Main Summit Sessions Agenda: Day 1

Wednesday, August 21, 2019


7:45 AM - 8:30 AM


Join your colleagues from around the globe as we kick off the AI Summit with a complimentary warm breakfast.

8:30 AM - 8:45 AM

Let's Make a Difference!

Welcome to the Summit and welcome to Xavier University. We look forward to working with you to advance the industry through the power of AI.


  • Marla Phillips, Director, Xavier Health, Xavier University

8:45 AM - 9:15 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.


  • Oliver Christ, Executive Vice President, PROSYSTEM, an NSF International Company

  • Marla Phillips, Director, Xavier Health, Xavier University

9:15 AM - 10:00 AM

FDA Vision and Initiatives: The Power of AI

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 use of artificial intelligence on many fronts. Walk away with an understanding of how FDA is moving forward to advance the industry through the power of AI.


  • Marla Phillips, Director, Xavier Health, Xavier University


  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA-ORA

  • Bakul Patel, Associate Center Director for Digital Health, CDRH-FDA

10:00 AM - 10:20 AM


10:20 AM - 11:05 AM

TRACK 1 (Foundations of AI)

Management and Oversight: AI Governance

Business leaders want agility in developing cutting-edge Artificial Intelligence solutions. Such innovation requires a novel leadership approach to ensure effective deployment across the enterprise. Traditional governance models might inadvertently shutdown the out-of-the-box thinking that drives innovation. Understand how to lead your organization to success, including aspects of the quality of data feeding the model, learning methods to be employed, defining and designing appropriate algorithms, validation of the data models needed to establish trust, and operationalizing the solution.


  • Goverdhan Pallerla, Data & Analytics Leader, The Christ Hospital Health Network


  • Michael Shepherd, Lead AI Research Technologist, Dell

TRACK 2 (AI Success Stories)

AI in Bioreactor Production: Predicting Final Protein Titer

Biologics production requires highly sophisticated, complex cell based processes. To better understand and work faster to improve the development of these processes, the speaker will share how Takeda used AI on the early perfusion bioreactor data to attempt to predict the final protein titer. Through the power of AI, only data from half of the total run time was needed to predict the final total titer accurately enough to determine if the run was acceptable. During this session, you will understand the challenge, approach and future thinking experienced by Takeda.


  • Toni Manzano, R&D Director, Bigfinite


  • Walt Mullikin, Head of Enterprise Analytics, Takeda

TRACK 3 (AI in Healthcare)

Genetics, Genomics, AI…Oh My!

Through this session you will understand the implications of applying AI techniques to the field of genomics in terms of privacy, security, data sharing, discriminatory use of results against the patient, and computational challenges. Learn how to mitigate these challenges in your company through examples of current real world use of genomics.


  • Marla Phillips, Director, Xavier Health, Xavier University


  • Bruce J. Aronow, PhD., Co-director, Computational Medicine Center, Cincinnati Children’s Medical Center (CCHMC)

  • Don Wright, Founder, President and CEO, Clarigent Health

11:05 AM - 11:15 AM

Relocation Break

Participants are provided a short break for anyone wishing to attend a different track.

11:15 AM - 12:00 PM

TRACK 1 (Foundations of AI)

Streamline Your Legal and Privacy Approach to AI

In order to reduce risk to your company and the patients you serve, this session will focus on domestic security, privacy frameworks, and regulations with consideration for other markets that help define product design and AI implementation. Experts will discuss with you various angles to consider related to: Where should the data be stored? How is the data shared? What are the cross-border implications? What are the privacy rules to consider for clinical trials such as deidentifying patient data before it can be shared? How do these views differ between regulatory bodies (e.g. US – HIPAA; EU – GDPR; China – NMPA)? Don’t miss this opportunity to streamline your approach to security and legal implications of AI!


