Conclusions

The best biomarker for any given situation can come from a wide range of sources, so it is critical that no promising option be excluded. Matching the application and question to be answered are far more important that the platform used for analysis or if a technique is resident within a particular labo ratory or company. It should be recognized, however, that it is difficult to consider approaches that one has no idea exist. Nevertheless, those people providing biomarker support to drug discovery and development teams must keep in mind as wide a range of options as possible. The Internet has made specialized testing by reference laboratories, teaching hospitals, and research groups significantly more accessible. In addition, directories of tests and the groups that perform them are available [65], as well as characterized genomic biomarkers being described on the FDA Web site [66].

Genomic, proteomic, and metabonomic technologies can provide essential information when identifying new biomarkers, but have been slow to be implemented into clinical applications. Although often critical to identifying new targets or biomarker options, the extensive data sets produced, variability in sample and platform conditions, challenges of validating multiplexed measurements and algorithms, and lack of experience have limited their usefulness in clinical trials to a few diseases. The fields are rapidly progressing and hold great promise, especially when specific focused questions are defined prior to conducting the tests. To paraphrase Helmut Sterz, "use of a little grey matter at the beginning can save a lot of white powder, chips, instrumentation, and time." All too often, the quantity of information obtained from many "omics" experiments cannot be realized effectively due to limits on data mining tools and the realities of clinical trial conduct. People cannot be subjected to the same degree of environmental and genetic control possible with animal studies, and many diseases represent a constellation of effects rather than changes induced by a single cause or gene.

Our experience in developing, validating, translating, and implementing new biomarkers has emphasized repeatedly that the question to be answered must drive the technology used. It is also vital that the solution be "fit for purpose" with respect to the parameter being measured, platform selected, and level of assay definition or validation [67]. Sometimes the biomarker must utilize a cutting-edge technology and novel approaches, but more commonly the question can be answered without an exotic assay, often with a test that already exists in someone else's laboratory.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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