Pharma IT Articles

There was a time when information technology (IT) professionals needed only technical skills to obtain positions in the pharma and biotech industries. Today, this has all changed. Recently, the demand for skilled professionals in pharma has been hot, and that's expected to continue as 2007 unfolds.

In today's highly competitive pharma and biotech environments, hiring managers are seeking candidates with strong technical and domain skill sets, as well as extensive industry knowledge, resulting in a much more critical eye when trying to fill crucial IT positions. But with a tight job market, hiring managers will have a hard time finding candidates with a combination of tech skills and industry expertise, and will need to wade deeper than before into the talent pool.

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When revenue gains soften, costs start to attract greater executive attention. And so it is with Pharma. It’s widely acknowledged that the pressure to control and reduce costs is the next major challenge facing companies contributing to the Pharma industry’s global value chain. Growing generic competition, imminent patent expirations, and shorter pipelines are all contributing to eroding margins.

But as part of their efforts to improve financial performance, many pharmaceutical companies are finding it hard not to turn the cost-cutting spotlights on IT. And for good reason; not only does the Pharma industry, according to recent research, spend six times more on IT than the average U.S. industry (15% of revenues vs. 2.5%) but many companies are still waiting to chalk up measurable IT-driven business value from this huge and growing investment. It’s little wonder that pharmaceutical executives are asking why IT costs so much and yet seems to deliver so little.

Bryan L. Singer, CISSP
The adoption of open networks in manufacturing environments, and the expanding connectivity and decentralization of computer systems and databases, are making the need to secure a company's automation and production systems more important than ever. The direct linking of manufacturing systems to information systems through the presence of Ethernet on the factory-floor creates an environment where traditional information technology (IT) and manufacturing worlds collide. This trend increases the vulnerability of these systems to the same security threats facing today's IT environments. Attacks — whether direct or indirect — from hackers, worms, viruses, and employees can affect the safety and security of people, products, processes, and productivity.

How many of you have validated Programmable Logic Controllers (PLCs) or computers in the past? How many of you are going to have to do it again? And how many of you think that it is an awful, complicated, and terrible thing to have to do? If the answer is "Yes," I used to feel that way as well.
My first experience with PLC validation was absolutely awful; I knew there had to be a better way. I knew that it had to be much easier than I had made it and that I could somehow communicate that to others.

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Applied Clinical Trials, Mar 2, 2003

As discussed in the companion article in last month’s issue of BioPharm, many needs of pharmaceutical development and manufacturing, from excipients to contract laboratory services, increasingly are being purchased through e-procurement processes (1). o­ne such process, the o­nline reverse auction, allows buyers to exchange information with sellers and solicit and accept bids from multiple sellers in a Webbased electronic marketplace.

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Bridging the gap between compliant spreadsheet production and limitations in available technology can be achieved by the use of custom-created electronic solutions.

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Like all new technologies, the potential benefits of Linux also carry risk for pharmaceutical developers.

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Fail more often and fail faster. Pharmaceutical companies are increasingly realizing that the key to a successful product pipeline is eliminating the inevitable unsuccessful products as quickly as possible. And in the pursuit of failure, the most powerful tool is information. The massive commercial databases that contain terabytes of information — including the entire human genome — ought to make it easier than ever to eliminate dead ends. But there’s just o­ne problem: Every year large pharmaceutical companies spend billions of dollars o­n R&D o­nly to scrap hundreds of products that don’t pan out. The “what if” results that can kill a drug before it reaches clinical trials often show up o­nly after years of development. Until recently, 15 years was not uncommon. So the sooner researchers can see the endgame in their data, the better.

The author discusses how to identify some of the performance qualification tests to apply to spectrometry software, how to write the test procedures and instructions, and how to execute the actual testing.


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