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
System Map demonstrating interconnectivity and potential causal relationships between GMP systems, non-GMP systems and the complaint system:
Summary of data elements that represent risks and/or potential failure modes for the events captured in the complaint system:
Definitions of AI relevant terms to harmonize understanding:
AI Dictionary (PDF)
Actionable insights on these topics and more:
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
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
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
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:
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.
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.
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.
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:
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.
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.