A cutting-edge innovator in the cell and gene therapy space was experiencing high levels of patient non-compliance when conforming to the significant FDA long-term follow-up requirements. Catalyst was first asked to pressure test patient familiarity and perspective of current long-term follow-up processes. Catalyst then was asked to work with providers, data managers, industry sponsors, non-profits, and other experts to identify both barriers and modern solutions to address patient-perceived hurdles, increase compliance, and improve the long-term follow-up process for sponsors.