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Impact of European Union Clinical Trial Directive (EU CTD) on Cost of Manufacturing Products for Clinical Trial

Presented at: BIO 2005 Philadelphia, PA, June 22, 2005

This presentation focuses on the effect of the European Union’s Clinical Trial Directive (EU CTD) on biopharmaceutical manufacturing strategies and costs. New and costly compliance issues now face companies wishing to conduct clinical trials in Europe, and these higher costs of compliance are likely to slow the growth of the biopharmaceutical industry in Europe and reduce the probability of discovering valuable new biologic compounds. The impact of the directive will depend on its interpretation by regulatory agencies; the most conservative interpretation may result in increased costs of entering early clinical development in Europe, forcing these development activities to other countries outside the EU. Further, the EU CTD may significantly affect manufacturing capacity for early stage clinical trial material, since facilities that have served this market may not be equipped to meet the more stringent requirements.