Vice provost, IP
and technology transfer
University of Washington
Name: James Severson
Position: Vice provost, intellectual property and technology transfer, University of Washington
Background: President, Cornell University Research Foundation; various tech-transfer positions, University of Minnesota; various positions in new technology assessment and market development, Amersham Biosciences; past president, Association of University Technology Managers
Last month the Federation of American Societies for Experimental Biology issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research.
The federation also unveiled a framework for a set of national guidelines at a meeting of representatives from more than 75 scientific societies held last month in Washington, DC; and launched a web-based resource, called the Conflict of Interest Toolkit, to help researchers, institutions, publications, and industry put FASEB’s recommendations into practice.
James Severson, vice provost of intellectual property and technology transfer at the University of Washington, was one of several advisory committee members on the FASEB project, and provided the perspective of the technology transfer community. Last week, BTW caught up with Severson to discuss his thoughts on the project and on managing financial relationships in university technology transfer.
How did you become a member of the advisory committee on this project?
I was invited to participate by Leo Furcht from the University of Minnesota, who at the time was the vice president for public policy for FASEB. They put this coalition together in 2005 right after a series of articles published in the Los Angeles Times about conflicts of interest at the National Institutes of Health.
Several things came out of that. One is that I am a past president of [the Association of University Technology Managers], so they viewed my participation as a connection to the technology transfer community, which they viewed as critical to the process. In addition, I am a current board member of the Council on Government Relations, a Washington, DC-based organization that includes more than 160 universities, teaching hospitals, and research organizations. COGR represents a broad collection of universities that are involved in research, and I’d been involved in several initiatives at COGR related to the management of conflict of interest.
Those were really the reasons, but I had also been at the University of Minnesota early in my career, and I knew Leo Furcht from that portion of my career.
What are some broad examples of financial relationships between universities and industry?
From a tech-transfer standpoint, we see relationships that usually relate to startups or to a transaction that we’re involved in – someone has a relationship with a company, and that has an impact on our ability to complete a transaction.
But there are other outside activities that faculty engage in like consulting, and just straight-up investments made by them or their families that may be seen as a potential conflict. In the last 10 or 12 years, we all have adapted our financial interest policies to reflect the guidelines that were issued by National Science Foundation and National Institutes of Health in 1995. There are thresholds in those policies that relate to the level of financial involvement that an individual can have with an entity when they’re having a relationship, or it may have an impact on their research.
Does FASEB believe that there was a lot of inconsistency from institution to institution in the way these policies were implemented or interpreted?
I think that was one of the thrusts – this sense that FASEB had from its membership. FASEB represents individual member organizations, so these are scientists. These are scientific societies that the research scientists belong to, so this initiative, to me, represents scientists talking to scientists. From the work that FASEB had done, and from a workshop that it had sponsored in 2005, the sense was that we’ve all adapted policies based on the NSF and NIH, but everybody’s different. The University of Washington is different from the University of Minnesota, which is different from the University of Chicago, and so on. And while the basic principles are the same, the implementation may vary, and certainly the language may vary. As there is more interdisciplinary work that goes on between institutions, the question becomes, “Who do I report this to? What do I report?” And scientists are mobile, too. Somebody might say, “I just moved from X to Y, and this looks different, and why does it look different, and what do I do here?”
So part of what FASEB is trying to do is clear the swamp a little bit and to provide some consistency. That’s a hard thing to do, because each institution obviously cherishes its own independence. But for them to say, “Hey, you’ve got a problem,” and they want compliance, then they’ve got to make it easy for people to comply.
This framework that was unveiled by FASEB in July mentions financial relationships between academia and industry specifically in biomedical research. Is that just a consequence of FASEB’s involvement, or is this a bigger issue in biomedical research than in other areas?
