AI Article Synopsis
- Drug development faces challenges due to differences in disease mechanisms and how patients respond to medications.
- To tackle these issues, researchers are using biomarker strategies and technologies like microarrays to better understand variability among patients.
- The FDA launched a voluntary program in 2004 for drug sponsors to submit exploratory genomic data, allowing them to share information without immediate regulatory consequences, fostering collaboration with organizations like the European Medicines Agency and highlighting valuable lessons from case studies.
Article 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.
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| http://dx.doi.org/10.1038/nrd3116 | DOI Listing |
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