FDA and Gene Logic to set genomic industry standards
collaborate in developing a set of industry standards for genomic
data sent to the regulator.
The collaboration is part of the FDA's Critical Path Initiative, intended to improve the predictability and efficiency of drug development, and aims to create a set of quality control (QC) methods and metrics for genomic data submissions to the agency. Genomic data is becoming increasingly important to pharmaceutical companies, enabling an individual's drug response profile to be predicted, increasing the chances of treatment success while minimising the risks of adverse drug reactions. With 'personalised medicine' starting to become a reality and more and more companion diagnostics being described in new drug applications, this data is becoming increasingly important. Indeed, bioMerieux has just announced that it will be developing a companion diagnostic for Ipsen's breast cancer therapy, BN 83495, that targets the steroid sulfatase enzyme. One major hurdle to the use of the data is the current lack of quality control guidelines issued by the FDA for microarray genomic data submissions. "Currently there are no industry standards in place for microarray data submission to the FDA, and projects focused on understanding the QC issues will help drive the development of baseline standards for the submission of microarray data to the FDA in the future," said a senior FDA official. Gene Logic has developed proprietary genomics databases and services to enable its customers to discover and prioritise drug targets, identify biomarkers, predict toxicity and obtain insights into the efficacy of compounds. "Industry and FDA consensus is that biomarkers are valuable tools for assessing the safety and efficacy of drug candidates," said Dr Donna Mendrick, vice president of toxicgenomics at Gene Logic. "This collaboration between Gene Logic and the FDA is a step on the path to achieving a common understanding of key microarray QC procedures that may lead to the development of preliminary microarray data standards for the submission of microarray data to the FDA." According to Ken Browne, managing director of Select Biosciences and organiser of the Advances in Microarray Technology conference held in Edinburgh earlier this year, "microarrays are now more heavily regulated in terms of the bioinformatics which has led to more credible results being generated than when people were doing their own thing and publishing results that were very difficult to reproduce." This push for experiment standardisation is currently a hot topic in the 'omics' world, with the European Molecular Biology Laboratory (EMBL) recently publishing a set of reporting guidelines for proteomics data that aims to increase the consistency of biological information to allow full integration, exchange and comparison of proteomic biomarker data.
