An artificial intelligence summit where world healthcare leaders come together


AI Summit 2022 Agenda


Tuesday, October 25, 2022

8:00 A.M. – 4:00 P.M.

AI Summit Workshop Agenda 

ModeratorS
  • Jeff Ballyns, Associate Director Regulatory Policy, BD 
  • Pat Baird,  Regulatory Head of Global Software Standards, Philips  
  • Steve Frigon, Data Integration Team Lead, The Christ Hospital Health Network 

8:10 A.M. – 9:30 A.M.

 “I was suddenly thrown onto a project and I don’t understand these words…”: ML Concepts 101 

ModeratorS
  • TBA
Speakers
  • Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
9:30 A.M. – 10:30 A.M.

Post-Market Considerations for Learning systems: What are some of the examples of how this has been implemented in the last three years? 

ModeratorS
  • TBA
Speakers
  • TBA

10:30 A.M. – 10:50 A.M.

Break

10:50 A.M. – 12:35 P.M.

Predetermined Change Control Plan: Best Practices  

Join a group discussion focused on how AI/ML is revolutionizing medical device development, how it presents technical challenges,  and how to account for device modifications occurring at an increasing rate. This session will discuss the Predetermined Change Control Plan (PCCP) paradigm and industry-proposed best practices for addressing the iterative improvements that can occur post-launch for AI/ML-enabled medical devices. The session will present and discuss examples for both traditional medical devices and In Vitro diagnostics. The discussion will touch on key topics such as how to utilize Real World Data (RWD), metrics to use to address the unique challenges posed by AI/ML applications, and it will cover the recommended elements for a Software prespecification plan and an Algorithm change protocol. 

ModeratorS
  • Jeff Ballyns, Associate Director Regulatory Policy, BD 
  • Pat Baird,  Regulatory Head of Global Software Standards, Philips  
Speakers
  • TBA

12:35 P.M. – 1:35 P.M.

Lunch

1:35 P.M. – 2:35 P.M.

MDUFA V: Introduction of the Predetermined Change Control Plan and What does it Mean Now 

ModeratorS
  • TBA
Speakers
  • TBA

2:35 P.M. – 2:55 P.M.

Break

2:55 P.M. – 3:55 P.M.

ML in Healthcare: use case development through adoption and implementation 

ModeratorS
  • Steve Frigon, Data Integration Team Lead, The Christ Hospital Health Network 
Speakers
  • TBA
3:55 P.M.4:00 P.M.

Closing

Wednesday, October 26, 2022

7:45 A.M. – 8:30 a.M.

Breakfast

Join your colleagues from around the globe as we kick off the AI Summit with a complimentary hot breakfast!

8:30 A.M. – 8:45 A.M.

Let’s Make a Difference!

Welcome to the summit, and welcome to HCP Collaborative’s AI Summit. This purpose-driven summit will lead you to actionable learning and implementation plans.

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative 

8:45 A.M. – 9:15 A.M.

The Solution Exchange

Start your day with solutions! This fast-paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues. You’ll address the challenges discussed throughout the summit, while tying your ideas to the hopes of a patient whose life is depending on you.

ModeratorS
  • Toni Manzano, Co-Founder & CSO, Aizon
  • Mac McKeen, RAC, FRAPS, Fellow, Regulatory Science, Boston Scientific Corporation

9:15 A.M. – 10:15 A.M.

Insight from the FDA Digital Health Center of Excellence

Moderator
  • TBA – to be announced
Speakers
  • Dr. Matt Diamond, Chief Medical Officer, Digital Health, COE U.S. Food and Drug Administration

10:15 A.M. – 10:35 A.M.

Break

10:35 A.M. – 11:20 A.M. 

TBA – to be announced

Moderator
  • Rohit Nayak, Co-Founder and CEO, Band Connect Inc | CEO, Electronic Registry Systems, Inc.
Speaker
  • Bakul Patel, Senior Director, Global Digital Health Strategy & Regulatory, Google
11:20 A.M. – 12:20 P.M.

Update on Global Regulatory and Standards Landscape

From white papers and proposals to enforceable guidance, global authorities are moving forward in their work to regulate AI in life sciences. Don’t miss this important update on the current state of regulations, standards, and guidance.

