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That Collaborative Spirit

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It used to be that shaking hands with industry was considered selling out, and more than just a small smudge on an academic's ivory-colored résumé. Not anymore. Practically unheard of 30 years ago, collaborations in the life sciences between academia and industry are flourishing. And while traditional stereotypes still stick — pharma's got the big bucks and academia's got the brains — tables are starting to turn.

With the discovery of recombinant DNA technology and the founding of Genentech in the late 1970s, the biotechnology industry was born, and with it, the concept of merging academic and industry research. Some major advances in biology to come out of the biotech revolution — monoclonal antibodies, DNA sequencing, microarrays, PCR, and RNAi — have also changed the way molecular biology is done, making collaborations increasingly necessary. Moreover, with the advent of systems biology and interdisciplinary science, the so-called divide is shrinking. For instance, the pharmaceutical industry is becoming more and more open to collaborations for early-stage drug research; while academia, with the help of technology transfer and licensing offices, is becoming savvier about how to market its knowledge to interested third parties — and make a profit, to boot.

Crossing the divide

While genetic engineering revolutionized the life sciences and decreased the gap between academia and industry, there still exists a divide — largely philosophical — between the two. "There's a long history that goes way back of physicians and academic researchers working with industry, but there was always kind of a snobbery — basic research was more noble than applied research," says Tom Stossel, director of translational medicine at Brigham and Women's Hospital in Boston. The watershed moment, he thinks, was the founding of the biotechnology and medical device industries in the late 1970s "when very prominent scientists worked with investors to found companies. It was really the discoveries in recombinant molecular biology that enabled them, [and] it sort of changed that ethos that there was something demeaning about doing applied research."

And while some think the partnering is an awkward marriage between two people who don't know each other very well, Harvard's Vicki Sato thinks it's a perfectly natural union. "Where academia ends and where industry starts used to be pretty clear, [but] I think there's now a lot of overlap," she says. Sato — who started her career at Harvard in the late 1970s, helped build two companies, and returned to Harvard several years ago — says there were very few academic-industry collaborations in the life sciences when she began her career. Over the last few decades, she says, collaborations have flourished, whether it's academics founding companies or industry-academic partnerships taking hold. And they work for a reason. "The mission of an academic science lab is to enhance knowledge and to understand something about biological and medical processes that we didn't understand before," Sato says, "[and] the job of the private sector is to translate some of those lessons into practical solutions for problems that aren't solved."

There's also the reality of systems biology research, which has become too large-scale for any lab to take on alone. "The fact [is] that very little meaningful modern science is done by a single investigator [in] a single lab," says Bob Zaugg, vice president of business development at the Burnham Institute in San Diego. "We're seeing more and more collaborative activity going on, both within our institution as well as scientists at other institutions who each bring part of the answer, and each addressing part of the story."

The Burnham is a good example of an academic institution losing its inhibitions and diving headfirst into collaboration. The institute recently partnered with neighbor Johnson & Johnson to help the pharma run an early-stage drug screening program focused on immunology and inflammation. The Burnham will donate its high-throughput screening facility, funded by a six-year, $100 million NIH grant, to work with J&J's compound library to identify drug targets which J&J will then pursue. "The objective is to find things in our library that light up in the assay and then share those results with J&J, who will then go into their proprietary library of compounds to find things that are similar," Zaugg says. It's a way to speed up the discovery process, and a path that pharma is taking more and more often — less funding and an urgent need to revamp the drug discovery process have forced many pharma companies to turn to academics with either high-throughput facilities or specialized knowledge to speed up early stage research.

Over at Columbia University, Rudy Leibel was handpicked by the school's technology transfer office to partner with AstraZeneca. Leibel, who is head of the division of molecular genetics and co-director of Columbia's Naomi Berrie Diabetes Center, uses microarrays, sequencing, and computational analysis to study the genetics behind type 2 diabetes and obesity.

Internationally regarded for his work on obesity, Leibel had specific expertise that was key to the pharma's interest. After several meetings that decided what projects would be initiated, where the research would be conducted — in his lab or at AstraZeneca — and who would do what, they set out on what Leibel calls "very much of a collaborative effort." One of the big pluses is that the pharma has a lot of computational expertise in-house, a necessity for any large-scale collaboration. "The pharmaceutical industry happens to be more highly dependent on these computational biological techniques for both drug design and for analyzing data from microarrays or other similar tools," Leibel says. "They actually have groups of individuals on hand who are very expert in these areas and … the computational people at AZ have been very helpful to us at analyzing [our] findings, and I think that will continue to be the case."

