AI Summit Agenda: Day 2
Friday, August 24, 2018

 

7:45 AM - 8:30 AM

Breakfast

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

Foundation of AI - Part II

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!

Moderator:

  • Paul Kostoff, Managing Partner, Cincinnati Data

Speaker: 

  • Jesse Livezey, Post-Doctoral Researcher, Lawrence Berkeley National Laboratory
  • Nick Ranly, Account Executive – Life Sciences, Siemens PLM Software
  • Jeff Spencer, Portfolio Development Executive, Siemens

9:15 AM - 10:00 AM

Foundation of AI - Part III

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!

Moderator:

  • Paul Kostoff, Managing Partner, Cincinnati Data

Speakers: 

  • Walt Mullikin, Head of Enterprise Analytics, Shire Pharmaceuticals
  • Microsoft Representative TBD

10:00 AM - 10:20 AM

Break


10:20 AM - 11:15 AM

AI in Action - Part II.  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 and Sanjay Joshi share 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.

Moderator:

  • Andrew Langsner, Managing Partner, Cincinnati Data

Speaker: 

  • Patrick Hall, Senior Director of Product, H2O.ai
  • Sanjay Joshi, Chief of Technology, Healthcare and Life Sciences, H2O.ai

11:15 AM - 12:00 PM

AI in Action - Part III

Learn from more examples of how your colleagues are implementing artificial intelligence in their companies, while keeping in mind the crawl-walk-run progression. You can identify the readiness of your company on that continuum to explore how to advance the predictive capabilities through the power of AI in a way that is right for your organization. Don’t miss this opportunity to take this new insight back to your company to champion the future of how your company operates.

Moderator:

  • Matthew Schmucki, Quality Lean Coach, AstraZeneca

Speakers: 

  • Pharmaceutical Manufacturer TBD

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:

  • Drug Discovery 
  • Research and Development
  • Clinical Trials
  • Regulatory Affairs
  • Supply Chain
  • Manufacturing Operations
  • 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:

  1. 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.
  2. 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.
  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.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

2:30 PM - 2:50 PM

Break


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.

Moderator:

  • Marla Phillips, Director, Xavier Health, Xavier University

Speakers: 

  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs, ORA-FDA (invited)
  • Art Czabaniuk, Program Division Director, Division of Pharmaceutical Quality Operations III, ORA-FDA (invited)
  • Michael Kopcha, Director of the Office of Pharmaceutical Quality, CDER-FDA (invited)
  • Bakul Patel, Associate Center Director for Digital Health, CDRH-FDA (invited)
  • Berkman Sahiner, Electrical Engineer, FDA-CDRH (invited)
  • Cisco Vicenty, Program Manager - Case for Quality, Office of Compliance, CDRH-FDA (invited)