Main Summit Sessions Agenda: Day 2

Thursday, August 22, 2019

 

7:45 AM - 8:30 AM

Breakfast

Join your colleagues for a complimentary warm breakfast in the Xavier University Cintas Center to jump-start your day.


8:30 AM - 8:45 AM

Day 2 Opening

Participants will feel the Xavier Difference at the Xavier AI Summit, a purpose driven, action-oriented experience. We will start the day with highlights from Day 1, and prepare you for meaningful discussions 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:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speaker: 

  • Marla Phillips, Director, Xavier Health, Xavier University


8:45 AM - 9:45 AM

Let’s Tour the Healthcare AI Space: An International View

The United States is not the only country exploring AI in healthcare. This is a global movement with a variety of motivational factors and constraints. During this session, some of the international work in the healthcare AI space will be introduced as a way to pull all of the work together into one place for you, including Asian regulatory guidance, African Digital Health initiatives, and a suite of projects being sponsored by the World Health Organization. We are all too busy to be unknowingly duplicating efforts, and very importantly, not building on synergies due to unawareness. This session will help you to be a visionary leader within your organization and across the industry.

Moderator:

  • Walt Mullikin, Head of Enterprise Analytics, Takeda

Speaker: 

  • Pat Baird, Head of Global Software Standards, Philips


9:45 AM - 10:05 AM

Break


10:o5 AM - 10:55 AM

TRACK 1 (FOUNDATIONS OF AI)

AI and Risk Management

In the future, medical device and pharmaceutical manufacturers that include AI/Machine Learning (ML) algorithms in their regulated products will face challenges with developing robust risk management plans that address safety, efficacy, privacy and security risks unique to AI/ML products. Looking at AI/ML enabled products from a Total Product Life Cycle (TPLC) perspective, risk management and associated controls will be vital to success or failure of these products in the market. Risk management techniques will vary between supervised learning and unsupervised learning requiring a cross-discipline approach to data sets and algorithmic risk mitigations. In this panel, we will explore how to leverage existing risk management processes, such as ISO 14971, IMDRF-like risk framework (International Medical Device Regulators Forum), Safety Assurance Case approach, and hazard analysis. Let's not reinvent the wheel, but rather, build on the strengths that already exist. We encourage you to bring your risk questions to engage with the panel.

Moderator:

  • Bob Banta, Consultant - Global Device Quality Assurance, Eli Lilly

Speakers: 

  • Bob Banta, Consultant - Global Device Quality Assurance, Eli Lilly

  • Pat Baird, Head of Global Software Standards, Philips


TRACK 2 (AI SUCCESS STORIES)

The Power of Cloud Computing in Action

Learn about real life applications in life science industries of machine learning and artificial intelligence solutions from AWS Machine Leaning Solutions Lab.

Moderator:

  • Toni Manzano, R&D Director, Bigfinite

Speakers: 

  • Kyle Johnson, Data Science Practice Manager, Amazon Web Services (AWS), and Adjunct Professor at Carnegie Mellon University

  • Industry Speaker TBA


TRACK 3 (AI IN HEALTHCARE)

Aye What? The Patient Engagement Dilemma

Join us for a discussion on how to incentivize Patient ownership of their health. How is this accomplished? On one hand, highly publicized data breaches bring up concerns about privacy and security on the other a CMS ruling is encouraging the market to have openness and transparency with EHI and Claims data. This session will discuss the potentials and pitfalls using business cases like smart speakers, wearables and medical device ingestibles.

Moderator:

  • Steve Frigon, Sr. Clinical Systems Analyst, Data Integration & Data Management Team, The Christ Hospital Health Network

Speaker: 

  • Oliver Christ, Executive Vice President, PROSYSTEM, an NSF International Company


10:50 AM - 11:00 AM

Break


11:00 AM - 12:00 PM

Xavier AI Initiative: Working Team Kick-Off

FDA and industry experts have identified key challenges and opportunities to advance the effective use of AI across the industry. Take this exciting opportunity to join in deep dive discussions with one of the Xavier AI Working Teams. These facilitated break-out 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! Choose from the following 2 teams:

  1. AI in Operations (AIO)

  2. Continuously Learning Systems (CLS)

Team Leaders:

  • Pat Baird, Philips, CLS Team Co-Leader

  • Toni Manzano, Bigfinite, AI in Mfg Team Co-Leader

  • Rohit Nayak, Tech Accelerator, CLS Team Co-Leader

  • Nick Ranly, Siemens, CPQA Team Co-Leader

  • Mark Zhong, PwC, CPQA Team Co-Leader


12:00 PM - 12:45 PM

Lunch with Your Team

This networking lunch will allow the Team Leaders to continue working with you to establish the 2019 - 2020 goals for each of the Xavier AI Working Teams.


12:45 PM - 1:45 PM

Xavier AI Initiative: Working Teams (Continued)

Continue to engage in deep dive discussions with one of the Xavier AI Working Teams. These facilitated break-out 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! Choose from the following two teams:

  1. AI in Operations (AIO)

  2. Continuously Learning Systems (CLS)

Team Leaders:

  • Pat Baird, Philips, CLS Team Co-Leader

  • Toni Manzano, Bigfinite, AI in Mfg Team Co-Leader

  • Rohit Nayak, Tech Accelerator, CLS Team Co-Leader

  • Nick Ranly, Siemens, CPQA Team Co-Leader

  • Mark Zhong, PwC, CPQA Team Co-Leader


1:45 PM - 2:05 PM

Break


2:05 PM - 2:50 PM

Using AI with Confidence for High Pressure Decisions

Using AI to support your decisions can be intriguing to you and your organization, but when the risk is high, and the pressure is on...will you trust the output? In this session, we will explore real use-cases of how AI has been used to make high pressure decisions (whether health, life, financial). The panel members will share how they were able to make decisions from the data given, which is different from data they are used to seeing. Imagine your employees saying: "I don't see a p-value, so how can I trust this?" We need to provide the roadmap between AI and what they are used to seeing. Our expert panel will explore with you how they gained confidence in the output, what they looked for, and how they trained their people on AI to support their ability to make these decisions.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers:

  • Speakers TBA


2:50 PM - 3:55 PM

Fireside Chat

In a world of fast-paced innovation and vast opportunity, it is important that all stakeholders move collaboratively forward to shape the future of technologies used throughout the entire product lifecycle. Don’t miss this opportunity to engage with FDA and Industry Experts on where we can go from here…together. Learn first-hand what these stakeholders see as the possibilities, challenges and critical steps to incorporating the power of AI in a responsible and effective way.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

  • Zach Rothstein, Vice President, Technology and Regulatory Affairs, AdvaMed

Speakers:

  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, FDA-ORA (invited)

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA-ORA

  • John Daley, Vice President, Quality and Regulatory Affairs, IBM Watson Health

  • Bakul Patel, Associate Center Director for Digital Health, CDRH-FDA

  • Additional Speakers TBA


3:55 PM - 4:00 PM

To Your Success!

Thank you for joining us, and we look forward to staying engaged with you throughout the year on advancing the power of artificial intelligence for the benefit of the patients you serve.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University