Health Affairs, 23, no. 1 (2004): 64-76 doi: 10.1377/hlthaff.23.1.64 © 2004 by Project HOPE	New Online   Pay Cuts For Medicare Docs   Access To Care Woes   Public Coverage More Efficient   Empowering Consumers

This Article Abstract Figures Only Reprint (PDF) Submit a response to this article Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Add to My Personal Archive Download to Citation Manager Reprints & Permissions Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (7) Citing Articles via Google Scholar Google Scholar Articles by Campbell, E. G. Articles by Biles, B. Search for Related Content PubMed PubMed Citation Articles by Campbell, E. G. Articles by Biles, B. Related Collections Pharmaceuticals Research And Technology

Environment

Inside the Triple Helix: Technology Transfer And Commercialization In The Life Sciences

Abstract

 
The transfer and subsequent application of academic research results has demonstrable benefits for health care, researchers, universities, companies, and local economies. Nonetheless, at least three general concerns exist: bias in the reporting of results, limited revenues from these activities, and the lack of data to evaluate technology transfer activities. Future efforts with regard to technology transfer in the life sciences will need to recognize its importance without ignoring concerns or overestimating benefits. Next steps include better monitoring of university–industry relationships, the development of a better data system, the dissemination of best practices in technology transfer management, and evaluation of national technology-transfer policies.

The process by which the public’s expectations are met is commonly referred to as technology transfer, defined broadly as the sharing and dissemination of scientific knowledge between researchers and research organizations and those who can make practical use of the information, including physicians, health care providers, and industry.⁴ Commercialization occurs when scientific findings are put to practical use in the form of new health care products (prescription drugs and medical devices). In the life and health sciences, the conversion of research findings into new medical applications is referred to as going "from bench to bedside."

In recent years many findings from biomedical research have moved into widespread use in medicine. The rate of use of sophisticated medical procedures is now greater in the United States than in any other country and likely plays a major role in increased U.S. health care spending.⁵ At the same time, concerns exist regarding the potential for increased development of commercial products, especially prescription drugs, based on the national investment in life-sciences research at academic institutions.⁶ Of interest are the set of innovative drugs classified by the U.S. Food and Drug Administration (FDA) as priority new molecular entities (PNMEs)—the types of drugs most likely to originate from academic research.⁷ Since 1990 the number of PNME approvals has remained essentially constant at twelve per year, on average. At the same time, PNMEs declined from 19 percent to 9 percent of all drug approvals, while the NIH budget increased by more than 200 percent (Exhibit 1).

View larger version (19K): [in this window] [in a new window]   EXHIBIT 1 Priority New Molecular Entities (PNMEs) Per Total Drug Approvals Versus Change In National Institutes Of Health (NIH) Budget, 1990–2002

This trend also could be related to the ineffective transfer of technology between the academic and industrial sectors. University policies and practices might not adequately encourage collaboration with industry, and industry might not be fully aware of new innovations emerging from academic institutions.

This paper examines the current status of the technology transfer and commercialization processes and potential requirements for optimizing the exchange of new knowledge in the life sciences between academe and industry. In particular, we explore (1) the mechanisms of technology transfer and commercialism in academic institutions; (2) the importance of technology transfer and commercialization; (3) concerns regarding technology transfer and commercialization in biomedical science; and (4) the management and policy options to enhance technology transfer.

Mechanisms Of Technology Transfer And Commercialism

Top Editor's Notes Mechanisms Of Technology... Importance Of Technology... Concerns About Technology... Opportunities To Improve... Notes

 
The mechanisms by which university science is transferred to the commercial sector include general knowledge dissemination, university-industry relationships (UIRs), and commercialization activities.

General dissemination of knowledge. Academic scientists routinely communicate their research findings to the scientific community and to the general public. The most common mechanism is publication in the professional literature. This form of technology transfer is growing, especially in the life and health sciences, which in 1999 accounted for 60 percent of all scientific and engineering articles. The number of articles published in peer-reviewed journals included in the clinical medicine, biomedical research, and health sciences section of the Science Citation Index (SCI) grew by 17.5 percent from 1987 to 1999 (Exhibit 2).⁹ Additional outlets include professional conference presentations, continuing medical education courses for physicians, informal personal discussions/conversations, and the graduation of new scientists. Scientific research is also beginning to be published and distributed via the Internet through organizations such as BioMed Central.

