GxP Lifeline Feature Article

How Soon Can You Get Me That Six-Year-Old Data?

By Daniel R. Matlis


Discusses the need to promote electronic records from second class, low-value data to real-time actionable facts.

On January 10, 2007, The Food and Drug Administration (FDA) notified pharmaceutical companies  of its recommendation that they reevaluate, confirm or repeat analytic studies used in the approval of some drug products.
 
The action was a result of FDA inspections at two MDS Pharma Services (MDS Pharma) Canadian facilities that raised questions about the validity and accuracy of test results from studies conducted by MDS Pharma from 2000 through 2004.

MDS Pharma performed pharmacokinetic testing services for a number of pharmaceutical companies. These studies are used to measure the level of drug in a patient’s blood. The results of pharmacokinetic studies are required by FDA for the approval of a New Drug Application (NDA).

As a result of these findings, the Agency sent over 1,000 letters to sponsors of pharmaceutical products for both brand-name and generic drugs.

At sponsor companies affected by this notification, document management organizations sprung into action to retrieve and review affected studies as expeditiously as possible.

You might think that with all the computerized systems in life science companies today, they should be able to locate and analyze this information relatively quickly. However, that is not often the case.

Life science companies have been stockpiling raw data in various standalone computer systems for more than 30 years. This has lead to the creation of “Data Islands.” Compounding this challenge is the industry’s affinity for paper records. Paper has been a long history as the gold standard for regulatory record keeping. It is not unusual for printed reports to be stamped with “Official Copy” while electronic records have been relegated to “Information Purposes Only” status.

As a result of our industry’s historical reliance on paper records and the “Data Island” approach to electronic recordkeeping, it is likely that some of these pharmacokinetic testing studies were comfortably resting in environmentally-controlled archive facilities and media vaults.

Under these circumstances, it can often take hours, days and in some cases weeks to find the right box or tape, retrieve it, parse it and find the pharmacokinetic study in question.  Only then would scientists be able to analyze the impact of the study on the drug and the patients.

This event serves to highlight a critical issue facing our industry:  the need to promote electronic records from “second class” low-value data to real-time actionable facts. To achieve this goal, life science companies must apply business and analytic intelligence tools to distill vast amounts of ineffectual data into information, knowledge and ultimately actionable facts.

According to a recent study, the amount of data required to support compliance activities in the life sciences industry has increased by 400% in the previous four years from 376 PetaBytes in 2003 to 1644 PetaBytes in 2006 (a PetaByte equals one quadrillion bytes).

The use of integrated information management and communication platforms has become critical to success in our industry. The range of applications are vast. From manufacturing intelligence to support of FDA’s Process Analytical Technology (PAT) Initiative, to fully electronic New Drug Application submissions. From adaptive clinical trials to the use of manufacturing data to improve product design. From the use of customer input in product marketing to competitive intelligence.

In this changing healthcare environment, business, legal, regulatory and governance constraints necessitate the use of fully integrated systems to achieve transparency and transform useless data into actionable facts in real time.

Although information technology provides a powerful tool to bridge this “knowledge gap,” we must always keep in mind that technology can only enable change.

Reaping the benefits of these technologies requires organizational and cultural changes to enable people to benefit from their use.

Daniel R. Matlis is president of Axendia, an analysis firm focusing on the life sciences and healthcare markets and author of Life-Science Panorama.  He can be reached at (215) 262-8037.

Read more about electronic management software solutions:


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Quality Audit ? A Tool for Continuous Improvement and Compliance

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Automating Document Control Processes

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How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market




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FDA Link

  • FDA Notifies Pharmaceutical Companies to Confirm or Repeat Analytic Studies Used in the Approval of a Number of Drug Products
    Full Article


  • Guidance for Industry: Computerized Systems in Clinical Investigations
    Full Article