab, Johns Hopkins University
9:10 am – 10:10 am
The Journey To Bringing A Diagnostic Screening Algorithm To Market: Validation, Product Design, And Regulatory Considerations
Moderator:
- Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Speaker:
- View PDF Presentation – by Patrick Pavlick, Senior Digital Diagnostics Director, Sanofi
10:10 am – 10:30 am
BREAK
10:30 am – 11:30 am
Transparency Vs. Explainability: Practicalities, Benefits, And Issues – View PDF Presentation
Moderator:
- Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals
Speakers:
- 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
11:30 am – 12:30 pm
FDA’s PCCP Draft Guidance Deep Dive
Moderator:
- Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
- Alex Cadotte, Senior Director, Digital Health and Imaging, MCRA – No slides used in this discussion
- View PDF Presentation – by Mira Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence, FDA
- Cassie Scherer, Senior Director US Regulatory and Global Digital Health Policy, Medtronic – No slides used in this discussion
12:30 pm – 1:30 pm
LUNCH
1:30 pm – 2:15 pm
Managing The AI Software Development Life Cycle – View PDF Presentation
- Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
- Kip Wolf, President & Principal Consultant, Thaumazo Bioscience Management, Inc.
