1

Eric G. Campbell, Ph.D.

Assistant Professor

Harvard Medical School

Massachusetts General Hospital

Commercialization in Academe: Lessons from the Life Sciences

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The Plan

Thesis

Frequency of Relationships

Benefits of Relationships

Risks of Relationships

Implications for Policy and Management

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ThesisAcademic 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.

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Data Sources:

• Surveys – 1985 -- top 50 universities (biotechnology faculty)– 1995 -- US life science companies– 1995 -- top 50 universities (faculty)– 1996 -- all medical schools (faculty)– 2000 -- all medical school (geneticists and life

scientists)– 2000 -- all medical schools (faculty)– 2003 -- case studies at 4 universities

• Other sources from general literature

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Academic industry relationships and commercialization are fundamental to the modern

life science economy: Faculty AIRs

7

28

43 46

80

0

10

20

30

40

50

60

70

80

90

Equity Research$ Gifts Consult Any of these

% o

f A

cade

mic

Lif

e Sc

ient

ists

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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

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Company Participation

38

59

88 90

0

10

20

30

40

50

60

70

80

90

100

Training $ Research $ Consultants AnyRelationships

% o

f L

ife

Scie

nce

Com

pani

es

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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

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Faculty Benefits

66%60%

49%

34%29%

0%

10%

20%

30%

40%

50%

60%

70%

Less red tape Increasedopp. forstudents

Increaseddept. prestige

Salaryincreases

Helped inpromotion

% o

f F

acul

ty w

ith

Indu

stry

$

10

No. ofPublications

Teachingtime (hr)

No. ofService

Activities

PublicationTrendsScore

PublicationInfluence

Score

adjusted mean

AIRs

Yes 14.6 16.9 2.3 4.2 1.2

No 10.1** 16.6 1.8** 2.1** 1.2

*The means have been adjusted by multivariate analysis of variance to control for differencesdue to academic rank, years in profession, sex, total research funding, or clinical department.**P<0.05 for the comparison with the subgroup receiving industrial support.

Increased Faculty Academic Productivity

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AIRS Appliedfor a

patent

PatentIssued

Patentlicensed

TradeSecret

Prod.underreview

Prod. onthe

market

Start-upCompany

Yes 42.0% 25.0% 18.5% 14.5% 26.7% 26.1% 14.3%

No 24.0% 12.6% 8.7% 4.7% 5.5% 10.8% 6.0%

All comparisons between the subgroup with industrial support and the subgroup without such support weresignificant at the p<.05 level using multivariate logistic regression analysis.

Increased Faculty Commercial Productivity

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Industry Benefits

56%53%

37%

29%

0%

10%

20%

30%

40%

50%

60%

Keep staff current New productideas

Recruiting Invent newproducts

% o

f Spo

nsor

ing

Com

pani

es

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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

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Challenges:

• Reduced Faculty Productivity

• Secrecy/Data Withholding

• Alter the Outcomes of Research

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Reduced Academic Productivity

Variable No. ofPublications

Teachingtime (hr)

No. ofService

Activities

PublicationTrendsScore

PublicationInfluence

Score

adjusted mean

Amount of industrialsupport (% ofresearch budget) 1-33 16.8 17.7 2.8** 5.0 1.3

34-66 16.4 19.3 2.2 5.3 1.2

67-100 12.1** 15.8 2.1 2.3** 1.0**

All respondents 11.3 16.5 1.9 2.7 1.2

*The means have been adjusted by multivariate analysis of variance to control for differencesdue to academic rank, years in profession, sex, total research funding, or clinical department.**P<0.05 for the comparison with both subgroups receiving different levels of industrialsupport.

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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.

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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.

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Faculty Secrecy

27.20%

14.00%

16.50%

4.70%

0%

5%

10%

15%

20%

25%

30%

Delay > 6 months Trade Secret

Per

cent

age

of F

acul

ty

Industry Funded

Non-Industry Funded

Blumenthal et; al., 1996

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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

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Actors in the Debate

• Individual Scientists

• Universities

• Professional Associations

• Professional Journals

• Government Agencies

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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

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Disclosure

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