In the year since GT looked into the rapidly expanding field of biomarker research in its 2004 July/August cover story, there are no signs that the business and research community is losing interest just yet. In fact, with FDA officials having finally released a guidance document in March designed to encourage the use of biomarkers in drug development research and clinical trials, it’s clear that the idea of using biomarkers to guide drug development, serve as diagnostics, and target medicines toward specific populations is here to stay, even if big pharma isn’t necessarily happy about the demise of the blockbluster drug model of developing products.
But there are reasons to take a critical look at the pace of biomarker discovery and development, as well as the assumption that biomarkers are the way to turn a profit while a startup inches its way through drug discovery. According to Leigh Anderson, who is involved in biomarker research through his Plasma Proteome Institute, the pace of FDA approvals for new diagnostic biomarkers has actually declined over the past 10 years, which isn’t an optimistic statistic for the many companies hoping that discovering biomarkers will create cash flow in the relatively near term.
But past performance is no guarantee of future failure. And recent FDA guidance goes a long way toward clarifying what exactly is necessary to convince regulators that a biomarker is valid. Although some of the regulatory kinks may still need working out, there’s a sense the tide may be turning toward faster biomarker acceptance and commercialization.
In other stories a year ago, GT wrote about the resources available for researchers interested in taking a biodefense angle to biological research, and what sorts of projects the various funding agencies were likely to support. As it turns out, quite a few microbiologists are annoyed with the shift in federal funding priorities toward biodefense, and in March of last year more than 750 microbiologists sent an open letter to NIH Director Elias Zerhouni complaining that the emphasis on biodefense research was hurting the ability to engage in equally if not more important work in basic microbiology.
A column in the 2004 July/August issue touched on the trials and tribulations of Lance Liotta and Emanuel Petricoin, who at the time co-directed the joint NCI-FDA clinical proteomics program. The two were singled out as having engaged in consulting arrangements that — although approved by their superiors — were later deemed inappropriate. In response, NIH released new, fairly strict ethics guidelines in March that raised the ire of long-time NIH employees and led to speculation that an exodus of scientists would ensue. With some notable exceptions (Liotta and Petricoin among them), that has yet to happen.
Next Month in GT
Don’t miss these features in the September issue:
Standardization of microarrays.
Arrays have become a basic part of the integrated biologist’s toolbox in the past 15 years, but even now scientists are hard-pressed to find agreement across platforms, let alone a clear way to submit microarray data to the FDA. We’ll examine the types of standards microarray scientists are clamoring for and update you on the field’s progress toward them.
As genomics becomes more closely associated with high-throughput screening, integrated biology is starting to make its mark on cell-based screening assays. These are increasingly important to pharma and academic scientists and are changing the way researchers can ask biological questions. We’ll introduce you to the pioneers and leaders in the cell-based assay arena and look at the technology involved as well as how it’s being applied.