Moderator
  • Eric Henry, Senior Quality Systems & Compliance Advisor, FDA & Life Sciences Practice, King & Spalding LLP
Speakers
  • Eric Henry, Senior Quality Systems & Compliance Advisor, FDA & Life Sciences Practice, King & Spalding LLP
  • Pat Baird, Regulatory Head of Global Software Standards, Philips
12:20 P.M. – 1:15 P.M.

Networking Lunch

Sit with FDA officials, speakers, industry experts, and your colleagues to discuss topics that are important to you. Enjoy the discussion with others who share your passion. Tables will be set aside for: 

Topic Tables:

  • AI Experts Network
  • Continuous Process Validation
  • Expandability vs. Architectural transparency
  • User Adoption of AI
1:15 P.M. – 2:00 P.M.

AI in the Time of COVID

Get an in-depth look at how software as a medical device (SaMD) is designed, developed, and marketed during the challenging times of the COVID-19 pandemic. This session will follow how an AI-enabled SaMD smartphone app was developed to adapt the traditional Veritor IVD diagnostic instrument to the home environment to interpret COVID-19 diagnostic tests. The session will cover the EUA process to bring a medical device to market via FDA’s emergency use authorization, the use of a predetermined change control plan to add additional mobile platforms to the EUA, and transitioning to permanent market access via 510(k).

Moderator
  • Jeff Ballyns, Associate Director Regulatory Policy, BD
Speaker
  • Ling Koh, Regulatory Affairs Manager, BD
2:00 P.M. – 2:50 P.M.

Precision Medicine: Personalized Medicine of the Future

AI and Precision Medicine are revolutionizing healthcare by harnessing the power of personal DNA and data analytics to provide increasingly individualized care. This allows The Christ Hospital Health Network to be more proactive when treating patients. In using a patient’s genetic classification, more effective drug choices and dosing recommendations can be made by physicians, which leads to a better patient experience and more affordable care.  

Moderator
  • Steve Frigon, Data Integration Team Lead, The Christ Hospital Health Network
Speaker
  • Burns Blaxall, Precision Medicine Program Director, The Christ Hospital Health Network
2:50 p.M. – 3:35 P.M.

How AI can be used in 3DP Smart Manufacturing

TBA – to be announced

Moderator
  • Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
Speakers
  • Todd Goldstein, Director of 3D Design and Innovation, Northwell Health

3:35 P.M. – 3:55 P.M.

Break

3:55 P.M. – 4:55 P.M.

AI in Action: Wearables

Moderator
  • Matthew Schmucki, Data Scientist, Global Quality, AstraZeneca
Speakers
  • Shruti Rajagopalan, Regulatory Compliance Manager, Google
4:55 P.M. – 5:00 P.M.

Closeout

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative 

5:00 P.M. – 7:00 P.M.

Networking Reception

The summit will surely result in lots of energy as you and your colleagues explore the “what ifs” and “how tos” of AI. Please stay with us for the summit networking reception to enjoy lively dialogue, drinks, and hors d’oeuvres before closing out the first day of AI !

Thursday, October 27, 2022

7:45 A.M. – 8:30 A.M.

Breakfast

Join your colleagues for a complimentary hot breakfast to jump-start your day.

8:30 A.M. – 8:35 A.M.

Day 2 Opening 

Participants will feel the AI Initiative difference at the AI Summit – a purpose driven, action-oriented experience. We will start the day with highlights from Day 1, and prepare you for meaningful discussion and collaboration throughout the day. We insist that our content is meaningful and impactful, so you can’t help but walk away with practical applications to implement when you return to work!

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative
8:35 A.M. – 8:50 A.M.

Day 2 Kick-off

ACT Sheet Review: Key Takeaways we want to start thinking about … Has your solution changed? Has your Solutions Exchange Idea changed since yesterday? (What have you learned that has changed any of your perspectives?)

Moderators
  • Toni Manzano, Co-Founder & CSO, Aizon
  • Mac McKeen, RAC, FRAPS, Fellow, Regulatory Science, Boston Scientific Corporation
8:50 A.M. – 9:50 A.M.

Lessons learned and Pitfalls When Deploying AI in GxP environments

AI is an amazing tool for improving and increasing the level of knowledge and scientific understanding around complex processes, but when we work in biopharma, there are some critical considerations that must be taken into account. During this session we will dig in on key aspects when delivering AI results in biopharma contexts based on the experience of implementing AI solutions.

Moderator
  • Cindy Ipach, President & CEO, Compliance Insight
Speaker
  • Toni Manzano, Co-Founder & CSO, Aizon


9:50 A.M. – 10:10 A.M.

