AI Summit Agenda: Day 1
Thursday, August 23, 2018


7:45 AM - 8:30 AM


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

Let's Make a Difference!

Welcome to the Summit and welcome to Xavier University.  We look forward to working with you to advance the industry through the power of AI.


  • Marla Phillips, Director, Xavier Health, Xavier University

8:45 AM - 9:15 AM

The Solution Xchange

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


  • Marla Phillips, Director, Xavier Health, Xavier University

9:15 AM - 10:10 AM

Watson for Drug Discovery

Learn how Watson for Drug Discovery (a cloud-based, cognitive solution) analyzes scientific knowledge and data to reveal known and hidden connections that can help increase the likelihood of scientific breakthroughs. The platform allows researchers to generate new hypotheses with the help of dynamic visualizations, evidence-backed predictions and natural language processing trained in the life sciences domain. It is used for both new drug target identification and drug repurposing. See how the power of AI can be used by your company to strengthen your product pipeline.


  • Mac McKeen, Fellow, Regulatory Science, Boston Scientific Group


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

10:10 AM - 10:30 AM


10:30 AM - 11:00 PM

FDA Vision: The Power of AI

As we look to the future of the pharmaceutical and medical device industries, FDA and industry must continue to work together to move beyond our current paradigms of discovery, research and development and operations. FDA is actively engaged in exploring the power of artificial intelligence on many fronts. Walk away with an understanding of FDA’s vision for the use of AI across the industry.


  • Marla Phillips, Director, Xavier Health, Xavier University


  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, FDA
  • Bakul Patel, Associate Center Director for Digital Health, CDRH-FDA

11:00 am - 12:00 Pm

Deep Learning Demystified

In our first foundations of AI session, we are excited to announce that deep learning expert Jesse Livezey will take us through the process of building, extracting knowledge from, and interpreting AI algorithms. Instead of being black boxes, Jesse maintains that building AI systems follows a replicable and intuitive process that is suited for implementation across the healthcare industry. He will also cover findings from his own research and how deep learning is prepared to improve healthcare offerings from predictive modeling for radiology, to our ‘neuroscientific’ understanding of the human brain, to wearable diagnostic smart tech that can save lives. Please join us for Jesse’s presentation, which will provide the foundational knowledge needed to sift through the hyperbole of the AI news media cycle, understand how algorithms are developed and used, and keep us at the forefront of knowledge regarding the direction of AI in healthcare.


  • Paul Kostoff, Managing Partner,


  • Jesse Livezey, Postdoctoral Researcher, Lawrence Berkeley National Laboratory

12:00 PM - 1:00 PM

Lunch Networking by Topic

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 on how AI can be used in:

  • Manufacturing Operations 
  • R&D and Clinical Trials
  • Quality Operations

1:00 PM - 3:00 PM

Live AI Demo Exhibition

Participants will be guided through a fast-paced AI demonstration exhibition that will give each person an opportunity to see how artificial intelligence really works.  We have asked solution providers to set up live demonstrations for participants to cycle through during a facilitated hands-on session. Each participant will have an opportunity to visit with four providers during the exhibition, thus giving them exposure to several ways in which AI works behind the scenes. These small-group demos also allow participants to ask lots of questions. Don’t miss this opportunity “ask the experts”! Service providers will be set up during the networking reception and on Day 2 for you to visit, go back to providers you already visited, and ask even more questions.


  • Kumar Madurai, Principal Consultant, CTG


  • Live demo exhibitors will give participants an opportunity to see AI in action.

3:00 PM - 3:15 PM


3:15 PM - 4:15 PM

Xavier AI Initiative: Working Team Deliverables and Next Steps with You

The future is here. It is time for our industry to move from reactive to predictive! FDA and industry work teams will present real pathways to the power of AI for your operations. Work team leaders will share the deliverables achieved for the following two teams and discuss new workstreams and opportunities for you to engage:

  1. Evaluation of Continuously Learning Systems - CLS
  2. Continuous Product Quality Assurance - CPQA


  • Marla Phillips, Director, Xavier Health, Xavier University


  • Charlene Banard, Senior Vice President, Global Quality, Technical Operations, Shire Pharmaceuticals
  • Mac McKeen, Fellow, Regulatory Science, Boston Scientific Group
  • Berkman Sahiner, Senior Biomedical Research Scientist, FDA-CDRH
  • Mohammed Wahab, Quality Head, Professional Services - Informatics & Analytics, Abbott Laboratories, Diagnostic Division
  • Mark Zhong, Management Consultant, PwC

4:15 PM - 5:00 PM

Xavier AI Initiative: Working Team Kick-Off

All participants will be engaged in the working team or special interest group of their choice.  Team Leaders will facilitate the formation of the team charter along with the participants, as key discussion points and deliverables will be identified.  Participants will choose from any of the following:

  1. Continuous Product Quality Assurance (CPQA): This team is launching Phase 2 of their work to develop 2-3 different types of algorithms that will scan GMP and non-GMP data to identify correlations not previously recognized.  The team will demonstrate the effectiveness of the algorithms using publicly available data.
  2. Evaluation of Continuously Learning Systems (CLS): This team is launching Phase 2 of their work to address the use of explainability as a means of evaluation.  This is an important effort since FDA and industry are accustomed to verification and validation.  However, systems that continuously learn need to be “validated” through other means in order to establish credibility for the end user.
  3. AI in Manufacturing Operations – Special Interest Group: This group will be formed to discuss current use of AI in operations, challenges in implementing AI, successful practices, and important considerations.  The group will refine the goals, but will start with this common interest.


  • Tom Meyer, Chief Operations Officer, Xavier Health, Xavier University
  • Marla Phillips, Director, Xavier Health, Xavier University
  • Michelle Rich, Associate Director, Xavier Health Xavier University

Team Leaders: 

  • CPQA: Lacey Harbour (Ken Block Consulting), Nick Ranly (Siemens), Mark Zhong (PwC)
  • CLS: Pat Baird (Philips), Rohit Nayak (Tech Accelerator), Kelly Nienburg (PwC)
  • Special Interest Group: Discussion led by Walk Mullikin (Shire) and Tom Meyer (Xavier)

5:00 PM - 7:00 PM

Networking Reception and Live Demo Exhibit

The summit will surely result in lots of energy as you and your colleagues explore the “what ifs” and “how tos” of AI. Stay with us for the summit networking reception to enjoy lively dialog with colleagues, FDA and speakers, and take another opportunity to explore hands-on demos with expert service providers.  Enjoy drinks and hors d’oeuvres before closing out the day.