Global expansion and a reduction in approval timelines
Case study
Challenge
ICON’s Regulatory Project Management (RPM) team was approached by a client to help establish a global footprint and reduce the approval timelines for the first wave of targeted countries located in the US, Europe, and Asia Pacific. China was among the first wave of countries; the intention was to file in a near parallel time frame to other wave 1 markets to allow for quicker patient access to the therapy.
Solution
The RPM played a key role in translating complex regulatory requirements into execution timeline plans for delivery. The team was up-to-date on completing the program’s regulatory activities and considered interdependencies among several submission activities to identify document re-use and proactively highlight submission risks and mitigation strategies.
The RPM planned submission scenarios, outlining the benefits and drawbacks of each scenario using visual management tools. The RPM presented these scenarios to senior management to facilitate the decision-making process. The group partnered with the regional team for local submission intelligence to ensure a supporting publishing strategy was built by the publishing teams.
Outcome
As a result of ICON’s delivery, the cross-functional team handled major changes that arose in the regulatory environment in China. ICON successfully negotiated with the Center for Drug Evaluation (CDE) in China to convert the clinical trial application (CTA) to a new drug application (NDA).
During negotiations, the RPM’s strategies helped achieve priority review, which enabled drug approval to take place years earlier than anticipated. The expedited timelines were a significant accomplishment for the client and program. The RPM was recognised for their leadership and was included in the team that received an Oncology R&D Innovation Award for the development and execution of an innovative submission strategy for the rare oncology disease product in China.