Necessity driving leery pharma "open"

PHOENIX -- It's almost as if the topic were taboo: the open-source concept in drug development gets little play in the agenda at the Partnerships in Clinical Trials conference. The topic had a way of coming up, though.

When it comes to open-source drug R&D, "the clinical side is the conservative side," says Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development. But the downturn in the economy has stimulated thinking among big pharmas.

"A cultural shift is happening as companies downsize in some cases," he says. Success in open-source development efforts, perhaps first in translational medicine, "will lead to changes that are profound," says Getz.

Let's hope so. "This is an industry in deep, deep crisis," says Tomasz Sablinski, managing director at Celtic Therapeutics and the chief force behind Transparency Life Sciences, a fledgling open-source drug development enterprise. "It's not going to be saved by tweaking."

He says pharma's increasing use of outsourcing is merely a shifting of money within the same financially inefficient system. "Pharma is unhappy now; CROs are happy," he says. "CROs will become unhappy."

Sablinsky's open-source idea, as we've reported, involves contributions of compounds, computer code and drug development expertise as well as collaborations with patient-engagement web sites like Cure Together and use of telemedicine apps for clinical trial monitoring.

Clearly the idea is gaining some traction in drug development. Open-source clinical trial software OpenClinica, maintained by Akaza Research, now boasts more than 11,000 users. That's a 10-percent rise from last July, when the company announced a three-fold increase over the previous two years. 

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