Itasca, IL (PRWEB) December 7, 2005
Pharmaceutical manufacturers spend over a billion dollars to commercialize any new drug. However, very few drug companies leverage the data that they create during drug development to improve efficiencies and speed time to market, or to meet FDA's model for the Critical Path between discovery and launch.
A benchmarking survey published in the November/December, 2005 issue of Pharmaceutical Manufacturing magazine suggests that fundamental change is needed in the way that pharmaceutical companies handle drug development data. It also indicates a drastic need to improve overall IT infrastructures and work processes in order to help reduce drug development costs.
Most drug companies still store drug development data in separate silos, the survey finds. They also manage their data inconsistently and in an unstructured manner that results in waste and rework, leaves them vulnerable to greater regulatory scrutiny, prolongs development timeframes and increases costs.
In addition, the survey suggests, most drug development professionals are dissatisfied with their IT systems and frustrated by what they can, and cannot, do.
Among the survey's findings:
- Nearly 25% of respondents could not trace drug development data back at all, and no respondents indicated that full traceability was even possible. Data traceability and visibility were issues for both large and small companies.
- Fewer than 5% of respondents use structured databases to store drug development data.
- Drug development professionals spend, on average, five hours per week looking for data. Some respondents spend eight hours or more on data retrieval each week.
- Roughly two-thirds of respondents could not find the data they needed between 10 to 20% of the time, triggering rework and duplication of tests and procedures.
Designed to shed light on current practices and to help drug manufacturers benchmark and improve their data management practices, the survey was developed and interpreted for Pharmaceutical Manufacturing magazine by Dr. Ken Morris, Purdue University's Associate Head of Industrial and Physical Pharmacy, as a consultant to Conformia Software, Inc. Conformia is currently working with FDA on a cooperative research and development agreement (CRADA) to determine the root causes of drug development bottlenecks. Coauthoring the survey and summarizing its results with Dr. Morris were Sam Venugopal, Director, and Michael Eckstut, Vice President of Conformia's Life Science Business Operations.
To read the survey, please visit Pharmaceutical Manufacturing magazine's web site.
Published 10 times per year by Putman Media, LLP, Pharmaceutical Manufacturing magazine is dedicated to sharing the best practices that will help speed time to market for new drugs and reduce drug manufacturing costs, currently estimated at $90 billion per year.
Subscription to the print publication is free of charge to qualified professionals within the U.S., and the magazine is available in digital format for subscribers outside of the U.S. For more information on the magazine and its affiliated publications on Process Analytical Technologies and Pharmaceutical Track and Trace technologies, please visit its web site.
# # #