AI Summit: Day 2
Friday, August 25, 2017


7:45 AM - 8:30 AM


Join your colleagues for a complimentary warm breakfast in the Xavier University Cintas Center to jump-start Day 2!

8:30 AM - 8:45 AM

Day 1 Break Out Session Summaries: Progress, Direction and Questions

The team leaders will provide a brief summary of the work team discussions that occurred during the Break Out sessions on Day 1. The goal of the summit is to form work teams that will develop artificial intelligence solutions to augment human decisions in the area of quality, regulatory and supply chain operations for open access to the global industry.

8:45 AM - 9:15 AM    

AdvaMed Digital Health/Machine Learning Policy Development

As our industry continues to push the cutting edge of technology further and further, we need to make sure we understand how it should and should not be used, as well as the implications of its use. AdvaMed has formed a Digital Health/Machine Learning team to explore policy development to support the advancement of digital capabilities. The progress on this policy development will be shared by members of the AdvaMed team, and is an aspect participants need to be cognizant of as we continue to develop new solutions.


  • John Daley, Vice President, Quality and Regulatory Affairs, IBM Watson Health
  • Bakul Patel, Associate Center Director for Digital Health, FDA
  • Zach Rothstein, Associate Vice President, Technology and Regulatory Affairs, AdvaMed

9:15 AM - 10:00 AM

Validation of AI for GMP Decisions?

AI Experts will share the varying levels of how AI systems are trained, as well as how the output is validated. To what extent can we use AI to make GMP decisions when the system is constantly learning/changing? Participants will be challenged to explore the differences between decisions made through artificial intelligence and those made by the human brain. The similarities are surprising!


  • Walter Mullikin, Head of Enterprise Analytics, Shire Pharmaceuticals

10:00 AM - 10:20 AM


10:20 AM - 11:35 PM

Current AI Applications in Quality, Regulatory and Supply Chain

Presentations will be shared with participants on how organizations have already used the power of AI in quality, regulatory and supply chain operations. The challenges, successes, and how they got started will be explored in this exciting session that will be sure to expand our minds on the possibilities that can be explored by your organization, FDA officials, and the industry.


  • Kumar Madurai, Principal Consultant / Solutions Manager – Technology Solutions, CTG
  • Oliver Yu, Chief Technical Officer and Co-Founder, FDAZilla

11:35 AM - 1:00 PM

Track 2: Lunch Networking by Topic

Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion on how AI can be used in:

  • Validation
  • Continuous Product Quality Assurance
  • Clinical Trials and Diagnostics

11:35 AM - 1:00 PM

Track 1: Lunch Networking Session for AI Experts

AI Experts will have an opportunity to network with each other during a separate lunch session designed specifically for them.  Use this opportunity to share successful practices, failures solutions, and advances in the field of artificial intelligence while creating connections that will last you the rest of your career.

1:00 PM - 2:30 PM

Break-out Sessions for Solution Development

Facilitated working team sessions will incorporate all the input and ideas generated throughout the summit from their colleagues, AI experts and senior leaders. The teams will begin to work through the process that will result in their solution stream output.

  • Team 1:  Validating Continuously Learning Systems
    Team Leader: Berkman Sahiner, FDA Electrical Engineer, CDRH
    Team Leader: Mohammed Wahab, Sr. Quality Assurance Manager, Abbott
  • Team 2:  Continuous Product Quality Assurance
    Team Leader: Charlene Banard, Chief Quality Officer, Shire
    Team Leader: David Lonza, Deputy Advisor to the President, Lachman

2:30 PM - 2:50 PM


2:50 PM - 3:50 PM

Solution Stream Readouts

Participants will present the scope, process and solution output they develop during the AI working team discussion sessions related to quality, regulatory and supply chain challenges. All summit participants will engage in table discussions in order to provide robust feedback to help the working teams further develop their AI solutions.

3:50 PM - 4:40 PM

FDA Strategic Priorities and Vision for the Power of AI

FDA Officials will share the strategic priorities they have involving the implementation of artificial intelligence, including the newly formed Digital Health Unit that reports directly to CDRH Center Director, Jeff Shuren. FDA will also share their opinions on what has been developed by the participants over the course of the past two days. How can FDA and industry use the power of AI to increase the assurance of product quality, and therefore, increase the assurance of patient safety? As always, Xavier engenders an incredibly strong collaboration between FDA and industry that will enable us to shape the future of the industry together…today.


  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA, FDA
  • Bakul Patel, Associate Center Director for Digital Health, FDA
  • Francisco (Cisco) Vicenty, Program Manager, Office of Compliance, FDA – CDRH

4:40 PM - 5:00 PM

Where Do We Go From Here?

The end of the Summit is actually just the beginning. Through the Xavier Center for Artificial Intelligence, participants will have an opportunity to continue their efforts on Work Teams that will meet to develop the output needed by data scientists in order to implement the quality, regulatory and supply chain AI solutions.

The teams will be supported by a sophisticated infrastructure led by Xavier University to include an ecosystem of mentors and AI experts with a formal charter to cover a succinct opportunity identified during the summit.

The target duration of the work is one year, with each team meeting at a frequency that appropriately fosters the advancement of their work towards the end product.
The work teams will present their solutions during next year’s summit—AI Summit 2018.


  • Marla Phillips, Director, Xavier Health