OHSU Spins Off Biotech Startups At Rapid Pace

A Growing Number Of New Biotech Companies Aim To Bring Cutting-edge Research To The Public

By Sara Selgrade

Perched high atop the hills of Portland, Oregon Health and Science University (OHSU) is literally the pinnacle of biomedical research in Oregon. OHSU provides cutting edge medical research to the community, and it recently has become a rich source of biotech innovation and entrepreneurship, with over 132 inventions, five startup companies, and over one million dollars of income from commercial products.

According to OHSU's Director for Technology and Research Collaborations, Arundeep Pradhan, the goal of the university's technology transfer program is to "find the right home for a technology that ensures it is going to be commercialized.”

He adds that the success of OHSU's commercial technologies depends upon a combination of the nature of the technology, the market for the technology, and the entrepreneurial drive of the faculty.

The startup companies now emerging from OHSU seem to indicate a strong entrepreneurial drive among the faculty. A professor in the Department of Biomedical Engineering, Stephen Hanson comments that his own desire to commercialize his work comes from an interest in translating research into clinical applications. "I think at the base of this is really an urge on the part of an engineer to want to see a solution to a problem with a product that actually helps people.”

Hanson has used his engineering skill to bring a number of products to the public. His research focuses on the ultimate pump, the human heart. Hanson holds 20 patents and has founded four companies related to treatment of cardiovascular disease. His most recent startup company, Cylerus, founded in 2007, develops technology for local drug delivery to artificial blood vessels. These drugs help ensure that the artificial vessels remain clear and allow free flow of blood.

Improving blood flow and cardiovascular health was also the goal of Hanson's previous startup company, Revitus. That company, recently merged with BioVascular, Inc., aimed to target cardiovascular disease by using drugs to lower platelet counts in the blood. With his many approaches to improving cardiovascular function, Hanson expresses a sense of duty to commercialize his technology. "I also believe it's an obligation on the part of researchers like myself who do things with an applied focus to try to see their ideas translated into useful products in the marketplace. It will help people and help the economy.”

Other OHSU researchers appear to support Hanson's view. With similar goals of advancing health and commercializing research, two other faculty members founded a startup biotech company, Molecular MD, in 2007.

The brainchild of OHSU researchers Brian Druker and Michael Heinrich, Molecular MD relies on their expertise about the aberrant fusion of two genes, BCR and ABL, which is responsible for many cases of chronic myelogenous leukemia (CML). The company markets diagnostic assays for CML patients that detect the aberrant BCR-ABL fusions and monitor response to treatment with Gleevec, the major drug targeting BCR-ABL.

Beginning with detection of BCR-ABL in chronic myelogenous leukemia, Molecular MD hopes to expand its offerings to many other diseases. The goal of the company, according to Druker, "is to perform molecular testing so we can match patients diagnosed with cancer with the right therapies and then monitor their response to therapy.” He adds, "as we enter a molecular era in cancer diagnosis and therapy, we need to have the ability to diagnose what the molecular abnormalities are quickly and accurately, because that's going to allow matching individualized therapy, or personalized medicine.”

Personalized medicine is more than a catch phrase at Molecular MD. Druker's motivation in founding the company came from his experience as a physician treating patients with CML. His frustration at the lack of a standardized test to monitor his patients' treatment sparked his interest in developing an assay to fulfill this unmet need. If patients are tested at different labs, according to Druker, "we're comparing apples and oranges. We have no idea whether they're the same, better, or worse.” Driven to standardize testing and establish a reliable way to monitor a patient's response to treatment with Gleevec, Druker helped develop an assay to monitor how many copies of BCR-ABL persist after drug treatment.

Molecular MD's method of BCR-ABL monitoring has developed into an important measure of disease progression. The assay is sensitive enough to detect less than 0.1 percent mutant copies of the gene. This 0.1 percent of the aberrant BCR-ABL fusion to the normal gene is known as major molecular response. A ratio at or below major molecular response, indicating fewer mutant copies of the gene, has been shown to correspond to improved outcomes for the patient. Given the prognostic value of the assay, according to Molecular MD's Chief Operating Officer Stephane Wong, once a patient's BCR-ABL levels rise above 0.1 percent, "you should as quickly as possible change their treatment because probably the treatment is not working well and they should be put on a different regimen to minimize the chances of developing additional mutations that may be difficult to treat.” The consistency of Molecular MD's test is a boon to physicians making decisions about patient treatment. A reliable test to monitor BCR-ABL has turned out to be both an important model for diagnostic test development and a critical component of the success of Molecular MD, whose revenues are driven by BCR-ABL testing.

The marketing and startup of Molecular MD has been a successful partnership between the OHSU scientific founders and investment and startup management company BioCatalyst International.

According to Druker, the partnership with Biocatalyst was crucial to launching Molecular MD. "Having a single investor whose goal is to help set up biotech companies made this opportunity possible. If I'd thought about setting up a biotech company on my very own and doing all the hiring, financing, and operations, I couldn't do it.” Druker describes the relationship as a perfect marriage of his scientific expertise and BioCatalyst's business acumen.

There is similar feeling in the company. Stephane Wong, chief operating officer of Molecular MD, cites the key role of OHSU and Brian Druker in the founding of the company. "OHSU was instrumental in providing us not only with the skill set of Brian, but his discoveries in BCR-ABL, that have enabled our company to be launched.”

Launching Molecular MD was a major effort that has succeeded due to the fortuitous coincidence of solving an unmet need just as demand for that solution increases. At the time when Druker developed a reproducible BCR-ABL assay to help doctors treat CML, a number of large pharmaceutical companies were entering the final stages of clinical trials of drugs related to the successful drug Gleevec. ”Pharmaceutical companies when they're in phase III of testing, they need to have a reliable standardized assay. Obviously, the way the FDA is going to determine if a treatment is efficacious or not is if the test results are believable and sufficiently sensitive,” according to Wong. In this way, the commercialization of BCR-ABL testing allows for better assessment of drugs targeting the mutant gene.

Increased drug efficacy and better patient care are at the heart of all OHSU's 2007 startup companies. By bringing biomedical advances to the public, OHSU and its researchers are returning the public's investment. As summarized by Stephen Hanson, scientific founder of Cylerus, "major medical research universities in the country have received enormous support from federal agencies like the National Institutes of Health, and one way we repay that is by getting things out there that will benefit the country medically and economically.”

Sara Selgrade recently received a Ph.D. in genome sciences from the University of Washington.