Turning quantity into quality: novel quality assurance strategies for data produced by high-throughput genomics technologies

The pharmaceutical industry is facing the challenge of managing the exponential increase in volume, diversity and complexity of data generated by high-throughput technologies such as genome sequencing, gene-expression profiling, protein-expression profiling, metabolic profiling and high-throughput screening. These novel ‘genomics’ technologies are expected to reshape the approach of life science companies to research. Unfortunately, in many cases genomics technologies have been used uncritically, and some preliminary results have been disappointing. The lack of standardized data validation and quality assurance processes is recognized as one of the major hurdles for successfully implementing genomics technologies. This is particularly important for industrialized drug discovery processes, because more and more key conclusions and far-reaching decisions in the pharmaceutical industry are based on data that is generated automatically. Therefore, automated, specialized quality-control systems that can spot erroneous data that might obscure important biological effects are needed urgently. In this article, special emphasis is placed on DNA microarray technologies, a key genomics technology that suffers from severe problems with data quality. A generic, automatable data-quality-assurance workflow is discussed that will ultimately improve the quality of the drug candidates and, at the same time, reduce overall drug-development costs.