Assembling The Team
Expertise in a number of specialized fields is required to take a potential therapy to a Phase I clinical trial. A clinical strategy and Phase I clinical trial plan need to be drafted. Drug candidate of a quality appropriate for nonclinical safety studies needs to be procured. Formal nonclinical safety studies need to be conducted under Good Laboratory Practice (GLP). Drug candidate manufactured under Good Manufacturing Practice (GMP) needs to be procured. A Clinical Trial Application needs to be assembled and submitted to the relevant regulatory body. Quality assurance and regulatory oversight of all these is required to ensure regulatory body approval for testing in humans. None of this begins without raising the considerable amount of money required for these activities, which is often dependent on securing intellectual property protection of the therapeutic. As a member of the innovation community, the PP1P is able to direct investigators to the appropriate resources in the public or private sectors to plan and execute their program.
Clinical Needs Assessment
Located at the Cross Cancer Institute (CCI), the Program is ideally situated for the translation of oncology projects. The CCI Clinical Trial Unit (CTU) conducts Phase I – III trials with high quality and attention to patient safety, has one of the highest per capita recruitment rates in Canada, and has clinical experts across the spectrum of cancer care to advise translational researchers. The CCI CTU Phase I program has expertise in the evaluation of clinical safety, biomarkers, pharmacodynamics and pharmacokinetics, and advanced cancer imaging modalities. The CTU is fully supported for health agency submissions and statistical analysis. Our location also allows ready access to patients, tissue, and specific expertise within the Department of Oncology, the University of Alberta, and the Cancer Research Institute of Northern Alberta (CRINA).
Project Management Framework
Translation of a discovery project to Phase I clinical trial in humans typically takes in excess of 3 years. The process is distributed between numerous service providers and subject matter experts, who may be spread across the country, continent or globe. Utilizing a project management framework, the PP1P ties these parties together to ensure smooth hand-offs among project partners. Planning in advance and monitoring tightly during execution helps prevent slipping of schedules, and resulting cost increases and lost time.