A biomedical researcher might be excused for feeling confused about the National Institutes of Health's (NIH's) attitude toward its grantees' relationships with for-profit companies. On the one hand, NIH has invested billions in translational research and is expected to launch the new $50 million Cures Acceleration Network in 2011. On the other hand, proposed new rules for NIH grantees seek to strictly monitor all ties between academic scientists and the industry partners required to move treatments from the lab to patients.
Unveiled in May, the proposed rules state that NIH-funded scientists must fully disclose virtually all financial ties to industry, including travel reimbursement, speaking fees, and consulting fees, that might be perceived as compromising research objectivity.
"The relationships which I think are really working for both sides -- that is, for the people in my lab and for the people in industry settings -- are the ones which have been evolving over years of good communication. Long-term relations and some sort of trust have to be built up, and that takes a while." -- Roman Giger
No one -- and certainly not NIH -- is arguing that financial ties between academic investigators and companies, which are pervasive in biomedical research, should be severed. In announcing the new rules, NIH Director Francis Collins and his colleague Sally Rockey acknowledged, in a Journal of the American Medical Association editorial, that partnerships between researchers and companies are "essential." But, they wrote, "Plain and simple, Americans do not want financial conflicts of interest (FCOI) to influence federally funded research."
Conflicts of interest are just one of the challenges that academic scientists face in cultivating productive relationships with industry. Yet the payoff of a successful industry collaboration can be huge. So, is there a "right way" to partner with industry to improve the odds of meeting those challenges? Here, insiders who have managed such relationships for years offer tips for moving science forward while maintaining the public trust.
Get out and talk about your work
For a new investigator interested in making industry contacts, the only way to get noticed is to be visible. Industry is more interested than ever in making contacts with academic scientists, says infectious disease specialist Gail Cassell, vice president of scientific affairs at Eli Lilly and Co. in Indianapolis. Industry scientists find interesting new research -- and the researchers behind it -- by attending scientific meetings.
That's how Charles Sawyers, a 2009 Lasker Award winner and chair of human oncology and pathogenesis at Memorial Sloan-Kettering Cancer Center in New York City, made the connection with Bristol Myers Squibb (BMS) that led to second-generation treatments for chronic myeloid leukemia (CML).
Sawyers conducted some of the first, dramatically successful clinical trials on Gleevec, which inhibits specific enzymes at play in certain cancers, particularly CML. Curious why some patients' cancer returned after treatment with Gleevec, Sawyers studied the mutations leading to drug resistance and developed hypotheses about what characteristics drugs needed to defeat that resistance. He had no idea whether existing compounds could meet those requirements, but after he presented his work at a meeting, a call came from BMS, leading to a successful collaboration and ultimately to the CML drug dasatinib (Sprycel).
It's a mistake to fear talking publicly about your ideas, Sawyers says. "Don't try to keep your stuff secret because you are worried about getting scooped." There are "benefits to getting out and talking about [your work] that enhance the impact of your work much more so than whether ... you are the absolute first paper on your topic."
Don't try to guess which companies would make good collaborators, he says. Network at meetings and make personal connections to learn as much as you can about industry science, and let industry scientists learn about you. "Even if you do have company connections, it's not easy to find out what's going on in companies, because they are all siloed, for obvious reasons," Sawyers says. "So you have to get out there and promote your stuff."
Invest in a true collaboration
Roman Giger, an associate professor of cell and developmental biology at the University of Michigan, Ann Arbor, studies neurodegeneration and treating spinal cord injury. He has worked with industry from the outset of his career, consulting for companies and participating in company-sponsored research. While on the faculty at the University of Rochester Medical Center, Giger partnered with Johnson & Johnson to test the ability of engineered receptors to restore connectivity lost in injured neurons. That collaboration ended when he moved to Michigan, but he has maintained other industry collaborations.
