In bed with big pharma

As accusations of undisclosed financial conflicts among university researchers swirl, drug makers and academics are entering a new stage of closer collaboration. Instead of striking traditional licensing deals with academic labs that produce commercializable results, companies are starting to reach farther back, all the way to the inception of basic research projects. The motivation from both sides is obvious: Pharma has a pipeline problem, and universities are clamoring for research dollars as public funding feels the pinch of the deflating economy. But closer relationships and earlier-stage collaborations between academia and pharma companies do not come without potential conflict of interest issues of their own. "There are both opportunities and pitfalls to such relationships," Johns Hopkins bioethicist linkurl:Jeremy Sugarman;http://faculty.jhsph.edu/?faculty_id=1608 told The Scientist. About a year ago, Merck Research Laboratories created a formal department to actively seek out early stage research collaborations with external partners. Catherine Strader, vice president of that department, called external basic research, said that Merck plans to draw at least 25% of its early pipeline over the next five years from deals with academic labs, as well as small pharmaceutical and biotech companies. "What we're trying to do is go find the science at the source," she said. "Merck is not interested in just funding research," Strader added. "We want to collaborate. No one company has all the science in the world within its own walls." Merck isn't the only one. Well-developed products or technologies that could be licensed by pharma companies are rare these days, said Pfizer spokesperson Ed Bryant, adding that increased competition and licensing costs have driven pharmaceutical companies to consider a different strategy. "We had to shift to develop collaborations with talented academic groups to generate intellectual property earlier on." For an agreement between an industrial and an academic partner to work, issues such as publishing freedom and intellectual property must be carefully delineated. "Reviewing a manuscript and providing suggestions doesn't seem to pose any substantial ethical problems at its face value," Sugarman said. "But suppression or delaying manuscripts begins to raise ethical issues. You want to have specific wording that guarantees scientific and intellectual freedom." According to linkurl:Jeffrey Conn,;http://www.connlab.com/ a pharmacologist at Vanderbilt University who finds himself in the midst of such a partnership with Johnson & Johnson's mental health arm, Janssen Pharmaceutica, the deal was closely examined by the university's conflict of interest committee. That issue, he said, "is always right up front." Vanderbilt's agreement with the company 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. "We have a very high level of expertise" in early stage drug discovery, said Conn, who is listed as an inventor on several patent applications, mostly for the use of positive allosteric modulators of metabotropic glutamate or muscarinic acetylcholine receptors. The deal includes safeguards for academic freedom and scientific integrity. "First of all, we insist on an ability to publish," Conn said. 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." Though Conn declined to share the specific contract wording that dealt with possible publishing delays, he said that he would provide pre-publication manuscripts to Janssen as "more of a heads-up that this is going to be submitted, more than anything." Conn, who will receive more than $1 million in NIH funding this year, also said that 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," he said. "That's really going way beyond a typical academic lab's process for data management." The project's pre-clinical nature means "it is both premature and beyond the scope of this specific agreement to discuss any clinical research or post-approval activities," said Sri Ramaswami, senior director of global R&D communications at Johnson & Johnson Pharmaceutical Research & Development. But to Conn, it's worth it. "[Academics] feels a real satisfaction when we see companies launch programs based on what we're doing, regardless of whether or not we're involved," he said. In January, pharmaceutical company Baxter and Northwestern University launched a broad collaboration in which the company would provide at least $1 million per year to yet-to-be-determined researchers at the school. Norbert Riedel, Baxter's chief scientific officer, told __The Scientist__ that the collaboration will focus on new medical devices and technology platforms that could be developed at Northwestern's Robert R. McCormick School of Engineering and Applied Sciences. Riedel added that Northwestern faculty funded by Baxter will not be asked by the company to participate in any marketing activities relating to the products they may help develop. "The mission of academic independence and the right to publish is one that we are not only aware of, but one that we completely respect," he said. "There will be no conflicts that a researcher would find him or herself in with regard to being involved in any commercial or marketing strategies that we would be involved in. I draw a very clear line between what the research faculty does and what we do." According to McCormick Engineering and Applied Sciences dean, linkurl:Julio Ottino,;http://www.chem-biol-eng.northwestern.edu/people/faculty/ottino.html the school will be requesting applications for the Baxter funding shortly, adding that conflicts of interest are on the minds of Northwestern faculty and administrators. While the university did not craft special rules prohibiting graduate students who receive federal funding from working on Baxter projects, he said, "I don't think that will happen. We are very careful about that." When asked if the university would be publicizing the names of the Northwestern researchers who successfully win Baxter funds, Ottino said it was up to the individual investigator. "We are not going to make an announcement," he said. "On the other hand, we'll not prohibit anyone from telling the outside this is what's going on." In another example of such a collaboration, Pfizer and Washington University in St. Louis in January, 2008, signed a five-year, $25 million agreement to fund research at the university. The deal is only the most recent iteration of a relationship that Washington University has maintained with Monsanto since 1992 and has yielded drug development targets, such as HIV proteins and COX2 inhibitors. (Pfizer absorbed Monsanto's pharmaceutical arm in 2002). "The decision was to kind of revolutionize the agreement, to make it a true collaborative agreement," said linkurl:Sam Stanley,;http://wuphysicians.wustl.edu/physician2.aspx?PhysNum=737 Washington University's vice chancellor of research. The agreement funds research on the biology of inflammation, providing grants from $500,000 to $750,000 per year for three years. According to Stanley, two projects were funded in 2008, two new proposals will be funded this year, and two more in 2010. Proposals are reviewed by committees consisting of Wash. U. and Pfizer scientists, who match a Pfizer research team with labs chosen to receive the funding. "[Pfizer] really serves a matchmaking role," Stanley said. Stanley said that Pfizer is an "excellent partner," and that the company "respects Washington University's need to publish and disseminate the results of our research." But what that respect means to different universities and different companies clearly varies -- Bryant, the Pfizer spokesman, noted that the company does retain the right to delay the submission of a manuscript for "enough time" to file appropriate patents prior to publication, though he did not clarify how much time was typically considered "enough." While universities, pharmaceutical companies and the public may benefit from earlier and more intertwined research partnerships, Sugarman noted, detailed agreements that account for the success of corporations and the freedom of academics are crucial. "The question would be, 'To what extent would the needs of industry shape the kinds of research questions people would pursue?'" he said. Pharmaceutical companies should develop partnerships that help them meet their goals, he added, but "academia also has an obligation towards science, society and general understanding." **__Related stories:__***linkurl:NIH to act on conflicts within 1 year;http://www.the-scientist.com/blog/display/55264/ [5th December 2008]*linkurl:Academic medicine to the rescue;http://www.the-scientist.com/article/display/54666/ [June 2008]

In bed with big pharma

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