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RIP, Data Managers?


By Mark D. Uehling

July | August 2006 | There was no shortage of action at this year’s Drug Information Association (DIA) conference — in the sessions, on the exhibit floor, and some merely designed to coincide with the conference.

ClinPhone, for example, went public on the London Stock Exchange, raising $102 million. Its once-private finances are now open for inspection. ClinPhone had roughly $62 million in revenues in the 2005 fiscal year, with an eye-opening average of 411 studies in progress at any time.

Medidata and Cytel announced a partnership to speed adaptive trials, integrating their electronic data capture (EDC) and statistical software expertise to allow adaptive decisions to unfold within the Medidata platform. “We have a lot of enthusiasm and excitement about how adaptive trials can change science and medicine,” says Glen de Vries, Medidata’s chief technology officer. “We are at a major turning point.”

Middleware from DataLabs
DataLabs announced two new tools, one for clinical trial management and another middleware product to connect other standards-driven platforms to its own. “There are a lot of different applications,” says Zik Syed, VP, product management. “The last thing we want to do is add one more application that doesn’t talk to anything else.”

Another name with a larger presence at DIA was United BioSource. The Washington, D.C., company is trying to combine three difficult areas of expertise in post-marketing work for industry: contract research, technology, and consulting. Sensing an industry need, the firm is straddling the gap between clinical research and the post-approval phase of a drug’s commercial existence.

United BioSource founder and CEO Ethan Leder says the company has done twice as much business in the first half of 2006 as it did in all of 2005. The company has 550 employees and has acquired eight firms since raising $150 million in 2003. A high percentage of his workers have advanced degrees. But to attract conservative pharma customers, keeping the trains running on time is key. “You need stellar project management capabilities,” says Leder.

Do people working in data management have a future? Some presenters didn’t think so. Joseph Anderson, principal associate at Waife & Associates, says a wired planet will destroy the need for data management on a project-by-project basis. “[EDC] will obviate the need for data management as we know it,” says Anderson. “The world has gotten incredibly small, and it’s changing our thinking about how we ought to do the piece of work called data management.”

Anderson believes the industry is significantly overstaffed. “Some pharmaceutical companies in data management are massively overstaffed. They have two times, three times, and four times as many people as other companies that are doing the same kind of work. We really haven’t paid attention to cost. There are alternatives.”

Getting to Know You
Johnson & Johnson (JNJ) reported on a surprisingly quantitative, even scientific effort to study what distinguishes average teams from superlative ones. The research was based on a 63-item questionnaire.

The JNJ teams were cross-functional, composed of gnarly aggregations of expertise across the company. The first insights were relatively predictable: The most effective teams have just six to eight people. Paperwork apparently matters. Clarifying and recording what the team needed to do was important. “There was a high level of attention to documentation,” says JNJ consulting director Matthew Mangino. “We thought it would be a baseline. It was a differentiator.”

And the stronger teams got to know each other quite well. “We didn’t find that as much on the average-performing teams,” Mangino says. That’s moderately impressive, as many of the JNJ teams were highly dispersed around the globe, not occupants of the same New Jersey office park.

A few dictatorial, authoritarian tendencies were appreciated. One team leader banned all Blackberries, cell phones, and text messaging during team meetings — and enforced the ban. People on the team appreciated the rule and the leader for sticking to it.

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