Big Data and Information Governance in Life Sciences

The clamor around big data’s applications and how best to tame them was one of the key themes which emerged at this year’s BIO International Convention,
held in Chicago. Hosted by the Biotechnology Industry Organization(BIO), the event drew 13,594 industry leaders from 47 states, theDistrict of Columbia, Puerto Rico, U.S. Virgin Islands and 62 countries.
I was there and fortunate to have the opportunity to gain first-handinsight into the industry’s challenges and opportunities, as well as thestrategies and tactics that forward thinking companies are utilizing toextract value from Big Data and improve the therapeutic options ofpatients.

The volume of datagenerated by all aspects of life sciences is staggering. Estimated to bearound 150 exabytes in 2011, this almost inconceivable aggregate ofinformation has been increasing at a rate of 1.2-2.4 exabytes per year.To put this in context, one estimate holds that all words ever spoken byhuman beings could be stored in five exabytes of data. And just howmuch is an Exabyte? An exabyte is 10^18 bytes, or one million terabytes.
Truly staggering!

Theincredible vastness of this information presents an unprecedented set ofopportunities for the biopharma enterprise, particularly aroundpersonalized medicine and companion diagnostics. It also presents somestiff challenges regarding information governance: All this data must becaptured, curated, stored, searched, shared, transferred, analyzed, andvisualized while maintaining 21 CFR Part 11 compliance.

The scene at BIO was set in the first day’s Personalized Medicine and Diagnostics Forum. One of the sessions, Big Problems Need Big Solutions–Fixing the Health Care System Using Big Data,
addressed the potential value biopharmaceutical companies could realizethrough exploring the databases of payers, hospital groups, and CROs,in addition to their own datasets. An integration of these datasetswould allow researchers to determine which patients will benefit fromcertain drugs and which could experience side effects. It would alsoassist in identifying patterns and causality in complex diseases,potentially feeding back into the drug development process.

How might an integration, synthesis, and governance of data such as this be achieved?

OpenText specializes in providing Enterprise Information Management(EIM) solutions that can help life sciences organizations deal with thechallenges of Big Data. From Electronic Lab Notebooks and LIMS to FDAfilings, OpenText Pharmaceutical & Life Sciences solutions ensure compliance with federal regulations for data governance while helping solve critical process challenges.

What about the future? New ways of delivering solutions are being explored. Is innovation in the cloudthe answer – might it be the new “space” to accelerate scientificdiscovery and development? Subsequent sessions at BIO delved into thisquestion and others, exploring the trends, challenges, and bestpractices of drug development in the cloud as it relates to ecosystempartnerships, data analytics, and compliance.

Aswe work to implement current capabilities and aim toward futurestandards-based collaboration, the conclusion is clear: Collaborationacross biopharma, technology providers, and regulatory agencies will beessential to develop the standards, technology, and approaches necessaryto critically evaluate data and generate useful information forimproved health outcomes in patients. The taming of Big Data is not asimple task for Life Sciences, but the innovation that can flow fromthat is well worth the effort! Now is the time to get on board and explore the possibilities.

Jaleel Shujath

Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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