Tuesday, May 19, 2009

Notes From BIO: The Pathology of Personalized Medicine

Translating the vision of personalized medicine into reality is no simple matter, but here's an obstacle we hadn't considered before: the need to update the 19th century science of tumor pathology to address 21st century demands for biomarkers.

Pathologists rely on microscopic analysis of formalin-fixed, paraffin-embedded dead tumor cells--an analytical process that is logistically complicated and involves destroying most of the biological information contained in living tumor cells. For biopharma companies hoping to develop more targeted cancery therapy, there has to be a better way.

That, in a nutshell, is the business plan for Baltimore-based Biomarker Strategies, a 2007 start-up formed by Johns Hopkins professor of pathology and oncology Douglas Clark. Clark described the problem--and his company's proposed solution--during a panel discussion this morning on Integrating Genetic Markers in Drug Development.

Biomarker Strategies is developing an ex-vivo life tumor cell biomarker identification device--called SnapPath--which, Clark says, can help identify appropriate biomarkers and guide treatment choices, essentially at the patient's bedside.

We have no idea if SnapPath is a viable solution, but we appreciate the case study in the complexity involved in making targeted medicine a commercial reality. The science is revolutionary, but it will work only if there are also revolutionary changes in the practice of medicine to enable their use in the real world.

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