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An artificial intelligence summit where world healthcare leaders come together.


2022 AI Summit Presentations

Presentation links are found immediately

after their listing in the schedule.


Tuesday, October 25, 2022

Workshop

7:15 A.M. – 8:00 a.M.

Breakfast

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

8:00 A.M. – 4:00 P.M.

AI Summit Workshop: AI/ML AND THE PREDETERMINED CHANGE CONTROLS PLAN:
FROM BASICS TO ADVANCED IMPLEMENTATION

Continuous Learning: Providing a crash course on AI/ML terminology, data requirements, and performance metrics. Discussion on Machine Learning and dealing with ever-evolving software/device modifications. Providing a future look at the regulatory landscape and implementation of the Predetermined change control plan paradigm. Ending with a walk-through of a use case utilizing these tools.

Facilitators
  • 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 

8:00 A.M. – 8:10 A.M.

 Welcome to the workshop

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

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

Good Machine Learning Practice for the Medical Device Total Product Life Cycle

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Speaker
  • Shawn Forrest, Digital Health Specialist at the Digital Health Center of Excellence, FDA

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. 

Speakers

12:35 P.M. – 1:35 P.M.

Lunch

1:35 P.M. – 2:35 P.M.

Data Visualization: from data to decision 

Creating an artificial intelligence tool is only the beginning. The output needs to be visualized and used to make decisions. Come learn the basics of data visualizations and how to efficiently show data to support your story. We will discuss how to make elegant charts, how to direct the design of dashboards, and provide some steps to create or strengthen your data culture.

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Speaker:
  • Matthew Schmucki, Data Analyst, Corporate Quality & Strategy, AstraZeneca

2:35 P.M. – 2:55 P.M.

Break

2:55 P.M. – 3:55 P.M.

ML in Healthcare: use case development – adoption through implementation

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speaker
  • Patrick Pavlick, Director of Diagnostic and Informatics, Rare Diseases, Sanofi
3:55 P.M.4:00 P.M.

Closing

Wednesday, October 26, 2022
Main Session Day 1

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

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Speakers
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative 
  • Matt Diamond, Chief Medical Officer, Digital Health, COE, U.S. Food and Drug Administration
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
  • Cindy Ipach, President & CEO, Compliance Insight

9:15 A.M. – 10:00 A.M. 

Building Trust in AI Systems: Where are we now? A discussion of approaches in motion.

A panel discussion reviewing the evolution of recent trends and approaches for building trust in AI systems.

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Moderator
  • Rohit Nayak, Co-Founder and CEO, Band Connect Inc. | CEO, Electronic Registry Systems, Inc.
Speakers
  • Bakul Patel, Senior Director, Global Digital Health Strategy & Regulatory, Google
  • Koen Cobbaert, Senior Manager – Quality, Standards & Regulations, Philips

10:00 A.M. – 10:20 A.M.

Break

10:20 A.M. – 11:20 A.M.

Updates from FDA’s Digital Health Center of Excellence

Join Matthew Diamond, Chief Medical Officer of the Digital Health Center of Excellence (COE) as he shares insight into FDA’s current activities and ongoing initiatives, priorities, and plans as the agency continues to embrace the use of AI in product submissions, design, manufacturing, and post-marketing activities. Diamond has a unique vantage point; he shares opportunities from both within FDA and across the entire industry about how AI may be useful in areas you might not have considered. Don’t miss your chance to hear directly from FDA’s Chief Medical Officer of Digital Health, and ask your questions!

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative 
Speaker
  • Matt Diamond, Chief Medical Officer, Digital Health, COE U.S. Food and Drug Administration
11:20 A.M. – 12:20 P.M.

Update on the 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.

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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: 

  • 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 the transition to permanent market access via 510(k).

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Moderator
  • Jeff Ballyns, Associate Director Regulatory Policy, BD
SpeakerS
  • Ling Koh, Regulatory Affairs Manager, BD
  • James Hunter, Associate Director, Point of Care, BD
2:00 p.M. – 2:50 P.M.

How AI can be used in 3DP and Smart Manufactuing: from the perspective of industry, health systems, and academia

The future of healthcare is precise, personalized, and involves point of care with a wide variety of applications.  Each application has its own unique set of challenges that change based on risk and the stakeholders’ perspective. Foreseeing these challenges, in 2021 FDA issued the discussion paper 3D Printing Medical Devices at the Point of Care to expound upon pertinent challenges and request stakeholder feedback. Within this paper, the concept of the 3D Printing medical device production system (MDPS) as a medical device was presented.  In this session, we will look into the concept of the MDPS from the perspective of different stakeholders and also the necessity of AI to make this in-hospital MDPS POC solution a reality.

