Friday, January 18, 2008

Connections - Drug Development and the New Renaissance

It is several years since I first read "The New Renaissance" by Douglas Robertson but I am still fascinated by the additional perspectives it provides on today's work. The thesis is that certain developments in methods of communicating information enable advances in civilisation. The developments cited are spoken language, writing, printing and, most recently, networked computing. Each development results in orders of magnitude increases in the amount of information available to individuals. The increased access to information supports improvements in civilisation in technology, health, science, politics and virtually every other area as well.

The project connection comes up as we approach the completion of a major project to submit to the US and European agencies an application for approval to market a drug. The submission document represents an enormous amount of information about the drug. Much of the information about the its efficacy and safety is derived from extensive trials. There are many other sources, internal and external, addressing such aspects as the manufacturing process, conduct of the trials, literature searches, financial certification, labelling, test methods and scores of others. Collecting, managing, verifying and consolidating all this information within any reasonable time scale would scarcely be possible without information technology.

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