Break

10:10 A.M. – 10:55 A.M.

QMS Case Study: A Real-World Experience Aligning AI/ML Activities with a Compliant QMS

With a dearth of regulations and guidance addressing AI/ML-enabled medical devices, establishment of an effective Quality Management System (QMS) for such devices can be a challenge.  This session compiles lessons learned in the creation and implementation of multiple QMS’s for SaMD. This includes AI/ML-enabled medical devices to enable accelerating your innovation, while ensuring compliance to regulatory requirements that are not yet a perfect fit for today’s technological demands.

Moderator
  • Eric Henry, Senior Quality Systems & Compliance Advisor, FDA & Life Sciences Practice, King & Spalding LLP
Speaker
  • Sundar Selvatharasu, Chief Compliance Officer – GxP Operations, Sierra Labs
10:55 A.M. – 11:55 A.M.

 AI Initiative Working Teams Kick Off!

The future is here. It is time for our industry to move from reactive to predictive! FDA and industry working teams will share their leading edge initiatives being undertaken. These teams are blazing the trail to successful implementation of AI in FDA-regulated environments and sharing the details! Whether you formally join the working teams or not, this is a great opportunity for you to discuss solutions along with AI experts and your industry colleagues. Hear directly from the Team Leaders of the following three teams:

  • AI in Operations (AIO)
  • Good Machine Learning Practices (GMLP)
  • AI at the Point of Care (AI@POC)
Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative
Speakers
  • Steve Frigon, Data Integration Team Lead, The Christ Hospital Network 
  • Toni Manzano, Co-Founder & CSO, Aizon
  • Pat Baird, Regulatory Head of Global Software Standards, Philips
  • Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
  • Scott Thiel, Global Head of Regulatory Policy and Intelligence, Hologic
11:55 A.M. – 12:55 P.M.

 Networking Lunch

Sit with FDA officials, speakers, industry experts, and your colleagues to discuss topics that are important to you. Enjoy the discussion with others who share your passion. Tables will be set aside for: 

  • AI Experts
  • GxP Standards and Practices
  • AI Implementation & Operations in Health
  • AI & Human Factors in Non-AI Environments
12:55 P.M. – 2:10 P.M.

AI Initiative Working Teams: BreakOut Sessions

Continue to engage in a deep-dive discussion with one of the AI Initiative’s Working Teams. These facilitated breakout sessions will provide each team with the infrastructure and direction needed to support its success to work together beyond the summit. The resulting deliverables will be made available for regulators and the global industry. Whether you formally join a team or not, this is a great opportunity for you to discuss solutions along with AI experts and your industry colleagues. Feel free to provide your input for future work! Choose from the following three teams:

  • AI in Operations (AIO)
  • Good Machine Learning Practices (GMLP)
  • AI at the Point of Care (AI@POC)
SPEAKERS
  • Lacey Harbour (AIO), Regulatory Affairs Manager, Thermo Fisher Scientific
  • Cindy Ipach (AIO), President & CEO, Compliance Insight
  • Toni Manzano (AIO), Co-Founder & CSO, Aizon
  • Kip Wolf (AIO),  Head of Technical Operations and Portfolio Management, X-Vax
  • Sundar Selvatharasu (AIO), Chief Compliance Officer – GxP Operations, Sierra Labs
  • Steve Frigon (AI@POC), Data Integration Team Lead, The Christ Hospital Network 
  • Pat Baird (GMLP), Regulatory Head of Global Software Standards, Philips
  • Rohit Nayak (GMLP), Co-Founder and CEO, Band Connect Inc | CEO, Electronic Registry Systems, Inc.

2:10 P.M. – 2:25 P.M.

Break and Travel to Plenary

2:25 p.M. – 3:25 P.M.

Insight from the American Medical Association (AMA)

TBA – to be announced

Moderator
  • Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
Speakers
  • Jesse Ehrenfeld, M.D., MPH, President-Elect, American Medical Association
3:25 P.M. – 4:55 P.M.

Fireside Chat with AI Experts

TBA – to be announced

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative 
Speakers
  • Jesse Ehrenfeld, M.D., MPH, President-Elect, American Medical Association
  • Dr. Matt Diamond, Chief Medical Officer, Digital Health, COE U.S. Food and Drug Administration
  • Bakul Patel, Senior Director, Global Digital Health Strategy & Regulatory, Google
4:55 P.M. – 5:00 P.M.

Closeout

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative