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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

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

Session Chair(s)

Jake  Doran

Jake Doran

Head of Digital

Lykos Therapeutics, 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

Clarivate Analytics, United States

Global Life Sciences Solutions Lead

Sheila  Mahoney Jewels, MBA


Sheila Mahoney Jewels, MBA

LifeSciHub , United States

Drug Development Multi-Functionalist

Matt  Neal, MA


Matt Neal, MA

Atara Biotherapuetics, United States

Senior Director, Regulatory Affairs Operations

Sylva Jana Krizan, PhD, RAC


Sylva Jana Krizan, PhD, RAC

Amazon Web Services (AWS), United States

Global Compliance, Healthcare and Life Sciences

Robert  Connelly, MBA


Robert Connelly, MBA

Incyte, United States

Senior Director, Global Regulatory Operations

Steve  Gens, MS


Steve Gens, MS

Gens & Associates Inc., United States

Managing Partner

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