NEW YORK (GenomeWeb) – With their collaboration announced last week, George Mason University and Inova Health Systems aim to create an infrastructure that will drive clinical translation and implementation of personalized medicine technologies, representatives of both parties told GenomeWeb.
The university and hospital system are joining together to establish a variety of shared resources, putting into more direct contact two portions of the personalized medicine pipeline — research and validation and the end user — that have often remained somewhat disconnected during the development process.
Under the agreement, the instititutions are establishing facilities including a Scientific Connector Facility, an Inova-Mason Proteomics Center, and Mason-Inova Institute for Personalized Medicine Public Policy and Ethics.
Bringing together the resources of Virginia’s largest public university and one of its largest hospital systems (Inova sees more than 2 million patients), the partnership aims to create what GMU researcher Emanuel Petricoin called a "sandbox opportunity" for GMU and Inova researchers as well as outside entities like drug and laboratory technology companies interested in moving personalized medicine into the clinic.
"One of the hopes is that if we can place these [personalized medicine] technologies in the context of a huge healthcare system that touches a million patients, this could provide a really great magnet for private industry to come participate," Petricoin said. "It is not often that you have a healthcare system that sees so many patients and that is investing so much in precision medicine [partnering] with a large public university."
Indeed, for many molecular diagnostics companies, testing the utility of their assays and implementing them within actual healthcare systems has proven to be as or more challenging than development of the tests themselves.
As Devansu Tewari, a gynecologic oncologist within Kaiser Permanente Southern California, told GenomeWeb last month in an interview discussing Vermillion and its OVA1 ovarian cancer test, particularly as the US healthcare system "moves from a one-size-fits-all strategy to a value-based patient-centric approach," it is essential that test developers carefully examine the performance of their tests in the actual care pathways they hope to place them into.
To that end, economic and reimbursement analyses from Inova will help guide what projects the collaborators do take on, said Thomas Conrads, associate director of science technologies at Inova's recently launched Center for Personalized Health, a health research center the company is building on the 117-acre former Exxon Mobil campus in Merrifield, Virginia. That site will house Inova's new Dwight and Martha Schar Cancer Center as well as the Inova-Mason Proteomics Center.
"If, for instance, we do the medical economic assessment and the reimbursement assessment [for a test], and, for whatever reason the patient population can't support the development of that test, then that project probably won't be on the table," Conrads told GenomeWeb.
"Science can point to new directions and is exciting," Petricoin said. "But it has to be validated; it has to be clinically useful; it has to be able to be implemented in a clinical infrastructure that touches many patients; and it has to save costs."
GMU and Inova have for years collaborated at the level of individual scientists and clinicians, Petricoin said, noting that he and Conrads have in the past worked together on a number of projects. Collaboration at an institutional level, however, is something new for the two parties.
The agreement was in part facilitated by $16 million in funding from the state of Virginia. Inova is also putting $2.5 million toward the collaboration. Additionally, home builder Dwight Schar and his wife Martha donated $50 million for the new cancer center.
In the long run, Conrads said, the collaboration plans to fund its research primarily through grants and contracts with private industry. "Whatever the seed funding you are hearing about right now, the onus is on us to make sure that this is something that is sustainable, impactful and provides deliverables," he said.
As the establishment of the new Proteomics Center would suggest, proteomics is a focal point of the new collaboration. Petricoin is, with Lance Liotta, co-director of GMU's Center for Applied Proteomics and Molecular Medicine, which will continue to operate as before. The new Inova-GMU Proteomics Center provides a space for focusing on the later, more translational stages of proteomics work, Petricoin said.
"From our side, we are always interested in new technology development, and our center will always consist as a kind of technology development [center]," he said. "But I think this effort [with Inova] is very much focused not on technology development but on implementation — technologies that are ready for primetime but that we need to prove vigorously. We are going to implement these technologies and apply them to the clinic and test their utility in real, rigorous clinical trials."
The opportunity to access Inova's patient network is of particular interest to GMU researchers given the university's lack of a medical school, Petricoin noted.
The collaboration will be "very much focused on highly translational endpoints … that are absolutely driven by real problems clinicians are having at the bedside," Conrads said.
"This will all be capitalizing on opportunities where clinical samples are being collected right next door," he added. "This [proteomics effort] will be nested within an entire new infrastructure for Inova that will be supported by an institutional biobanking program. So it really will be very clinically driven opportunities where proteomics can play a big role. We're not going to be doing yeast proteomics."
Cancer will be a primary focus of the proteomics collaboration, with specific emphasis given to investigating the role of the tumor microenvironment.
"The applied effort will focus on the tissue microenvironment, looking at the effects of therapies not only in affected disease cells like tumor cells, but also in the immune system, the stromal compartments, and so on," Petricoin said, noting that this has been a long-standing area of interest for both him and Conrads.
The institutions also are also planning proteomics projects looking into cardiovascular disease and metabolic disorders, Conrads said.