Search This Blog

Wednesday, March 28, 2012

The Virtual Lab

I used to sit in meetings listening to one non-PhD research associate after another randomly talk about the highlights of their last week or two. The PhD scientists would listen carefully and look as though they were deep in thought. When the young lab workers spoke they were nervous. They really did not have a point nor did they care much about what they were talking about. They were told to give a presentation so they reluctantly came up with their best effort. A typical presentation lasted only a few slides. They would show something simple such as a western blot. The PhD would ask questions as if it were somehow more complicated. "Can you see any host cell impurities?" The kids would respond, "I don't think so," always mitigating their answers.

As the company progressed the undergraduate degree was less and less important when hiring new lab staff. New employees were picked up from the facilities group and the dish washing room. The most desirable trait was knowing that you could work with someone. Personality trumped skills and education. After all, it was just a lab tech we needed.

These kinds of experiences have led me to create the Cargo Cult Scientist. The location of the laboratory would be no more consequential than the location of a Cargo Cult Airport. No drugs will ever reach the market. No planes will land. The problem then is in the offices where the leaders ply their trade.

The news from Cetero this week pulls the curtain back on the Wizard of Oz. Most biotech science is virtual. Of all the clients who were burned by Cetero, none of them uncovered the truth behind their CRO. The FDA, a government agency, provided the oversight. The leaders, as usual, saw what they wanted to see and had no further questions.

The filing for bankruptcy allows Cetero management to sell the business, leaving the new owners “free and clear” of any liability coming from lawsuits related to problems uncovered by the FDA. Last July, the Food and Drug Administration notified Cetero that it had uncovered “objectionable conditions” at a company lab in Houston, including “widespread falsification of dates and times,” manipulation of data and other deficiencies that raised questions about the reliability of test results. In my own Cargo Cult experience, falsification of dates and times, manipulation of data etc. was fairly common. The kind of honesty we need in order to make science productive was never present. PhD scientists retreated to the office for obvious reasons. In the lab, cells and proteins are the boss. By making other people work in that environment created a buffer. If you were concerned about host cell contaminants you could ask a nervous technician if they see any on their western blot. "I don't think so." Good enough. 

The virtual lab is subject to two different interests, the clients and the FDAs. The former needs data to sell their IP. The latter needs data to keep us honest. The most successful virtual companies of the future will be the ones who realize that they too have an interest in keeping their CROs honest. 

No comments: