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Harvard NeuroDiscovery Center Betting POC Work Will Bridge Tech-Transfer Gap

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Craig Kennedy
Deputy director
Harvard NeuroDiscovery Center
NAME: Craig Kennedy
 
POSITION: Deputy director, Harvard NeuroDiscovery Center
 
BACKGROUND: Senior director, technology development program, Biomarin Pharmaceutical; Director, corporate development, Cell Genesys; Director, strategic programs, Myriad Genetics; Senior manager, corporate development, Life Technologies; Manager, worldwide marketing and strategic planning, Ciba Geigy; Branch chief, Office of Technology Development, National Institutes of Health
 
Universities and non-profit research institutions hoping to move their life-science innovations into the clinic are increasingly coming to two conclusions: They need to attract venture capital investment or industry partners to fund the research, and to win that funding they must first develop their technologies to at least the proof-of-concept stage.
 
As such, many institutions have implemented mechanisms such as internal seed funds, campus-affiliated incubators, entrepreneurial services, and alumni angel networks to advance their discoveries downstream.
 
Harvard University, despite its size, monetary resources, and research capabilities, is certainly no stranger to the funding gap. One recent initiative to address this issue at the school is the Harvard NeuroDiscovery Center.
 
Founded in 2001 by Joseph Martin, then dean of the Harvard Medical School, and Dennis Selkoe, a prominent Alzheimer’s disease researcher at Harvard-affiliated Brigham and Women’s Hospital, the center straddles the line between academia and industry by drawing upon the neurodegenerative disease expertise of the Harvard community and helping to translate neuroscience discoveries into more attractive targets for industry development.
 
To do this, the center maintains an affiliation with Harvard, operates under its own $10 million research budget, and attempts to cultivate a delicate working relationship with both its academic and medical affiliates’ tech-transfer offices and industry concerns.
 
Last week, BTW caught up with Craig Kennedy, deputy director of the Harvard NeuroDiscovery Center, to discuss the center’s mission, opportunities, and challenges.
 

 
What was the goal of the Harvard NeuroDiscovery Center when it was founded in 2001?
 
The original gift for about $40 million was made to the Harvard Medical School essentially to embark upon translational research in neurodegeneration. At the time it was felt that this was a fairly neglected field. Interestingly enough, since that time the industry has come around to recognize the fact that there is a lot of potential in the neurodegenerative field. It’s still fairly split – Alzheimer’s, Parkinson’s, and multiple sclerosis have become very attractive. However, the other diseases are still fairly neglected – ALS and Huntington’s are good examples. I think the field is still neglected in the very small orphan markets, but the larger ones are attracting attention.
 
How has the center’s mission or research focus changed since it was founded?
 
I think the change has been one of experience, in particular with bringing drug discovery expertise into the academic environment. This is one of the first examples of an academic institution doing this. There are a handful of laboratories out there like this within the academic setting, but no one has really brought in a full-fledged drug-discovery unit that you might find at a Merck or Sepracor into the academic environment. We have learned lessons over the past five years about what is and isn’t working.
 
What type of people did you bring in to the center? Did most of them have an industry background?
 
We went out and hired drug-discovery professionals – basically, high-throughput chemical entity investigators. In fact, our lead investigator, Ross Stein, who runs our Laboratory for Drug Discovery and Neurodegeneration, was on the team that developed Velcade, which is Millennium’s main compound. So there is some success there from an industry perspective, and we brought them in very early on to replicate that in the academic environment.
 
When did you join and in what capacity?
 
I was hired in 2006. The center recognized that they had a number of projects that were progressing toward a stage at which a technology assessment could be made. I was brought in to assess the commercial value of about 30 projects. Obviously you select one or two that look very promising, and the next step was to say, ‘OK, what further work do we need to do to bring these to a stage where they would be very attractive?’ In particular, I came in with project-management skills to say, ‘We need to get to the proof of principle, and these are the things we need to do. We need to do animal studies and achieve a proof of principle on these compounds.’ I think I also helped to bring a well-defined development schedule and [identify] those milestones that are relevant to the project.
 
These projects at the center are being conducted by faculty members that are associated with Harvard and other institutions, correct?
 
Yes. One of the things that was important to the gift originally was the recognition that academia generally works in a very ‘silo’-like approach. [Researchers] generally get an NIH grant, they work, and they publish, and that is their incentive, the end result of their work.
 
The Harvard-affiliated community, however, is an incredibly vast community. There was never any organization that basically pulled the community together and said, ‘Here are certain objectives we would like to meet, and here is a mechanism to meet those goals.’ When you think about the Harvard-affiliated community, it is probably the largest in the world. We’re centered out of the Harvard Medical School, but the list includes Massachusetts General Hospital, Brigham and Women’s, Dana-Farber [Cancer Center], Joslin [Diabetes Center], Beth Israel Deaconess; and the list goes on and on, to the point where our membership, just in the neurodiscovery community, is about 600 or 700 people. There is nowhere in the world where you can get that many people just focused on neurodegenerative disease. So there was a critical mass within that community that allowed us to promote our agenda within that community.
 
