Team delivered an initial US BLA and EU MAA Major Amendment (Gastroenterology)

ICON’s Regulatory Project Managers (RPMs) were approached by a client to deliver, in parallel, an initial US Biologics License Application (BLA) and an EU Marketing Authorisation Application (MAA) Major Amendment for a new formulation within an existing program. The scope of services comprised the full clinical package, including six case study reports/individual case study reports (CSRs/iCSRs), and a full chemistry, manufacturing, and controls (CMC) package for one drug and two devices. Moreover, ICON was required to work under a tight deadline to achieve the aggressive client submission target, which was caused by a five-month delay in data delivery
by the third-party vendor.

The RPM partnered closely with the client’s regulatory leads to plan, prepare, and co-host a submission kick-off meeting 18 months prior to the target submission date. The team developed a detailed submission timeline plan based on data delivery and document preparation assumptions. Key task relationships were built into the timeline, allowing for prompt and accurate scenario planning and risk assessment throughout the submission duration.

Six months before filing, the team detected a series of delays in critical data delivery. The RPM used the submission timeline, tools, and working group forum to conduct immediate and ongoing impact analyses. The RPM used these analyses to propose solutions and reach an agreed path forward in a controlled and centralised manner. The RPM used a comprehensive submission timeline, high-level timeline dashboards, a detailed submission dashboard, and a submission risk log to ensure that communication with the senior leadership and the team was timely, accurate, and meaningful. The RPM managed and communicated resource constraints and worked closely with the team to ensure these did not impact the submission.

Regimented control checks and timeline tracking by the RPM contributed to the team delivering a high quality, complete submission only 10 weeks after delivery of the final clinical data and only five weeks after the initial client target despite a five-month delay in data delivery from the third-party vendor. The RPM’s deep understanding of the key drivers of a successful submission, combined with a mature project management toolkit, allowed delays and potential submission impacts to be clearly communicated to the team.