View larger version (16K): [in this window] [in a new window]   EXHIBIT 2 Number Of Articles Published In Professional Journals In Medicine And The Health Sciences (In The Science Citation Index), 1987–1999

In the early 1990s more than 90 percent of life-science companies participated in some form of UIR, with the most prevalent being the retention of university faculty as consultants.¹² In addition, 59 percent of surveyed firms sponsored 1,500 campus-based research projects at a cost of more than $340 million. Based on these reports, it was estimated that the life-science industry as a whole supported more than 6,000 research projects and spent $1.5 billion for university-based research in the life sciences.

Data on industry-sponsored research on university campuses suggest that these relationships tend to be small in size and short in duration. Industry executives estimate that 71 percent of industry-funded research projects from 1994 to 1995 were funded at less than $100,000 a year. Only 6 percent of life-science firms provided annual funding of $500,000 or more. Further, the typical relationship lasted two years or less.

However, some relationships can be quite extensive. One example of a large-scale UIR is an agreement between the Massachusetts General Hospital (MGH) and a German drug company, Hoechst A.G. Hoechst funded not only research at the MGH, but also the creation of a new department of genetics and the construction of a research building. Other similar relationships existed between, among others, Harvard Medical School and Dupont; the Washington University and Monsanto; Yale University and Bristol-Myers Squibb; and the University of California, Berkley, and Novartis.¹³

Commercialization activities. From 1991 to 2000 commercialization activities at universities increased significantly (Exhibit 3). Invention disclosures to university technology-transfer offices increased 79 percent, from 4,063 to 7,253; patent applications increased 253 percent, from 1,033 to 3,643; patents granted increased 131 percent, from 1,118 to 2,581; and licenses executed increased 158 percent, from 907 to 2,343. The number of start-up company formations also increased 92 percent, from 145 in 1994 to 278 in 2000 (data not shown).

View larger version (24K): [in this window] [in a new window]   EXHIBIT 3 Commercialization Activities At Universities: Invention Disclosures, New Patent Applications, Patents Granted, And Licenses Executed, 1991–2000

Technology-transfer offices have grown in recent years. Between 1992 and 2000 the number of professional licensing staff devoted to technology transfer in universities doubled. At the same time, the ratio of such professionals to total research spending declined, from approximately one per $187 million to one per $59 million, which indicates a sizable increase in universities’ interest in commercializing their research output.¹⁴

Importance Of Technology Transfer And Commercialization

Top Editor's Notes Mechanisms Of Technology... Importance Of Technology... Concerns About Technology... Opportunities To Improve... Notes

 
The transfer and commercialization of the findings of life-sciences research has demonstrable benefits for health care, the productivity of university researchers and their institutions, and local economic development.

Improvements in health care. Americans have benefited greatly from research in the life and health sciences. The evidence is especially strong in the area of cardiovascular disease, but persuasive cases have been made for treatment of diabetes, specific cancers, degenerative joint disease, and mental illness as well.¹⁵

Many important discoveries can be traced to university-based biomedical research. An analysis of U.S. industry patent citations found that researchers in academic institutions authored half of all papers referenced on drug patents between 1993 and 1994.¹⁶ Another study estimated that 27 percent of new products and 29 percent of new processes commercialized by drug companies in the 1980s would have encountered long delays in development were it not for academic research.¹⁷

Increased research productivity. Findings from a 1994–95 survey of more than 2,000 life-science faculty found that those with industry funding published many more articles in peer-reviewed journals than faculty without industry funding.¹⁸ Although it is not possible to determine a causal relationship between industry funding and increased productivity, there are at least two potential explanations for this relationship. It may be that industry funds scientists who are already more productive, or that industry funding provides additional resources to faculty, which in turn increases their productivity.

Faculty might benefit from increased publications, since publications represent one of the main criteria by which faculty are promoted, receive tenure, and obtain research grants and prizes.¹⁹ At an institutional level, more publications by faculty can translate into greater prestige and, perhaps, an increased ability to attract top faculty and future research funding.

Industry-sponsored research is also associated with an increased likelihood of commercialization activity among faculty and institutions (Exhibit 4). A 1996 survey found that compared to faculty without industry support, those with industry funding were much more likely to have applied for a patent, had a patent granted or licensed, had a product under review or on the market, or started a company.²⁰ It could be that industry seeks out scientists who are commercially inclined or that the problems on which industry-funded scientists work are more commercially focused than work undertaken by non-industry-funded scientists.

