Regulatory project management scenario planning (Oncology)

A client approached ICON’s Global Regulatory Affairs (GRA) team when their non-small cell lung cancer (NSCLC) second-line therapy received a major objection at Day 180. The clinical team’s response strategy was to include raw data from clinical studies to strengthen a subsequent justification related to the frontline indication filing. The ICON regulatory project manager (RPM) was asked to provide scenario planning related to accelerating the marketing authorisation application (MAA) approval through various clock-stop scenarios.

ICON led a series of scenario planning workshops to discuss procedural timelines and determine the feasibility of one-, two-, and three-month clock stops. The team drafted submission timeline scenarios and facilitated discussions to assess the risks and impacts of shifting data deliverables. ICON GRA mapped dependencies and efficiencies for the scenarios using Microsoft Project tools. The RPM presented considerations to the team, such as task overlap and resourcing, using dashboards to enable team discussion. ICON used the RPM visual scenarios to evaluate and balance decision-making.

The RPM successfully facilitated and monitored the execution of the timeline and submission delivery based on the one-month clock stop, achieving an accelerated approval timeline. The RPM’s regulatory planning experience allowed for timeline efficiencies as the upstream strategic plans were coordinated with the downstream publishing plans in a way that facilitated front loading and incremental delivery.
The RPM enabled cross-functional team collaboration and communication, allowing the team to evaluate the feasibility of the one-month clock stop with clear considerations and risk management. The team presented a clear path forward on how to achieve shorter timelines that coincided with the raw data available for the frontline. This strategic planning helped the team satisfy the major objection and led to MAA approval.