University Investigators and University Investigators and Small Biotech CompaniesSmall Biotech Companies
Jane Shelby, PhDBozeman, Montana
Funding and Regulatory Consultant Biotech Industry
Executive Director of Health Sciences – Montana State UniversityFaculty WWAMI Medical Education ProgramUniversity of Utah School of Medicine Department of Surgery – Tenured Associate Professor
Common models of Common models of interactioninteractionSmall biotech company licenses IP
(pending or patent issued)◦Investigator relationship varied
Advisory Board, collaborations, financial holding
University investigator(s) establishes a start-up biotech company for commercialization of IP
Founder, owner/director/CSO, financial holding
Traditional COITraditional COIconfidentialitypublishingintellectual property rights and
ownershipfinancial holdings
Industry and University Industry and University CulturesCulturesIndustry - typically defines the
goals, objectives and timelines for their researchers
Academia - researchers have the freedom to define their own goals, objectives and timelines◦additional complexity to assure
ethical provisions for student participation in research
Incubators/Small Biotech Incubators/Small Biotech Start-upsStart-upsFuzzy boundaries
◦spin-offs from academic laboratories are often located as private research labs, which may share space and facilities with the academic lab (third bench on the left is corporate)
◦they may be physically separated and housed nearby or at an off-campus university science park
Fuzzy BoundariesFuzzy BoundariesCompeting LoyaltiesCompeting Loyalties
Time/effort commitment for Lab Director
Separation of university/corporate IP, projects
Managerial issues Employee vs. student Professor supervises a graduate student,
while at the same time employing that student as a research assistant
Most complex if trainee is doing work in corporate lab
Possible benefits for students Possible benefits for students and postdocsand postdocscorporate funding provides
opportunity for engagement of students in research
trainees may receive training in commercial laboratories
opportunity for post graduate/training employment
Possible risks for traineesPossible risks for traineesReduced quality and quantity of student
advisingBiased thesis advice (finish thesis/project or
stop and join the company)Biased advice regarding timing of student-led
publication, (delaying submission for publication to protect commercially valuable discoveries)
Moves to delay graduation to keep talent around
Biased advice on choice of research topics (commercial vs. academic interest-driven)
Biased career advice (pursue a post-doctoral position/academic career path, or to join the company)
Institutional based Institutional based guidelines guidelines Workload/remuneration for graduate
students and post-docs in bioscience labsAppropriate time-to-completion for
graduate degreesHave open discussions both of the
requirements of good mentoring, and the dangers and varieties of COI
Establish a process of self-evaluation for professors involved in graduate supervision, regarding the full range of factors known to be liable to corrupt supervisory judgment.
Institutional based Institutional based guidelines guidelines Implement policies regarding
treatment of students whose graduate research is being done in whole or in part in commercial labs
Establish guidelines regarding limitations on spin-off companies recruiting students prior to the completion of their degrees
MacDonald C, William Jones B. Account Res. 2009 Apr-Jun;16(2):106-26.Supervisor-student relations: examining the spectrum of conflicts of interest in bioscience laboratories.
Supervisor/Director Supervisor/Director ResponsibilityResponsibilityAcknowledge and guard against
factors that might bias the teaching, advising, and mentoring of students
Talk openly about COI with trainees using concrete examples–this is an important part of the mentoring process
◦ MacDonald C, William Jones B. Account Res. 2009 Apr-Jun;16(2):106-26.Supervisor-student relations: examining the spectrum of conflicts of interest in bioscience laboratories.
Fuzzy Boundaries…..need Fuzzy Boundaries…..need clarity for a sustainable clarity for a sustainable healthy relationship between healthy relationship between industry and academiaindustry and academiaInstitutional and individual
responsibilityTransparent process and open
communicationMentoring of trainees in all areas
of COI