Pharmacovigilance Brings More Data Integration Problems for Pharmas, Predicts Life Science Insights

FRAMINGHAM, MA – December 8, 2004 – The recent Vioxx withdrawal and suspicion over other blockbuster drugs have intensified pressures on pharmaceutical companies to disclose all negative as well as positive results of industry-sponsored clinical trials. However, for most pharmaceutical companies, processes for monitoring drug safety are scattered throughout the organization. To give a complete picture of a clinical trial, pharmas must integrate data from trial protocols, patient records, clinical records, adverse event reports and genomic data. Currently, no solution capable of meeting these needs exists. Life Science Insights predicts that the first vendor to market with a comprehensive solution will own the space.

Life Science Insights' outlook for the year ahead includes:

— Technology spending will increase in later stages of the pharmaceutical value chain, in areas such as clinical trial management systems, electronic data capture, and electronic lab notebooks. Spending on technology for classic discovery and development will remain flat.

— Big pharma IT divisions are moving away from the "mother ship" model. Individual business units are making more and more IT decisions and those units (genomics, medicinal chemistry, pre-clinical development) are willing to pay for informatics technologies that will enable innovation or enhance productivity.

— Pharmaceutical companies are increasingly looking for a low-cost edge. R&D is a good place to look, especially as countries such as China and India ramp up their R&D capabilities. Academic institutions will play a more significant role in commercial drug discovery.

— Computational biology as a discipline will go away as most biology becomes computational. The controversial art of in silico property prediction will become more acceptable over time. Core versus non-core IT functions will be further divided and non-core IT will become increasingly outsourced.

— CIOs will have a larger seat at the R&D table. While CIOs managing non-core businesses will be spending more time in Asia, funding sources will increasingly come from both corporate IT and the business unit itself.

— Although not required, a growing number of standards including SDTM (study data tabulation model), SAFE (secure access for everyone), and SEBIX (secure electronic biopharmaceutical information exchange) for submitting and managing clinical data will become "de rigueur."

— IT organizations are scrambling to comply with a growing list of regulatory mandates and meet deadlines. Pharma lawsuits by states' attorney generals will drive a new market for compliance software, and make Sarbanes-Oxley look like a picnic. Look for biopharmas to hire a CCO – Chief Compliance Officer.

— The 2002 NIH Roadmap, proposed by director Elias Zerhouni, could lead to a dramatic, but welcome, reduction in the number of NIH institutes, with other government agencies looking to fill the void. Life Science Insights sees a growing role for venture philanthropists such as the Bill and Melinda Gates Foundation.

— The pendulum is slowly swinging back to tools and platforms and the rush to revenue is decreasing. Technologies that enable the drug discovery and development process will see increased funding in the near term.

Life Science Insights' annual Predictions are designed to identify and highlight intriguing opportunities and pivotal choices facing the life sciences industry in the year ahead. The predictions draw upon existing Life Science Insights' research and are vetted through a global review process.

For more information on the "Top 10 Predictions for the Biopharmaceutical Industry in 2005," telebriefing or to listen to a real audio replay or receive a copy of the presentation, please contact Tammy Gilson-Hodge at 508.988.6746.

Life Science Insights, an IDC Company, provides market research, analysis and consulting services to decision makers in life science markets. Clients include pharmaceutical and biotechnology companies, contract research organizations (CROs), government research organizations and technology vendors. Life Science Insights' team of specialist analysts and consultants provide intelligence and advice on technology trends, key market drivers, and end-user intentions. Founded in January 2004, Life Science Insights is headquartered in Framingham, MA. Visit for more information.

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