Of Ivy and Industry: Harvard's Quest to Do Business

Erica P. Johnson The marble Harvard Medical School quadrangle sits up on a slight plateau, like an ancient temple, rising above Boston's busy Longwood section. Inside, glass windows soar above well-worn staircases. Persian carpets cover the floors. Slim, antique lockers line the halls of the lower floors. The quad is like an island of antiquity, surrounded by bustling medical complexes specializing in futuristic high-tech medicine. Here in the temple, there is little bustle. Decisions evolve slowly here, and then only after a long and careful academic debate. This is, after all, Harvard. Perhaps no US institution remains as entrenched in the traditional academic research mode as does Harvard University. A generation after the Bayh-Dole Act of 1980 spawned a rush of industry-academic partnerships imitated around the world, Harvard keeps a tight rein on faculty relationships with industry. Yet, as the genomics revolution creates vast new opportunities for researchers to work with industry on new technologies, Harvard is reexamining its rules and goals. "All academic places are trying to figure out how to embrace research opportunities that take advantage of the expanding capability," says Ed Harlow, dean of research at Harvard Medical School. "We're in the same boat as everybody else, trying to understand what's best for science in our situation." GRANT HAVEN Harvard has taken the traditional route partly because it was burned in earlier ethical debates, but also because it has enough power and prestige to continue to do first-rate research while relying largely on traditional government support. Nearly 75% of research done at the medical school and Harvard's affiliates is funded through the National Institutes of Health. "Harvard has always been first and foremost a world-class research institution and hasn't paid as much attention to industrialization as some of the others," says Kevin Pang, vice president of Decision Resources, a Waltham, Mass., pharmaceutical and biotech consulting firm. Pang earned his PhD in physiology and biophysics at Harvard. Pang says Harvard continues to impress with scientific publications and patents, but lags behind some comparable institutions in the creation of new companies that have the potential to return hefty royalties. "Harvard doesn't have the cachet Massachusetts Institute of Technology does in spinning out new high-tech companies. That's not to say it doesn't happen, but it doesn't happen with the velocity it does at other universities." Former Harvard president Derek Bok, who has just written Universities in the Marketplace: The Commercialization of Higher Education, a book that examines the ties between universities and industry, recalls that during his tenure as president Harvard was the target of criticism for receiving research support from the Monsanto and Hoechst chemical companies. "People took issue with that," Bok relates. "I think we were careful to structure those relationships so that we were careful not to compromise academic principles. But people felt private industry was buying Harvard." That kind of attention, says Bok, goes along with being Harvard, which is perhaps the most visible academic institution in the world. "You always get that kind of thing. Just as now they're saying Harvard is straight-laced," he says. "That goes with the territory. You get singled out on both sides." Not every school could afford to be so pure, says David Blumenthal, director of the Institute for Health Policy at Massachusetts General Hospital and Partners HealthCare System. "Harvard is more restrictive than any other university, and it's probably true that relatively few universities could withstand the pressure as long as Harvard has." RICHES AND RESEARCH The intersection of academia and industry is a key issue at Harvard, particularly following the recent biotech boom that brought many academic researchers closer to business than ever before. "The first priority is the programmatic content, not necessarily the financial bottom line," says Susanne E. Churchill, Harvard's associate dean for research since 1998 and former director of the medical school's Office of Sponsored Projects. Churchill stops to consider an opposing view: "Others argue that because it so often has a strong fiscal component to it, it's better elsewhere depending on how the institution is organized." Indeed, Harvard will have a new neighbor this fall after it opens a $250 million (US) genetics research building. Merck & Co. is opening a similar facility right next door. Merck has just ended a five-year program in which it contributed $1 million each year to Harvard's Institute of Chemistry and Cell Biology. Going forward, Merck has made a "generous gift" to support graduate education at Harvard, says Churchill, who declined to disclose the exact amount. Merck has had a similar program at MIT and other schools, Churchill says. Even with its determination to remain independent academically, Churchill acknowledges that Harvard wants the work