Are drug giants driving university research?
St. Louis • In their quest for the next big drug discovery, pharmaceutical companies are increasingly teaming up with some of the nation's top universities, recruiting campus scientists as partners and offering schools multimillion-dollar deals to work on experimental drugs in development.
Big Pharma has long sought to profit from academia's innovations in more limited arrangements. Now the two sides are often joining forces as equals. But the drug makers' aggressive pursuit of university research has drawn the ire of academic purists who question whether the partnerships put profits ahead of, or on equal footing with, science for science's sake.
"What it does is to blur the boundaries between academic medical centers and investor-owned companies," said Marcia Angell, former editor-in-chief of the New England Journal of Medicine and a prominent critic of the pharmaceutical industry's new coziness with major campuses.
Pfizer Inc., Astra Zeneca PLC and Eli Lilly and Co. are among the major international drug companies signing agreements with schools such as New York University, Harvard and the University of California at San Francisco.
Driving the change is the expiration of patents for such lucrative name-brand drugs as Seroquel, Lipitor and Protonix, which industry observers say accounted for nearly $36 billion in U.S. sales in 2011 and 2012. More than ever, drug makers need new revenue to replace diminished profits from drugs that now have generic rivals.
"There's a real need on Big Pharma to be innovative in how it fills its pipeline," said Van Ellis, a Washington-based life-sciences lawyer and partner with the Morrison & Foerster firm. "And academia is incredibly concerned with how to support research."
A 2011 research report by the Biotechnology Industry Organization found that just 1 in 10 prospective drugs in clinical trials from late 2003 through 2010 ultimately received approval from the federal Food and Drug Administration, a testament to the low success rates of drugs still in the experimental phase. Previous reports showed an approval rate of 1 in 5 or 1 in 6.
One of the earliest campus collaborations was announced in 2010 between Washington University in St. Louis and Pfizer, which signed a five-year, $22.5 million deal to identify new uses for hundreds of drug compounds for which research had stalled during or on the verge of clinical trials.
At the time, Larry Shapiro, dean of the university's medical school, expressed his hope that the project would yield "many discoveries."
But Washington University's experience illustrates some of the industry's challenges. Scarcely two years later, Pfizer shut down the St. Louis lab to focus on partnerships at other schools.
A Washington University spokeswoman referred questions about that decision to the drug maker, which said in a statement the decision was a joint one that "evolved to reflect the mutual needs and strengths of both organizations."
Pfizer, based in New York, is continuing to fund its five initial research projects with the university, but has higher hopes for its five-year, $85 million partnership with the University of California at San Francisco, where two dozen Pfizer scientists are practically working side-by-side with their university counterparts in a 20,000-square-foot building on the school's sprawling Mission Bay campus.
Executive Vice Chancellor and Provost Jeffrey Bluestone, whose own research has focused on the body's immune response at the molecular level, said the university's Center for Therapeutic Innovation creates an open network of researchers that goes beyond the narrow focus on specific projects initially cultivated in campus labs on behalf of drug manufacturers.
"There was an opportunity to try to think differently about the relationship between industry and academia," he said. "Typically, industry partnerships had been at arms-length, and often at great distances, where you would try to fit a [university]research project in with your [full-time] job you had with the company."
The new collaborations allow scientists to spend more time on research and less on paperwork, Bluestone added.
"With the idea that we do this together, we don't have to worry about intellectual property and tech transfer and all that really early on," he said. "We can build in milestones and timelines that allow us to really make decisions along the way. â¦ It's really a different model."
Those arguments don't mollify Angell, who is now a senior lecturer at Harvard Medical School's Division of Medical Ethics.
Academic medical centers and teaching hospitals "have particular missions that justify their tax-exempt status," Angell said. "They're supposed to educate the next generation of doctors. They're supposed to be doing cutting-edge research, not just research on drugs â¦ and they're supposed to be taking care of the sickest and neediest people in society."
That public-service mission is "quite different from the mission of investor-owned companies. They're supposed to maximize profits."
In addition to its efforts in St. Louis and San Francisco, Pfizer has entered into similar research partnerships with the University of California at San Diego, Boston University, Harvard, Tufts, the University of Massachusetts and seven academic medical centers in New York City.
Neither Pfizer's competitors nor the university partners are standing idle.
Harvard also has a research deal with French manufacturer Sanofi-Aventis and Belgian drug maker UCB. The Yale School of Medicine has a multiyear cancer research collaboration with Gilead Sciences Inc., a California company that sells HIV treatments such as Atripla and Truvada. And the University of Pennsylvania has an umbrella agreement with Astra Zeneca PLC, whose U.S. headquarters are just down the road in Delaware.
Bluestone, a former Pfizer advisory board member, is aware of both the promise and the pitfalls of these partnerships. He called the truncated St. Louis effort "a great project" that fell victim to a shift in corporate priorities after Pfizer's 2009 purchase of rival Wyeth for $68 billion.
"We've gone into this thing with our eyes wide open," he said. "Some [experiments] may work, some may not. Some may disappear next year." Drugmaker deals with elite schools
Pfizer • Drugmaker has deals with the following schools: Washington University (St. Louis), University of California at San Francisco, University of California at San Diego, Boston University, Harvard, Tufts, the University of Massachusetts and seven academic medical centers in New York City.
Sanofi-Aventis • Harvard has a research deal with the French manufacturer.
UCB • Harvard also has a research deal with the Belgian drugmaker.
Gilead Sciences Inc. • California company that sells HIV treatments such as Atripla and Truvada has a multiyear cancer research collaboration with the Yale School of Medicine.
Astra Zeneca PLC • U.S. headquarters are in Delaware, near the University of Pennsylvania, with whom it has an umbrella agreement.