Despite concerns about financial conflicts of interest among university researchers, drug makers are increasingly funding basic research instead of waiting to strike licensing deals with academic labs after they produce commercializable results. A prime example is Merck Research Laboratories, which has created a formal department to seek out early-stage research collaborations with external partners. Catherine Strader, vice president of the external basic research department, says Merck plans to draw at least 25% of its early pipeline over the next five years from deals with academic labs and with small pharma and biotech companies. Pfizer, too, has shifted “to develop collaborations with talented academic groups to generate intellectual property earlier on,” says company spokesperson Ed Bryant, adding that increased competition and licensing costs have driven pharmaceutical companies to consider a different strategy.

But earlier-stage collaborations come with some baggage in the form of potential conflicts of interest, observers say. For an industry-university agreement to work, issues such as publishing freedom and intellectual property rights must be carefully delineated. “Reviewing a manuscript and providing suggestions doesn’t seem to pose any substantial ethical problems at its face value,” says Johns Hopkins bioethicist Jeremy Sugarman. “But suppression or delaying manuscripts begins to raise ethical issues.” Jeffrey Conn, a pharmacologist at Vanderbilt University who is navigating such a partnership with Johnson & Johnson’s mental health division, Janssen Pharmaceutica, says the university’s COI committee examined the deal closely. Vanderbilt’s agreement with Janssen provides $10 million to Conn’s lab over three years to fund his search for candidate compounds to treat schizophrenia. A further $100 million may be available to Conn, who directs Vanderbilt’s program in drug discovery, upon the attainment of defined milestones. But the deal includes safeguards for academic freedom and scientific integrity. “First of all, we insist on an ability to publish,” Conn says. Janssen collaborators “do request to see the manuscripts prior to publication, but they can’t stop the process. That’s really the lifeblood of us as academic researchers.” In addition, rigorous rules are in place for verifying experimental results. “Every lab notebook entry has to be reviewed, signed, and dated by someone else working in the group who is independent of these particular studies,” Conn says.

Go to: The Scientist (registration required)

Editor’s note: Look for an in-depth examination of the COI best practices that universities are establishing for these relationships in a coming issue of Technology Transfer Tactics.

Posted March 18th, 2009 under Tech Transfer

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