View larger version (23K): [in this window] [in a new window]   EXHIBIT 4 Commercialization Activities By Life-Sciences Faculty With And Without Academic–Industry Research Relationships, 1996

Local economic development. Technology transfer can have a substantive impact on regional economies. University researchers and their institutions played a seminal role in the establishment of local high-technology industries in a number of scientific fields, including biotechnology. For example, scientists at the Massachusetts Institute of Technology (MIT), Harvard University, Stanford University, and the University of California have played pivotal roles in founding local electronics and biotechnology companies such as Raytheon, Data General, Digital Equipment Corporation, Genetics Institute, Biogen, and Genentech.²¹

In turn, the development of these industries has created high-paying technical and professional jobs, increased tax revenues, and increased the inflow of venture capital and other research-related services. For example, it has been estimated that MIT graduates have founded 4,000 firms which, in 1994 alone, employed at least 1.1 million people and generated $232 billion in sales.²²

Concerns About Technology Transfer And Commercialization

Top Editor's Notes Mechanisms Of Technology... Importance Of Technology... Concerns About Technology... Opportunities To Improve... Notes

 
Bias in the reporting of research. Data suggest that research funding from industry is associated with reports favorable to industry sponsors. For example, research concerning the effects of UIRs on the outcome of studies of the efficacy and safety of calcium-channel antagonists in treating cardiovascular disorders suggests that these relationships could alter the outcome of science.²³ Between March 1995 and September 1996 more than seventy studies were published that were supportive, neutral, or critical regarding the safety and efficacy of using these compounds in a clinical setting. Henry Stelfox and colleagues surveyed the authors of these studies about their relationships with the companies that produced either the antagonists or competing products. They found that 96 percent of authors whose research was supportive of the use of calcium-channel antagonists had financial relationships with companies that produced them, compared with only 60 percent of those whose findings were neutral and 37 percent of those whose findings were critical. A recent literature review found eleven studies also concluding that industry-sponsored research tends to yield industry-friendly conclusions.²⁴ Similar bias was found in published cost-effectiveness analyses of new oncology drugs.²⁵

Bias in the reporting of results has the potential to damage the careers of individual scientists, mislead the work of other scientists, and damage the reputations and public images of individual universities. Derek Bok, the former president of Harvard University, suggested that such bias could ultimately undermine academe’s reputation for objectivity, which in turn could jeopardize the public’s generous support of research; this support is predicated in part on the belief that the results of research represent faculties’ best efforts to detect the truth, untainted by commercial interests.²⁶

Limited revenues. A second concern is that technology transfer produces limited revenues for most universities. Of the total $1.7 billion in licensing revenues earned by the 140 respondents to the 1999–2000 annual survey of the Association of University Technology Managers (AUTM), the top ten income-producing universities generated $1 billion, or 60 percent of all licensing revenues (Exhibit 5). Furthermore, the bulk of the top ten’s licensing income derived from a small number of highly lucrative licenses. Examples include the hepatitis B vaccine at the University of California, San Francisco; Taxol at Florida State University; Gatorade at the University of Florida; Cisplantin at Michigan State University; and vitamin D technologies at the University of Wisconsin.

View larger version (21K): [in this window] [in a new window]   EXHIBIT 5 Cumulative Distribution Of Licensing Income Among Universities, 1999 And 2000

Although no studies have directly investigated the cost-effectiveness issue, data suggest that many universities might be spending more on technology transfer than they receive in revenues from such activities. For example, more than 20 percent of respondents in the 2000 AUTM survey, for which full data were available, spent more on just one expense—patenting-related legal fees—than they received in licensing income for the entire year. More than half received less than $1 million in revenues above their legal fees. Since a sizable portion of licensing revenues consists of running royalties, a percentage of which by law must be paid out to faculty inventors for federally funded studies (institutional policies are generally in the 30–50 percent range of royalties received), even institutions in this group might have to subsidize their technology-transfer programs from other sources.²⁸

Lack of data to evaluate and improve technology transfer activities. There are no systematic national data regarding technology transfer and commercialization in the life and health sciences. Although technology-transfer data are collected by professional associations, the federal government, and independent researchers, the data are not specific to the life and health sciences, are often not comprehensive, and fail to capture the broader economic impact of university technology transfer. The lack of data makes it difficult or impossible to establish best practices for technology transfer, to evaluate policies and management practices, to perform comparative analyses between institutions, or to examine the impacts of external market changes on the technology-transfer function of universities.