Leibel is convinced that the reason AstraZeneca sought his lab out is that collaborations such as these lead to more rapid development of drugs. He believes that the pharma industry tends to fluctuate over time with regard to how much of the basic research they keep in-house and, currently, there is a push to outsource the basic science and to keep the translational and early drug design work on the inside. "I think that's the reason why AZ sought us out, to help them with some of the basic research that's needed to help in the process of finding novel mechanisms of disease that might be 'druggable,'" Leibel says.

Garry Neil, vice president of the Corporate Office of Science and Technology at J&J, agrees that the divide is lessening on both sides, partly out of a need to share information and toolsets. "What I've seen over the last 10 years or so is a continued evolution of the scientific community towards trying to make their research more relevant to patient care" as well as pharma recognizing that its strengths lie more on the side of practical R&D while academic institutions are more skilled at developing new disease models, he says. "There's a lot of great innovation [in academia] that we want to take advantage of," including increasingly detailed knowledge of biological pathways, new animal models, growing computational know-how, and high-throughput screening centers.

Getting the word out

In academia, scientists are taught to compete, not collaborate. However, with systems biology dictating larger studies, collaborative efforts have become more necessary — and, therefore, more common. Fueling many of these alliances have been university technology transfer offices.

Tech transfer has become central to accelerating collaboration, due in the US almost entirely to the Bayh-Dole Act passed by Congress in 1980. Bayh-Doleallowed universities to retain IP rights to their federally funded research, thereby encouraging them to commercialize important findings. Today, it's a burgeoning field, a way both to publicize the research institute and sell the discoveries coming out of it. While universities have always been havens for research for the sake of research — finding the unexpected, as Sato puts it — there is increasingly a push to perform. Labs are more often encouraged to seek collaborations with industry, and tech transfer offices are becoming more aggressive in getting their research in front of industry and government. "There are challenges, but we find that there is a great deal of interest and willingness to work with and collaborate with us," J&J's Neil says.

Leon Sandler, executive director of MIT's Deshpande Center for Technological Innovation, says his job is to "select, direct, and connect" university scientists to commercially viable research and more effective methods. "Our mission is moving technology from the labs at MIT into the commercial world," he says. That mission is slightly different from a typical tech transfer office's goal, in that the Deshpande staff actively helps shape what researchers pitch, what gets funded, and what's commercially developed. "We are taking a much more active role in the innovation process," Sandler says.

J&J just infused the center with $750,000 over five years to develop the most promising research in several areas, including biotech and nanotech. Having a connection with industry is important. "Ultimately we're trying to understand, what are the markets for products and what is the market need?" Sandler says. "What often happens is what the academics think they need is not what they really need. We're really looking [for] feedback and direction."

J&J's Garry Neil agrees. "There's a whole spectrum of collaborations [out there] that could include running assays internally, or providing intellectual input and guidance, which is often the thing that they're most interested in — what would be the appropriate experiments to run that would be most convincing to make a portfolio decision on?"

Hitting their stride

A success story in academic transfer is the case of Regulus, a micro-RNA therapeutics company built off of Tom Tuschl's work at Rockefeller University on small noncoding RNAs. Regulus was formed as a joint venture between Alnylam, a leader in the field of RNAi therapeutics, and Isis, a leader in antisense technologies. Tuschl is one of the founders of Alnylam as well as a member of Regulus' scientific advisory board. "The academic work that he pioneered was key," says Regulus' President and CEO Kleanthis Xanthopoulos. The company currently has about 20 collaborations with outside labs, and what Xanthopoulos has seen is an increasing desire from academics to collaborate. "If anything we've seen an eagerness to collaborate with companies like Regulus because academics now realize that you need a lot of additional tools and you can learn a lot more" if your approach considers both basic science and industrial applications, Xanthopoulos says. Regulus employs a dedicated director of external collaborations who coordinates the ongoing partnerships.

Even at places where tech transfer is just taking hold, like the University of Texas, San Antonio, momentum is building. Recently, UTSA and the University of Texas Health Science Center at San Antonio entered into an exclusive license and sponsored-research agreement with Merck to develop a vaccine for chlamydia. It's the first for UTSA and for the freshly named South Texas Technology Management office, set up several years ago to license and commercialize academic work coming out of schools in southern Texas.

UTSA is a member of the University-Industry Demonstration Partnership and the Government-University Industry Research Roundtable, both sponsored by the National Academies to help foster collaborative research. The goal is to make it "easier for universities to work with industry and industry to work with universities," says Marianne Woods, senior associate VP for research administration at UTSA. "I think some of the major challenges [to collaborating] are communication — understanding that industry has to make a profit and universities understanding that what we develop as academics has to get out of our institution and has to serve the public."