of its scientists to be relevant in the world beyond academia. "While we are doing superb and excellent discovery science, it is limited in its potential to the extent that we don't use that to inform development of therapeutic agents, ideas, and substances," she says. One of the biggest stumbling blocks is reconciling the academic tradition of open discussion of new findings with industry's desire to preserve its competitive edge with secrecy and intellectual property protections. "We haven't figured out how to do that," admits Churchill. "If you talk to industry they say academia is too restrictive, that you can't work with them. They don't understand where we're coming from. They ask more than we can give them and [still] maintain our independence." Courtesy of Aero Photo, Inc At the same time, however, Churchill says Harvard's basic research is struggling with evolving beyond the lab. "How do you take what we have in the very early stages and get it to the point where you can absorb some of the risk to understand it a little bit more, then go to an industrial partner and say, 'This might be useful in the following ways,'" Churchill says. "That is one thing we spend a lot of time thinking about--the developmental interface. How can we do this better so our science stands a better chance of going somewhere?" Today's young scientists are much more open to working with business than they have been in the past, Churchill notes. "They have a greater deal of comfort around the notion that you can contribute to science and perhaps earn personal wealth at the same time, and that those are not necessarily incompatible." "Most scientists don't have a clue about what's really involved in starting a company," continues Churchill. "Many of us are now ... [wondering if we] should be providing education to the potential faculty entrepreneur to help him or her understand exactly what is involved in starting a business? Should we be facilitating introduction to capital? Should we be playing any sort of a role that values which technology and which ideas merit going on? Those are questions none of us really know the answer to." Harvard has no prohibition against scientists forming their own companies or serving on scientific advisory boards, but it does require them to disclose their interests. Harvard strictly prohibits investigators from accepting sponsored research in their faculty labs from any companies with which they have business connections. "Some would argue we're overly careful and potentially we stifle innovation," she says, "but the rare bad apple could really taint everything." Much of Harvard's skittishness dates back more than a decade to a scandal involving a Harvard-affiliated researcher, Scheffer C.G. Tseng, who violated policy and then manipulated clinical trial data to show the effectiveness of an eye ointment he had developed. He and his family earned more than $1 million by trading in stock of the company that developed the product. Harvard considered relaxing its rules in 2000 but withdrew a faculty proposal the day after Jesse Gelsinger died during gene therapy trials at the University of Pennsylvania. Once again, a faculty committee has been formed to outline a process for drafting a new conflict-of-interest policy. "That will take some time," says Blumenthal, "but it's certainly possible that they will be liberalized in one way or another." COUNTDOWN ON COMMERCE Churchill says Harvard is able to skirt one big area of potential conflict because it does not have its own teaching hospital. But that cuts more than one way. Harvard is relieved of the clinical responsibilities associated with care of the sick and with conducting research and clinical trials. However, it becomes more complicated to administer operations across multiple separate institutions. Harvard also misses out on the potential revenues from running drug trials, and it does not have a base of grateful patients to turn to for donations. "The downside of that is our revenue stream is not as diverse as when you have a hospital," says Churchill. That lack of revenue diversity was not such a problem when NIH funding was being doubled over the past five years. Now, that growth is leveling off. Churchill says the Bush administration has proposed only a 2% increase in NIH funding in 2004. "We, like our colleagues, are very concerned," she says. "We are lucky in that we will probably be successful in sustaining much of our growth, but not all of it." Of course, in true Harvard form, her observation has prompted debate: "We're deep in discussions about what this means." All this questioning comes with the privilege and the burden of bearing the prestigious name of Harvard, she says. "We take a lot of time because our positions are so public. Ultimately we remain slow to change because of that. We probably tend to be more conservative than sister institutions of the same size, but there is a responsibility to take our time." Susan Warner (swarner@comcast.net) is a freelance writer in Philadelphia. PLANNING HARVARD'S COMING QUARTER