AI Summit Agenda: Day 2
Friday, August 24, 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. Take some time to engage further with our expert live demo exhibitors for more hands-on demonstrations!

8:30 AM - 9:15 AM

Predictive Decision-Making through the Power of AI

Medical Device and pharmaceutical manufacturers are increasingly incorporating Digital Enterprise best practices to gain Product Intelligence throughout the Total Product Quality Lifecycle. The future of Product Intelligence goes beyond reactive and proactive decisions to predictive capabilities that are revealed through the intersection of data from multiple GXP and non-GXP systems. Several real-world examples will engage you on a transformative journey that will ensure your company has the right systems in place to take advantage of new AI capabilities.


  • Kumar Madurai, Principal Consultant, CTG


  • Nick Ranly, Account Executive – Life Sciences, Siemens PLM Software
  • Jeff Spencer, Portfolio Development Executive, Siemens

9:15 AM - 10:00 AM

Building an AI/ML Culture

The buzz about AI/ML is everywhere these days. Companies are talking it up, a few have a firm grasp on how to effectively use and/or deliver AI/ML, most are just at the door step. They are talking, learning, initiating pilot projects, experimenting with tools and techniques, being bombarded by vendors and struggling to hire skilled resources. At Shire, Walt has been leading the charge to establish the foundational capabilities for AL/ML and working to build an AI/ML culture. In his talk, Walt with share his experiences in the hope that this will help you on your own AI/ML journey. Successful companies who fully embrace AI/ML at all levels will be the leaders.


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


  • Orrin Edenfield, Cloud Solution Architect, Advanced Analytics & AI, Microsoft
  • Walt Mullikin, Head of Enterprise Analytics, Shire Pharmaceuticals
  • Shawn Remacle, Director, Health Solutions, Microsoft US Health and Life Sciences

10:00 AM - 10:20 AM


10:20 AM - 11:15 AM

Operationalizing Quality: A Machine Learning Interpretability Approach

While understanding and trusting models and their results is a hallmark of good (data) science, model interpretability is a serious legal mandate in the more regulated verticals of the insurance and healthcare industries. Moreover, scientists, physicians, researchers, patients, and humans in general have the right to understand and trust the models and modeling results that affect their work and their lives. Today, many are embracing deep learning and machine learning techniques, but what happens when people want to explain these impactful, complex technologies or when these technologies inevitably make mistakes?  Patrick Hall shares several approaches beyond the error measures and assessment plots typically used to interpret deep learning and machine learning models and results. Wherever possible, interpretability approaches are deconstructed into more basic components suitable for human story telling: complexity, scope, understanding, and trust.


  • Andrew Langsner, Managing Partner,


  • Patrick Hall, Senior Director of Product,

11:15 AM - 12:00 PM

A Practical Use for AI in Quality

Your colleagues from Amgen will present their strategy and approach, share practical use cases, and discuss lessons-learned from implementing AI in Quality processes. One use case will focus on the difficulty in performing robust trending of deviations. Through the power of Natural Language Processing (NLP), unstructured data (words) can be assessed to identify potential trends and take corrective action. This is just the first step. The real goal is to correlate NLP results with structured data (numbers) from the field, manufacturing and development to develop a predictive capability. The ability to accurately predict product quality will be an integral component of Continuous Product Quality. This session will involve attendee participation in small group exercises.


  • Cindi Linville, QA Manager, Best Sanitizers


  • Mark A. DiMartino, Director, Quality Data Sciences, Amgen
  • Dan Weese, Executive Director, Quality Data Science, Amgen

12:00 PM - 1:00 PM

Lunch Networking by Topic and Live Demo Exhibit

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 - 2:30 PM

Break-out Sessions for Working Team Development

Take this exciting opportunity to join a working team that interests you, so you can engage with your colleagues to establish key aspects of the team charter. 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.  What a great opportunity for you to implement solutions developed with AI experts and your industry colleagues!  

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:

  • Continuous Product Quality Assurance (CPQA): This team is launching Phase 2 of their work to address the necessary culture and infrastructure needed for successful AI implementation. This will be assessed from a crawl-walk-run methodology so each organization can apply the learnings that are appropriate for their position on the AI implementation continuum.
  • 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.
  • 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: Nick Ranly (Siemens)
  • CLS: Pat Baird (Philips), Rohit Nayak (Tech Accelerator), Kelly Nienburg (PwC)
  • Special Interest Group: Discussion led by Tom Meyer (Xavier)

2:30 PM - 2:50 PM


2:50 PM - 4:00 PM

Fireside Chat with FDA

In a world of fast-paced innovation and vast opportunity, it is important that FDA and industry 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 your industry colleagues on where we can go from here…together. Learn first-hand what FDA is seeing as the possibilities, challenges and critical steps to incorporating the power of AI in a responsible and effective way.


  • Marla Phillips, Director, Xavier Health, Xavier University
  • Zach Rothstein, Associate Vice President, Technology and Regulatory Affairs, AdvaMed


  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, ORA-FDA
  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA-FDA
  • Dr. Jesse Ehrenfeld, Professor of Anesthesiology, Surgery, Biomedical Informatics and Health Policy, Vanderbilt University School of Medicine
  • Bei Ma, Vice President, Global Healthcare Business Development, BSI Group America
  • Bakul Patel, Associate Center Director for Digital Health, CDRH-FDA
  • Berkman Sahiner, Senior Biomedical Research Scientist, FDA-CDRH
  • Cisco Vicenty, Program Manager - Case for Quality, Office of Compliance, CDRH-FDA

4:00 PM - 4:05 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. 


  • Marla Phillips, Director, Xavier Health, Xavier University