1 Eric G. Campbell, Ph.D. Assistant Professor Harvard Medical School Massachusetts General Hospital Commercialization in Academe: Lessons from the Life Sciences

2 The Plan Thesis Frequency of Relationships Benefits of Relationships Risks of Relationships Implications for Policy and Management

3 Thesis Academic industry relationships and commercialization are fundamental to the modern life science economy. They cannot and should not be prohibited. But their benefits should not be exaggerated, nor their risks minimized or ignored. These relationships must be disclosed, monitored and managed in a manner that protects the investments and the integrity of involved individuals, institutions and science in general. Failure to do so could result in loss of public confidence and support for the research enterprise—a priceless resource whose integrity and independence are critical to the future of the scientific endeavor.

4 Data Sources: Surveys – top 50 universities (biotechnology faculty) – US life science companies – top 50 universities (faculty) – all medical schools (faculty) – all medical school (geneticists and life scientists) – all medical schools (faculty) – case studies at 4 universities Other sources from general literature

5 Academic industry relationships and commercialization are fundamental to the modern life science economy: Faculty AIRs

6 Institutional AIRs –Departments funded by companies MGH-Hoechst created genetics department Harvard Medical School and Dupont Washington University and Monsanto Yale and Bristol Meyers –Endowed chairs –Donated Equipment (eg. MRIs, CTs, etc) –University owned equity

7 Company Participation

8 But their benefits should not be exaggerated, nor their risks minimized or ignored: Academic Benefits –Research Funding—1996 industry provided 12% of all research academic Life Science research funding

9 Faculty Benefits

10 Increased Faculty Academic Productivity

11 Increased Faculty Commercial Productivity

12 Industry Benefits

13 Risks of these AIRs : AIRs may “…. burden university administration and divert the faculty. Graduate students may be drawn into projects in ways that sacrifice their education for commercial gain. Research performed with an eye towards profit may lure investigators into conflicts of interest or cause them to practice forms of secrecy that hamper scientific progress. Ultimately, corporate ties may undermine the university’s reputation for objectivity.”--Derek Bok, President Harvard University

14 Challenges: Reduced Faculty Productivity Secrecy/Data Withholding Alter the Outcomes of Research

15 Reduced Academic Productivity

16 Industry Secrecy: Students 57% of companies with AIRs reported that confidential, proprietary information sometimes or often emerges from their sponsorship of graduate students. 80% of companies with AIRs require students and fellows to keep research information confidential.

17 Industry Secrecy : Faculty 82% of companies require academic researchers to “keep information confidential to allow for filing of a patent application.” 58% typically require academics to keep information confidential for more than six months.

18 Faculty Secrecy Blumenthal et; al., 1996

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20 These relationships must be disclosed, monitored and managed in a manner that protects the investments and the integrity of involved individuals, institutions and science in general. Disclosure-Minimal acceptable response (can’t manage what you don’t know about) Review-Develop common set of standards for what is acceptable and what is not Manage- Develop mechanisms for appropriate management of problematic relationships Ban-Some relationships might be banned Ignore—Eg. Universities pay virtually no attention to consulting

21 Actors in the Debate Individual Scientists Universities Professional Associations Professional Journals Government Agencies

22 Failure to manage these relationships Increased federal regulations Increased secrecy in science Loss of public belief in the integrity of the academic research enterprise Less willingness of patients to participate in clinical research

23 Disclosure Funding from: –The National Institutes of Health –The Commonwealth Fund –The Greenwall Foundation Bioethics Program