James Casey, director of the UTSA Office of Contracts and Industrial Agreements, was instrumental in encouraging the university to join the Government-University Industry Research Roundtable. His office provides assistance to faculty who are looking to pursue outside partnerships. "These partnerships are very important," he says. "The problem issues do need to be addressed, [and] the intellectual property and publication are two of the more common ones."

In fact, in a report that the US President's Council of Advisors on Science and Technology submitted to the Bush administration weeks before it left office, the group called for more government involvement in facilitating innovative industry-academia partnerships. The report compiled information collected by PCAST over the past two years from discussions with more than 20 university--private sector research partnerships. One of the main thrusts of the report was that industry should sponsor more research; currently, industry supports only about 5 percent of all academic R&D in the US. The government needs to lend a hand, too, by providing corporate incentives through changes in tax credits, helping to improve tech transfer with more guidance documentation, and in general, encouraging openness toward innovation and collaboration.

Regulus' Xanthopoulos sees a downside to all this activity, however. Just about every discovery these days, he says, is being actively marketed, and while it's a necessary evil, the amount of solicitations Regulus gets from academics to license their IP has grown tremendously. "It's actually overwhelming," he says. "What we've seen — and this may be a little unfortunate — is a lot of the technology transfer offices have become much more aggressive in advocating collaboration with companies, but for a very specific, self-serving purpose, which is to generate revenues for the institution."

To be sure, commercializing research is not the only reason a company would want to collaborate with a university lab. At MIT, for instance, there are hundreds of companies that sponsor university-led research through the school's Industrial Liaison Program. Often, the companies are not directly involved in the work, but they keep track of the lab's progress and keep lines of communication open to see where the work is headed, says Sandler of MIT's Deshpande Center.

Another reason that industry might tap into the academic sphere is to increase the general knowledge base of a particular field or to find specific expertise that only a handful of scientists have, as in the case of Columbia's Leibel and AstraZeneca. Drawing on academic labs also helps the company make contacts and recruit future employees. "Companies depend on people," Sandler says. "They're always looking to hire students as they graduate from MIT. So, if you're sponsoring research, a) you build your name at the university, and b) you might get closer relationships with students and faculty."

Bridging the gap

The challenges to starting a collaboration and making it successful are numerous, and most experts interviewed think that the biggest hurdle is effective communication. "A good collaboration — whether it's a university-industry collaboration or if it's two businesses working together — a lot of it is based on the relationship," says MIT's Sandler. "Collaborations are about people."

However, adds Xanthopoulos at Regulus, "Nothing's really natural. Like any relationship, a lot is about managing expectations."
Part of managing those expectations involves the larger issue of educating academics about what industry does — and, more importantly, how companies operate and what their goals are. Many academics don't know much about the drug discovery process, a driving area of collaboration. Working as part of a team, having project management goals and project deadlines, communicating results regularly in meetings — these don't necessarily come naturally to an academic used to working alone in a lab.

"Unfortunately, most of my colleagues in medicine don't understand the incredible difficulty and risks involved with product development, and don't have a clue about what's involved in extracting value [from their work]," Brigham and Women's Stossel says. Plus, tech transfer offices aren't always well-staffed and may not succeed in finding outside champions. Networking is key, and it's a full-time job, especially for people without prior experience.

Over at Duke University, Allen Roses has set up the Drug Discovery Institute to help bridge the divide. It operates as a virtual institute inside the university, and is composed of drug discovery experts. The handful of scientists at its helm have experience in industry and are tasked with either finding faculty that might have something that would be useful for drug discovery and helping them decide what they need to do with it, or resuscitating old projects and moving them along the drug discovery pathway. Their expertise, combined with the proximity and involvement with fellow academics at Duke, has been "one of the things about it that makes it workable," Roses says. "The team concept that is very useful in the pharmaceutical pipeline is [a] somewhat difficult concept to establish in any academic institution where individual activity is what's rewarded."

Roses also points out that typical academic-industry collaborations can take a lesson from successful public-private consortiums like the SNP Consortium and the Serious Adverse Events Consortium; these have put lots of data into the public domain in short periods of time and with little bureaucracy. He advises potential collaborators to really partner and not just affiliate, and for everyone to make clear their goals. "It's not about the partnerships, it's about what are the specific ends of the partnerships — what are they going to do, how fast are they going to do it, where's the work going to be done, and how do we get that accelerated for important problems," Roses says.

