Business and Data Analytics to Achieve Productive Outcomes

By Todd Simpson, CIO, FDA

The U.S. Food and Drug Administration (FDA) regulates foods, drugs, biologics, medi­cal devices, cosmetics, dietary supplements, tobacco products, electronic prod­ucts and more. Between 2009 and 2013, the FDA’s roles and respon­sibilities increased considerably as a result of five significant pieces of legislation, leading to an even larger amount of data influx from multiple sources. Analyzing this vast amount of data created a tremendous chal­lenge, especially when scrutinizing data around adverse events, which could mean the difference between life and death.

Last year, in order to gain a more complete understanding of what was needed to utilize this data to make real-time decisions, the FDA con­ducted a business intelligence (BI) assessment to determine the best technology to help meet the FDA’s growing analytics needs. The assess­ment uncovered system-wide bot­tlenecks, constrained resources, and delayed time to value with key data sets across the roughly 114,000 re­ports and more than 145 data sets that currently only leverage the web intelligence feature of the SAP BusinessObject Suite.

New Year. New Technology

Because of the assessment, the FDA decided to enhance our BI technol­ogy to meet the growing analytics needs, update technical and archi­tectural components that were caus­ing latency and reporting issues, improve data sharing abilities, pro­vide better end-to-end visibility, and expand access to end-user training.

The expanded use of BI tools will help provide real-time insights using data gathered on post-market drug safety, adverse effects tied to a prod­uct or products, and import and reg­istration data for tobacco products. It will also improve monitoring ca­pabilities for food safety and inspec­tion data and delivering financial reporting, among others.

Real-time Insights for Real-time Decisions

The FDA’s strategic goals are de­pendent on accessing data efficiently and analyzing it effectively. The organization is focused on mak­ing sure we have the “right tool for the right job,“ which means real-time dashboards to track signals and occurrences around outbreaks and adverse events that do not re­quire formatting and manipulation employing countless down-stream tools, and utilizing Google-like search and exploration capabilities.

These new capabilities will pro­vide for better reporting on post-market drug safety as well as im­proved real-time insights when identifying adverse effects tied to a product or group of products. This will allow the FDA to make decisions quickly that would have previously taken much longer regarding the safety of prod­ucts being used by the public.

These improved exploration ca­pabilities will also allow the agency to analyze data sets to uncover trends in products that are out of compliance. This was not previously pos­sible due to integrated systems, pre­venting re­viewers from seeing a holistic view all the data that was gathered across disparate data sets.

Moving Forward with Globalization

With globalization it is imperative to create an environment where in­formation sharing, data-driven risk scoring, assessment and analysis providing enhanced intelligence are critical. Data gathered from multi­ple sources needs to be searchable in order for users to obtain a com­prehensive picture of how a product or group of products is performing. This will also give users a more com­plete view of medical events world­wide, so that we can better plan and address them, before they escalate.

In addition, to providing global insights, integrating data across the organization will allow teams to share best practices and recog­nize great work that can be lev­eraged in new ways to protect public health.

Solving Challenges in Adverse Event Reporting

The FDA has collected adverse event data through many sources—in­ternal to FDA and external. Once this data was collected, there were complex statistical algorithms ap­plied to see if the information col­lected was alarming to determine if the FDA should do further investi­gation. The process of integrating data, co-relating, processing, visu­alizing and making statistical sense of the adverse events data to issue timely and lifesaving warnings is a time consuming task. The BI tools that we are implementing this year will allow the FDA to better analyze the data to make quicker, better de­cisions for food and product safety.

The impact of realizing this vi­sion is profound for the FDA as all of the agency’s strategic goals are de­pendent on accessing data efficiently and effectively. The exponential growth of data–structured, unstruc­tured, social media, predictive, and more–requires an enterprise-level BI strategy for predictive and advanced analytics.

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