After the vans started breaking down Grodman sold them and entered the clinical lab business.
Both drugs and devices must now be pre-certified for efficacy as well as for safety, in stages from lab testing to clinical trials, before ever having a shot at the market.
Six years ago, radiologist Michael Zalis found himself spending a lot of time logging in and out of separate electronic health records at Massachusetts General Hospital to gather lab data, clinical notes, and other non-imaging information scattered in multiple databases.
After all, very few compounds get out of the lab and into human clinical trials.
"We have lab data and some clinical data that confirms this, " Lawenda says.
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We've had furtive glances of Sony's upcoming NEX-6 before, but only in the very clinical space of a government test lab.
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Biotech executives dread what they call "the valley of death, " the period of time between a drug's conception in a lab and its first clinical trial.
But if a drug has already been through enough tests in cell cultures and lab animals to justify starting clinical trials, the odds of success have risen to one in nine.
Less than three years ago, bioinformaticians at Stanford University set out to capture information buried, not just in insurance claims, lab tests or medical codes, but in the rich narrative of 10 million clinical notes gleaned from 1.8 million patients on Epic Systems electronic health records.
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"It is like lightning to have something in clinical trials" so fast, says former Bear postdoc Kimberly Huber, who did the early lab work leading to the theory and is now a professor at UT Southwestern Medical Center.
Biggest bugbear: the Clinical Laboratory Improvement Amendments (or CLIA) passed by Congress in 1988, requiring a federal license for every lab in the land, including those with automated machines only.
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