Looking ahead

Many experts agree that collaborations will continue to be the deciding factor in translating research into therapeutics or clinically useful devices. By its nature, systems biology is multidisciplinary and relies on advances in information technology; collaborations, says Woods at UTSA, will continue to reflect that. "The collaborations have become more intense," she says.

Vicki Sato adds, "I think information technology has been an important component of facilitating broad-based and complex collaborations."

Open software and standards for freely sharing data are becoming the norm when it comes to computational tools behind most big science. "The amount of data generated is ever-increasing," says Kristen Zannella, biotechnology and pharmaceutical industry marketing manager at The MathWorks, whose Matlab software is used by both industry and academia for a variety of different applications, including image processing and computational biology. "Matlab encourages collaboration in its users because it is an open, flexible environment," she adds. With an eye toward the future, the company also sponsors student competitions like iGEM, or the International Genetically Engineered Machine contest.

"Competitions create this type of product-driven atmosphere and follow real-world practices, allowing the students to experience the industry mindset and approach," says Liz Callahan, corporate relations manager.

Sato thinks it's becoming more common to see goal-oriented, multi-disciplinary institutes in academia that are neither purely academic nor purely industrial. The Harvard Stem Cell Institute and the Broad Institute are two such places that are "blending this quest for knowledge very successfully with a goal of solving particular problems, whether it's making stem cell technology medically useful or developing technologies that could radically improve the efficiency of discovering and testing drugs," she says.

And at places like Duke's Drug Discovery Institute, an entrepreneurial environment and access to former industry scientists might be just what academics need in order to learn how to switch tacks. Roses says, "Academics don't have a clue about how drugs are made or how to move them forward. They [regard] drug discovery as the valley of death — what they're referring to is the stuff they don't know about."

Experts agree that finding funding will likely continue to be difficult, especially through the downturn. In any case, matching up research with an interested third party — whether an investor, venture capitalist, or more frequently, a pharmaceutical company — is almost always a challenge. Fortunately for academics, tech transfer offices will continue to aggressively market their scientists' research to industry partners, says Regulus' Xanthopoulos, and he advises researchers to tap into this network.

In fact, B&W's Stossel sees tech transfer offices as spread too thin, having neither the time nor the bandwidth to match researchers with the right outlet. This should be researchers' cue to start learning more about the process and reaching out independently, he notes. "It really behooves [academics] to take that on themselves, and this is where the effort ought to be going, to teach people how to do that," he says. He's started an organization, the Association of Clinical Researchers and Educators, to raise awareness of the value of physician-industry interactions. "If academe thinks it's going to sustain itself, and if it really is serious about its desire to get the fruits of the knowledge that it produces out into the community, it's going to have to work with industry," Stossel says.

SIDEBAR: Public-private consortiums: A model of collaborative research

One type of collaboration that isn't exactly academic-industrial is that of the public-private consortium. These types of alliances are funded and operated through a partnership, usually a branch of the government and one or more private companies. The organizations involved pool resources with the express goal of producing results and data that is immediately put into the public domain for further use. Not only is large-scale science made possible by access to more and larger sample sets and data, but snags that slow down the process — bureaucracy and IP issues, to name a few — can ultimately be avoided.

The RNAi Consortium, based at the Broad Institute, is one well-known public-private partnership. It's created libraries of shRNAs for 15,000 human and 15,000 mouse genes, which are used by scientists all over the world to perform functional screens for finding possible disease targets. The consortium includes six MIT- and Harvard-associated institutions and five international life sciences organizations.

Another well-established public-private partnership is the Biomarkers Consortium, launched in 2006, which is a collaboration started in part by the Foundation for NIH to identify and validate new biomarkers.

Another, the SNP Consortium, has had tremendous success. First established in 1999 by 10 big pharma companies and the Wellcome Trust, the consortium's initial goal of mapping 300,000 common SNPs throughout the human genome eventually led to the International HapMap project. The Serious Adverse Events Consortium is taking advantage of pharma to acquire sample sets for adverse drug reactions — rare genotypes that are difficult to acquire in the numbers the SAEC needs to run genome-wide association studies for identifying variants linked to increased susceptibility to adverse drug reactions.

"Within 18 months to two years, both [consortiums] had accomplished their purpose, moving things along in a directed way without a huge bunch of bureaucracy," says Allen Roses regarding the SNP Consortium and the SAEC.

Part of the lure of setting up these partnerships is to accelerate clinical and translational research. "The body of scientific knowledge continues to accumulate at a breathtaking pace, and there are high expectations from society that we're going to be able to translate that knowledge into cures and preventions for diseases," says J&J's Garry Neil.

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