Has there been any difficulty in working with the tech-transfer and commercialization arms of each of the institutions involved in this partnership?
 
I started at the National Institutes of Health in the early 1980s and was one of the early members of trying to implement tech-transfer programs there. Right after the Technology Transfer Act of 1986, the question became, ‘How do we implement this act, so to speak, from an NIH and university perspective?’
 
Back then I think two models were presented to us. One is what I called a legal model, and the other what I called the business model. The legal model is essentially practiced by 90 percent of tech-transfer offices today. It is a quasi-legal office that concentrates on the mechanisms, which may be a confidential disclosure form, a material transfer agreement, a sponsored research agreement, and eventually, hopefully, a licensing agreement.
 
That model worked extremely well in the early days of biotechnology. In essence, the industry came to the NIH and to the universities. I remember venture capitalists and companies knocking on my door, asking me to give them anything. It was very easy. The issue was essentially just the transfer of that technology, and usually that meant just the granting of rights. It was nothing more than a contract under which the biotech company would take those rights and would develop the technology. And obviously, the money was there to pour into that.
 
That worked very well until the industry matured. As it matured, obviously a lot of these research projects and collaborations failed. We basically had a “death valley” of these technologies. And as the industry matured, people at corporations and in venture capital became much more sophisticated such that they proceeded to pull back from very early-stage technologies.
 
So the other model that was provided to the tech-transfer offices in the 1980s was a business model. Examples of that model were at MIT and Stanford. That model tried to leap into business formation, to create more value on the commercial side. The MIT Forum, for example, provided entrepreneurial help to its investigators, and out of this, for example, came star [entrepreneurs] like [MIT’s] Robert Langer.
 
That is essentially the dichotomy that the tech-transfer community is faced with today. Will it continue to basically provide those rights through a contract, while recognizing the fact that there is a real gap because there is nobody there to develop these technologies further through proof of concept?
 
Going back to your question, the tech-transfer offices here mostly still operate on that second model. So what we do at the NeuroDiscovery Center is to insert that business model between the two. We are developing mechanisms to insert creative organizational changes – what I call innovative intermediates – to take technology further downstream. The neuro-related drug-discovery sector is moving along that continuum, hopefully to some lead candidates. Now we’re creating some partners and innovative organizations that will perhaps then take it and help us perform a proof of concept. To some extent the NeuroDiscovery Center supports certain projects that have great potential to perform POC, so we have to be very selective in what projects we choose.
 
That, in a nutshell, is the model we’re trying to create. We’re able to do that while recognizing that some of the tech-transfer offices are encumbered by the organizations they work in – a university, a hospital. For example, a hospital is not going to think about start-up companies. We recognize that issue, and that they can only take a technology so far, so we support their efforts. We will leave the tech-transfer activities to the experts there, but simultaneously we are developing and implementing the business model to help take these projects further downstream.
 
What about when the time comes to license a technology to a company? Does the NeuroDiscovery Center get a stake in the licensing and royalty agreement? Have you worked through that yet?
 
We have. We basically perform a lot of the classic business development activities and draw up the business plan. We work with the tech-transfer offices to draw that up, and part of that, of course, is a well-written patent application. We actually have supported the filing of quality patent applications to what we believe is our product candidate or therapeutic idea. Sometimes it is not a classic academic application where you are just trying to claim a matter of composition and perhaps a list of diseases. We try to focus on a particular composition of matter, with a particular disease, and with a particular POC, and data to do that. So when we come to [patent] prosecution, we know where we’re going, so it is not a general, broad claim to which hopefully somewhere down the road we will have a collaboration where we can add data to it.
 
Then, once we identify a candidate or a collaborator, we bring this to the tech-transfer offices, and they are very happy for us to do that. When we do that, we act as kind of an agent. We work between the company or the licensee, and the hospital or institution. We make it clear that we have an interest here, and we encourage and try to influence the license terms to be beneficial to all the parties. We’ve been successful in doing licensing agreements in about a third of the time that it would take in a typical negotiating process between a company and a tech-transfer office.
 
But I think the lesson here is that we can focus on one or two things, where tech-transfer offices get a number of invention disclosures and have limited resources. We can focus and pick out the ones that we believe we should put a lot of effort into. The important thing here is that we believe we complement the tech-transfer offices, and can help them move these technologies forward recognizing that the industry has changed. It’s a different world out there, and when the world changes, institutions have to change their business models, and that’s what we’re trying to do.
 
Any early successes to this point?
 

Yes, but they are still in negotiations. Until these are signed, sealed, and delivered, we can’t describe them. We firmly believe in one of our projects where we have a pivotal technology platform that will enhance the efficacy not only of existing drugs in multiple sclerosis, but also drugs in other autoimmune diseases such as diabetes. We’re pulling this project forward to the point where we get that proof of concept, and we actually have identified some people who might be very interested in it — not only from a licensing perspective, but also trying to get this platform into someone’s hands that can exploit it.

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