Join FDA and industry experts for quality, regulatory, and supply chain solutions generated through the power of AI.

AI Realized – Today and Tomorrow.  The Xavier Center for Artificial Intelligence presents the AI Summit 2017, August 24-25. Be part of the future of our industry by:

  • Understanding the current use of AI in the medical device and pharma industries that you can reapply today
  • Exploring cutting-edge possibilities of how the power of AI can be applied to solve your quality, regulatory, and supply chain challenges – today and tomorrow
  • Engaging in AI industry-wide solution discussion sessions
  • Joining an AI Solution Team during the summit and beyond
  • Shaping the future of our industry…now

Who Should Attend:

  • Medical Device professionals
  • Pharmaceutical professionals
  • FDA Officials
  • Global regulators
  • Quality operations, regulatory affairs and supply chain professionals
  • Data Analytics professionals
  • AI experts
  • AI end users
  • Those who are interested in AI applications, but are not versed in AI
  • Vice Presidents, Directors, Managers, Supervisors and non-supervisors
  • Small, medium and large organizations

What Can We Do Together?  Here are just a few examples:

  1. Continuous Audit System:  Develop an expert process to audit all of your documents constantly, instead of conducting an annual audit on 2% of your documents.  Start by interviewing expert auditors and investigators to identify their “if/then” thought process on how they conduct audits.  Move from “audit findings” to predicting areas of failure.
  2. Predicting Product Failure:  Fold-in as much data and variables as you can surrounding your production process to identify sources of influence on your product quality that weren’t previously realized (think of incoming variables, facility, human, time of year, supply base, stock prices, every specification range, etc.).  Work together to identify which common and uncommon variables could be included.
  3. True Root Cause:  Identify triggers in your investigations and CAPA documents that could signal deeper root causes and trends that have not been recognized, then develop a consistent process for root cause identification across your organization.  Output could include a standard list of root causes and related failures for industry use.
  4. Robust Supplier Selection and Monitoring:  Develop a process to scan external information related to suppliers during the due diligence process – prior to signing a contract.  Then continue monitoring external information on your supplier’s performance with other clients that could impact your products.  Identify what types of information and sources to scan.

What If My Company is Small or Has Not Started With AI?

  • All of the examples above can benefit every company, since each example can be implemented by humans.   The output of our work will identify successful practices from industry-wide experts that can be used by humans in all organizations.  The next step would be to have those practices augmented through the power of AI.
  • The work we will accomplish together will help some companies understand the criticality of moving beyond paper-based systems to simple electronic systems, let alone implementing AI.  Humans cannot reasonably identify trends and assess large amounts of information if the information is contained on paper, thus exposing your patients and company to unidentified risk.
  • If your company is ready to start with AI, the systems can be developed on your own, you can hire consultants, or you can contract with solution providers.  Since all of those examples can be scaled to what you are ready for, the power of AI is within your reach – today.


Summit Core Team - FDA and Industry Representatives:


Time Description
7:45 AM - 8:30 AM

Join us for Breakfast at Xavier University

Join your colleagues for a nice 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 Xavier University and welcome to the Center for Artificial Intelligence.  We look forward to working with you to advance the industry through the power of AI.

8:45 AM - 9:30 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.

9:30 AM - 10:00 AM

The Power of AI Working in our Health Care Systems

Our Keynote Speaker will share how artificial intelligence is already advancing health care today.  These advances give us hope as the diagnosis and treatment of complex conditions is unraveled by AI, putting powerful information in the hands of our doctors.

10:00 AM - 10:20 AM


10:20 AM - 11:00 AM

Senior Leader Vision for AI Implementation

Senior Leaders will discuss with each other and participants what their vision is for the implementation of AI.  The realization of AI is powerful, and can transform our industry – moving us from reactive to predictive.  Learn what the Senior Leader vision is for AI implementation, and how that vision can benefit your organization.

11:00 AM - 12:00 PM

How Machine Learning Works

Before we dive into the possibilities of applying AI across quality, regulatory and supply chain operations, let’s come to a common understanding of how machine learning works.  This will enable participants to understand what kind of output is needed by data scientists in order to take that output and develop artificial intelligence programs.  Our goal is to ensure our solutions can be put into action!

12:00 PM - 1:00 PM

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:

  1. Quality Operations
  2. Regulatory Affairs
  3. Supply Chain
1:00 PM - 1:45 PM

The Power of Natural Language Processing

Participants will gain an understanding of how computers can be used to scan unstructured data (text) to identify information and trends that humans are unable to detect.  Additionally, the volume of information that can be assessed through natural language processing (NLP) is far beyond human capabilities, and provides humans with robust information from which proactive and predictive decisions can be made.  By understanding the power of NLP, participants can explore all the possibilities of how NLP can be used in their organizations and across the industry.

1:45 PM - 2:30 PM

The Steps Leading to Successful AI Implementation

Whether your organization has implemented AI, is in the process of implementing AI, or is just trying to figure out where to begin, this session will guide participants down the path of the steps needed for successful implementation.  Michael Shepherd will walk us through how Dell implemented AI for the first time within their own internal systems.  His experience and guidance will set you and your organization up for success – whether you are exploring a basic foundational approach or advanced applications.  Don’t miss this session of expert insight.

2:30 PM - 2:50 PM


2:50 PM - 3:45 PM

The Possibilities of AI Implementation in Quality, Regulatory and Supply Chain

Through discussions during the March 2017 FDA/Xavier PharmaLink Conference, the April 2017 Lunch and Learn Session on AI, and the May 2017 FDA/Xavier MedCon Conference, many ideas were gathered from close to 150 industry members and FDA officials across the pharmaceutical and medical device industries.  We have formulated examples of how AI can be implemented across quality, regulatory and supply chain operations for our participants to develop into real solutions.  We will walk through these examples, involve participants in table discussions, and set the stage for break out sessions on solution development.  The realization of AI will set your mind in motion to explore the seemingly endless possibilities of real applications of AI that are within your reach.

3:45 PM - 5:00 PM

AI Realized: Solution Development Break-out sessions

The future of AI is here today.  We will advance the pharmaceutical and medical device industries by augmenting human decisions with artificial intelligence such that our decisions are more informed.  This will move us from reactive to proactive, then from proactive to predictive, and finally from predictive to prescriptive such that our actions are right-first-time.  Participants will choose a working team discussion session that will be facilitated by AI Experts.  AI Experts will guide participants in the development of the scope, process, and possible solution output for implementing AI across quality, regulatory and supply chain challenges.

5:00 PM - 7:00 PM

Networking Reception

The summit will surely result in lots of energy as you and your colleagues explore the “what if’s” and “how to’s” of AI.  Stay with us for the Summit Networking Reception to enjoy lively dialog, drinks and hors d’oeuvres before closing out the day.

August 25, 2017

Time Description
7:45 AM - 8:30 AM

Join us for Breakfast at Xavier University

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

8:30 AM - 9:00 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.

9:00 AM - 9:45 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!

9:45 AM - 10:05 AM


10:05 AM - 11:35 AM

Current AI Applications in Quality, Regulatory and Supply Chain

Three different 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.

11:35 AM - 1:00 PM

Lunch Networking by Topic

Participants will select which solution stream is most interesting to them as we strive to leave the summit with working teams formalized.  These working teams will continue to develop the solutions that can be adopted by the global industry.  The solution streams will come from those developed on Day 1:

  1. Quality Operations
  2. Regulatory Affairs
  3. Supply Chain
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.

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 2 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.

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 1 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.