Building and Sailing the Ship Simultaneously: A Programmatic Ecosystem for Cellular Based Therapies

Topic Significance & Study Purpose/Background/Rationale Immune effector cell (IEC) therapy is a rapidly changing scientific frontier. IEC therapies represent a significant novel opportunity to reduce morbidity and mortality of cancer. The complexity of developing these first-in-human therapies requires multidisciplinary engagement and infrastructure development beyond the scope of traditional modalities. In a large academic center, a need was identified to move these novel therapies from the bench to the bedside through a nurse led administration. Methods, Intervention, & Analysis Nursing led multi-disciplinary programmatic ecosystems supporting early phase clinical research, is essential for advancement of science and patient safety. The multidisciplinary ecosystem for IECs was designed to include 4 structured forums: Cell Therapy Forum, Clinical Trial Advisory Committee, Clinical Research Operations Meeting, and the Clinical Program Meeting. 1) The Cell Therapy Forum promotes early scientific development by engaging cross-divisional collaborations between faculty investigators to develop IEC therapies. 2) Prioritization of new IEC trials is accomplished in The Clinical Trial Advisory Committee; proposed trials are reviewed for scientific merit, and operational feasibility, with representation from investigators and administrative leaders. 3) Monitoring of the system wide IEC portfolio for compliance and safety issues is overseen by The Clinical Research Operations Meeting, with research, clinical, manufacturing, and administrative staff. 4) The Clinical Program Meeting is the platform for education and collaboration on policies and decision making for program development. Each of the 4 forums have a distinct and valuable role in influencing the scope, vision and mission of the IEC clinical research program. Findings & Interpretation Nursing leadership plays a pivotal role in the organization of an IEC program. The process to build an ecosystem that supports IEC novel agent inquiry from bench to bedside, and ultimately to formal dissemination of findings is a new frontier for oncology nurses. Discussion & Implications Nursing led collaboration enables initiation and scientific advancement of complex novel IEC therapies to facilitate evidence-based practice, engagement and dissemination of findings that effectively improves cancer outcomes.