New Research Uncovers Crucial Role of Public-Sector Research in Drug Discovery
New work from Boston University School of Management’s Ashley J. Stevens, D.Phil, co-authored by colleagues from across the University and the National Institutes of Health, has illuminated how public-sector research has had a more profound effect on improving public health than previously realized, most notably in the realm of drug discovery.
Stevens is a lecturer and Senior Research Associate at the School’s Institute for Technology Entrepreneurship and Commercialization (ITEC), as well as Special Assistant to the Vice President for Research at Boston University.
His article “The Role of Public-Sector Research in the Discovery of Drugs and Vaccines”* appeared recently in The New England Journal of Medicine and was co-authored by Jonathan J. Jensen (Boston University School of Management alumnus), Katrine Wyller (previous School of Management Technology Transfer Fellow), Patrick C. Kilgore, Sabarni Chatterjee, and Mark L. Rohrbaugh (National Institutes of Health).
153 new FDA-approved drugs, vaccines, or indications for existing drugs were discovered by PSRIs (four of which can be credited to current or former Boston University researchers).
Bayh-Dole and the Federal Technology Transfer Act
Stevens and his colleagues traced the impact on public health of two U.S. laws: the Bayh–Dole Act of 1980, allowing universities, nonprofit research institutes, and teaching hospitals to own the intellectual property resulting from federally funded research and license it according to terms of their choosing; and the Stevenson–Wydler Technology Innovation Act as amended by the Federal Technology Transfer Act of 1986, extending the same authority to federal laboratories.
These acts enabled studies conducted at public-sector research institutes (PSRIs)–universities, research hospitals, nonprofit research institutes, and federal laboratories–in the United States to be freely published in the scientific literature, and also converted into intellectual property and transferred, through license agreements, to the private sector, enabling its commercialization and public use.
New Discoveries about Drug Discovery
The authors, exploring the impact of these acts three decades on, found that 153 new FDA-approved drugs, vaccines, or indications for existing drugs were discovered through studies carried out by PSRIs (four of which can be credited to current or former Boston University researchers).
They also found that PSRIs tend to discover drugs that have a disproportionately important clinical impact. “Slightly over half of these drugs were for the treatment or prevention of cancer or infectious diseases,” Stevens explains. “Furthermore, drugs discovered by PSRI’s received Priority Review by the FDA at twice the rate as for all FDA drug approvals, indicating that PSRI discovered drugs were expected to have a disproportionately high therapeutic impact.”
“Slightly over half of these drugs were for the treatment or prevention of cancer or infectious diseases; Drugs discovered by PSRI’s received Priority Review by the FDA at twice the rate as for all FDA drug approvals.”
As he and his colleagues write, “Our data show that PSRIs have contributed to the discovery of 9.3 to 21.2% of all drugs involved in new-drug applications approved during the period from 1990 through 2007.”
The paper has had broad influence since its publication, being widely cited in the media and heavily quoted by policy makers in Washington noting the significant economic spillover from federal investments in basic science. Recently, Francis Collins, director of the National Institutes of Health, cited the study in his explanation of the NIH’s proposed 2012/13 budget.
Ultimately, Stevens comments, “we believe that our study supports the concept that the emergence of biotechnology in the mid-1970s, combined with policy changes implemented in the early 1980s regarding the ownership and management of the intellectual property of PSRIs, allowed–and will continue to allow–these institutions to play an important role in the downstream, applied phase of drug discovery.”
*“The Role of Public-Sector Research in the Discovery of Drugs and Vaccines,” Ashley J. Stevens, D.Phil., Jonathan J. Jensen, M.B.A., Katrine Wyller, M.B.E., Patrick C. Kilgore, B.S., Sabarni Chatterjee, M.B.A., Ph.D., and Mark L. Rohrbaugh, Ph.D., J.D., The New England Journal of Medicine, February 20, 2010.