The FDA sits some of the largest datasets in the world on drugs and other regulated products, and the agency's recently appointed IT chief plans to push for more of those data to become available to outsiders via open source projects. During an appearance in Boston this morning, Eric Perakslis, the FDA's chief information officer, presented part of his vision for transforming IT that supports regulation of products that comprise more than a fifth of U.S. commerce.
Perakslis, a former IT leader for R&D at healthcare giant Johnson & Johnson ($JNJ), began work as the agency's CIO and chief scientist of informatics about 6 months ago, becoming the fifth person in the post since 2008. In a report last month, the Government Accountability Office (GAO) harped on the fact that unstable leadership in IT at the FDA over the years has jeopardized efforts to modernize the agency's information technology and an overhaul with a $280 million price tag.
Only giving brief mention to the critique from the GAO, Perakslis noted his preference for avoiding massive IT projects that government has been known for and that can take 5 years to wrap up. Rather, he envisions tackling multiple projects with shorter timelines of 6 months or less to 18 months that can deliver results faster. He has decided to seek expanded use of cloud computing, which will enable the FDA to "get out of the business of racking and stacking servers," he said. And the agency plans to increase use of mobile devices such as iPhones and phase out paper-based systems of keeping records.
The FDA has consolidated its data centers as part of its overall modernization effort, according to the GAO report, which said that the agency's IT budget for fiscal 2011 was $439 million--more than $170 million of which went into modernization and development. Perakslis told FierceBiotech IT in an interview that he has submitted a draft strategic plan that addresses some of the complaints in the GAO report and his strategy for updating IT.
For instance, Perakslis wants to make significant portions of the agency's large stockpile of liver toxicity data available to outside groups. The project is called Liver Toxicity Knowledge Base. Liver toxicity factors heavily into the safety of drugs, and the data from the FDA could aid efforts to study side effects of marketed drugs and aid developers in avoiding liver injury with experimental therapies.
"We're actually pushing into open source much faster," Perakslis said during his keynote talk at the 10th annual Bio-IT World Expo.
Those who know Perakslis understand why he values swift activity on the innovation front. He's a cancer survivor and said during an interview that the experience of fighting cancer has made him believe in the power of open source as a vehicle for streamlining research activities.