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Oak Ridge, Georgetown Systems Bio Research Pact Could Produce Commercial Prospects

Georgetown University Medical Center and Oak Ridge National Laboratory last week announced that they have entered into a cooperative research and development agreement that will combine GUMC’s clinical expertise with ORNL’s supercomputing resources.
The five-year agreement will be driven by basic research projects that focus on so-called “systems medicine,” according to the partners. And although the alliance is in a very early stage, its multidisciplinary and collaborative nature suggests future technology-transfer and commercialization agreements, according to officials.
Under the CRADA agreement, GUMC researchers will have access to a variety of supercomputing resources and systems biology expertise to support projects in the areas of structural biology, genetics, biomarker discovery, computational biology, radiation biology, cancer, and physiology, among others.
The agreement is GUMC’s first CRADA with a federal research institution, and is also ORNL’s first with an academic institution.
“The galvanizing theme was really around systems medicine: the idea of being able to create a synergistic research objective by pulling disparate research tools and perspectives together, such as computational biology, engineering, and bioinformatics, against a singular problem,” Andrew Deubler, vice president for enterprise development at Georgetown University Medical Center, told BTW this week.
Deubler added, however, that the nature of a CRADA is such that it suggests a potential commercial outcome that would benefit society. “The CRADA is really defined to articulate those parameters,” Deubler said. “They inherently feel like they’re being geared toward a commercial angle, but here the research itself is very much galvanized more around systems biology.”
Kristina Thiagarajan, the NIH program manager for ORNL, agreed that she could “see a potential for commercial products or spinoffs, but ultimately the drive for this partnership is for ORNL’s unique resources, assets, and expertise to help support Georgetown’s mission at the school of medicine.”
That mission was laid out early last year by Howard Federoff after he was appointed executive vice president for health sciences and executive dean of the Georgetown School of Medicine, according to Thiagarajan.
“ORNL has a history of working with university partners, and Georgetown is one that we had been discussing ideas with for a few years,” she said. “When Howard Federoff came on board with Georgetown, he had a unique vision of systems medicine, which is an absolute complement to the systems biology here that is accomplished through our [US Department of Energy] mission. So it was a great marriage.”

“They inherently feel like they’re being geared toward a commercial angle, but here the research itself is very much galvanized more around systems biology.”

So far the institutions have initiated three projects under the CRADA. The first involves using ORNL’s computing capabilities to use atmospheric pressure surface sampling and ionization methods along with mass spectrometry to probe paraffin-embedded tissue to map biomarker metabolites in tumor samples.
Another project involves studying genetic and mechanistic interactions between adverse responses to stress and risk for obesity, and it will incorporate genotype data to identify components of the interactions in order to develop personalized therapeutic targets.
The third study will involve using a membrane developed by ORNL to help develop technology to detect early cancer metastasis using circulating tumor cells in the patient’s blood.
According to Deubler, the computing power at ORNL’s disposal is one of the few resources for dealing with the enormous amounts of data expected to be generated from some of the CRADA projects.
“In looking at the systems biology paradigm, where you’re talking about [all] the data relative to a biological problem, there are fundamental stages where that information has to be reduced in order for a physician to be able to demonstrate it back to a patient,” Deubler said.
“Georgetown has great capacity on the clinical side,” he added. “In order to be able to capture the load of data necessary, and to reduce and visualize it, the decision we made at Georgetown – and I think a lot of universities are going to have to make this decision – [was whether] we wanted to invest … in that kind of infrastructure, or [whether] there were partners we can pull into the mix.”
Thiagarajan added that ORNL has “a lot of muscle we can provide Georgetown in terms of computational power”. Other ORNL resources that GUMC researchers can tap include structural biology resources such as a neutron-scattering research facility called the Spallation Neutron Source, and the Collaborative Cross, a collection of mouse strains that respresent the genetic diversity of the world population, Thiagarajan said.
The initial collaborative projects are somewhat atypical in that Georgetown and ORNL, rather than a federal agency other research sponsor, are funding them. This is due to the fact that systems medicine research is so early-stage that it requires the institutions to conduct more proof-of-principle studies to make them viable candidates for competitive funding, Deubler and Thiagarajan said.
“The reason we agreed to do it is because systems biology is such a new domain that external funders really don’t have a fundamental understanding of it,” Deubler said. “We felt we needed to fund these initial projects to begin to give some definition of what we were trying to do so we could entice funders.”
The internal funding also demonstrates to external funders “the commitment between Georgetown and ORNL in this space,” Deubler added. The amount of seed money committed to each project was not disclosed.
If and when the projects begin to move toward commercialization, many of the details of the tech-transfer process are governed by the CRADA, which provides a fairly rigorous collaborative blueprint, according to Deubler.
“They are fairly standard in terms of what they require,” he said. “They cover legal issues, commercialization issues, [and] freedom-to-publish issues. Funding issues are very clear in terms of how funding will flow between Georgetown and [ORNL]. The language, I think, becomes more customized from agency to agency, because their inherent infrastructures are different.”
As far as IP development is concerned, one of the key factors of the agreement was defining which institution would own the fundamental inventorship of the concept, Deubler said.
For instance, in the project that involves using ORNL’s artificial membrane to help detect circulating tumor cells in blood, a Georgetown scientist brought the fundamental research to ORNL, Deubler said. “So in that case, the ownership of IP would really reside with Georgetown, and the partnership was developed with ORNL to really enhance her science.”
However, each case will be different, he added. “We certainly want to be as liberal as we can with regards to the licensing rights – how we generate revenue off of this shared work,” Deubler said. “As we begin to find commercial value and begin to think about licensing this technology, that’s where Oak Ridge and Georgetown really need to come together and determine what we contributed to the growth of the science to decide how we determine the licensing rights.”
Already at least one project, involving defining the genetic interface between genetic susceptibility to stress and obesity, is moving to the next stage, which means seeking federal funding and pulling in additional academic, government, and industrial partners.
GUMC and ORNL together with Howard University, Medstar, and the Veterans Administration are in the process of applying for NIH funding through its Clinical and Translational Science Award program, Thiagarajan said.
Further ideas for projects over the five-year term of the CRADA will be vetted by both GUMC and ORNL.
“We won’t necessarily wait for opportunities to come up, or specific solicitations from NIH,” Thiagarajan said. “Ninety percent of NIH extramural funding comes from investigator-initiated ideas. So we have a number of ideas from this partnership that we’re going to move forward at the appropriate time.”

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