CENTURY Courtesy of Steve Gilbert Ed Harlow Two years ago, dozens of Harvard researchers and administrators holed up on the top floor of a campus library for the summer. When they were done, the room was plastered with plus-sized Post-it notes and a plan to conquer cancer. "We asked our researchers what would be the most important thing that could happen in their discipline 25 years from now. What would really make a difference?" asks Ed Harlow, dean of research at Harvard Medical School. "It forces researchers to stop thinking about their next grant or their five-year goal," he says, "but to think about a dream." Medical research at Harvard is shaped by the school's lack of its own medical center. Harvard uses a network of 17 teaching hospitals and other affiliated institutions for clinical training and research, including Massachusetts General Hospital, Brigham and Women's Hospital, and Children's Hospital Boston. "We have to interact with affiliates who are strong in research in their own way," Harlow says. "Our job is to think across those boundaries." One way to do that, he says, is with initiatives focused on specific diseases. He points to the Dana-Farber Cancer Institute--the subject of the Post-it notes--and the Harvard Center for Neuro-degeneration and Repair (HCNR). Within the framework of a disease-focused initiative, he says, researchers then break down the task further. At HCNR, for example, research objectives are organized around five core areas that Harlow says are unlikely to get support elsewhere: translational research, brain imaging, molecular pathology, drug-screening, and bioinformatics. "These areas are broad enough that they became centers of development, and they all have a different flavor in how they do things." Within the framework of a single disease and the core research objectives, scientists are urged to think of creative solutions to the roadblocks in their research. Clinicians and scientists in one core area may focus solely on lab work, while others may provide services in the community. "But all these are areas of involvement with a particular discipline within the neurodegenerative process," says Harlow. The possibility of increasing space throughout the Harvard University system in the next five to six years is now prompting administrators to think about new ways to structure programs, Harlow says. This fall, a new $250 million research building will open adjacent to the quad; it will house Harvard's genetics and pathology departments and other faculty. In all, 800 researchers will move to the new building. "People are thinking, 'Does it make sense to move people? Does it make sense to think about a whole new interdisciplinary approach to science?' This is very much an opportunity for a new way of thinking over a long time frame," Harlow relates. He stresses the need to break down today's "silo approach" to research and foster more collaboration in biology. "We're at a very interesting inflection point in biology," he says, "but its clear there will be a lot of opportunities that really can't be done on an individual level." Harlow argues that the current system of biological research is overly weighted toward individual work, from the financing of research grants to career advancement. Science is growing bigger and more complex, he says, and large coordinated efforts are necessary to do the job. "In reality when you go back to government funding, it's a zero-sum game," he says. "If you want to fund 10 scientists together, it's got to come out of somebody's hide." There is no one-size-fits-all approach to developing research strategies, cautions Harlow, who was appointed to his position in March 2002 with the mission of coordinating long-range planning and initiatives that extend beyond the medical school. Harlow, who is also chair of the Department of Biological Chemistry and Molecular Pharmacology, has been a professor at Harvard since 1991. "In my mind, it's so specific to the individual projects that one wants to see happen at each institution," says Harlow. Industry, he says, confronts biological research in a much more collaborative way, bound by the financial goals and organizational structure of each company. "There are models in science in which collaborations are rewarded, such as physics, but it's not so true in biology," Harlow says. "I think it's a cultural thing and we just have to get over it." --Susan Warner function sendData() { document.frm.pathName.value = location.pathname; result = false if (document.frm.score[0].checked) result = true; if (document.frm.score[1].checked) result = true; if (document.frm.score[2].checked) result = true; if (document.frm.score[3].checked) result = true; if (document.frm.score[4].checked) result = true; if (!result) alert("Please select") return result; } .myradio{background-color : #94bee5} Please indicate on a 1 - 5 scale how strongly you would recommend this article to your colleagues? Not recommended 1 2 3 4 5 Highly recommended Please register your vote

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