University Investigators and Small Biotech Companies Jane Shelby, PhD Bozeman, Montana Funding and Regulatory Consultant Biotech Industry Executive Director of Health Sciences – Montana State University Faculty WWAMI Medical Education Program University of Utah School of Medicine Department of Surgery – Tenured Associate Professor

Common models of interaction Small 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 COI confidentiality publishing intellectual property rights and ownership financial holdings

Industry and University Cultures Industry - 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 Start-ups Fuzzy 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 Boundaries Competing 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 and postdocs corporate 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 trainees Reduced quality and quantity of student advising Biased 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 guidelines Workload/remuneration for graduate students and post-docs in bioscience labs Appropriate time-to-completion for graduate degrees Have 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 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 Apr-Jun;16(2): Supervisor-student relations: examining the spectrum of conflicts of interest in bioscience laboratories.

Supervisor/Director Responsibility Acknowledge 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 Apr-Jun;16(2): Supervisor- student relations: examining the spectrum of conflicts of interest in bioscience laboratories.

Fuzzy Boundaries…..need clarity for a sustainable healthy relationship between industry and academia Institutional and individual responsibility Transparent process and open communication Mentoring of trainees in all areas of COI