Why bother? Because companies have resources -- reagents, proprietary mouse models, the ability to conduct toxicology studies, and so on -- that even major research universities may lack, Giger says. On the other hand, access to these resources usually comes with strings attached, such as corporate review of manuscripts and, in some cases, the right of first refusal to commercialize promising findings that arise from the collaboration, Giger says.
Don't make the mistake of viewing companies simply as writers of checks. Cassell, who has worked both in academia and in industry, says that industry scientists want to engage with their academic partners. "The outcome will be much more successful if it's viewed as a collaboration, not as just another pot of money."
Giger concurs. In his experience, "the relationships which I think are really working for both sides -- that is, for the people in my lab and for the people in industry settings -- are the ones which have been evolving over years of good communication. Long-term relations and some sort of trust have to be built up, and that takes a while."
Make sure there are no surprises
As soon as you have made the decision to collaborate with a company on a research project, get your university's tech-transfer office involved.
"Be clear what the agreement is," says Judith Kramer, executive director of the nonprofit Clinical Trials Transformation Initiative, a public-private partnership led by Duke University Medical Center and the U.S. Food and Drug Administration (FDA). Kramer, who from 1993 to 1996 was vice president and U.S. director of clinical research at Burroughs Wellcome & Co. (which later merged with Glaxo Inc., now GlaxoSmithKline), says defining roles and expectations at the beginning of a partnership will save grief down the road. Your tech-transfer office will know what questions to ask.
The tech-transfer office should also be able to help you understand when to back away. Kramer says there is a growing realization that the further into the development process the academic partner stays involved, the more value there is for both parties. But direct involvement in testing a drug can become ethically tricky. Both the Institute of Medicine and the Association of American Medical Colleges say physician-scientists who stand to gain financially from FDA approval of a drug or device should stay out of the clinical trials.
Be careful about consulting
"The most common time there is conflict of interest is not with inventorship," says Harry Greenberg, senior associate dean for research at the Stanford University School of Medicine in Palo Alto, California, and director of the Stanford Center for Clinical and Translational Education and Research. In his experience, the biggest issues arise when a scientist has a consulting relationship with a company that is also developing a piece of intellectual property from the consultant's lab.
The Federation of American Societies for Experimental Biology (FASEB) further clarifies this in its Conflict-of-Interest Toolkit: "When holding a role in a start-up company, be guided by agreed-upon limits to the scope of the relationship. Close interaction between the inventor of the technology and the licensing company is often very beneficial because the inventor of a technology often has the most expertise to help translate that technology into a useful product. But investigators with dual roles (research faculty and company founder/consultant) face challenges of potential overlap of research interests, thereby blurring the line between institutional responsibilities and outside interests."
The FASEB guidelines also note that rules can vary across institutions. For example, Greenberg says that Stanford has adopted rules that prohibit faculty members from co-developing inventions. In addition, he says, Stanford's rules strongly discourage faculty members from participating in paid speaking engagements on behalf of companies. A 2009 Institute of Medicine report on conflict of interest in medical research recommended that physicians in particular avoid industry speakers bureaus, which generally serve a marketing function.
"Investigators need to use their moral compass," Kramer says. "Be mindful of who's asking you to do what and who gets what from it."
For those who might still be worried about how a relationship with a company looks to the outside world, keep in mind that the public generally approves of scientists working with industry. According to a 2008 poll of U.S. residents conducted by Research!America, 94% of Americans think universities and companies should work together to find new treatments, and 81% think it's a good idea for pharmaceutical companies to fund research conducted in universities.
Nations such as China, Japan, and Russia have recognized the value of public-private collaborations in biomedical research and are moving aggressively to invest in these areas, Cassell says. "If we're not careful and let the pendulum swing too far backward in the other direction, then we will not be competitive in science and technology," she says. What's more, Cassell notes, the U.S. investment in biomedical research was about $40 billion in 2009, including stimulus spending; Congress, the public, and patients are going to be expecting results.