  • Cindi Linville, QA Manager, Best Sanitizers


  • Danny Tobey, M.D., J.D., Partner, DLA Piper

TRACK 2 (AI Success Stories)

Boosting the Business Case of AI in Visual Inspection

AI is the path forward to enhance our and any business, but there are several challenges that can slow down the uptake of this technology. Some of these challenges are: 1) An existing vision infrastructure may not justify the capital investment to new AI-enabled equipment for an incremental benefit, 2) If we leverage the state of the art AI models, hardware requirements may invert the business case or limit replicability, 3) different  product presentations and equipment setups may reduce training set size compromising performance or yielding a large black box with interpretability challenges and limited capacity to cope with changes, and 4) labeling can become the bottleneck. In this presentation we will discuss some paths we are taking to enhance our existing vision infrastructure to leverage the latest AI developments with limited capital investment, and we will trigger the discussion to see how you can accelerate the use of AI in your organization.


  • Toni Manzano, R&D Director, Bigfinite


  • David laurí Pla, Senior Data Scientist/ AI, Pfizer

TRACK 3 (AI in Healthcare)

Harried and Hurried: Will AI Help? A Provider’s Perspective

With physician burnout at an all-time high, how will the promises of Artificial Intelligence enhance clinical decision support? Learn the provider’s perspective on: what is physician “burnout”?; promises versus opportunity of AI and healthcare big data; and how will AI assist in modifying behaviors? Lessons learned from evidence-based medicine will give you insight as early as possible on what the end result needs to be for healthcare providers to confidently use your product.


  • Hima Chalasani, Manager – Data Integration & Data Management, The Christ Hospital Health Network


  • Carlos A. Aguilar, MD, MS, FACP, Chief Medical Information Officer, The Christ Hospital Health Network

12:00 PM - 1:00 PM

Lunch Networking by Topic

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:

  • Quality Assurance

  • Manufacturing Operations

  • Supply Chain Operations

  • “AI Implementers” - those actively using AI Solutions will share challenges and opportunities

1:00 PM - 2:15 PM

Xavier AI Initiative: Working Team Deliverables and Next Steps with You

The future is here. It is time for our industry to move from reactive to predictive! FDA and industry working teams will present real pathways to the power of AI for your operations. Hear directly from the Team Leaders for the following three teams:

  1. Continuous Product Quality Assurance (CPQA)

  2. Continuously Learning Systems (CLS)

  3. AI in Manufacturing


  • Mac McKeen, Fellow, Regulatory Science, Boston Scientific Corporation


  • Pat Baird, Philips, CLS Team Co-Leader

  • Toni Manzano, Bigfinite, AI in Mfg Team Leader

  • Rohit Nayak, Tech Accelerator, CLS Team Co-Leader

  • Nick Ranly, Siemens, CPQA Team Co-Leader

  • Mark Zhong, PwC, CPQA Team Co-Leader

2:15 pM - 2:35 PM


2:35 PM - 5:00 PM

Live AI Technology Demos

AI immersion through Live Demos give you an opportunity, in small groups, to see what new AI technologies exist, what they can do and how they work. Ask AI experts your questions, and understand further what this technology can do for your company—be a catalyst for your management and technical experts!


  • Michelle Rich, Associate Director of Program Development, Xavier Health, Xavier University

Live Demo Exhibitors: 

  • Sparta Systems: AI-Augmented Quality Management

  • Bigfinite: Step Changes in Manufacturing Operations with Predictive Insights usiing AI/ML and Pharma 4.0

  • Putting the Power of AI into the Hands of Pharmaceutical Subject Matter Experts

  • AstraZeneca: Live Creation of AI

5:00 PM - 7:00 PM

Networking Reception and Live Demo Exhibit

The summit will surely result in lots of energy as you and your colleagues explore the “what ifs” and “how tos” of AI. Stay with us for the summit networking reception to enjoy lively dialog with colleagues, FDA and speakers, and take another opportunity to explore hands-on demos with expert service providers. Enjoy drinks and hors d’oeuvres before closing out the day.