Washington Editor

Gene Logic Inc. has agreed to share its quality-control methods and metrics with the FDA to help the agency better understand disparate genomic data submitted as part of approval applications.

There currently are no federal or industry standards in place for assessing the quality of genomic data submitted to the FDA, said Donna Mendrick, scientific fellow and vice president of toxicogenomics at Gene Logic.

While the agency has capable and experienced biostatisticians, toxicologists and other scientists on its staff to review genomic data, Mendrick told BioWorld Today, the FDA lacks the resources, such as access to large databases, for which to compare data and universal standards to determine what are good data vs. bad.

"So they have no intrinsic way of looking at the sponsor's genomic data and determining if it is of good or bad quality," she said.

Since the 1970s, the public and private sectors have made substantial investments in biomedical research, but investment in the processes needed to predict and evaluate product performance, the so-called regulatory science, has waned, according to the FDA.

To bridge the gap between scientific research and the medical product development process, drug regulators in 2004 launched the FDA Critical Path Initiative, an attempt to stimulate and facilitate the use of new scientific and technical methods, such as computer-based predictive models and biomarkers for safety and effectiveness.

Gene Logic's collaboration with the FDA is part of that initiative, Mendrick noted.

The Gaithersburg, Md.-based firm's more than 10 years of experience gathering and analyzing genomic data has led the company to develop strict quality-control standards, she said. The firm has processed more than 200,000 microarrays to obtain genomic data and has developed more than 40 quality metrics.

Gene Logic's BioExpress system includes more than 40,000 samples of human and animal tissues, including normal and disease conditions in more than 200 tissue types. The system contains millions of gene expression profiles, curated references to public data and clinical information about the donors and the samples.

The firm's ToxExpress program has more than 14,000 animal samples from multiple species that have been exposed to safe and toxic drug products, Mendrick said.

Because few gene expression data currently are available in the public domain, she noted, it has been difficult for the scientific community, industry and government to develop and agree on universal quality-control standards.

However, Mendrick said, through its partnership with the FDA, Gene Logic is hoping to help the agency identify standards that can be brought before the scientific community and industry for evaluation.

"The reality is, sponsors want to know their data are good," Mendrick said. But, she said, until there are universal standards in place, companies will not feel comfortable about the quality of data they submit to the FDA.

The results of Gene Logic's collaboration with the FDA will be made public, Mendrick noted. However, she said, there is no set timeline for the release of that information.

FDA has published a list of 76 examples of high-priority projects for its Critical Path Initiative. Some of the projects under way include a collaboration with the Juvenile Diabetes Research Foundation on standards for an artificial pancreas, a partnership with Duke University on drug-eluting stents and a project with Arizona-based Critical Path Institute about safety biomarker research.