Careers in Clinical Research Obstacles and Opportunities (1994) / Chapter Skim
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Academic-Industry Relationships
Academic-Industry Relationships
Pages 197-218
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From page 197... ...
Through He 1960s and early 1970s, industry support for research, in-house as well as sponsored research in academic institutions, slowed. The reasons for this waning of research investment have never been confirmed, but possibly include disappointing returns on overly optimistic expectations of the role and potential returns of broadly conceived basic research by industry, cost-accounting approaches to management that tended to put lower priority on long-range activities like fundamental research, and economic recessionary periods limiting corporate investment in research (National Science Board, l9Xl)
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From page 198... ...
In l9X2 the Small Business Innovation Development Act required that all federal agencies with research budgets in excess of $100 million award 1.25 percent of their research funds to small, forprofit companies to encourage innovation and stimulate economic competitiveness through the translation of fundamental research into commercial products. These goals were reinforced by the passage of the Federal Technology Transfer Act in 1986, which provided incentives for collaboration between industry and the federal agencies.
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From page 199... ...
In effect, academic institutions were granted the authority and incentive to protect the intellectual property of their faculty who were supported by federal research funds, own patents resulting from federally sponsored research, and seek industrial partners to transfer technology to the marketplace (Waugaman and Porter, 1992~.
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From page 200... ...
In the development of these opportunities, the clinical investigator plays a key role in transferring the technology to improved patient care. The extent, consequences, and management of these new academic-industry relationships in the life sciences have been reviewed recently by Blumenthal (1992~.
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From page 202... ...
Thus, academic scientists frequently tend to work independently, or in small collaborative units, to achieve their scholarly goals. Whereas companies stifle the flow of proprietary information among competitors, research within companies frequently is undertaken by a team approach (testimony to the committee by Dr.
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From page 203... ...
The doctor-patient relationship is built on a foundation of trust and respect, and any compromise of this relationship to further the interests of business or financial gain runs counter to medical ethics and academic principles. As recently stated by David Kessler, FDA Commissioner, FDA could not do its job without complete trust in the clinical trials of medical products performed by academic clinical investigators (St.
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From page 204... ...
Monsanto initiated the relationship in 1982 to support research in areas in which the company lacked expertise. Although the funding allows uninhibited pursuit of fundamental knowledge, the company reserves the right to review research results 30 days prior to submission for publication in order to have adequate time to decide on exclusive licensing to develop commercial products (National Academy of Sciences, Government-University-Industry Research Roundtable, 1986~.
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From page 205... ...
The benefits include a mutually supportive environment for industry and the academic institution, with the potential for collaboration that may spawn new ideas and the synergism for a dynamic academic-industIy en~ise. An evolving paradigm of academically based research with significant involvement of industry might be the creation of centers of excellence focusing on a specific research theme combining the support of academic institutions, industry, the federal government, and other sources.
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From page 206... ...
universities involved in biotechnology research revealed that 47 percent provided consultant services to industry, 23 percent participated as principal investigators on at least one indusby-funded project, and ~ percent owned equity in a privately traded company that marketed products that were
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From page 207... ...
Some scientific fields have evolved in such a manner that commercial applications derive more readily and rapidly from academically based research than was previously the norm. In the heals research arena, biotechnology could be cited as a prime example.
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From page 208... ...
In the clinical research arena this has involved clinicians in the design and execution of clinical studies or trials during the various phases of the drug or device approval process. The unique contributions of academic clinical investigators have been access to sufficiently large patient populations and the objective assessment of the compound or device under investigation.
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From page 209... ...
Thus, industry is highly dependent on the preparation of highly sldlled individuals from academia BENEFITS FOR ACADEMIC INSTITUTIONS, FACULTY AND STUDENTS With the increasing competition for and the reduced rate of growth of the available federal funds for research, academic institutions have actively sought other sources of support, particularly from industry. Universities and their faculty generally would prefer that industry provide unrestricted funds for both basic research and clinical trials.
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From page 210... ...
Nonetheless, a slate of issues has emerged, and these issues need to be considered in developing positive interrelationships between academic institutions and industry (National Academy of Sciences, 1991~. Scientific Communication and Proprietary Rights The apparent conundrum is one of preserving basic academic values while protecting the rights of ownership of commercially valuable products or processes (Low, 1983~.
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From page 211... ...
For example, approximately one third of faculty engaged in biotechnology research reported that their choice of research topics had been influenced by the likelihood that the research results would have commercial application, whereas less than 10 percent of those without industry support indicated that their choice had been so influenced. Moreover, biotechnology faculty with industrial support were more than four times as likely as their colleagues without such support to report that proprietary information had resulted from their investigations (Blumenthal et al., 1986a)
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From page 212... ...
Regardless of the resolution of these issues, the public gains from the commercialization effort because it brings forth novel therapies that improve medical care. Exclusivity of Information Recently, growing concern has been voiced in many sectors regarding the exclusivity of scientific results stemming from federally supported research.
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From page 213... ...
Some fops provide a basic modest consulting fee along with equity opportunities such as stock options. However, this kind of compensation is not provided for academic investigators who perform clinical trials with company products, because it might create an investigator bias in the interpretation of results.
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From page 214... ...
Clearly, bias created through conflicts of interest by investigators undermines the academic research process and the credibility of academic research institutions. The heterogeneity of academic research institutions and their affiliates suggests that there is no universally applicable standard or formula for dealing with conflicts of interest.
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From page 215... ...
Varnn and Kukich (1985) have proposed a partial list of management guidelines for academic institutions to consider in these relationships that include the following: retain publication rights, retain ownership of all patents, minimize the use of proprietary information in research and do not require graduate students to sign confidentiality agreements, create research units with faculty, and hire full-time researchers to staff such units if necessary, do not permit faculty to consult with sponsors in the area of the sponsored research, do not permit a faculty entrepreneur's company to sponsor his or her research on campus, share personnel and resources with industry, which is beneficial for both parties, and prepare model research agreements for potential industrial sponsors.
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From page 216... ...
Continued federal support of research is needed, because NIH-supported research has been an important incubator of new ideas and novel discoveries. A cohort of clinical investigators must also be trained to transfer technology between the laboratory bench and the bedside.
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From page 217... ...
Thus, clinical investigators trained in academia will also be needed in industry to help in the translation of advances in biomedical research to the development and application of new products. Given the monumental opportunities that will soon be available and the current nature of the enterprise, the critical human resource pool will be seriously deficient.
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