alexa Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Pharmaceutical Sciences

Pharmaceutical Sciences

Journal of Developing Drugs

Author(s): Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Carl K,

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Abstract Heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses are major challenges in drug development. To address these challenges, biomarker strategies based on a range of platforms, such as microarray gene-expression technologies, are increasingly being applied to elucidate these sources of variability and thereby potentially increase drug development success rates. With the aim of enhancing understanding of the regulatory significance of such biomarker data by regulators and sponsors, the US Food and Drug Administration initiated a programme in 2004 to allow sponsors to submit exploratory genomic data voluntarily, without immediate regulatory impact. In this article, a selection of case studies from the first 5 years of this programme - which is now known as the voluntary exploratory data submission programme, and also involves collaboration with the European Medicines Agency - are discussed, and general lessons are highlighted. This article was published in Nat Rev Drug Discov and referenced in Journal of Developing Drugs

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