By Dr. Stephen Prescott
Copyright © 2017, The Oklahoma Publishing Co.
Licensing. For the Oklahoma Medical Research Foundation, that means taking a discovery we’ve made and giving a partner in the private sector the right to develop and commercialize that discovery.
Until the 1980s, for the vast majority of research we did at OMRF — or that took place at the University of Oklahoma Health Sciences Center and other academic medical centers around the country — this was impossible.
You see, most biomedical research that occurs in academic and nonprofit settings is funded in part by the federal government, primarily through the National Institutes of Health. And, historically, when a researcher working on a federally funded project at an institution like OMRF or OUHSC made a discovery, that pretty much spelled the end of the road for any potential commercialization of that work.
What technically happened was that the biomedical researchers assigned their inventions to the federal government, and then the federal government had the right to develop and commercialize those inventions. But what actually happened was nothing. Of all the biomedical inventions assigned to the government, not a single one ever became a drug.
Recognizing that this system was broken, in 1980, President Jimmy Carter signed the Bayh-Dole Act into law. Bayh-Dole gave institutions like OMRF and OUHSC, rather than the government, the right to take ownership of inventions that had been backed by federal funding. With that right to take ownership came the right to pursue commercialization opportunities.
On its surface, Bayh-Dole sounds inequitable. The government pays institutions to make discoveries, then the institutions get to reap the benefits of that work.
But under the old regime, the government reaped no benefits; it failed to transform a single discovery into a health care product that reached hospitals and clinics. And, more importantly, neither did America’s patient population, which saw no therapeutic benefit from all the tax dollars invested in research.
Luckily, Bayh-Dole erased that track record of futility. Since the law was enacted, federally funded research at academic and nonprofit institutions has given birth to more than 200 vaccines and drugs that reached the market. Among those are three different medications born at OMRF.
Each time one of those therapies makes it to market, the institution where it was born gets a small royalty share of the sales. Typically — and this has been the case for OMRF — these are not eye-popping numbers, usually in the 2 percent range. Those dollars, though, don’t represent a windfall to the institution; instead, they go right back into labs, funding additional research.
This system has helped diversify and stabilize the research funding base at institutions like OMRF. While small relative to our overall research budget, these additional dollars from commercial sources do help protect against the ever-shifting winds of federal funding.
A report this summer from the Biotechnology Innovation Organization and Association of University Technology Managers underscores what a powerful economic engine this system has become. The report found that over the past two decades, licensing by academic and nonprofit institutions to industry has contributed $1.3 trillion to the U.S. economy and supported up to 4.2 million American jobs.
Of course, as with all economic impact reports produced by an organization looking to trumpet its own virtues, this one is no doubt a bit hyperbolic. But the hard statistics that underlie it speak volumes.
More than 1,000 new companies spun out of universities and nonprofits in 2015, the last year covered by the report. In that same year, these institutions filed for nearly 16,000 patents. Each of these figures represented a significant gain over the previous year and the continuation of a long upward trend.
Moreover, patenting and licensing activities also serve as the seeds for new research collaborations with industry. Last month saw a perfect example of one such partnership at OMRF.
We entered into a collaboration agreement with GSK, one of the world’s leading health care companies, for the discovery, development and commercialization of novel therapies to prevent organ damage and death caused by conditions such as acute pancreatitis, lung injury and trauma. The collaboration is part of GSK’s Discovery Partnerships with Academia initiative, which, as you might expect, is focused on teaming academic and industry scientists to develop innovative medicines.
Led by Dr. Charles Esmon, our scientists will work on research projects to develop new treatment strategies for a variety of illnesses and injuries. If that work results in a promising breakthrough, GSK will spearhead the process of transforming that new insight into a therapy to treat patients.
Like every lab-based project, the odds are long that this one will result in a new drug. The most commonly cited figure says that for every 10,000 compounds developed in the lab, only one makes it to the market. Still, Dr. Esmon has a remarkable track record; his work has resulted in two different drugs that received FDA approval.
Whatever the ultimate outcome of this project, it’s clear that academic and nonprofit partnerships with industry are here to stay. Working together has given an important boost to research — and vastly improved the treatment landscape for patients.
A physician and medical researcher, Dr. Stephen Prescott is president of the Oklahoma Medical Research Foundation and can be reached at [email protected].