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Moderator
  • Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
Speakers
  • Todd Goldstein, Director of 3D Design and Innovation, Northwell Health
  • Federico (Fede) Anzil, Advanced Technology and Digital Manufacturing Manager, Lima Corporate
2:50 P.M. – 3:40 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, Executive Director, Precision Medicine, The Christ Hospital Health Network

3:40 P.M. – 4:00 P.M.

Break

4:00 P.M. – 5:00 P.M.

From Start to Finish: Considerations for AI-based SaMDs on Wearable Devices

Follow the journey from concept through post-market surveillance as we walk through the important milestones and considerations for AI-based SaMDs on wearable devices. Using actual examples, this session will dive into the design, development, verification, validation, and submission considerations companies face in order for AI-based SaMD wearable devices to be brought to market.

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Moderator
  • Matthew Schmucki, Data Scientist, Global Quality, AstraZeneca
Speaker
  • Shruti Rajagopalan, Regulatory Compliance Manager, Google
5:00 P.M. – 5:05 P.M.

Closing Remarks

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

5:05 P.M. – 6:00 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
Main Session Day 2

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 the AFDO/RAPS Collaborative difference at the AI Summit: a purpose driven, action-oriented experience. We’ll 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!

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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: We want to start thinking about Key Takeaways – what are some of your Key Takeaways? Doing a review, how would you categorize the Key Takeaways on your ACT sheet? What have you learned that has changed any of your perspectives?

Moderators
  • Toni Manzano, Co-Founder & CSO, Aizon
  • Cindy Ipach, President & CEO, Compliance Insight
8:50 A.M. – 10:05 A.M.

DEPLOYING AI IN GXP ENVIRONMENTSLessons learned and Pitfalls!

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
Speakers
  • Toni Manzano, Co-Founder & CSO, Aizon
  • Vishaka Rajaram, Director of Operations Transformation, Price Waterhouse Cooper


10:05 A.M. – 10:25 A.M.

Break

10:25 A.M. – 11:10 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
11:10 A.M. – 12:10 P.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 the leading edge initiatives they’re undertaking. 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 (AI@POC)
  • Toni Manzano, Co-Founder & CSO, Aizon (AIO)
  • Pat Baird, Regulatory Head of Global Software Standards, Philips (GMLP)
12:10 P.M. – 1:10 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
1:10 P.M. – 2:25 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)

Ai in Operations
(AIO)

Co-Chairs:

  • Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
  • Cindy Ipach, President & CEO, Compliance Insight
  • Toni Manzano, Co-Founder & CSO, Aizon
  • Kip Wolf, Head of Technical Operations and Portfolio Management, X-Vax
  • Sundar Selvatharasu, Chief Compliance Officer – GxP Operations, Sierra Labs

Good Machine Learning Practices (GMLP)

Co-Chairs:

  • Pat Baird, Regulatory Head of Global Software Standards, Philips
  • Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
  • Rohit Nayak, Co-Founder and CEO, Band Connect Inc. | CEO, Electronic Registry Systems, Inc.

AI @ The Point of Care (AI@POC)

Co-Chairs:

  • Steve Frigon, Data Integration Team Lead, The Christ Hospital Network 
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative

2:25 P.M. – 2:40 P.M.

Break and Travel to Plenary

2:40 p.M. – 3:40 P.M.

Insight from the American Medical Association (AMA)

The American Medical Association is committed to helping physicians harness AI in ways that safely and effectively improve patient care. The AMA uses the term augmented intelligence (AI) as a conceptualization of artificial intelligence that focuses on AI’s assistive role, emphasizing that its design enhances human intelligence rather than replaces it. Also, the AMA partners with technology and healthcare leaders to bring physicians critical insights on AI’s potential applications and ensure that physicians have a voice in shaping AI’s role in medicine. Hear from the AMA’s president-elect in this informative session.

View Presentation

Moderator
  • Timothy Hsu, Director of Health Technology Initiatives, AFDO/RAPS Healthcare Products Collaborative
Speaker
  • Jesse Ehrenfeld, President-Elect, American Medical Association
3:40 P.M. – 4:55 P.M.

Fireside Chat with AI Experts

After a day filled with information and collaboration, settle in for a casual, unscripted conversation about all that is AI – from defining AI to regulating AI. Eric Henry, Senior Quality Systems & Compliance Advisor, FDA & Life Sciences Practice, King & Spalding LLP, will host this opportunity to participate in a session that brings the discussion of AI & Health full circle.

Moderator
  • Eric Henry, Senior Quality Systems & Compliance Advisor, FDA & Life Sciences Practice, King & Spalding LLP
Speaker
  • Jesse Ehrenfeld, President-Elect, American Medical Association
4:55 P.M. – 5:00 P.M.

Closeout

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