The extent to which data are needed can be illustrated by comparison with the field of health services research. The systematic collection and analysis of data on clinical practice patterns have documented and confirmed long-suspected problems in patient safety, racial disparities in health care, and quality of care.²⁹

Opportunities To Improve Management and Policy

Top Editor's Notes Mechanisms Of Technology... Importance Of Technology... Concerns About Technology... Opportunities To Improve... Notes

 
Monitor and manage university-industry relationships. In modern science, UIRs are a fact of life. However, it is imperative to recognize and address the risks of these relationships. A number of professional groups have begun to grapple with improving the management of the university–industry interface, including the Association of American Medical Colleges (AAMC), Association of American Universities (AAU), and Pharmaceutical Research and Manufacturers of America (PhRMA).³⁰ These activities should be encouraged and evaluated for their effectiveness.

In monitoring and managing UIRs, an increasing number of universities require all faculty and senior administrators to regularly disclose financial relationships with companies that have life sciences or health care interests. These disclosures should be reviewed carefully and confidentially by academic managers. Disclosure constitutes the minimal acceptable response of academic institutions to the demonstrated risks posed by UIRs, since it is impossible for academic institutions to learn from their experience with UIRs if they do not know they exist.³¹

Beyond disclosure, academic institutions should develop explicit policies for deciding which UIRs are desirable and which are not. There is no current consensus regarding the acceptability of certain forms of UIRs. For example, some universities might prohibit research involving living human subjects on the part of investigators with major financial interests in companies that could benefit from the results of that research, while other universities allow such relationships but require that they be closely monitored. The AAMC’s recent guidelines on individual and institutional conflicts of interest constitute valuable guidance.

In addition, individual scientists and the broader scientific community should be mindful of UIRs’ potential to bias the reporting of some scientific findings. Disclosure of the source of research support that is required by most scientific journals and peer review for publications and for presentations at scientific meetings constitute minimal protection against such bias and could be a form of best practices in management of UIRs. Further, universities should guard against the potential for conflicts of interest when senior faculty or administrators have relationships with companies that could bias major operational decisions such as the acquisition of a particular vendor’s high-tech equipment.

Improve the data system for technology transfer. Having better data is critical to understanding the strengths, weaknesses, costs, and outcomes of the nation’s technology transformation process in the life and health sciences. Work to improve data on technology transfer would respond to the recommendation by the President’s Council of Advisors on Science and Technology to develop a set of metrics to better quantify technology-transfer practices and their effectiveness.³²

The new data system should provide information at both the individual institution and national levels regarding the structure of university activities, the elements of the process of technology transfer, and the key outcomes of commercialization. Specific areas in which better information could be provided include cooperative activities between research organizations and the private sector, the use of university facilities, and personnel exchange programs. In addition, other forms of data that could be regularly collected include institutional policies and practices regarding UIRs, royalty-sharing policies, average time from option to license, and time to various product or firm milestones.

Development of such a data system could be led by a collaborative working group consisting of university officials, scientists, economists, biotech firm executives, investors, and experts and researchers on the technology transfer process. It could be housed and maintained in an organization such as the AUTM, the American Association of the Advancement of Science, or the AAU. The AAMC already collects a wide range of data related to medical school and hospital finances, medical school faculty, and medical education. Support for the new data system could come from various sources, including dues that organizations pay to belong to a professional association, contributions from industry, and grants from independent foundations.

Develop and disseminate best practices. Very little is known regarding best practices in academic technology transfer. Examples of topics in which best practices could be investigated include the modeling of specific aspects of the technology-transfer processes; defining measures of success for both processes and outcomes of technology transfer; and identifying different approaches to technology transfer that yield specific outcomes such as the use of exclusive versus nonexclusive licenses.³³

Additionally, best-practices research could focus on the central elements of successful technology transfer driven by research results, including the organization, costs, and management of a technology-transfer office; the identification and assessment of intellectual property and decisions on intellectual property; and the use of incentives for researchers’ involvement in technology transfer. Universities should also be encouraged to share their experiences with management of conflicts of interest created by UIRs, experiences with negotiating protections from restrictive industry covenants, and other matters pertinent to protecting the scientific environment in universities.

