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Feb 1, 2011 (Vol. 31, No. 3)

Dislodging Personalized Medicine Logjams

Increased Use of High-Quality Biospecimens Set to Change Drug Development Practices

  • Not All Biospecimens Are Created Equal

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    Biospecimens are critical to each segment of the personalized medicine value chain.

    With the enhanced value proposition of biospecimen analysis, it should be noted that not all biospecimens are created equal. Biospecimen collection is a complex exercise in logistics.

    The most important criterion for all biospecimens is quality. For example, when working with tissue samples, processing time is critical. Molecular changes take shape within minutes of surgical removal of a tumor. The gold standard for acceptable cold ischemia time—the time after a tissue blood supply has been cut off and captured in the appropriate preservative—is 15 to 30 minutes.

    The best biospecimen providers not only track processing time data points but also offer strict quality control measures to gauge the impact of these times on specimen quality.

    Another essential requirement is sufficient clinical annotation or associated data from the patient donor. Demographic data including age, sex, and race is standard. Information such as diet, exercise, and smoking and other lifestyle factors is also beneficial. Finally, extensive disease-specific criteria, as well as associated pathology reports for tissue samples are a must.

    The most important requirement, however, for biospecimens is appropriate ethical standard compliance. Internal review board or ethical committee review of collection protocols focus on identity privacy, informed consent by donors, proper regulatory conformity with legal guidelines such as HIPAA, and more.

    From target discovery and early lab studies to late-stage clinical trials and patient diagnosis, biospecimens will play an increasingly important role. In many ways they are positioned to be the linchpin to turning personalized medicine theory into practice.

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