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Regulatory Submissions, Information, and Document Management Forum

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Session 3: Artificial Intelligence Panel: Regulatory Affairs in the Age of Artificial Intelligence

Session Chair(s)

Jake  Doran

Jake Doran

  • Head of Digital
  • MAPS Public Benefit Corporation (MAPS PBC), United States
Karen  McCarthy Schau

Karen McCarthy Schau

  • Director, Risk-based Study Management
  • Vertex Pharmaceuticals, United States
Thomas  Noto

Thomas Noto

  • Senior Director, Regulatory Operations
  • Lexicon Pharmaceuticals, United States
In this panel discussion, we will explore how the Regulatory function is positioned in the age of Artificial Intelligence and emerging technologies. From exploring whether it is hype or reality, to evaluating potential use cases, to building business cases, and evaluating organizational readiness for a change of this magnitude; this session will bring together industry leaders to share insight into how Artificial Intelligence will impact Regulatory. As more and more use cases are defined and practical implementation is realized, how will we see the application and impact play out over the next few years?
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Understand various use cases for Artificial Intelligence across Regulatory
  • Understand the challenges and obstacles organizations face when embarking on exploratory initiatives, such as AI
  • Learn about the impact a regulated environment and health authorities will have on adoption of this technology


Christopher  Mundy, MS


Christopher Mundy, MS

  • Global Life Sciences Solutions Lead
  • Clarivate Analytics, United States
Sheila  Mahoney Jewels, MBA


Sheila Mahoney Jewels, MBA

  • Drug Development Multi-Functionalist
  • LifeSciHub , United States
Matt  Neal, MA


Matt Neal, MA

  • Senior Director, Regulatory Affairs Operations
  • Atara Biotherapuetics, United States
Sylva Jana Krizan, PhD, RAC


Sylva Jana Krizan, PhD, RAC

  • Global Compliance, Healthcare and Life Sciences
  • Amazon Web Services (AWS), United States
Robert  Connelly, MBA


Robert Connelly, MBA

  • Senior Director, Global Regulatory Operations
  • Incyte, United States
Steve  Gens, MS


Steve Gens, MS

  • Managing Partner
  • Gens & Associates Inc., United States