Funding for best-practices research could come from a number of sources. Examples of federal agencies that could support this include the NIH, the National Science Foundation, the Department of Commerce, the Department of Energy, and the Agency for Healthcare Research and Quality. Additional funding could come from industry trade organizations and nonprofit foundations.

Evaluate key aspects of national technology-transfer policies. By most measures, the Bayh-Dole Act of 1980 has stimulated a substantial acceleration in the patenting and licensing of university-developed technologies, a trend that continues to this day. A recent article in the Economist referred to the Bayh-Dole Act as the "golden goose of innovation."³⁴

A key concept underlying Bayh-Dole was that exclusive licenses are an important incentive for the development of a technology. Some argue, however, that the patenting and exclusive licensing of basic technologies in the life sciences could in fact restrict future innovation, and some even suggest that it serves as a tax on innovation, since using these technologies often involves fees and complex material-transfer agreements.³⁵ Some examples of basic technologies with pharmaceutical implications are the patenting and exclusive licensing of stem-cell lines and DNA sequences. The counterargument is that patenting and exclusive licensing of even basic technologies is essential, since the development time horizons are so long and adequate incentives to develop high-risk technologies thus are needed.

Examples of other policy-relevant questions include the following: (1) Should federal march-in rights provided for under Bayh-Dole be used to extract lower drug prices from drug companies?³⁶ (2) Should basic technologies such as DNA sequences, protein structures, and disease pathways be patented, and, if so, would it be best to do so in a nonexclusive manner? Unfortunately, empirical evidence to address these and other questions is largely nonexistent. The best source of data, collected by federal agencies from universities about their technology-transfer activities stemming from federal research and development (R&D) support, is in disarray and difficult to use for the tracking of innovations into the marketplace.³⁷

Evaluation of key technology-transfer policies could be performed by individual researchers or an independent commission comprising biomedical scientists, university officials, technology-transfer administrators, biotechnology and pharmaceutical firm executives, the investment community, former NIH and FDA officials, lawyers, and researchers on science and the economy. The Commonwealth Fund Task Force on Academic Health Centers serves as an example of a commission that has performed similar analyses.³⁸

The national investment of public funds in life-sciences research represents an implicit social contract in which the public receives new and better commercial products and services. Because funding from the NIH for life-sciences research has doubled in the past five years, technology transfer and commercialization in the life and health sciences has a great potential to contribute to improvements in human health and care. However, major challenges remain.

Addressing existing concerns will require national efforts in monitoring university–industry relationships, developing better data, disseminating best practices in management, and evaluating major national policies. If efforts in these and related areas are carefully designed, cognizant of the risks, and sustained over the next decade, the benefits of academic-based life-sciences research could be increased through effective technology transfer. Failure in this area could cause the nation’s huge investment in university research to fall short of its full potential.

Editor's Notes

Top Editor's Notes Mechanisms Of Technology... Importance Of Technology... Concerns About Technology... Opportunities To Improve... Notes

 
Eric Campbell is an assistant professor at Harvard Medical School, where David Blumenthal is a professor of medicine and health policy. Joshua Powers is an assistant professor and coordinator of the Ph.D. Program in Higher Education Leadership, Department of Educational Leadership, School of Education, Indiana State University, in Terre Haute. Brian Biles is a professor of health policy in the George Washington University Department of Health Policy, Washington, D.C.

Support for the investigators was provided by the Ewing Marion Kauffman Foundation in Kansas City, Missouri. The authors acknowledge the contributions of the Foundation’s Panel of Advisors on the Life Sciences and staff. The Foundation has asked the Panel to explore ways to accelerate opportunities for life sciences entrepreneurship. Panel members include Carl Schramm, CEO, Ewing Marion Kauffman Foundation; Solomon Snyder, professor of medicine, the Johns Hopkins University; Michael Johns, director, the Robert Woodruff Health Sciences Center at Emory University; James Mongan, president and CEO, Partners HealthCare System; and James Utaski, founding partner, Whitestone Capital LLC. Information on the foundation’s Technology Transfer and Commercialization initiative is available at www.kauffman.org.

