Mar 15–18, 2020

Pragmatic Artificial Intelligence in Biopharmaceutical Industry

2:35pm3:15pm Wednesday, March 18, 2020
Location: LL21 D

Who is this presentation for?

C level/VP/Director




Adverse drug reactions are currently 4th leading cause of death in US. With our aging population living longer, taking more medications and more vulnerable to drug-drug interactions, the situation is going to worsen before it improves. Conversely, there are exciting advances in hardware (GPUs, Cloud Computing) and machine learning (natural language processing, attention-based neural networks, expert-defined Bayesian networks) that will help us realize the FDA’s vision of proactive pharmacovigilance. If operational improvements are made now to take advantage of future technological breakthroughs, then we can avert the coming iatrogenic crisis.

The current state of inbound Serious Adverse Event (SAE) reporting involves submission of potential SAEs by phone, fax, email, or PDF. These initial reports are often processed and tracked manually, and routed through Clinical Operations, Drug Safety, and Medical Writing departments who use different systems and find it difficult to collaborate. This presentation covers the approaches one of the largest Contract Research Organizations in world is taking to implement a scalable, end-to-end, global workflow system to optimize triaging, tracking, processing and review of SAE reports. It is expected to generate higher case closure rates, improved compliance/on-time reporting, better quality, improved metrics reporting, collaboration and workload management, and increased client satisfaction. Without doing such foundational operational work to enable us to efficiently process millions of adverse events from diverse sources, we will never have the quality data necessary to produce future artificially intelligent systems.

Prerequisite knowledge

Basic Understanding of Pharmaceutical Industry and Drug Development Basic Understanding of Natural Language Processing

What you'll learn

How to begin implementing and getting immediate value from AI techniques to improve Drug Safety and Pharmacovigilance.
Photo of Steven Beales

Steven Beales


An expert in the field of safety reporting technology, Mr. Beales has 25 years of experience in IT, and has spent over 16 years in the pharmaceutical industry. He joined WCG ePharmaSolutions in 2009 and led implementation of the company’s Clinical Trial Portal at Genentech across 100+ countries. In 2015, he led implementation of the Clinical Trial Safety Portal at a top 5 pharma organization, which included a data-driven rules engine configured with safety regulations from those countries, which saved this organization hundreds of millions of dollars. Over 50 million safety alerts have been distributed by these two portals via the cloud. Prior to joining WCG ePharmaSolutions, Mr. Beales was the Chief Software Architect at mdlogix, where he led the implementation of the CTMS systems for Johns Hopkins University, Washington University at St. Louis, the University of Pittsburgh, and the Interactive Autism Network for Autism Speaks.

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