AI Team Deliverables

The deliverables below are from the 2017-18 AI Summit working teams. Join us at this year’s summit as the teams unveil the outcome of their most recent work. Meet the authors, engage in discussion, and help shape the direction of the FDA/industry teams.

Continuously Learning Systems (CLS) Team

Continuous Product Quality Assurance (CPQA) Team


Featured Speakers


Agenda Highlights

Actionable insights on these topics and more:

What we are continuously trying to do here is get back to our goal of giving people access to technologies, but we’re also realizing that our current methods don’t quite work well.
— Bakul Patel, director for digital health at the FDA in Smithsonian Magazine
  • FDA Vision
    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.

  • Foundation of AI
    Continue to deepen your understanding of “how it works” through foundational topics that could include “how machine learning works,” “how to validate AI,” “how natural language processing works,” and “what is naturals language generation?”. These types of topics will open your mind as to how your organization can take advantage of the power of AI even beyond how it is being used today. Be the champion to advance your company!

  • AI in Action
    What is AI? How are AI systems built? How do we unpack knowledge from AI algorithms? Far from being indecipherable “black boxes,” you will instead find that building AI systems follows a replicable and intuitive process that is especially suited for implementation across the industry. Be confident in how your organization can implement AI!

  • Live AI Technology Demos
    Participants will take a guided tour of technology that can be used to implement AI in your organization. These small-group demos also will show you AI in action and will give you a chance to ask your questions.

  • Putting AI Into Motion Across GxP Organizations
    Whether you are already using the power of AI in your organization, or just getting started, this workshop will support your ability to advance the impact of your results. Spend the day during this hands-on pre-summit workshop diving into the challenges, opportunities and successful practices of machine learning, natural language processing, natural language generation. Gain a deeper understanding of how to increase the success of the outcomes, decrease the risk of decisions you make from the algorithms, and increase the confidence you have in relying on the results.


Join FDA and Industry Experts to Develop Quality, Regulatory, and Supply Chain Solutions Through the Power of AI

Be a part of the conversation; join our    LinkedIn AI group    today!

Be a part of the conversation; join our LinkedIn AI group today!

AI Realized. The Xavier Artificial Intelligence Initiative presents AI Summit 2019. Be a part of the future of our industry by:

  • Understanding the current use of AI in the medical device and pharma industries

  • Exploring cutting-edge possibilities of how the power of AI can be applied to solve your challenges in quality, regulatory, and supply chain

  • 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

Register now for AI Summit 2019, with the summit workshop, Putting AI Into Motion Across GxP Organizations, August 20, and the main summit sessions, August 21-22.

AI could help improve our oversight and accelerate bringing products to market. It has the potential to fill in the gaps that we can not see or get to in our current approach/paradigm.
— Cisco Vicenty, Program Manager – Case for Quality, CDRH, FDA

AI Summit 2019 Sponsors

Because of the generosity of our sponsors, we can continue our work to advance AI solutions in pharma, device, and combination products. Thank you!

Premium Sponsor —

Distinguished Sponsor —


Who Should Attend

Those looking for solutions to launch or improve AI capabilities:

  • Quality, Regulatory, Operations, R&D, Clinical Trials and Supply Chain functions

  • Data scientists and cross-functional peers

  • Regulators

  • Any life science industry

  • Companies of all sizes

  • Consultants and service providers to the life science industries


What Can We Do Together?

Here are just a few examples:

AI holds enormous promise for the future of medicine, and we’re actively developing a new regulatory framework to promote innovation in this space and support the use of AI-based technologies.
— Scott Gottlieb, M.D., FDA Commissioner
  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.


Experience the Xavier Difference

Your one-of-a-kind experience with us is rooted in our mission of:

Inspiring Collaboration

  • Feel the purpose-driven nature of this summit as soon as you enter the room.

  • Expect orchestrated engagement with your peers across the industry on topics you are passionate about.

  • Find participants openly sharing their expertise to help advance the industry in collaboration with regulators.

  • Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities.

Leading Innovation

  • Identify solutions that will protect your patients around the world, your company brand, and your business.

  • Talk about the “elephant in the room” to get to the real pain that plagues our industry.

  • Learn what you didn’t know you didn’t know! Walk away with real solutions.

  • Hear directly from leaders who passionately challenge the status quo.

Making a Difference

  • Work through real working models that can improve the reliability of your product…today.

  • Learn how you can be part of the solution.

  • Understand who your stakeholders are so you can implement meaningful and sustainable change.

  • Leave the summit armed with action plans that are orchestrated throughout the summit and solidified before you leave.