Notes

Top Editor's Notes Mechanisms Of Technology... Importance Of Technology... Concerns About Technology... Opportunities To Improve... Notes

 

1. Commonwealth Fund Task Force on Academic Health Centers, Bench to Bedside: The Current Status of Research at Academic Health Centers (New York: Commonwealth Fund, 1999), 11.
2. Office of Management and Budget, Budget of the United States Government, Fiscal Year 2003 (Washington: OMB, 2002), 144; and National Institutes of Health, "NIH Almanac—Appropriations, Section 1," www.nih.gov/about/almanac/appropriations/index.htm (16 October 2003).
3. S.A. Schroeder, J.S. Zones, and J.A. Showstack, "Academic Medicine as a Public Trust," Journal of the American Medical Association 262, no. 6 (1989): 803–812.[Abstract]
4. PCAST Subcommittee on Federal Investment in Science and Technology, "Draft Summary Report: Technology Transfer of Federally Funded R&D" (Washington: President’s Council of Advisors on Science and Technology, 2003).
5. U.E. Reinhardt, P.S. Hussey, and G.F. Anderson, "Cross-National Comparisons of Health Systems Using OECD Data, 1999," Health Affairs (Mar/Apr 2002): 169–182; R.A. Rettig, "Medical Innovation Duels Cost Containment," Health Affairs (Fall 1994): 7–28; and J.P. Newhouse, "An Iconoclastic View of Health Cost Containment," Health Affairs (Supplement 1993): 152–171.
6. U.S. General Accounting Office, Technology Transfer: NIH–Private Sector Partnership in the Development of Taxol, Pub. no. GAO-03-829 (Washington: GAO, 2003).
7. A.S. Relman and M. Angell, "America’s Other Drug Problem," New Republic (16 December 2002): 27–41.
8. A. Pollack, "Three Universities Join Researcher to Develop Drugs," New York Times, 31 July 2003.
9. CHI Research, unpublished data from analysis of the Science Citation Index, 2001.
10. D. Blumenthal et al., "Relationships between Academic Institutions and Industry in the Life Sciences—An Industry Survey," New England Journal of Medicine 334, no. 6 (1996): 368–373[Abstract/Free Full Text]; and D. Blumenthal et al., "Participation of Life Science Faculty in Research Relationships with Industry," New England Journal of Medicine 225, no. 23 (1996): 1734–1739.
11. D. Blumenthal, "Academic–Industry Research Relationships in the Life Sciences: Extent, Consequences, and Management," Journal of the American Medical Association 268, no. 23 (1992): 3334–3339.
12. Blumenthal et al., "Relationships between Academic Institutions and Industry."
13. N. Bowie, University–Business Partnerships: An Assessment (Lanham, Md.: Rowan and Littlefield, 1994).
14. Data from the annual survey of the Association of University Technology Managers.
15. D.M. Cutler and M. McClellan, "Is Technological Change in Medicine Worth It?" Health Affairs (Sep/Oct 2001): 11–30; and V.R. Fuchs and H.C. Sox, "Doctors’ Views on Thirty Medical Innovations," Health Affairs (Sep/Oct 2001): 30–43.
16. F. Narin, K.S. Hamilton, and D. Olivastro, "The Increasing Linkage between U.S. Technology and Public Science," Research Policy 26, no. 3 (1997): 317–330.[CrossRef]
17. E. Mansfield, "Academic Research and Industrial Innovation," Research Policy 20, no. 1 (1991): 1–12.[CrossRef]
18. Blumenthal et al., "Participation of Life Science Faculty."
19. M.F. Fox, "Publication, Performance, and Reward in Science and Scholarship," in Higher Education: Handbook of Theory and Research, vol. 1, ed. J.C. Smart (New York: Agathon Press, 1985), 255–282.
20. Blumenthal et al., "Participation of Life Science Faculty."
21. H. Etzkowitz, "The Making of an Entrepreneurial University: Traffic among MIT, Industry, and the Military, 1860–1960," in Science, Technology, and the Military, ed. E. Mendelsohn, M.R. Smith, and P. Weingart (New York: Kluwer Academic Publishers, 1988), 515–540; H. Etzkowitz and L. Peters, "Profiting from Knowledge: Organizational Innovations and the Evolution of Academic Norms," Minerva (Summer 1991): 133–166; and N.S. Dorfman, "Route 128: The Development of a Regional High-Technology Economy," Research Policy 12, no. 6 (1983): 299–316.[CrossRef]
22. Massachusetts Institute of Technology, "MIT: The Impact of Innovation: A Special Report of the BankBoston Economics Department," 18 September 2003, web.mit.edu/newsoffice/founders/summary.html (16 October 2003).
