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