There are two reasons, I think. The first is that yes, it is FASEB, which is an umbrella organization that covers a number of societies that work in the life sciences, so that is going to be their focus. I also think that the bulk of funding that comes into life sciences laboratories is NIH funding, and as a result of the scrutiny that was applied to NIH in 2005, there was a concern at one point that the kind of prohibitions on external consulting that were being talked about at NIH might be extended to the extramural research community. So part of it was, “We need to organize ourselves better and show that we’ve got the situation in such a state that these prohibitions don’t come out to the extramural programs.” It’s really a direct connection between life sciences and the NIH and linking back to these investigative reports.
Having said that, the policies at my institution and at almost all other institutions apply broadly, whether you’re in the biology department, the school of medicine, or the college of engineering.
I also think the other issue is that a lot of life sciences research is going to involve humans, and the stakes are obviously much greater there.
Is there any legislation in place that guides financial relationships between academia and industry? For instance, does the Bayh-Dole Act contain guidelines for financial relationships in instances of technology transfer?
No, I don’t think Bayh-Dole addresses that at all, and I’m not aware of any other [legislation]. The two main pieces that people have used that have been central to policy development and revisions have been the NSF and NIH guidelines issued in 1995. There is also a series of guidelines issued by the Food and Drug Administration that contains a different set of thresholds, but that relates more to the financial interests involved in providing data in trials that are used to approve a drug or device. That’s much different than basic research. I’m not aware of any legislation, although we do have specific state legislation in Washington that was an overlay to the federal guidelines. There may be state laws that relate particularly to state institutions, but I’m not aware of any federal legislation.
From the tech-transfer perspective, what are some of the major pitfalls to avoid or things to be vigilant about in terms of managing financial relationships?
We’re like most institutions in that we’re involved in creating the relationships and there is some other location – either a committee or individual – within the university who has the responsibility to review it. Our job is to identify circumstances that may be considered a conflict, to encourage disclosure, and to provide timely and accurate information so that people can make a good decision about it. We’re looking for relationships that exceed a threshold such as 5 percent ownership in a start-up company, or have an aggregate value of more than $10,000. We do that primarily through conversations that we have with the faculty and staff that are involved in these endeavors. We encourage them to make their disclosures, and make it clear to them and the external people with whom they are working that we can’t complete a deal until these things are done – that this is serious stuff. Most typically the issues are related to a startup, and to an equity ownership in the company. Or, it might involve the desire of a student or faculty member to take a leave of absence to help in the earliest stages of starting up a company. We’ve had more of that recently, where people are interested in taking off six months or a year to help get the company up and organized, and that involves a leave of absence. Strictly speaking, that’s not a financial interest, but it’s connected.
This seems like something that will continue to increase as the startup model is increasingly championed, especially in the life sciences, as a way of commercializing research.
That’s right. And almost all of us have state programs that are encouraging life sciences development. Many states have a life sciences strategy with state money going in. So there is more an emphasis on startups and economic development, particularly for state universities.
Getting back to the COI toolkit that FASEB launched, what are some of the goals moving forward? Is it just to get people to check out the website, or is there more action to be taken in this area?
I think we’re in a constant education mode on these issues. Even with faculty members that are pretty savvy about commercialization, this is not the highest priority for them. You’re doing a lot of ‘just-in-time work,’ where you’re not going to worry about something until you need to.
There are really two levels here. [For] those of us who are involved in transactions, we’re going to be doing this on a regular basis because it’s just part of what we do. The other piece is to encourage the institutions to take what FASEB has done seriously, and to take a look at some of the tools in the toolkit and adopt them as seems appropriate for local conditions. The next step is utilization, and getting the various institutions to say, “Yes, there is some value here, and we can use this in this way.”
This is an initiative that has gone on over several years and had several phases, and FASEB has worked very hard to make this a broad coalition. I think FASEB is also going to go out and get endorsements from other societies, and other organizations that have connections to university research. For instance, they specifically asked for COGR to endorse the initiative. We talked about this on the COGR board, and COGR provided a letter of support and endorsement. I think they’ll be looking for this from other organizations. They’re going to use a grass-roots effort to get faculty to say, “Yes, we should be doing this.”