23. H.T. Stelfox et al., "Conflict of Interest in the Debate over Calcium-Channel Antagonists," New England Journal of Medicine 339, no. 2 (1998): 101–106.
24. J.E. Bekelman, Y. Li, and G.P. Cross, "Scope and Impact of Financial Conflicts of Interest in Biomedical Research," Journal of the American Medical Association 389, no. 4 (2003): 454–459.
25. M. Friedberg et al., "Evaluation of Conflict of Interest in Economic Analyses of New Drugs Used in Oncology," Journal of the American Medical Association 282, no. 15 (1999): 1453–1457.[Abstract/Free Full Text]
26. Bowie, University–Business Partnerships.
27. I. Feller, "Technology Transfer from Universities," in Higher Education: Handbook of Theory and Research, vol. 9, ed. J.C. Smart (New York: Agathon Press, 1997), 1–42.
28. G. Graff, A. Heiman, and D. Zilberman, "University Research and Offices of Technology Transfer," California Management Review 45, no. 1 (2002): 88–115.
29. Institute of Medicine, To Err Is Human: Building a Safer Health System (Washington: National Academies Press, 2000); IOM, Crossing the Quality Chasm: A New Health System for the Twenty-first Century (Washington: National Academies Press, 2001); and IOM, Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (Washington: National Academies Press, 2002).
30. Association of American Universities, Report on Individual and Institutional Conflicts of Interest (Washington: AAMC, 2001).
31. Ibid.; and GAO, HHS Direction Needed to Address Financial Conflicts of Interest, Pub. no. GAO-02-89 (Washington: GAO, November 2001).
32. PCAST Subcommittee on Federal Investment in Science and Technology, "Draft Summary Report."
33. RAND, Technology Transfer of Federally Funded R&D (Santa Monica, Calif.: RAND, 2003), 58.
34. "Innovation’s Golden Goose," Economist (12 December 2002).
35. A.K. Rai and R.S. Eisenberg, "Bayh-Dole Reform and the Progress of Biomedicine," American Scientist (Jan–Feb 2003): 52–59.
36. A 27 March 2002 Washington Post article by Peter Arno and Michael Davis suggested that federal march-in rights provided under the Bayh-Dole Act be used extract cheaper prices for drugs developed from government-supported research. P. Arno and M. Davis, "Paying Twice for the Same Drugs," Washington Post, 27 March 2002. In a rebuttal, former Senators Birch Bayh (D-IN) and Robert J. Dole (R-KS) strongly rejected this proposal by saying, "Bayh-Dole did not intend that government set prices on resulting products. The law makes no reference to a reasonable price that should be dictated by the government. This omission was intentional; the primary purpose of the act was to entice the private sector to seek public-private research collaboration rather than focusing on its own proprietary research...The ability of the government to revoke a license granted under the act is not contingent on the pricing of a resulting product or tied to the profitability of a company that has commercialized a product that results in part from government-funded research. The law instructs the government to revoke such licenses only when the private industry collaborator has not successfully commercialized the invention as a product." B. Bayh and B. Dole, "Former Senators Defend Their Law," 11 April 2002, www.autm.net/news/senators.html (16 October 2003).
37. GAO, Intellectual Property: Federal Agency Efforts in Transferring and Reporting New Technology, Pub. no. 03-47 (Washington: GAO, 2002).
38. See the Commonwealth Fund Web site, www.cmwf.org.

                      What's this?

This article has been cited by other articles:

				S. D. Brown, J. C. Daly, L. A. Kalish, and S. A. McDaniel Financial Disclosures of Scientific Papers Presented at the 2003 RSNA Annual Meeting: Association with Reporting of Non-Food and Drug Administration-approved Uses of Industry Products Radiology, June 1, 2006; 239(3): 849 - 855. [Abstract] [Full Text] [PDF]

				G. K. Sobolski, J. H. Barton, and E. J. Emanuel Technology Licensing: Lessons From the US Experience JAMA, December 28, 2005; 294(24): 3137 - 3140. [Full Text] [PDF]

				G. K. Sobolski Biotechnology Products and University-Based Science JAMA, June 15, 2005; 293(23): 2862 - 2862. [Full Text] [PDF]