The Academic Scientist as Entrepreneur: A Conflict of Interest?

2. The Academic Scientistas Entrepreneur:A Conflict of Interest? University of Maryland Baltimore Invention to Venture Series

3. The catalyst for unethical behavior arising from a conflict of interest: More money

4. Produces data which may be built upon Uses the scientific method Rules out alternatives to an idea Avoids risky approaches to a problem Produces something marketable Uses business development models Develops support for an idea Is comfortable accepting and managing risk Roles Entrepreneur Scientist

5. Similarities Scientist Entrepreneur • Reputation is a key asset • It’s all about gaining acceptance of a new idea • Passion for the enterprise is essential

6. Does conflict of interestpresent a legitimate concern? • Financial interests steer the academic activity to the point where it is compromised • Financial interest gives the appearance that the academic activity may be compromised • Maintaining full academic integrity would compromise the business plan and/or require excess resources

7. Science Gone Wrong What’s the worst that could happen?

8. R P Taleyarkhan

9. Woo Suk Hwang

10. Jesse Gelsinger

11. Conflicts of Interest • Most are financially based • Some are just accepted • Owning an hypothesis • Research results as proprietary information pending publication • Continuing research support • Developing intellectual property

12. Individual vs InstitutionalConflict of Interest

13. Existing Mechanisms Involving Conflicts of Interest • SBIRs • Industry-sponsored research • MIPs • University start-up or spin-off companies • Publicly funded research under capitalism (the Bayh-Dole Act)? • University affiliated Biotechnology Parks

14. Jim Hughes Vice President for Research and Development University of Maryland Baltimore Photo from Baltimore SmartCEO, July 2007 www. Smartceo.com “We don’t typically prevent those situations, but we do try to manage them.”

15. individuals must take particular care not to become involved in research relationships that would lead to their personal financial gain or that would adversely affect the professional or academic advancement of junior faculty members. CATEGORY I(a), (b), (c), and (d) Activities are Generally Not Allowable. The only exceptions are conflicts that arise in extraordinary circumstances such as the recruitment of a new Faculty Member, where a conflict may be allowed to continue for a finite time period with disclosure and the approval of the Standing Committee, the Dean and the CEO. Research Activities I(a) A Faculty Member Participating in Clinical Research on a Technology owned by or contractually obligated(4) to a Business(5) in which the Faculty Member, a member of his/her Family, or an Associated Entity has a consulting relationship, holds a stock or similar ownership interest, or has any other Financial Interest, other than receipt of University- or Hospital- supervised Sponsored Research support or post-market royalties under institutional royalty-sharing policies.(6) I(b) A Faculty Member receiving University- or Hospital-supervised Sponsored Researchsupport (whether in dollars or in kind) for Clinical Research or research which does not involve human subjects, from a Business in which he/she, a member of his/her Family, or an Associated Entity holds a stock or similar ownership interest. Sponsored Research (and the prohibition of equity ownership) is considered to have ended when the term of the Sponsored Research agreement has ended and publications reporting on the research are completed (or the decision made not to publish). It is the Faculty Member's responsibility to determine when that time has been reached. Harvard.edu

16. Mitigation Strategies • Disclose financial interests • Submit research to oversight / audit • Uncoupling the financial interest from the research

17. Failure to publish research results is likely a more prevalent behavior resulting from conflict of interest than publishing fabricated or falsified research results.

18. Can CoI be managed to satisfy research integrity conerns while adding value to both the academic and entrepreneurial efforts?

19. There shouldn’t be a problem with a “management” approach, except when… • Extraordinary measures are required to mitigate the conflict of interest • A particular business model requires less-than-rigorous academic treatment of the research

20. The research university’s reputation for research integrity is critical to its academic mission and is required to attract industry research partners.